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PB 71 of 2012 Other as amended, taking into account amendments up to National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 1) (PB 1 of 2020)
This instrument revokes and replaces the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (No. PB 108 of 2010) to determine the pharmaceutical benefits that are on the Pharmaceutical Benefits Scheme (PBS) through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands, and provides for related matters (responsible persons, prescribing circumstances, maximum quantities, numbers of repeats, and whether the pharmaceutical benefit is to be available only under special arrangements).
Administered by: Health
Registered 13 Feb 2020
Start Date 01 Feb 2020
End Date 29 Feb 2020
Table of contents.

Commonwealth Coat of Arms of Australia

National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the

National Health Act 1953

Compilation No. 88

Compilation date:                              1 February 2020

Includes amendments up to:            PB 1 of 2020

Registered:                                         13 February 2020

This compilation is in 6 volumes

Volume 1:       sections 1–26 and Schedule 1 (A–C)

Volume 2:       Schedule 1 (D–K)

Volume 3:       Schedule 1 (L–P)

Volume 4:       Schedule 1 (Q–Z), Schedules 2 and 3

Volume 5:       Schedule 4 (Part 1: A–R)

Volume 6:       Schedule 4 (Part 1: S–Z, Part 3), Schedule 5 and
                        Endnotes

Each volume has its own contents

 

About this compilation

This compilation

This is a compilation of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) that shows the text of the law as amended and in force on 1 February 2020 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

  

  

  


Contents

Schedule 4—Circumstances, purposes and conditions codes                     1

Part 1—Circumstances, purposes and conditions                                                                        1

Part 3General statement for drugs for the treatment of hepatitis C                       344

Schedule 5—Schedule equivalent                                                                                        351

Endnotes                                                                                                                                                             369

Endnote 1—About the endnotes                                                                                                    369

Endnote 2—Abbreviation key                                                                                                        370

Endnote 3—Legislation history                                                                                                     371

Endnote 4—Amendment history                                                                                                   376


Schedule 4Circumstances, purposes and conditions codes

(sections 10‑15,17, 18, 20 and 21)

Part 1Circumstances, purposes and conditions

 

Listed Drug

Circumstances Code

Purposes Code

Conditions Code

Circumstances and Purposes

Authority Requirements
(part of Circumstances;
or Conditions)

Sacubitril with valsartan

C6915

 

 

Chronic heart failure
Patient must be symptomatic with NYHA classes II, III or IV; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
Patient must receive concomitant optimal standard chronic heart failure treatment, which must include the maximum tolerated dose of a beta-blocker, unless contraindicated or not tolerated; AND
Patient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
Patient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
The treatment must not be co-administered with an ACE inhibitor or an angiotensin II antagonist.

Compliance with Authority Required procedures - Streamlined Authority Code 6915

Safinamide

C8624

 

 

Parkinson disease

The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination.

 

Salbutamol

C6367

 

 

Bronchospasm
Patient must be unable to achieve co-ordinated use of other metered dose inhalers containing this drug.

 

C6815

 

 

Asthma
Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer.

 

C6825

 

 

Chronic obstructive pulmonary disease (COPD)
Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer.

 

Salmeterol

C6355

 

 

Asthma
Patient must experience frequent episodes of the condition; AND
Patient must be currently receiving treatment with oral corticosteroids; OR
Patient must be currently receiving treatment with optimal doses of inhaled corticosteroids.

 

Sapropterin

C8897

P8897

 

Hyperphenylalaninemia (HPA) due to phenylketonuria (PKU)
Subsequent continuing
Must be treated by a metabolic physician; OR
Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician.
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; OR
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the Grandfather treatment restriction; AND
Patient must be undergoing regular phenylalanine testing and assessment of adherence to dietary modifications.
Patient must have been under 18 years of age at the time treatment with this drug was initiated for this condition.

Compliance with Authority Required procedures

 

C8898

P8898

 

Hyperphenylalaninemia (HPA) due to phenylketonuria (PKU)
Initial treatment - responsiveness testing
Must be treated by a metabolic physician.
Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have a baseline blood phenylalanine level above 360 micromole per L and be less than one month of age; OR
Patient must have a baseline blood phenylalanine level above 600 micromole per L and be more than one month of age; AND
The treatment must be for the purpose of initial responsiveness testing for a period of 24 hours in a patient less than one month of age; OR
The treatment must be for the purpose of initial responsiveness testing for a period of 7 days in a patient aged more than one month.
Patient must be under 18 years of age.
Dietary phenylalanine intake must be maintained at a constant level.
Patients or their parent/guardian should be assessed for their ability to comply with the sapropterin protocol and PKU diet prior to conducting initial responsiveness testing.

Compliance with Authority Required procedures

 

C8926

P8926

 

Hyperphenylalaninemia (HPA) due to phenylketonuria (PKU)
First continuing treatment
Must be treated by a metabolic physician; OR
Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician.
Patient must have previously received PBS-subsidised treatment under the Initial treatment - responsiveness testing restriction with this drug for this condition; AND
Patient must have demonstrated a response to treatment with this drug of greater than or equal to a 30% reduction in phenylalanine levels from baseline during initial responsiveness testing.
Patient must have been under 18 years of age at the time treatment with this drug was initiated for this condition.
Blood phenylalanine levels must be based on measurements taken during stable periods of the condition.
Dietary phenylalanine intake must be maintained at a constant level.

Compliance with Authority Required procedures

 

C8988

P8988

 

Hyperphenylalaninemia (HPA) due to phenylketonuria (PKU)
Grandfather treatment
Must be treated by a metabolic physician; OR
Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician.
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 May 2019; AND
Patient must have demonstrated a response to treatment with this drug of greater than or equal to a 30% reduction in phenylalanine levels from baseline during initial responsiveness testing; AND
Patient must have a documented diagnosis of PKU.
Patient must have been under 18 years of age at the time treatment with this drug was initiated for this condition.
Blood phenylalanine levels must be based on measurements taken during stable periods of the condition.
Dietary phenylalanine intake must be maintained at a constant level.
A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a grandfathered patient must qualify under the Subsequent continuing treatment criteria.

Compliance with Authority Required procedures

 

C10076

P10076

 

Hyperphenylalaninaemia
Initial treatment
Must be treated by a metabolic physician.
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency.
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.

Compliance with Authority Required procedures

 

C10081

P10081

 

Hyperphenylalaninaemia
Continuing treatment
Must be treated by a metabolic physician; OR
Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician.
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND
Patient must have previously been issued with an authority prescription for this drug; OR
Patient must have accessed non-PBS-subsidised treatment prior to 1 May 2014.
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.

Compliance with Authority Required procedures

Saquinavir

C4454

 

 

HIV infection
Continuing
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents.

Compliance with Authority Required procedures - Streamlined Authority Code 4454

C4512

 

 

HIV infection
Initial
Patient must be antiretroviral treatment naive; AND
The treatment must be in combination with other antiretroviral agents.

Compliance with Authority Required procedures - Streamlined Authority Code 4512

Saxagliptin

C6346

 

 

Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 6346

C6363

 

 

Diabetes mellitus type 2
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 6363

C7505

 

 

Diabetes mellitus type 2
Continuing treatment
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 7505

C7541

 

 

Diabetes mellitus type 2
Initial treatment
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have an HbA1c measurement greater than 7% despite treatment with dual oral combination therapy with metformin and an SGLT2 inhibitor; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin.
The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 7541

Saxagliptin with dapagliflozin

C7524

 

 

Diabetes mellitus type 2
Initial treatment
The treatment must be in combination with metformin; AND
Patient must have an HbA1c measurement greater than 7% despite treatment with dual oral combination therapy with metformin and a dipeptidyl peptidase 4 inhibitor (gliptin) or a sodium-glucose co-transporter 2 (SGLT2) inhibitor; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin.
The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 7524

C7556

 

 

Diabetes mellitus type 2
Continuing treatment
The treatment must be in combination with metformin; AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 7556

Saxagliptin with metformin

C6333

 

 

Diabetes mellitus type 2
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with metformin.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination.

Compliance with Authority Required procedures - Streamlined Authority Code 6333

C6335

 

 

Diabetes mellitus type 2
Continuing
Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and saxagliptin.

Compliance with Authority Required procedures - Streamlined Authority Code 6335

C6344

 

 

Diabetes mellitus type 2
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination.

Compliance with Authority Required procedures - Streamlined Authority Code 6344

C7507

 

 

Diabetes mellitus type 2
Initial treatment
The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have an HbA1c measurement greater than 7% despite treatment with a PBS-subsidised regimen of oral diabetic medicines which includes metformin and an SGLT2 inhibitor for this condition; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin.
The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 7507

C7530

 

 

Diabetes mellitus type 2
Continuing treatment
The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 7530

Secukinumab

C6696

P6696

 

Severe chronic plaque psoriasis
Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply
Patient must have received insufficient therapy with this drug under the continuing treatment, Whole body restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND
The treatment must be as systemic monotherapy (other than methotrexate).
Must be treated by a dermatologist.

Compliance with Authority Required procedures

 

C8830

P8830

 

Severe chronic plaque psoriasis
Continuing treatment, Whole body
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 1 month old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C8831

P8831

 

Severe chronic plaque psoriasis
Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a dermatologist.

Compliance with Authority Required procedures

 

C8837

P8837

 

Severe chronic plaque psoriasis
Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 1 month old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

 

C8851

P8851

 

Severe chronic plaque psoriasis
Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 1 month old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

 

C8867

P8867

 

Severe chronic plaque psoriasis
Initial treatment - Initial 1, Face, hand, foot (new patient)
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, cyclosporin, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 1 month old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

 

C8892

P8892

 

Severe chronic plaque psoriasis
Continuing treatment, Face, hand, foot
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 1 month old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.
It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C8905

P8905

 

Severe chronic plaque psoriasis
Initial treatment - Initial 1, Whole body (new patient)
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, cyclosporin, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment.
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 1 month old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

 

C9063

P9063

 

Severe psoriatic arthritis
Continuing treatment - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

 

C9064

P9064

 

Severe psoriatic arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

 

C9069

P9069

 

Severe psoriatic arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C9078

P9078

 

Severe psoriatic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in in biological medicine of less than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9105

P9105

 

Severe psoriatic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9155

P9155

 

Severe psoriatic arthritis
Initial treatment - Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C9414

P9414

 

Ankylosing spondylitis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
All measurements provided must be no more than 1 month old at the time of application.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9428

P9428

 

Ankylosing spondylitis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND
Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; OR
Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; OR
Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C9429

P9429

 

Ankylosing spondylitis
Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.

Compliance with Authority Required procedures

 

C9430

P9430

 

Ankylosing spondylitis
Continuing treatment
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
All measurements provided must be no more than 1 month old at the time of application.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9431

P9431

 

Ankylosing spondylitis
Continuing treatment - balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.

Compliance with Authority Required procedures

 

C9503

P9503

 

Ankylosing spondylitis
Initial treatment - Initial 1 (new patient)
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; AND
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.
The BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. The BASDAI must be no more than 1 month old at the time of initial application.
Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C9872

P9872

 

Severe chronic plaque psoriasis
Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9901

P9901

 

Severe chronic plaque psoriasis
Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

Selegiline

C5338

 

 

Late stage Parkinson disease
The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination.

 

Sertraline

C4755

 

 

Major depressive disorders

 

C6277

 

 

Obsessive-compulsive disorder

 

C6289

 

 

Panic disorder
The treatment must be for use when other treatments have failed; OR
The treatment must be for use when other treatments are inappropriate.

 

Sevelamer

C5491

 

 

Hyperphosphataemia
Maintenance following initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non-calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.

Compliance with Authority Required procedures - Streamlined Authority Code 5491

C5530

 

 

Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non-calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.

Compliance with Authority Required procedures - Streamlined Authority Code 5530

 

C9762

 

 

Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non-calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.

Compliance with Authority Required procedures - Streamlined Authority Code 9762

Silver sulfadiazine

C6345

 

 

Stasis ulcers

 

C6362

 

 

Infection
Prevention and treatment
The condition must be in partial or full skin thickness loss due to burns; OR
The condition must be in partial or full skin thickness loss due to epidermolysis bullosa.

 

Simvastatin

 

P7598

 

For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements.

 

Sirolimus

 

P5795

CN5795

Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 5795

 

 

P9914

CN9914

Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 9914

Sitagliptin

C6346

 

 

Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 6346

C6363

 

 

Diabetes mellitus type 2
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 6363

C6376

 

 

Diabetes mellitus type 2
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 6376

 

C7505

 

 

Diabetes mellitus type 2
Continuing treatment
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 7505

 

C7541

 

 

Diabetes mellitus type 2
Initial treatment
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have an HbA1c measurement greater than 7% despite treatment with dual oral combination therapy with metformin and an SGLT2 inhibitor; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin.
The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 7541

Sitagliptin with metformin

C6333

 

 

Diabetes mellitus type 2
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with metformin.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination.

Compliance with Authority Required procedures - Streamlined Authority Code 6333

C6334

 

 

Diabetes mellitus type 2
Continuing
Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and sitagliptin.

Compliance with Authority Required procedures - Streamlined Authority Code 6334

C6344

 

 

Diabetes mellitus type 2
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination.

Compliance with Authority Required procedures - Streamlined Authority Code 6344

C6443

 

 

Diabetes mellitus type 2
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 6443

 

C7507

 

 

Diabetes mellitus type 2
Initial treatment
The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have an HbA1c measurement greater than 7% despite treatment with a PBS-subsidised regimen of oral diabetic medicines which includes metformin and an SGLT2 inhibitor for this condition; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin.
The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 7507

 

C7530

 

 

Diabetes mellitus type 2
Continuing treatment
The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 7530

Sodium acid phosphate

C5089

 

 

Hypophosphataemic rickets

Compliance with Authority Required procedures - Streamlined Authority Code 5089

C5095

 

 

Familial hypophosphataemia

Compliance with Authority Required procedures - Streamlined Authority Code 5095

C5114

 

 

Vitamin D-resistant rickets

Compliance with Authority Required procedures - Streamlined Authority Code 5114

C5123

 

 

Hypercalcaemia

Compliance with Authority Required procedures - Streamlined Authority Code 5123

Sodium phenylbutyrate

C9888

 

 

Urea cycle disorders
Grandfathered treatment
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2019.
An increase in the maximum quantity will be authorised to provide for up to one month's supply at a dose of up to 600 mg/kg/day in patients weighing less than 20 kg and up to 13 g/m 2 /day in patients weighing more than 20 kg.

Compliance with Authority Required procedures - Streamlined Authority Code 9888

 

C9919

 

 

Urea cycle disorders
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition.
An increase in the maximum quantity will be authorised to provide for up to one month's supply at a dose of up to 600 mg/kg/day in patients weighing less than 20 kg and up to 13 g/m 2 /day in patients weighing more than 20 kg.

Compliance with Authority Required procedures - Streamlined Authority Code 9919

 

C9993

 

 

Urea cycle disorders
Initial treatment
Patient must have elevated ammonia levels that are not controlled with diet alone and other adjunct care alone.
An increase in the maximum quantity will be authorised to provide for up to one month's supply at a dose of up to 600 mg/kg/day in patients weighing less than 20 kg and up to 13 g/m 2 /day in patients weighing more than 20 kg.

Compliance with Authority Required procedures - Streamlined Authority Code 9993

Sofosbuvir

C5969

P5969

 

Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks.

Compliance with Authority Required procedures

C5972

P5972

 

Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 24 weeks.

Compliance with Authority Required procedures

Sofosbuvir with velpatasvir

C5969

 

 

Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks.

Compliance with Authority Required procedures

Sofosbuvir with velpatasvir and voxilaprevir

C5969

 

 

Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks.

Compliance with Authority Required procedures

Somatropin

C5146

 

 

Short stature and slow growth
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C5147

 

 

Short stature associated with Turner syndrome
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with Turner syndrome category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C5151

 

 

Short stature associated with Turner syndrome
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with Turner syndrome category; AND
Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an annualised growth velocity for bone age at or above the mean growth velocity for untreated Turner Syndrome girls (using the Turner Syndrome - Ranke growth velocity chart) while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a bone age of 13.5 years or greater; AND
Patient must not have a height greater than or equal to 155.0 cm.
Patient must be aged 3 years or older.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C5158

 

 

Short stature associated with Turner syndrome
Initial treatment
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
Patient must have a current height at or below the 95thpercentile for age on the Turner syndrome growth curve for girls; AND
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must not have a bone age of 2.5 years or less; AND
Patient must not have a height greater than or equal to 155.0 cm; AND
Patient must not have a bone age of 13.5 years or greater.
Patient must be aged 3 years or older.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR
(b) A minimum of 6 months of recent growth data (height and weight) for older children (females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C5165

 

 

Growth retardation secondary to an intracranial lesion, or cranial irradiation
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must be aged 3 years or older.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C5166

 

 

Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a chronological age of 5 years or greater.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must be aged 3 years or older.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C5167

 

 

Short stature associated with Turner syndrome
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature assciated with Turner syndrome; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have had a height at or below the 95th percentile for age on the Turner syndrome growth curve for girls immediately prior to commencing growth hormone treatment; AND
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a bone age of 2.5 years or less; AND
Patient must not have a height greater than or equal to 155.0 cm; AND
Patient must not have a bone age of 13.5 years or greater.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must be aged 3 years or older.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. A height measurement from immediately prior to commencement of growth hormone treatment; AND
4. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND
5. Recent growth data (height and weight, not older than three months); AND
6. A bone age result performed within the last 12 months; AND
The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C5190

 

 

Short stature associated with Turner syndrome
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature associated with Turner syndrome; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have had a height at or below the 95th percentile for age on the Turner syndrome growth curve for girls immediately prior to commencing growth hormone treatment; AND
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a bone age of 2.5 years or less; AND
Patient must not have a bone age of 13.5 years or greater; AND
Patient must not have a height greater than or equal to 155.0 cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. A height measurement from immediately prior to commencement of growth hormone treatment; AND
4. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND
5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
6. A bone age result performed within the last 12 months; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C5230

 

 

Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have a chronological age of less than 2 years; AND
Patient must have a documented clinical risk of hypoglycaemia; AND
Patient must have documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. Confirmation that the patient has a documented clinical risk of hypoglycaemia; AND
4. Confirmation that the patient has documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND
5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C5236

 

 

Short stature associated with Turner syndrome
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature associated with Turner syndrome; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have had a height at or below the 95th percentile for age on the Turner syndrome growth curve for girls immediately prior to commencing growth hormone treatment; AND
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a bone age of 2.5 years or less; AND
Patient must not have a bone age of 13.5 years or greater; AND
Patient must not have a height greater than or equal to 155.0 cm.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. A height measurement from immediately prior to commencement of growth hormone treatment; AND
4. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND
5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
6. A bone age result performed within the last 12 months; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C5239

 

 

Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants
Initial treatment
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
Patient must have a chronological age of less than 2 years; AND
Patient must have a documented clinical risk of hypoglycaemia; AND
Patient must have documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. Confirmation that the patient has a documented clinical risk of hypoglycaemia; AND
5. Confirmation that the patient has documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C5247

 

 

Biochemical growth hormone deficiency and precocious puberty
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the biochemical growth hormone deficiency and precocious puberty category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must be aged 3 years or older.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C5285

 

 

Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must be aged 3 years or older.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C5286

 

 

Short stature associated with chronic renal insufficiency
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND
Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must be aged 3 years or older.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND
6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
If a patient receiving treatment under the indication 'short stature associated with chronic renal insufficiency' undergoes a renal transplant and 12 months post-transplant has an eGFR of equal to or greater than 30mL/min/1.73m2prescribers should seek reclassification to the indication short stature and slow growth.

Compliance with Written Authority Required procedures

C5299

 

 

Short stature associated with Turner syndrome
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with Turner syndrome category; AND
Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an annualised growth velocity for bone age at or above the mean growth velocity for untreated Turner Syndrome girls (using the Turner Syndrome - Ranke growth velocity chart) while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a bone age of 13.5 years or greater; AND
Patient must not have a height greater than or equal to 155.0 cm.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C5302

 

 

Short stature associated with Turner syndrome
Recommencement of treatment as a reclassified patient
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature associated with Turner syndrome; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have had a height at or below the 95th percentile for age on the Turner syndrome growth curve for girls immediately prior to commencing growth hormone treatment; AND
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a bone age of 2.5 years or less; AND
Patient must not have a height greater than or equal to 155.0 cm; AND
Patient must not have a bone age of 13.5 years or greater.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. A height measurement from immediately prior to commencement of growth hormone treatment; AND
4. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND
5. Recent growth data (height and weight, not older than three months); AND
6. A bone age result performed within the last 12 months; AND
The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C5318

 

 

Short stature associated with Turner syndrome
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with Turner syndrome category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must be aged 3 years or older.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C5319

 

 

Short stature due to short stature homeobox (SHOX) gene disorders
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature due to short stature homeobox (SHOX) gene disorders category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C5352

 

 

Short stature and slow growth
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must be aged 3 years or older.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C5382

 

 

Short stature associated with Turner syndrome
Initial treatment
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
Patient must have a current height at or below the 95thpercentile for age on the Turner syndrome growth curve for girls; AND
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must not have a bone age of 2.5 years or less; AND
Patient must not have a height greater than or equal to 155.0cm; AND
Patient must not have a bone age of 13.5 years or greater.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR
(b) A minimum of 6 months of recent growth data (height and weight) for older children (females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8334

 

 

Short stature and slow growth
Initial treatment
Patient must have a current height at or below the 1stpercentile for age and sex; AND
Patient must have a growth velocity below the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must not have a bone age of 2.5 years or less; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 160.1 cm; OR
Patient must be female and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 148.0 cm.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND
4. A bone age result performed within the last 12 months; AND
5. Confirmation of the patient's maturational or constitutional delay status; AND
6. If the patient has maturational or constitutional delay, confirmation that the patient has an estimated mature height below the 1stadult height percentile; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8335

 

 

Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth
Initial treatment
Patient must have a structural lesion that is not neoplastic; OR
Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND
Patient must have hypothalamic obesity; AND
Patient must have a growth velocity above the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have an annual growth velocity of greater than 14 cm per year if the patient has a chronological age of 2 years or less; OR
Patient must have an annual growth velocity of greater than 8 cm per year if the patient has a bone or chronological age of 2.5 years or less; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR
(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
7. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND
8. Confirmation that the patient has hypothalamic obesity; AND
9. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Testing for biochemical growth hormone deficiency must have been performed at a time when all other pituitary hormone deficits were being adequately replaced.

Compliance with Written Authority Required procedures

C8336

 

 

Short stature due to short stature homeobox (SHOX) gene disorders
Initial treatment
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
Patient must have a current height at or below the 1stpercentile for age and sex; AND
Patient must have a growth velocity below the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; OR
Patient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND
6. If the patient's condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient's increased risk of gonadoblastoma is in place; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8337

 

 

Short stature associated with biochemical growth hormone deficiency
Initial treatment
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must have a current height at or below the 1stpercentile for age and sex; OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and a growth velocity below the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR
(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1stpercentile for age and sex; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.

Compliance with Written Authority Required procedures

C8338

 

 

Short stature associated with chronic renal insufficiency
Initial treatment
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; OR
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND
Patient must have a current height at or below the 1stpercentile for age and sex; OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and a growth velocity less than or equal to the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be prepubertal.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR
(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1stpercentile for age and sex; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND
6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8342

 

 

Short stature associated with biochemical growth hormone deficiency
Initial treatment
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must have a current height at or below the 1stpercentile for age and sex; OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and a growth velocity below the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone age of 2.5 years or less; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR
(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1stpercentile for age and sex; AND
4. A bone age result performed within the last 12 months; AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.

Compliance with Written Authority Required procedures

C8343

 

 

Growth retardation secondary to an intracranial lesion, or cranial irradiation
Initial treatment
Patient must have had an intracranial lesion and have undergone a 12 month period of observation following completion of treatment for the intracranial lesion (all treatment); OR
Patient must have had an intracranial lesion, have received medical advice that it is unsafe to treat the intracranial lesion, and have undergone a 12 month period of observation since initial diagnosis of the intracranial lesion; OR
Patient must have received cranial irradiation without having had an intracranial lesion, and have undergone a 12 month period of observation following completion of treatment for the condition for which cranial irradiation was received; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must have a current height at or below the 1stpercentile for age and sex; OR
Patient must have a current height above the 1stpercentile for age and sex and a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have a current height above the 1stpercentile for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; OR
Patient must have a current height above the 1stpercentile for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR
(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1stpercentile for age and sex; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. (a) Confirmation that the patient has had an intracranial lesion and has undergone a 12 month period of observation following completion of treatment for the intracranial lesion (all treatment); OR
(b) Confirmation that the patient has had an intracranial lesion, has received medical advice that it is unsafe to treat the intracranial lesion, and has undergone a 12 month period of observation since initial diagnosis of the intracranial lesion; OR
(c) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion, and has undergone a 12 month period of observation following completion of treatment for the condition for which cranial irradiation was received; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8347

 

 

Short stature associated with chronic renal insufficiency
Initial treatment
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; OR
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND
Patient must have a current height at or below the 1stpercentile for age and sex; OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and a growth velocity less than or equal to the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR
(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1stpercentile for age and sex; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND
6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8348

 

 

Short stature and poor body composition due to Prader-Willi syndrome
Initial treatment
Patient must have diagnostic results consistent with Prader-Willi syndrome (the condition must be genetically proven); OR
Patient must have a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist; AND
Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with no sleep disorders identified; OR
Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified which are not of sufficient severity to require treatment; OR
Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified for which the patient is currently receiving ameliorative treatment; AND
Patient must not have uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient's current height; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must not have a chronological age of 18 years or greater.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. A minimum of 6 months of recent growth data (height, weight and waist circumference). The most recent data must not be older than three months; AND
4. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity]; AND
5. (a) Confirmation that the patient has diagnostic results consistent with Prader-Willi syndrome; OR
(b) Confirmation that the patient has a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist
6. Confirmation that the patient has been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months and any sleep disorders identified via polysomnography that required treatment have been addressed; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with 1 repeat allowed)
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8349

 

 

Biochemical growth hormone deficiency and precocious puberty
Initial treatment
Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; OR
Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; OR
Patient must be female and menarche occurred before the chronological age of 10 years; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR
(b) A minimum of 6 months of recent growth data (height and weight) for older children (males chronological age 12 and over or bone age 10 and over, females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. Confirmation that the patient has precocious puberty; AND
7. Confirmation that the patient is undergoing Gonadotropin Releasing Hormone agonist therapy, for pubertal suppression; AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8357

 

 

Growth retardation secondary to an intracranial lesion, or cranial irradiation
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than growth retardation secondary to an intracranial lesion, or cranial irradiation; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have had an intracranial lesion and have undergone a 12 month period of observation following completion of treatment for the intracranial lesion (all treatment); OR
Patient must have had an intracranial lesion, have received medical advice that it is unsafe to treat the intracranial lesion, and have undergone a 12 month period of observation since initial diagnosis of the intracranial lesion; OR
Patient must have received cranial irradiation without having had an intracranial lesion, and have undergone a 12 month period of observation following completion of treatment for the condition for which cranial irradiation was received; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1stpercentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1stpercentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1stpercentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1stpercentile for age and sex immediately prior to commencing treatment; AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. (a) Confirmation that the patient has had an intracranial lesion and has undergone a 12 month period of observation following completion of treatment for the intracranial lesion (all treatment); OR
(b) Confirmation that the patient has had an intracranial lesion, has received medical advice that it is unsafe to treat the intracranial lesion, and has undergone a 12 month period of observation since initial diagnosis of the intracranial lesion; OR
(c) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion, and has undergone a 12 month period of observation following completion of treatment for the condition for which cranial irradiation was received; AND
6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.

Compliance with Written Authority Required procedures

C8358

 

 

Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have a structural lesion that is not neoplastic; OR
Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND
Patient must have hypothalamic obesity; AND
Patient must have had a growth velocity above the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had an annual growth velocity of greater than 14 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had an annual growth velocity of greater than 8 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR
(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
6. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND
7. Confirmation that the patient has hypothalamic obesity; AND
8. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
9. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
10. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8360

 

 

Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a chronological age of 5 years or greater.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
When a patient receiving treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants reaches or surpasses 5 years of age (chronological), prescribers should seek reclassification to the indication 'short stature due to biochemical growth hormone deficiency'.

Compliance with Written Authority Required procedures

C8361

 

 

Biochemical growth hormone deficiency and precocious puberty
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the biochemical growth hormone deficiency and precocious puberty category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8362

 

 

Short stature and slow growth
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature and slow growth; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have previously received treatment under the indication short stature associated with chronic renal insufficiency, have undergone a renal transplant and a 12 month period of observation following the transplant, and have an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; OR
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment; OR
(b) Confirmation that the patient has previously received treatment under the indication short stature associated with chronic renal insufficiency, has undergone a renal transplant and a 12 month period of observation following the transplant, and has an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; AND
4. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
5. A bone age result performed within the last 12 months; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8365

 

 

Short stature associated with biochemical growth hormone deficiency
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); OR
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
(c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.

Compliance with Written Authority Required procedures

C8368

 

 

Growth retardation secondary to an intracranial lesion, or cranial irradiation
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8369

 

 

Short stature associated with chronic renal insufficiency
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with chronic renal insufficiency; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and a growth velocity less than or equal to the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; OR
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1stpercentile for age and sex immediately prior to commencing treatment; AND
4. Confirmation that the patient has an estimated glomerular filtration rate less than 30ml/minute/1.73m2; AND
5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8372

 

 

Short stature and slow growth
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Patient must be aged 3 years or older.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8373

 

 

Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8376

 

 

Short stature associated with biochemical growth hormone deficiency
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8377

 

 

Short stature due to short stature homeobox (SHOX) gene disorders
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature due to short stature homeobox (SHOX) gene disorders category; AND
Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8378

 

 

Short stature associated with biochemical growth hormone deficiency
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8380

 

 

Short stature and slow growth
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8386

 

 

Biochemical growth hormone deficiency and precocious puberty
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the biochemical growth hormone deficiency and precocious puberty category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8388

 

 

Short stature associated with chronic renal insufficiency
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND
Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND
Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8389

 

 

Short stature and slow growth
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature and slow growth; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have previously received treatment under the indication short stature associated with chronic renal insufficiency, have undergone a renal transplant and a 12 month period of observation following the transplant, and have an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; OR
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment; OR
(b) Confirmation that the patient has previously received treatment under the indication short stature associated with chronic renal insufficiency, has undergone a renal transplant and a 12 month period of observation following the transplant, and has an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; AND
4. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
5. A bone age result performed within the last 12 months; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8393

 

 

Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8394

 

 

Biochemical growth hormone deficiency and precocious puberty
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than biochemical growth hormone deficiency and precocious puberty; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; OR
Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; OR
Patient must be female and menarche occurred before the chronological age of 10 years; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. Confirmation that the patient has precocious puberty; AND
4. Confirmation that the patient is undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8396

 

 

Short stature associated with chronic renal insufficiency
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND
Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND
Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be prepubertal.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8398

 

 

Short stature associated with chronic renal insufficiency
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have diabetes mellitus; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND
Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8402

 

 

Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8403

 

 

Short stature due to short stature homeobox (SHOX) gene disorders
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature due to short stature homeobox (SHOX) gene disorders; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; AND
Patient must have had a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND
4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND
5. If the patient's condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient's increased risk of gonadoblastoma is in place; AND
6. Recent growth data (height and weight, not older than three months); AND
7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8407

 

 

Short stature and slow growth
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature and slow growth; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have previously received treatment under the indication short stature associated with chronic renal insufficiency, have undergone a renal transplant and a 12 month period of observation following the transplant, and have an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; OR
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment; OR
(b) Confirmation that the patient has previously received treatment under the indication short stature associated with chronic renal insufficiency, has undergone a renal transplant and a 12 month period of observation following the transplant, and has an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; AND
4. Recent growth data (height and weight, not older than three months); AND
5. A bone age result performed within the last 12 months; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8411

 

 

Short stature due to short stature homeobox (SHOX) gene disorders
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature due to short stature homeobox (SHOX) gene disorders; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; AND
Patient must have had a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND
4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND
5. If the patient's condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient's increased risk of gonadoblastoma is in place; AND
6. Recent growth data (height and weight, not older than three months); AND
7. A bone age result performed within the last 12 months; AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8415

 

 

Short stature associated with biochemical growth hormone deficiency
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8416

 

 

Biochemical growth hormone deficiency and precocious puberty
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the biochemical growth hormone deficiency and precocious puberty category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8417

 

 

Growth retardation secondary to an intracranial lesion, or cranial irradiation
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than growth retardation secondary to an intracranial lesion, or cranial irradiation; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have had an intracranial lesion and have undergone a 12 month period of observation following completion of treatment for the intracranial lesion (all treatment); OR
Patient must have had an intracranial lesion, have received medical advice that it is unsafe to treat the intracranial lesion, and have undergone a 12 month period of observation since initial diagnosis of the intracranial lesion; OR
Patient must have received cranial irradiation without having had an intracranial lesion, and have undergone a 12 month period of observation following completion of treatment for the condition for which cranial irradiation was received; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. (a) Confirmation that the patient has had an intracranial lesion and has undergone a 12 month period of observation following completion of treatment for the intracranial lesion (all treatment); OR
(b) Confirmation that the patient has had an intracranial lesion, has received medical advice that it is unsafe to treat the intracranial lesion, and has undergone a 12 month period of observation since initial diagnosis of the intracranial lesion; OR
(c) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion, and has undergone a 12 month period of observation following completion of treatment for the condition for which cranial irradiation was received; AND
6. Recent growth data (height and weight, not older than three months); AND
7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8418

 

 

Biochemical growth hormone deficiency and precocious puberty
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than biochemical growth hormone deficiency and precocious puberty; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; OR
Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; OR
Patient must be female and menarche occurred before the chronological age of 10 years; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. Confirmation that the patient has precocious puberty; AND
4. Confirmation that the patient is undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. Recent growth data (height and weight, not older than three months); AND
7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8419

 

 

Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a chronological age of 5 years or greater.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8420

 

 

Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have a chronological age of less than 2 years; AND
Patient must have a documented clinical risk of hypoglycaemia; AND
Patient must have documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. Confirmation that the patient has a documented clinical risk of hypoglycaemia; AND
4. Confirmation that the patient has documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND
5. Recent growth data (height and weight, not older than three months); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8422

 

 

Growth retardation secondary to an intracranial lesion, or cranial irradiation
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8423

 

 

Short stature associated with chronic renal insufficiency
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND
Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND
6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
If a patient receiving treatment under the indication 'short stature associated with chronic renal insufficiency' undergoes a renal transplant and 12 months post-transplant has an eGFR of equal to or greater than 30mL/min/1.73m2prescribers should seek reclassification to the indication short stature and slow growth.

Compliance with Written Authority Required procedures

C8424

 

 

Short stature associated with biochemical growth hormone deficiency
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); OR
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; OR
(c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. Recent growth data (height and weight, not older than three months); AND
6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.

Compliance with Written Authority Required procedures

C8425

 

 

Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must have a structural lesion that is not neoplastic; OR
Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND
Patient must have hypothalamic obesity; AND
Patient must have had a growth velocity above the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had an annual growth velocity of greater than 14 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had an annual growth velocity of greater than 8 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR
(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
6. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND
7. Confirmation that the patient has hypothalamic obesity; AND
8. Recent growth data (height and weight, not older than three months); AND
9. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
10. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8426

 

 

Short stature due to short stature homeobox (SHOX) gene disorders
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature due to short stature homeobox (SHOX) gene disorders category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8427

 

 

Short stature and poor body composition due to Prader-Willi syndrome
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature and poor body composition due to Prader-Willi syndrome; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have diagnostic results consistent with Prader-Willi syndrome (the condition must be genetically proven); OR
Patient must have a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist; AND
Patient must have been evaluated via polysomnography for airway obstruction and apnoea whilst on growth hormone treatment and any sleep disorders identified that required treatment must have been addressed; OR
Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with no sleep disorders identified; OR
Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified which are not of sufficient severity to require treatment; OR
Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified for which the patient is currently receiving ameliorative treatment; AND
Patient must not have uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient's current height; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a chronological age of 18 years or greater.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) Confirmation that the patient has diagnostic results consistent with Prader-Willi syndrome, OR
(b) Confirmation that the patient has a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist; AND
4. Confirmation that the patient has been evaluated via polysomnography for airway obstruction and apnoea whilst on growth hormone treatment or within the last 12 months, and any sleep disorders identified via the polysomnography that required treatment have been addressed; AND
5. Recent growth data (height and weight, not older than three months); AND
6. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity]; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

C8429

 

 

Short stature associated with biochemical growth hormone deficiency
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); OR
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; OR
(c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. Recent growth data (height and weight, not older than three months); AND
6. A bone age result performed within the last 12 months; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.

Compliance with Authority Required procedures

C8433

 

 

Short stature associated with chronic renal insufficiency
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with chronic renal insufficiency; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and a growth velocity less than or equal to the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; OR
Patient mus