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PB 95 of 2019 Arrangements as made
This instrument amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) to add, delete and make changes to drugs, forms, brands, responsible person codes, maximum quantities and repeats and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).
Administered by: Health
Registered 28 Nov 2019
Tabling HistoryDate
Tabled HR02-Dec-2019
Tabled Senate02-Dec-2019
To be repealed 24 Mar 2020
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

PB 95 of 2019

 

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 11)

 

National Health Act 1953

___________________________________________________________________________

 

I, BEN SLADIC, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.

 

Dated              27 November  2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BEN SLADIC

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health


 

 

___________________________________________________________________________

1          Name of Instrument

(1)          This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 11).

(2)          This Instrument may also be cited as PB 95 of 2019.

2          Commencement

This Instrument commences on 1 December 2019.

3          Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)

Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Schedule 1     Amendments

[1]             Part 1, Division 1, Section 4, definition for ‘CAR drug’

                   (a)        insert in the list after the entry “(cc) teduglutide”: (dd) tezacaftor with ivacaftor and ivacaftor

                   (b)        omit: (dd) tocilizumab        substitute: (ee) tocilizumab

                   (c)        omit: (ee) ustekinumab       substitute: (ff) ustekinumab

                   (d)        omit: (ff) vedolizumab       substitute: (gg) vedolizumab

[2]             Schedule 1, entry for Benralizumab

                           substitute:

Benralizumab

Injection 30 mg in 1 mL single dose pre‑filled syringe

Injection

Fasenra

AP

EMP

C9887 C9918 C9941 C9982

P9887

1

0

D

 

 

 

 

 

EMP

C9887 C9918 C9941 C9982

P9982

1

2

D

 

 

 

 

 

EMP

C9887 C9918 C9941 C9982

P9918 P9941

1

4

D

[3]             Schedule 1, entry for Dolutegravir with abacavir and lamivudine

                           omit from the column headed “Circumstances”: C4480 C4495             substitute: C9934 C9981

[4]             Schedule 1, after entry for Dolutegravir with abacavir and lamivudine

                           insert:

Dolutegravir with lamivudine

Tablet containing dolutegravir
50 mg (as sodium) with lamivudine 300 mg

Oral

Dovato

VI

EMP

C9909 C9934 C9987

 

60

5

D

[5]             Schedule 1, entry for Filgrastim

                           omit from the column headed “Authorised Prescriber” (all instances): MP      substitute: EMP

[6]             Schedule 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg [Brand: Inflectra]

                   (a)        omit from the column headed “Circumstances”: C8847

                   (b)        omit from the column headed “Circumstances”: C8911

                   (c)        omit from the column headed “Circumstances”: C9615

                   (d)        omit from the column headed “Circumstances”: C9782

                   (e)        insert in numerical order in the column headed “Circumstances”: C9877 C9900 C9975 C9994

[7]             Schedule 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg [Brand: Remicade]

                   (a)        omit from the column headed “Circumstances”: C8847

                   (b)        omit from the column headed “Circumstances”: C8911

                   (c)        omit from the column headed “Circumstances”: C9782

                   (d)        insert in numerical order in the column headed “Circumstances”: C9877 C9900 C9994

[8]             Schedule 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg [Brand: Renflexis]

                   (a)        omit from the column headed “Circumstances”: C8847

                   (b)        omit from the column headed “Circumstances”: C8911

                   (c)        omit from the column headed “Circumstances”: C9615

                   (d)        omit from the column headed “Circumstances”: C9782

                   (e)        insert in numerical order in the column headed “Circumstances”: C9877 C9900 C9975 C9994

[9]             Schedule 1, entry for Ivacaftor in each of the forms: Sachet containing granules 50 mg; Sachet containing granules 75 mg; and
Tablet 150 mg

                           omit from the column headed “Circumstances”: C9045 C9145             substitute: C9889 C9890

[10]           Schedule 1, entry for Lumacaftor with ivacaftor

                           substitute:

Lumacaftor with ivacaftor

Sachet containing granules, lumacaftor 100 mg and ivacaftor 125 mg

Oral

Orkambi

VR

EMP

C10005 C10007

 

56

5

D

 

Sachet containing granules, lumacaftor 150 mg and ivacaftor 188 mg

Oral

Orkambi

VR

EMP

C10005 C10007

 

56

5

D

 

Tablet containing lumacaftor
100 mg with ivacaftor 125 mg

Oral

Orkambi

VR

EMP

C9891 C9920

 

112

5

D

 

Tablet containing lumacaftor
200 mg with ivacaftor 125 mg

Oral

Orkambi

VR

EMP

C9857 C9943

 

112

5

D

[11]           Schedule 1, entry for Mepolizumab

                           substitute:

Mepolizumab

Powder for injection 100 mg

Injection

Nucala

GK

EMP

C9853 C9854 C9885 C9963

 

1

0

D

 

 

 

 

 

EMP

C9853 C9854 C9885 C9963

 

1

5

D

 

 

 

 

 

EMP

C9853 C9854 C9885 C9963

 

1

7

D

[12]           Schedule 1, entry for Mycophenolic Acid in the form Tablet containing mycophenolate mofetil 500 mg

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Mycophenolate APOTEX

GX

EMP

C5554 C5795 C9691 C9693

 

300

5

C

[13]           Schedule 1, entry for Octreotide in each of the forms: Injection 50 micrograms (as acetate) in 1 mL; Injection 100 micrograms (as acetate) in 1 mL; and Injection 500 micrograms (as acetate) in 1 mL            

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Octreotide GH

HQ

EMP

C6369 C6390 C8165 C9232 C9233 C9289

 

90

11

D

[14]           Schedule 1, entry for Omalizumab in the form Injection 75 mg in 0.5 mL single dose pre-filled syringe            

                           omit from the column headed “Circumstances”: C6563 C6603 C7634 C7636 C8136 C8192         substitute: C9849 C9851 C9855 C9881 C9882 C9886 C9916

[15]           Schedule 1, entry for Omalizumab in the form Injection 150 mg in 1 mL single dose pre-filled syringe            

                   (a)        omit from the column headed “Circumstances”: C6563 C6603

                   (b)        omit from the column headed “Circumstances”: C7634 C7636 C8136 C8192

                   (c)        insert in numerical order in the column headed “Circumstances”: C9849 C9851 C9855 C9881 C9882 C9886 C9916

[16]           Schedule 1, entry for Sevelamer

                           insert as first entry:

 

Tablet containing sevelamer carbonate 800 mg

Oral

Sevelamer Apotex

TX

EMP

C5530 C9762

 

360

5

C

[17]           Schedule 1, entry for Sirolimus in each of the forms: Tablet 0.5 mg; Tablet 1 mg; Tablet 2 mg; and Oral solution 1 mg per mL, 60 mL  

                   (a)        omit from the column headed “Circumstances”: C9693

                   (b)        insert in numerical order in the column headed “Circumstances”: C9914


 

[18]           Schedule 1, after entry for Tenofovir with Emtricitabine and Rilpivirine

                           insert:

Tezacaftor with ivacaftor and ivacaftor

Pack containing 28 tablets tezacaftor 100 mg with ivacaftor 150 mg and 28 tablets ivacaftor 150 mg

Oral

Symdeko

VR

EMP

C9846 C9880 C9960 C9961

 

See Note 1

See Note 2

D

[19]           Schedule 2, after details relevant to Responsible Person Code HN

                           insert:

HQ

Generic Health Pty Ltd

93 110 617 859

[20]           Schedule 3, entry for Benralizumab

                           substitute:

Benralizumab

C9887

P9887

Uncontrolled severe eosinophilic asthma
Balance of supply
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must received insufficient therapy with this drug under the Initial 1 (new patients or recommencement of treatment in a new treatment cycle) restriction to complete 32 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change of treatment) restriction to complete 32 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must not provide more than the balance of up to 32 weeks of treatment if the most recent authority approval was made under an Initial treatment restriction; OR
The treatment must not provide more than the balance of up to 24 weeks of treatment if the most recent authority approval was made under the Continuing treatment restriction.

Compliance with Written Authority Required procedures

 

C9918

P9918

Uncontrolled severe eosinophilic asthma
Initial treatment - Initial 2 (Change of treatment)
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must be under the care of the same physician for at least 6 months; OR
Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND
Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND
Patient must have had a blood eosinophil count greater than or equal to 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; OR
Patient must have had a blood eosinophil count greater than or equal to 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; AND
Patient must not receive more than 32 weeks of treatment under this restriction; AND
The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma.
Patient must be aged 12 years or older.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Eosinophilic Asthma (mepolizumab/benralizumab) Initial PBS Authority Application - Supporting Information Form, which includes the following:
(i) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment; and
(iii) eosinophil count and date; and
(iv) the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and
(v) the reason for switching therapy (i.e. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).
An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.
An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.
This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine.
At the time of the authority application, medical practitioners should request up to 4 repeats to provide for an initial course sufficient for up to 32 weeks of therapy, based on a dose of 30 mg every 4 weeks for the first three doses (weeks 0, 4, and 8) then 30 mg every eight weeks thereafter (refer to the TGA-approved Product Information).
A multidisciplinary severe asthma clinic team comprises of:
A respiratory physician; and
A pharmacist, nurse or asthma educator.

Compliance with Written Authority Required procedures

 

C9941

P9941

Uncontrolled severe eosinophilic asthma
Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must be under the care of the same physician for at least 6 months; OR
Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; OR
Patient must have had a break in treatment from the most recently approved PBS-subsidised biological medicine for severe asthma; AND
Patient must have a diagnosis of asthma confirmed and documented by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma, defined by the following standard clinical features: (i) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), or (ii) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, or (iii) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR
Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma; AND
Patient must have a duration of asthma of at least 1 year; AND
Patient must have blood eosinophil count greater than or equal to 300 cells per microlitre in the last 12 months; OR
Patient must have blood eosinophil count greater than or equal to 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; AND
Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
Patient must not receive more than 32 weeks of treatment under this restriction; AND
The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma.
Patient must be aged 12 years or older.
Optimised asthma therapy includes:
(i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated;
AND
(ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated.
If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.
The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:
(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND
(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.
The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.
This assessment, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply.
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 within the same treatment cycle.
A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 3 biological medicines within the same treatment cycle.
The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.
There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.
A multidisciplinary severe asthma clinic team comprises of:
A respiratory physician; and
A pharmacist, nurse or asthma educator.
At the time of the authority application, medical practitioners should request up to 4 repeats to provide for an initial course of benralizumab sufficient for up to 32 weeks of therapy, at a dose of 30 mg every 4 weeks for the first three doses (weeks 0, 4, and 8) then 30 mg every eight weeks thereafter.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Eosinophilic Asthma Initial PBS Authority Application - Supporting Information Form, which includes the following:
(i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and
(ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and
(c) the eosinophil count and date; and
(d) Asthma Control Questionnaire (ACQ-5) score.

Compliance with Written Authority Required procedures

 

C9982

P9982

Uncontrolled severe eosinophilic asthma
Continuing treatment
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND
The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 12 years or older.
An adequate response to this biological medicine is defined as:
(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline,
OR
(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5.
All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made at around 18 to 22 weeks after the first dose of PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.
The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this drug.
Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.
A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS subsidised treatment with this biological medicine for severe asthma within the current treatment cycle.
At the time of the authority application, medical practitioners should request the appropriate number of repeats to provide for a continuing course of this drug sufficient for up to 24 weeks of therapy.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Eosinophilic Asthma Continuing PBS Authority Application - Supporting Information Form which includes details of maintenance oral corticosteroid dose; or a completed Asthma Control Questionnaire (ACQ-5) calculation sheet including the date of assessment of the patient's symptoms.

Compliance with Written Authority Required procedures

[21]           Schedule 3, entry for Dolutegravir with abacavir and lamivudine

                           substitute:

Dolutegravir with abacavir and lamivudine

C9934

 

HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy with this drug for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9934

 

C9981

 

HIV infection
Initial treatment
Patient must be antiretroviral treatment naive.

Compliance with Authority Required procedures - Streamlined Authority Code 9981

[22]           Schedule 3, after entry for Dolutegravir with abacavir and lamivudine

                           insert:

Dolutegravir with lamivudine

C9909

 

HIV infection
Grandfathered treatment
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2019; AND
Patient must have been antiretroviral treatment naive prior to initiating this drug for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9909

 

C9934

 

HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy with this drug for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9934

 

C9987

 

HIV infection
Initial treatment
Patient must be antiretroviral treatment naive; AND
Patient must not have suspected resistance to either antiretroviral component.

Compliance with Authority Required procedures - Streamlined Authority Code 9987

[23]           Schedule 3, entry for Infliximab

                   (a)        omit:

 

C8847

 

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 therapy with this drug for this condition in the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 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, first or subsequent 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 first continuing or subsequent 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.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
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

                   (b)        omit:

 

C8911

 

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 therapy with this drug for this condition in the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 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, first or subsequent 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.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
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

                   (c)        omit:

 

C9615

 

Severe active rheumatoid arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a 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 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).
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.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.
Up to a maximum of 2 repeats will be authorised.
Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course 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.
If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9615

                   (d)        omit:

 

C9782

 

Complex refractory Fistulising Crohn disease
Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have an externally draining enterocutaneous or rectovaginal fistula.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) a signed patient acknowledgement.
The most recent fistula assessment must be no more than 1 month old at the time of application.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
An assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not provided within this 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.

Compliance with Written Authority Required procedures

                   (e)        insert in numerical order after existing text:

 

C9877

 

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 22 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, first or subsequent 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 first continuing or subsequent 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.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
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

 

C9900

 

Complex refractory Fistulising Crohn disease
Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have an externally draining enterocutaneous or rectovaginal fistula.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition.
The most recent fistula assessment must be no more than 1 month old at the time of application.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
An assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not provided within this 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.

Compliance with Written Authority Required procedures

 

C9975

 

Severe active rheumatoid arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a 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 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).
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 measurement of response to the prior course of therapy must be documented in the patient's medical notes.
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.
If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9975

 

C9994

 

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 22 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, first or subsequent 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.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
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

[24]           Schedule 3, entry for Ivacaftor

                           substitute:

Ivacaftor

C9889

 

Cystic fibrosis
Continuing treatment
Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND
Patient must have received PBS-subsidised initial therapy with ivacaftor, given concomitantly with standard therapy, for this condition; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be aged 12 months or older.
Patients receiving PBS-subsidised ivacaftor must be registered in the Australian Cystic Fibrosis Database Registry.
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug.
Patients who have an acute infective exacerbation at the time of assessment for continuing therapy may receive an additional one month's supply in order to enable the assessment to be repeated following resolution of the exacerbation.
Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks.
Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks.
Ivacaftor is not PBS-subsidised for this condition as a sole therapy.
Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis Ivacaftor Authority Continuing Application Supporting Information Form; and
(3) the result of a FEV1 measurement performed within one month prior to the date of application, if aged 6 years or older. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1 is measured; and
(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics; and
(5) height and weight measurements at the time of application; and
(6) a measurement of number of days of CF-related hospitalisation (including hospital in the home) in the previous 6 months.

Compliance with Written Authority Required procedures

 

C9890

 

Cystic fibrosis
Initial treatment - New patients
Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND
Patient must have G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on at least 1 allele; OR
Patient must have other gating (class III) mutation in the CFTR gene on at least 1 allele; AND
Patient must have a sweat chloride value of at least 60 mmol/L by quantitative pilocarpine iontophoresis; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be aged 12 months or older.
Patients receiving PBS-subsidised ivacaftor must be registered in the Australian Cystic Fibrosis Database Registry.
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug.
Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks.
Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks.
Ivacaftor is not PBS-subsidised for this condition as a sole therapy.
Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis Ivacaftor Authority Application Supporting Information Form; and
(3) a copy of the pathology report detailing the molecular testing for G551D mutation or other gating (class III) mutation on the CFTR gene; and
(4) the result of a FEV1 measurement performed within a month prior to the date of application, if aged from 6 years or older. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1 is measured; and
(5) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics; and
(6) sweat chloride result; and
(7) height and weight measurements at the time of application; and
(8) a baseline measurement of the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 12 months.

Compliance with Written Authority Required procedures

[25]           Schedule 3, entry for Lumacaftor with ivacaftor

                           substitute:

Lumacaftor with ivacaftor

C9857

 

Cystic fibrosis
Initial treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.
Patient must be 12 years of age or older.
The patient must be registered in the Australian Cystic Fibrosis Database Registry.
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug.
For the purposes of this restriction, PBS subsidised 'CFTR modulator' means ivacaftor, lumacaftor/ivacaftor and tezacaftor/ivacaftor.
Lumacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort.
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin.
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis lumacaftor with ivacaftor Authority Application Supporting Information Form; and
(3) a copy of the pathology report detailing the molecular testing for the patient being homozygous for the F508del mutation on the CFTR gene; and
(4) the result of a FEV1measurement performed within a month prior to the date of application. Note: FEV1must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1is measured; and
(5) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics; and
(6) height and weight measurements at the time of application; and
(7) a baseline measurement of the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 12 months.

Compliance with Written Authority Required procedures

 

C9891

 

Cystic fibrosis
Continuing treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be aged between 6 and 11 years inclusive.
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug.
Patients who have an acute infective exacerbation at the time of assessment for continuing therapy may receive an additional one month's supply in order to enable the assessment to be repeated following resolution of the exacerbation.
For the purposes of this restriction, PBS subsidised 'CFTR modulator' means ivacaftor, lumacaftor/ivacaftor and tezacaftor/ivacaftor.
Lumacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort.
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin.
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis lumacaftor with ivacaftor Continuing Authority Application Supporting Information Form; and
(3) the result of a FEV1measurement performed within a month prior to the date of application. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1is measured; and
(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics; and
(5) height and weight measurements at the time of application; and
(6) the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 6 months.

Compliance with Written Authority Required procedures

 

C9920

 

Cystic fibrosis
Initial treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.
Patient must be aged between 6 and 11 years inclusive.
The patient must be registered in the Australian Cystic Fibrosis Database Registry.
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug.
For the purposes of this restriction, PBS subsidised 'CFTR modulator' means ivacaftor, lumacaftor/ivacaftor and tezacaftor/ivacaftor.
Lumacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort.
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin.
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis lumacaftor with ivacaftor Authority Application Supporting Information Form; and
(3) a copy of the pathology report detailing the molecular testing for the patient being homozygous for the F508del mutation on the CFTR gene; and
(4) the result of a FEV1measurement performed within a month prior to the date of application. Note: FEV1must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1is measured; and
(5) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics; and
(6) height and weight measurements at the time of application; and
(7) a baseline measurement of the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 12 months.

Compliance with Written Authority Required procedures

 

C9943

 

Cystic fibrosis
Continuing treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.
Patient must be 12 years of age or older.
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug.
Patients who have an acute infective exacerbation at the time of assessment for continuing therapy may receive an additional one month's supply in order to enable the assessment to be repeated following resolution of the exacerbation.
For the purposes of this restriction, PBS subsidised 'CFTR modulator' means ivacaftor, lumacaftor/ivacaftor and tezacaftor/ivacaftor.
Lumacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort.
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin.
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis lumacaftor with ivacaftor Continuing Authority Application Supporting Information Form; and
(3) the result of a FEV1measurement performed within a month prior to the date of application. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1is measured; and
(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics; and
(5) height and weight measurements at the time of application; and
(6) the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 6 months.

Compliance with Written Authority Required procedures

 

C10005

 

Cystic fibrosis
Initial treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.
Patient must be 2 years of age or older.
The patient must be registered in the Australian Cystic Fibrosis Database Registry.
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug.
For the purposes of this restriction, PBS subsidised 'CFTR modulator' means ivacaftor, lumacaftor/ivacaftor and tezacaftor/ivacaftor.
Lumacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort.
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin.
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis lumacaftor with ivacaftor Authority Application Supporting Information Form; and
(3) a copy of the pathology report detailing the molecular testing for the patient being homozygous for the F508del mutation on the CFTR gene; and
(4) the result of a FEV1measurement performed within a month prior to the date of application, if aged from 6 years or older. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1is measured; and
(5) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics; and
(6) height and weight measurements at the time of application; and
(7) a baseline measurement of the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 12 months.
For patients who have initiated non-PBS subsidised treatment prior to 1 December 2019, date of initiating treatment, baseline FEV1and hospitalisation dates prior to initiating treatment (where available) should be provided.

Compliance with Written Authority Required procedures

 

C10007

 

Cystic fibrosis
Continuing treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be 2 years of age or older.
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug.
Patients who have an acute infective exacerbation at the time of assessment for continuing therapy may receive an additional one month's supply in order to enable the assessment to be repeated following resolution of the exacerbation.
For the purposes of this restriction, PBS subsidised 'CFTR modulator' means ivacaftor, lumacaftor/ivacaftor and tezacaftor/ivacaftor.
Lumacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort.
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin.
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis lumacaftor with ivacaftor Continuing Authority Application Supporting Information Form; and
(3) the result of a FEV1measurement performed within one month prior to the date of application, if aged 6 years or older. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1is measured; and
(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics; and
(5) height and weight measurements at the time of application; and
(6) the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 6 months.

Compliance with Written Authority Required procedures

[26]           Schedule 3, entry for Mepolizumab

                           substitute:

Mepolizumab

C9853

 

Uncontrolled severe eosinophilic asthma
Continuing treatment
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND
The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 12 years or older.
An adequate response to this biological medicine is defined as:
(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline,
OR
(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5.
All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made at around 18 to 22 weeks after the first dose of PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.
The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this drug.
Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.
A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS subsidised treatment with this biological medicine for severe asthma within the current treatment cycle.
At the time of the authority application, medical practitioners should request the appropriate number of repeats to provide for a continuing course of this drug sufficient for up to 24 weeks of therapy.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Eosinophilic Asthma Continuing PBS Authority Application - Supporting Information Form which includes details of maintenance oral corticosteroid dose; or a completed Asthma Control Questionnaire (ACQ-5) calculation sheet including the date of assessment of the patient's symptoms.

Compliance with Written Authority Required procedures

 

C9854

 

Uncontrolled severe eosinophilic asthma
Initial treatment - Initial 2 (Change of treatment)
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must be under the care of the same physician for at least 6 months; OR
Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND
Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND
Patient must have had a blood eosinophil count greater than or equal to 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; OR
Patient must have had a blood eosinophil count greater than or equal to 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; AND
Patient must not receive more than 32 weeks of treatment under this restriction; AND
The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma.
Patient must be aged 12 years or older.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Eosinophilic Asthma (mepolizumab/benralizumab) Initial PBS Authority Application - Supporting Information Form, which includes the following:
(i) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment; and
(iii) eosinophil count and date; and
(iv) the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and
(v) the reason for switching therapy (i.e. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).
An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.
An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.
This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine.
At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course sufficient for up to 32 weeks of therapy.
A multidisciplinary severe asthma clinic team comprises of:
A respiratory physician; and
A pharmacist, nurse or asthma educator.

Compliance with Written Authority Required procedures

 

C9885

 

Uncontrolled severe eosinophilic asthma
Balance of supply
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must received insufficient therapy with this drug under the Initial 1 (new patients or recommencement of treatment in a new treatment cycle) restriction to complete 32 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change of treatment) restriction to complete 32 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must not provide more than the balance of up to 32 weeks of treatment if the most recent authority approval was made under an Initial treatment restriction; OR
The treatment must not provide more than the balance of up to 24 weeks of treatment if the most recent authority approval was made under the Continuing treatment restriction.

Compliance with Written Authority Required procedures

 

C9963

 

Uncontrolled severe eosinophilic asthma
Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must be under the care of the same physician for at least 6 months; OR
Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; OR
Patient must have had a break in treatment from the most recently approved PBS-subsidised biological medicine for severe asthma; AND
Patient must have a diagnosis of asthma confirmed and documented by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma, defined by the following standard clinical features: (i) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), or (ii) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, or (iii) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR
Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma; AND
Patient must have a duration of asthma of at least 1 year; AND
Patient must have blood eosinophil count greater than or equal to 300 cells per microlitre in the last 12 months; OR
Patient must have blood eosinophil count greater than or equal to 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; AND
Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
Patient must not receive more than 32 weeks of treatment under this restriction; AND
The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma.
Patient must be aged 12 years or older.
Optimised asthma therapy includes:
(i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated;
AND
(ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated.
If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.
The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:
(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND
(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.
The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.
This assessment, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply.
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 within the same treatment cycle.
A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 3 biological medicines within the same treatment cycle.
The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.
There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.
At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course of mepolizumab sufficient for up to 32 weeks of therapy.
A multidisciplinary severe asthma clinic team comprises of:
A respiratory physician; and
A pharmacist, nurse or asthma educator.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Eosinophilic Asthma Initial PBS Authority Application - Supporting Information Form,
which includes the following:
(i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and
(ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and
(c) the eosinophil count and date; and
(d) Asthma Control Questionnaire (ACQ-5) score.

Compliance with Written Authority Required procedures

[27]           Schedule 3, entry for Omalizumab

                   (a)        omit:

 

C6563

 

Uncontrolled severe allergic asthma
Continuing treatment
Patient must have a documented history of severe allergic asthma; AND
Patient must have demonstrated or sustained an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.
An adequate response to omalizumab treatment is defined as:
(a) a reduction in the Asthma Control Questionnaire (ACQ‑5) or ACQ‑IA score of at least 0.5 from baseline, OR
(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ‑5 or ACQ‑IA score from baseline, OR
(c) a reduction in the time‑adjusted exacerbation rates compared to the 12 months prior to baseline.
All applications for continuing treatment with omalizumab must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ‑IA) assessment of the patient's response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time‑adjusted exacerbation rate must be made at around 18 to 22 weeks after the first dose of PBS‑subsidised omalizumab so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.
The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with omalizumab.
A patient who fails to respond to a course of PBS‑subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS‑subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased.
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA‑approved Product Information), sufficient for 24 weeks of therapy.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Severe Allergic Asthma Continuing PBS Authority Application ‑ Supporting Information form which includes details of maintenance oral corticosteroid dose; and
(c) a completed Asthma Control Questionnaire (ACQ‑5) or the Asthma Control Questionnaire interviewer administered version (ACQ‑IA) calculation sheet including the date of assessment of the patient's symptoms and is endorsed with the signature of the prescriber.

Compliance with Written Authority Required procedures

 

C6603

 

Uncontrolled severe allergic asthma
Initial treatment
Patient must have a diagnosis of asthma confirmed and documented by a paediatric respiratory physician, clinical immunologist, or allergist; or paediatrician or general physician experienced in the management of patients with severe asthma in consultation with a respiratory physician, defined by the following standard clinical features: forced expiratory volume (FEV1) reversibility or airway hyperresponsiveness or peak expiratory flow (PEF) variability; AND
Patient must have a duration of asthma of at least 1 year; AND
Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE; AND
Patient must have total serum human immunoglobulin E greater than or equal to 30 IU/mL; AND
Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
Patient must not receive more than 28 weeks of treatment under this restriction; AND
Patient must be under the care of the same physician for at least 6 months.
Patient must be aged 6 to less than 12 years.
Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.
Optimised asthma therapy includes:
(i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long‑acting beta‑2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative;
AND
(ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3‑5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.
If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in the relevant TGA‑approved Product Information) and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.
The initial IgE assessment must be no more than 12 months old at the time of application.
The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:
(a) An Asthma Control Questionnaire (ACQ‑5) score of at least 2.0, as assessed in the previous month (for children aged 6 to 10 years it is recommended that the Interviewer Administered version ‑ the ACQ‑IA be used),
AND
(b) while receiving optimised asthma therapy in the previous 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.
The Asthma Control Questionnaire (5 item version) or ACQ‑IA assessment of the patient's response to this initial course of treatment, the assessment of oral corticosteroid dose, and the assessment of exacerbation rate must be made at around 22 to 26 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.
This assessment, which will be used to determine eligibility for continuing treatment, must be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with omalizumab.
A patient who fails to respond to a course of PBS‑subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS‑subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased.
At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab of up to 28 weeks, consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA‑approved Product Information) to be administered every 2 or 4 weeks.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Severe Allergic Asthma Initial PBS Authority Application ‑ Supporting Information form,
which includes the following:
(i) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and
(ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and
(iii) acknowledgement signed by a parent or authorised guardian; and
(c) a copy of the IgE pathology report; and
(d) a completed Asthma Control Questionnaire (ACQ‑5) or the Asthma Control Questionnaire interviewer administered version (ACQ‑IA) calculation sheet including the date of assessment of the patient's symptoms and is endorsed with the prescriber's signature.

Compliance with Written Authority Required procedures

                   (b)        omit:

 

C7634

 

Uncontrolled severe allergic asthma
Initial and continuing treatment ‑ balance of supply
Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.
Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete 28 weeks treatment; OR
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 28 weeks treatment available under the Initial restriction or up to 24 weeks treatment available under the Continuing restriction.

Compliance with Authority Required procedures

 

C7636

 

Uncontrolled severe allergic asthma
Initial and continuing treatment ‑ balance of supply
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete 28 weeks treatment; OR
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 28 weeks treatment available under the Initial restriction or up to 24 weeks treatment available under the Continuing restriction.

Compliance with Authority Required procedures

 

C8136

 

Uncontrolled severe allergic asthma
Initial treatment
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must be under the care of the same physician for at least 6 months; OR
Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND
Patient must have a diagnosis of asthma confirmed and documented by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma, defined by the following standard clinical features: (i) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), or (ii) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, or (iii) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; AND
Patient must have a duration of asthma of at least 1 year; AND
Patient must have forced expiratory volume (FEV1) less than or equal to 80% predicted, documented on 1 or more occasions in the previous 12 months; AND
Patient must have past or current evidence of atopy, documented by skin prick testing or RAST; AND
Patient must have total serum human immunoglobulin E greater than or equal to 30 IU/mL; AND
Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
Patient must not receive more than 28 weeks of treatment under this restriction; AND
The treatment must not be used in combination with, or within 6 months of treatment with, PBS‑subsidised benralizumab or mepolizumab.
Patient must be aged 12 years or older.
Optimised asthma therapy includes:
(i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long‑acting beta‑2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated;
AND
(ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated.
If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA‑approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.
The initial IgE assessment must be no more than 12 months old at the time of application.
The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:
(a) an Asthma Control Questionnaire (ACQ‑5) score of at least 2.0, as assessed in the previous month, AND
(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.
The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, must be made at around 22 to 26 weeks after the first PBS‑subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
A patient who fails to respond to a course of PBS‑subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS‑subsidised treatment with benralizumab, omalizumab or mepolizumab for this condition within 6 months of the date on which treatment was ceased.
At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA‑approved Product Information) to be administered every 2 or 4 weeks.
A multidisciplinary severe asthma clinic team comprises of:
A respiratory physician; and
A pharmacist, nurse or asthma educator.
Omalizumab must not be used concurrently with benralizumab or mepolizumab, or within 6 months of each other. A patient is required to have ceased treatment with benralizumab or mepolizumab for 6 months prior to initiating treatment with omalizumab.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Allergic Asthma PBS Authority Application ‑ Supporting Information Form,
which includes the following:
(i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and
(ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and
(c) the IgE pathology report; and
(d) a completed Asthma Control Questionnaire (ACQ‑5) calculation sheet including the date of assessment of the patient's symptoms.

Compliance with Written Authority Required procedures

 

C8192

 

Uncontrolled severe allergic asthma
Continuing treatment
Patient must have a documented history of severe allergic asthma; AND
Patient must have demonstrated or sustained an adequate response to PBS‑subsidised treatment with this drug for this condition; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must not be used in combination with, or within 6 months of treatment with, PBS‑subsidised benralizumab or mepolizumab.
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must be aged 12 years or older.
An adequate response to omalizumab treatment is defined as:
(a) a reduction in the Asthma Control Questionnaire (ACQ‑5) score of at least 0.5 from baseline, OR
(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ‑5 score from baseline, OR
(c) a reduction in the time‑adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction).
All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment, the assessment of oral corticosteroid dose or the assessment of time adjusted exacerbation rate must be made at around 18 to 22 weeks after the first PBS‑subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.
The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
A patient who fails to respond to a course of PBS‑subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS‑subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased.
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA‑approved Product Information), sufficient for up to 24 weeks of therapy.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Allergic Asthma PBS Authority Application and Supporting Information Form which includes details of maintenance oral corticosteroid dose; or
(c) a completed Asthma Control Questionnaire (ACQ‑5) calculation sheet including the date of assessment of the patient's symptoms and is endorsed with the signature of the prescriber; for patients transitioned from the paediatric to the adolescent/adult restrictions an exacerbation calculation sheet may be submitted.

Compliance with Written Authority Required procedures

                   (c)        insert in numerical order after existing text:

 

C9849

 

Uncontrolled severe allergic asthma
Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must be under the care of the same physician for at least 6 months; OR
Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; OR
Patient must have had a break in treatment from the most recently approved PBS-subsidised biological medicine for severe asthma; AND
Patient must have a diagnosis of asthma confirmed and documented by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma, defined by the following standard clinical features: (i) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), or (ii) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, or (iii) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR
Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma; AND
Patient must have a duration of asthma of at least 1 year; AND
Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE, that is no more than 1 year old; AND
Patient must have total serum human immunoglobulin E greater than or equal to 30 IU/mL; AND
Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
Patient must not receive more than 32 weeks of treatment under this restriction; AND
The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma.
Patient must be aged 12 years or older.
Optimised asthma therapy includes:
(i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated;
AND
(ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated.
If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.
The initial IgE assessment must be no more than 12 months old at the time of application.
The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:
(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND
(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.
The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.
This assessment, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, 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 severe asthma within the same treatment cycle.
A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 3 biological medicines for severe asthma within the same treatment cycle.
A treatment break in PBS-subsidised omalizumab therapy of at least 6 months must be observed in a patient with uncontrolled severe allergic asthma, in whom omalizumab is the only appropriate treatment option, and who has either failed to achieve or sustain a response to the most recent PBS-subsidised omalizumab therapy.
The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.
There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.
At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.
A multidisciplinary severe asthma clinic team comprises of:
A respiratory physician; and
A pharmacist, nurse or asthma educator.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Allergic Asthma PBS Authority Application - Supporting Information Form,
which includes the following:
(i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and
(ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and
(c) the IgE result; and
(d) Asthma Control Questionnaire (ACQ-5) score.

Compliance with Written Authority Required procedures

 

C9851

 

Uncontrolled severe allergic asthma
Continuing treatment
Patient must have a documented history of severe allergic asthma; AND
Patient must have demonstrated or sustained an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.
An adequate response to omalizumab treatment is defined as:
(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or ACQ-IA score of at least 0.5 from baseline, OR
(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 or ACQ-IA score from baseline, OR
(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.
All applications for continuing treatment with omalizumab must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient's response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate must be made at around 18 to 22 weeks after the first dose of PBS-subsidised omalizumab so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.
The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with omalizumab.
A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased.
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks of therapy.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Severe Allergic Asthma Continuing PBS Authority Application - Supporting Information form which includes details of maintenance oral corticosteroid dose; and
(c) Asthma Control Questionnaire (ACQ-5) score or the Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.

Compliance with Written Authority Required procedures

 

C9855

 

Uncontrolled severe allergic asthma
Balance of supply in a patient aged 12 years or older
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must received insufficient therapy with this drug under the Initial 1 (new patients or recommencement of treatment in a new treatment cycle) restriction to complete 32 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change of treatment) restriction to complete 32 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must not provide more than the balance of up to 32 weeks of treatment if the most recent authority approval was made under an Initial treatment restriction; OR
The treatment must not provide more than the balance of up to 24 weeks of treatment if the most recent authority approval was made under the Continuing treatment restriction.

Compliance with Written Authority Required procedures

 

C9881

 

Uncontrolled severe allergic asthma
Initial treatment
Patient must have a diagnosis of asthma confirmed and documented by a paediatric respiratory physician, clinical immunologist, or allergist; or paediatrician or general physician experienced in the management of patients with severe asthma in consultation with a respiratory physician, defined by the following standard clinical features: forced expiratory volume (FEV1) reversibility or airway hyperresponsiveness or peak expiratory flow (PEF) variability; AND
Patient must have a duration of asthma of at least 1 year; AND
Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE; AND
Patient must have total serum human immunoglobulin E greater than or equal to 30 IU/mL; AND
Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 6 to less than 12 years.
Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.
Patient must be under the care of the same physician for at least 6 months.
Optimised asthma therapy includes:
(i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative;
AND
(ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.
If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in the relevant TGA-approved Product Information) and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.
The initial IgE assessment must be no more than 12 months old at the time of application.
The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:
(a) An Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month (for children aged 6 to 10 years it is recommended that the Interviewer Administered version - the ACQ-IA be used),
AND
(b) while receiving optimised asthma therapy in the previous 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.
The Asthma Control Questionnaire (5 item version) or ACQ-IA assessment of the patient's response to this initial course of treatment, the assessment of oral corticosteroid dose, and the assessment of exacerbation rate should be made at around 22 to 26 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.
This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with omalizumab.
A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased.
At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab of up to 28 weeks, consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Severe Allergic Asthma Initial PBS Authority Application - Supporting Information form,
which includes the following:
(i) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and
(ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and
(c) the IgE result; and
(d) Asthma Control Questionnaire (ACQ-5) score or the Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.

Compliance with Written Authority Required procedures

 

C9882

 

Uncontrolled severe allergic asthma
Balance of supply in a patient aged 6 to 12 years
Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.
Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete 28 weeks treatment; OR
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 28 weeks treatment available under the Initial restriction or up to 24 weeks treatment available under the Continuing restriction.

Compliance with Authority Required procedures

 

C9886

 

Uncontrolled severe allergic asthma
Continuing treatment
Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma.
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must be aged 12 years or older.
An adequate response to omalizumab treatment is defined as:
(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR
(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-IA score from baseline less than or equal to 0.5, OR
(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction).
All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment, the assessment of oral corticosteroid dose or the assessment of time adjusted exacerbation rate must be made at around 18 to 22 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.
The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this drug.
Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.
A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle.
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of this biological medicine consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for up to 24 weeks of therapy.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Allergic Asthma PBS Authority Application and Supporting Information Form which includes details of maintenance oral corticosteroid dose; or
(c) a completed Asthma Control Questionnaire (ACQ-5) calculation sheet including the date of assessment of the patient's symptoms and is endorsed with the signature of the prescriber; for patients transitioned from the paediatric to the adolescent/adult restrictions an exacerbation calculation sheet may be submitted.

Compliance with Written Authority Required procedures

 

C9916

 

Uncontrolled severe allergic asthma
Initial treatment - Initial 2 (Change of treatment)
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must be under the care of the same physician for at least 6 months; OR
Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND
Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND
Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the past 12 months or in the 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; AND
Patient must have total serum human immunoglobulin E greater than or equal to 30 IU/mL, measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; AND
Patient must not receive more than 32 weeks of treatment under this restriction; AND
The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma.
Patient must be aged 12 years or older.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Allergic Asthma (omalizumab) Initial PBS Authority Application - Supporting Information Form, which includes the following:
(i) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment; and
(iii) the IgE results; and
(iv) the reason for switching therapy (i.e. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.
An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 26 to 30 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.
This assessment at around 26 to 30 weeks, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine.
At the time of the authority application, medical practitioners should request an appropriate maximum quantity based on IgE level and body weight (refer to the TGA-approved Product Information) to be administered every 2 to 4 weeks and up to 7 repeats to provide for an initial course sufficient for up to 32 weeks of therapy.
A multidisciplinary severe asthma clinic team comprises of:
A respiratory physician; and
A pharmacist, nurse or asthma educator.

Compliance with Written Authority Required procedures

[28]           Schedule 3, entry for Sirolimus

                   (a)        omit:

 

C9693

 

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

Compliance with Authority Required procedures - Streamlined Authority Code 9693

                   (b)        insert in numerical order after existing text:

 

C9914

 

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

[29]           Schedule 3, after entry for Tenofovir with emtricitabine and rilpivirine

                           insert:

Tezacaftor with ivacaftor and ivacaftor

C9846

 

Cystic fibrosis - one residual function (RF) mutation
Initial treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have at least one residual function (RF) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor with ivacaftor; AND
Patient must have F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on at least 1 allele; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities.
Patient must be 12 years of age or older.
The patient must be registered in the Australian Cystic Fibrosis Database Registry.
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug.
For the purposes of this restriction, the list of mutations considered to be responsive to tezacaftor with ivacaftor is defined in the TGA approved product information.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis tezacaftor with ivacaftor Authority Application Supporting Information Form; and
(3) a copy of the pathology report detailing the molecular testing for the patient having at least one RF mutation on the CFTR gene; and
(4) the result of a FEV1measurement performed within a month prior to the date of application. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1is measured; and
(5) CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics; and
(6) height and weight measurements at the time of application; and
(7) a baseline measurement of the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 12 months.
For patients who have initiated non-PBS subsidised treatment prior to 1 December 2019, date of initiating treatment, baseline FEV1and hospitalisation dates prior to initiating treatment (where available) should be provided.

Compliance with Written Authority Required procedures

 

C9880

 

Cystic fibrosis - homozygous for the F508del mutation
Continuing treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be 12 years of age or older.
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug.
Patients who have an acute infective exacerbation at the time of assessment for continuing therapy may receive an additional one month's supply in order to enable the assessment to be repeated following resolution of the exacerbation.
For the purposes of this restriction, PBS subsidised 'CFTR modulator' means ivacaftor, lumacaftor/ivacaftor and tezacaftor/ivacaftor.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis tezacaftor with ivacaftor Continuing Authority Application Supporting Information Form; and
(3) the result of a FEV1measurement performed within a month prior to the date of application. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1is measured; and
(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics; and
(5) height and weight measurements at the time of application; and
(6) the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 6 months.

Compliance with Written Authority Required procedures

 

C9960

 

Cystic fibrosis - one residual function (RF) mutation
Continuing treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be 12 years of age or older.
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug.
Patients who have an acute infective exacerbation at the time of assessment for continuing therapy may receive an additional one month's supply in order to enable the assessment to be repeated following resolution of the exacerbation.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis tezacaftor with ivacaftor Continuing Authority Application Supporting Information Form; and
(3) the result of a FEV1measurement performed within a month prior to the date of application. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1is measured; and
(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics; and
(5) height and weight measurements at the time of application; and
(6) the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 6 months.

Compliance with Written Authority Required procedures

 

C9961

 

Cystic fibrosis - homozygous for the F508del mutation
Initial treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities.
Patient must be 12 years of age or older.
The patient must be registered in the Australian Cystic Fibrosis Database Registry.
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug.
For the purposes of this restriction, PBS subsidised 'CFTR modulator' means ivacaftor, lumacaftor/ivacaftor and tezacaftor/ivacaftor.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis tezacaftor with ivacaftor Authority Application Supporting Information Form; and
(3) a copy of the pathology report detailing the molecular testing for the patient being homozygous for the F508del mutation on the CFTR gene; and
(4) the result of a FEV1measurement performed within a month prior to the date of application. Note: FEV1must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1is measured; and
(5) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics; and
(6) height and weight measurements at the time of application; and
(7) a baseline measurement of the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 12 months.
For patients who have initiated non-PBS subsidised treatment prior to 1 December 2019, date of initiating treatment, baseline FEV1and hospitalisation dates prior to initiating treatment (where available) should be provided.

Compliance with Written Authority Required procedures