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PB 91 of 2021 Arrangements as made
This instrument amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021) to add three forms to the listed drug deferasirox, delete the listed drug interferon alfa 2a and alter circumstances for prescribing various listed drugs.
Administered by: Health
Registered 31 Aug 2021
Tabling HistoryDate
Tabled HR01-Sep-2021
Tabled Senate02-Sep-2021
To be repealed 11 Feb 2022
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

Commonwealth Coat of Arms of Australia

 

PB 91 of 2021

 

National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (September Update) Instrument 2021

 

National Health Act 1953

 

I, MARIANA CRANK, Assistant Secretary (Acting), Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under subsection 100(2) of the National Health Act 1953.

Date                 27 August 2021

 

 

 

 

 

 

 

MARIANA CRANK

Assistant Secretary (Acting)

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

 

 


Contents

1......... Name............................................................................................................................... 1

2......... Commencement............................................................................................................... 1

3......... Authority......................................................................................................................... 1

4......... Schedules......................................................................................................................... 1

Schedule 1—Amendments                                                                                                                          2

National Health (Highly Specialised Drugs Program) Special Arrangement 2021
(PB 27 of 2021)
                                                                                                                                      2

 

 

 


1      Name

(1)          This instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (September Update) Instrument 2021.

(2)          This instrument may also be cited as PB 91 of 2021.

2      Commencement

(1)          Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

1 September 2021

1 September 2021

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)          Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3      Authority

This instrument is made under subsection 100(2) National Health Act 1953.

4      Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

 

 

 

 


Schedule 1Amendments

National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021)

[1]        Part 1, Division 1, Section 6, definition for “medication for the treatment of hepatitis B

substitute:

medication for the treatment of hepatitis B means any of the following:

(a) adefovir;

(b) entecavir;

(c) lamivudine;

(d) tenofovir.

[2]        Schedule 1, entry for Adalimumab in the form Injection 20 mg in 0.2 mL pre-filled syringe

omit from the column headed “Circumstances”: C9384 C9417 C10582 C10583 C10619 C11520 C11521  substitute: C12111 C12112 C12114 C12117 C12120 C12166 C12169

[3]        Schedule 1, entry for Adalimumab in the form Injection 20 mg in 0.4 mL pre-filled syringe

substitute:

 

Injection 20 mg in 0.4 mL pre-filled syringe

Injection

Amgevita

C12111 C12112 C12114 C12117 C12120 C12166 C12169

 

See Schedule 2

See Schedule 2

 

 

 

Humira

C9384 C9417 C10582 C10583 C10619 C11520 C11521

 

See Schedule 2

See Schedule 2

 

 

 

Amgevita

C11526 C12116

 

2

5

[4]        Schedule 1, entry for Adalimumab in each of the forms: Injection 40 mg in 0.4 mL pre-filled pen; and Injection 40 mg in 0.4 mL pre-filled syringe

omit from the column headed “Circumstances”: C9384 C9417 C10582 C10583 C10619 C11520 C11521  substitute: C12111 C12112 C12114 C12117 C12120 C12166 C12169

[5]        Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen

substitute:

 

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Amgevita

C12111 C12112 C12114 C12117 C12120 C12166 C12169

 

See Schedule 2

See Schedule 2

 

 

 

Hadlima

C12111 C12112 C12114 C12117 C12120 C12166 C12169

 

See Schedule 2

See Schedule 2

 

 

 

Humira

C12111 C12112 C12114 C12117 C12120 C12166 C12169

 

See Schedule 2

See Schedule 2

 

 

 

Hyrimoz

C12111 C12112 C12114 C12117 C12120 C12166 C12169

 

See Schedule 2

See Schedule 2

 

 

 

Idacio

C12111 C12112 C12114 C12117 C12120 C12166 C12169

 

See Schedule 2

See Schedule 2

 

 

 

Amgevita

C11526 C12116

 

2

5

 

 

 

Hadlima

C11526 C12116

 

2

5

 

 

 

Hyrimoz

C11526 C12116

 

2

5

 

 

 

Idacio

C11526 C12116

 

2

5

[6]        Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe

substitute:

 

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Amgevita

C12111 C12112 C12114 C12117 C12120 C12166 C12169

 

See Schedule 2

See Schedule 2

 

 

 

Hadlima

C12111 C12112 C12114 C12117 C12120 C12166 C12169

 

See Schedule 2

See Schedule 2

 

 

 

Humira

C12111 C12112 C12114 C12117 C12120 C12166 C12169

 

See Schedule 2

See Schedule 2

 

 

 

Hyrimoz

C12111 C12112 C12114 C12117 C12120 C12166 C12169

 

See Schedule 2

See Schedule 2

 

 

 

Idacio

C12111 C12112 C12114 C12117 C12120 C12166 C12169

 

See Schedule 2

See Schedule 2

 

 

 

Amgevita

C11526 C12116

 

2

5

 

 

 

Hadlima

C11526 C12116

 

2

5

 

 

 

Hyrimoz

C11526 C12116

 

2

5

 

 

 

Idacio

C11526 C12116

 

2

5

[7]        Schedule 1, after entry for Deferasirox in the form Tablet 90 mg

insert:

 

Tablet, dispersible, 125 mg

Oral

Deferasirox Juno

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

168

2

 

 

 

 

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

168

5

[8]        Schedule 1, after entry for Deferasirox in the form Tablet 180 mg

insert:

 

Tablet, dispersible, 250 mg

Oral

Deferasirox Juno

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

168

2

 

 

 

 

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

168

5

[9]        Schedule 1, after entry for Deferasirox in the form Tablet 360 mg

insert:

 

Tablet, dispersible, 500 mg

Oral

Deferasirox Juno

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

168

2

 

 

 

 

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

168

5

[10]      Schedule 1, omit entry for Interferon Alfa‑2a

[11]      Schedule 1, entry for Teduglutide

(a)        omit from the column headed “Circumstances”: C9569 C9740 C9793 C9829

(b)        insert in numerical order in the column headed “Circumstances”: C12094 C12145 C12146 C12186

[12]      Schedule 1, entry for Tocilizumab in each of the forms: Concentrate for injection 80 mg in 4 mL; Concentrate for injection 200 mg in 10 mL; and Concentrate for injection 400 mg in 20 mL

(a)        omit from the column headed “Circumstances”: C9496

(b)        insert in numerical order in the column headed “Circumstances”: C12163

[13]      Schedule 1, entry for Vedolizumab

(a)        omit from the column headed “Circumstances”: C9682 C9683 C9708

(b)        omit from the column headed “Circumstances”: C9739

(c)        omit from the column headed “Circumstances”: C9792 C9796 C9815 C9825

(d)        insert in numerical order in the column headed “Circumstances”: C12080 C12083 C12135 C12137 C12179 C12219 C12220 C12221

[14]      Schedule 2, entry for Adalimumab

substitute:

Adalimumab

 

C9417, C10582, C10583, C10619, C12111, C12117, C12120, C12169

2 doses

3

 

C9384, C11520, C11521, C11526, C12112, C12114, C12116, C12166

2 doses

5

[15]      Schedule 2, entry for Teduglutide

substitute:

Teduglutide

C12094, C12145, C12186

1 pack

5

 

C11999, C12146

1 pack

11

[16]      Schedule 2, entry for Tocilizumab

substitute:

Tocilizumab

C8635, C8638, C9386, C9407, C9417, C9494, C10541, C10545, C10616, C11752, C11782, C12163

1 infusion

3

 

C10532, C10535, C10567, C10570

2 infusions

3

 

C8627, C8637, C9380, C9384, C9495, C10542

1 infusion

5

 

C10536, C10571

2 infusions

5

[17]      Schedule 2, entry for Vedolizumab

substitute:

Vedolizumab

C12080, C12083, C12135, C12137, C12179, C12219, C12220, C12221

1

2

 

C9738, C9771

1

Sufficient for treatment for 24 weeks

[18]      Schedule 3, entry for Adalimumab

insert in numerical order after existing text:

 

C12111

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
An adequate response to treatment is defined as:
(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, cervical spine 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).
At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide a sufficient amount for two doses. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months 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.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Written Authority Required procedures

 

C12112

 

Severe active juvenile idiopathic arthritis
Continuing treatment - balance of supply
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.

Compliance with Authority Required procedures

 

C12114

 

Severe active juvenile idiopathic arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
An adequate response to treatment is defined as:
(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, cervical spine 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).
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count submitted with the initial treatment application.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide a sufficient amount for two doses. Up to a maximum of 5 repeats will be authorised.
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months 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.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.
Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.

Compliance with Written Authority Required procedures

 

C12116

 

Severe active juvenile idiopathic arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
An adequate response to treatment is defined as:
(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, cervical spine 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).
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count submitted with the initial treatment application.
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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months 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.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Authority Required procedures - Streamlined Authority Code 12116

 

C12117

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or (ii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
(a) an active joint count of at least 20 active (swollen and tender) joints; OR
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide a sufficient amount for two doses. Up to a maximum of 3 repeats will be authorised.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C12120

 

Severe active juvenile idiopathic arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) - balance of supply
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.

Compliance with Authority Required procedures

 

C12166

 

Severe active juvenile idiopathic arthritis
First continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
An adequate response to treatment is defined as:
(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, cervical spine 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).
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count submitted with the initial treatment application.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide a sufficient amount for two doses. Up to a maximum of 5 repeats will be authorised.
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months 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.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Written Authority Required procedures

 

C12169

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Active joints are defined as:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count must be no more than 4 weeks old at the time of this application.
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 active joints, the response must be demonstrated on the total number of active joints.
At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide a sufficient amount for two doses. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

[19]      Schedule 3, omit entry for Interferon alfa‑2a

[20]      Schedule 3, entry for Teduglutide

(a)        omit:

 

C9569

 

Type III Short bowel syndrome with intestinal failure
Initial treatment
Must be treated by a gastroenterologist; OR
Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
Patient must have short bowel syndrome with intestinal failure following major surgery; AND
Patient must have a history of dependence on parenteral support for at least 12 months; AND
Patient must have received a stable parenteral support regimen for at least 3 days per week in the previous 4 weeks; AND
Patient must not have active gastrointestinal malignancy or history of gastrointestinal malignancy within the last 5 years; AND
The treatment must not exceed 12 months under this restriction; AND
Patient must not have previously received PBS‑subsidised treatment with this drug for this condition.
Baseline is the mean number of days of parenteral support per week over the four weeks immediately prior to initiating treatment with teduglutide under the PBS initial treatment restriction or four weeks immediately prior to initiating treatment with non‑PBS subsidised teduglutide for grandfathered patients.
A stable parenteral support regimen is defined as a minimum of 3 days of parenteral support (parenteral nutrition with or without IV fluids) per week for 4 consecutive weeks to meet caloric, fluid or electrolyte needs.
Baseline number of days of parenteral support should be documented in the patient’s medical records.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Short bowel syndrome with intestinal failure form; and
(3) details of baseline mean number of days on parenteral support per week for 4 consecutive weeks immediately preceding this application; and
(4) documented duration in months of prior dependence on parenteral support.

Compliance with Written Authority Required procedures

 

C9740

 

Type III Short bowel syndrome with intestinal failure
Subsequent continuing treatment
Must be treated by a gastroenterologist; OR
Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
Patient must have received PBS‑subsidised first‑continuing treatment with this drug for this condition and achieved a treatment response in the preceding treatment period; OR
Patient must have received PBS‑subsidised recommencement of treatment following a trial cessation period and not have previously experienced a failure to respond to treatment with this drug for this condition.
Treatment response
For applications for subsequent continuing treatment, treatment response is when there was a reduction in the mean number of days of parenteral support of at least 1 day per week since the last assessment for PBS‑subsidised treatment,
OR where a patient has completely ceased treatment with parenteral support for a period of at least 4 consecutive weeks.
The current mean number of days of parenteral support is calculated as the mean number of days in which any parenteral support is required (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over the immediately preceding 4 week treatment period
Treatment failure
For applications for subsequent continuing treatment, failure of treatment is defined as an increase in the mean number of days per week of parenteral support requirements of at least 1 day per week over the preceding 4 week period compared to the last assessment for PBS‑subsidised treatment of parenteral support (parenteral nutrition with or without IV fluids) to meet caloric, fluid or electrolyte needs.
Patients who experience failure of treatment must permanently discontinue treatment.
Treatment stability
Patients who neither demonstrate a treatment response nor a treatment failure since the last assessment for PBS‑subsidised treatment are considered to have a stable parenteral support regimen, defined as the same mean number of days of parenteral support (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over the 4 weeks preceding treatment period, where the number of days is greater than zero and the mean number of days of parenteral support is less than baseline. Patients with a stable parenteral support regimen over 6 months must undertake a trial cessation period. Patients who have re‑commenced after a trial cessation period are exempt from further trial cessation.
Trial cessation period
Patients who demonstrate a stable frequency of mean days per week of parenteral support in a 6‑month period commencing after the initial 12 months of treatment with this drug for this condition are required to undertake a trial of treatment cessation. Patients who have re‑commenced after a trial cessation period are exempt from further trial cessation.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Short bowel syndrome with intestinal failure Form; and
(3) details of the mean number of days reduction of parenteral support (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over the preceding treatment period or confirmation the patient has had 4 consecutive weeks without parenteral support (if applicable); and
(4) the current mean number of days per week of parenteral support over the preceding 4 week period.

Compliance with Written Authority Required procedures

 

C9793

 

Type III Short bowel syndrome with intestinal failure
First continuing treatment
Must be treated by a gastroenterologist; OR
Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
Patient must have previously received PBS‑subsidised initial treatment with this drug for this condition; OR
Patient must have received PBS‑subsidised treatment with this drug for this condition as a grandfathered patient; AND
Patient must have a reduction in parenteral support frequency of at least one day per week compared to the mean number of days per week at baseline.
Baseline is the mean number of days of parenteral support per week over the four weeks immediately prior to initiating treatment with teduglutide under the PBS initial treatment restriction or four weeks immediately prior to initiating treatment with non‑PBS subsidised teduglutide for grandfathered patients.
The current mean number of days of parenteral support is calculated as the mean number of days in which any parenteral support is required (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over the immediately preceding 4 week treatment period
Treatment failure
For applications for first continuing treatment, failure of treatment is defined as no change compared to baseline in the mean number of days per week in parenteral support (parenteral nutrition with or without IV fluids) to meet caloric, fluid or electrolyte needs.
Patients who experience failure of treatment must permanently discontinue treatment.
Current mean number of days of parenteral support should be documented in the patient’s medical records.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Short bowel syndrome with intestinal failure Form; and
(3) details of the mean number of days reduction of parenteral support (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs from baseline; and
(4) the current mean number of days per week of parenteral support over the preceding 4 week period.

Compliance with Written Authority Required procedures

 

C9829

 

Type III Short bowel syndrome with intestinal failure
Recommencement of treatment
Must be treated by a gastroenterologist; OR
Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
Patient must have received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have undertaken a trial cessation period due to experiencing a stable parenteral support regimen in the first continuing or subsequent continuing treatment phase, and not due to a treatment failure; AND
Patient must have experienced deterioration during a trial cessation period.
Trial cessation period
Patients who demonstrate a stable frequency of mean days per week of parenteral support in a 6‑month period commencing after the initial 12 months of treatment with this drug for this condition are required to undertake a trial of treatment cessation. Patients who have re‑commenced after a trial cessation period are exempt from further trial cessation.
Deterioration during the trial cessation period includes an increase in parenteral support frequency of more than or equal to one day per week from the pre‑cessation level, or other clinical parameters suggestive of deterioration including changes in renal function or urinary sodium levels or changes in body weight.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Short bowel syndrome with intestinal failure Form; and
(3) details of the reason for recommencement after trial cessation; and
(4) the current mean number of days per week of parenteral support over the preceding 4 week period
(5) details of completion of the trial cessation period including the start and end date.

Compliance with Authority Required procedures

(b)        insert in numerical order after existing text:

 

C12094

 

Type III Short bowel syndrome with intestinal failure
First continuing treatment
Must be treated by a gastroenterologist; OR
Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
Patient must have previously received PBS-subsidised initial treatment with this drug for this condition; OR
Patient must have received PBS-subsidised treatment with this drug for this condition as a grandfathered patient; AND
Patient must have a reduction in parenteral support frequency of at least one day per week compared to the mean number of days per week at baseline; AND
Patient must have, as a patient yet to turn 18 years of age, a reduction in the mean weekly parenteral support volume of at least 20% (mL per kg of body weight) relative to baseline.
Refer to the measurement(s) stated in the Initial treatment authority application for the baseline dependence on parenteral support. Determine the current mean use per week of parental support in days (for a patient of any age) and/or the mean volume per week in mL per kg (for a patient yet to turn 18 years of age). State these values in this authority application.
The current mean number of days of parenteral support is calculated as the mean number of days in which any parenteral support is required (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over the immediately preceding 4 week treatment period
The current mean weekly parenteral support volume is calculated as the mean mL per kg of body weight of parenteral support (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over the immediately preceding 4 week treatment period.
From 1 September 2021
Where the mean weekly volume of parenteral support in terms of mL per kg of body weight for 4 consecutive weeks has not been stated in an Initial treatment authority application for a patient yet to turn 18 years of age, provide in this authority application both:
(i) a known or estimated retrospective baseline value that would have applied to the patient immediately before commencing treatment with this drug, and
(ii) the current value (observed over the preceding 4 weeks)
Provide these values for a child only where mean weekly volume is to be used as an alternative response assessment to mean days of parenteral support per week. Otherwise, continue to use mean days per week.
A patient who has turned 18 years of age since their last authority application may be assessed for response using either the mean number of days of parenteral support or mean volume of parenteral support. Any subsequent authority application after this application must be assessed using the mean number of days of parenteral support.
Patients who do not meet the clinical criteria with respect to demonstrating the minimum reduction in parenteral support must permanently discontinue PBS subsidy.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

 

C12145

 

Type III Short bowel syndrome with intestinal failure
Recommencement of treatment
Must be treated by a gastroenterologist; OR
Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
Patient must have received PBS-subsidised treatment with this drug for this condition; AND
Patient must have undertaken a trial cessation period due to experiencing a stable parenteral support regimen in the first continuing or subsequent continuing treatment phase, and not due to a treatment failure; AND
Patient must have undertaken a trial cessation period for any medical reason other than lack of treatment efficacy; AND
Patient must have experienced deterioration during a trial cessation period.
Deterioration during the trial cessation period includes an increase in parenteral support use, as well as changes in renal function, urinary sodium levels and changes in body weight in the absence of an increase in parenteral support use. This is not an exhaustive list of the signs/symptoms of disease deterioration - the treating physician must be satisfied that in the absence of treatment with this drug, the patient's condition has deteriorated.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

 

C12146

 

Type III Short bowel syndrome with intestinal failure
Initial treatment
Must be treated by a gastroenterologist; OR
Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
Patient must have short bowel syndrome with intestinal failure following major surgery; AND
Patient must have a history of dependence on parenteral support for at least 12 months; AND
Patient must have received a stable parenteral support regimen for at least 3 days per week in the previous 4 weeks; AND
Patient must not have active gastrointestinal malignancy or history of gastrointestinal malignancy within the last 5 years; AND
The treatment must not exceed 12 months under this restriction; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition.
Provide a baseline value in this authority application of the amount of parenteral support per week, expressed as either:
(i) for a patient of any age, the mean number of days of parenteral support per week
(ii) for a patient yet to turn 18 years of age, the mean volume of parenteral support per week in mL per kg.
Determine the mean over the four weeks immediately prior to this authority application. For a patient yet to turn 18 years or age, both (i) and (ii) may be supplied, but provide at least (i). Assessment of treatment response/non-response in the 'First continuing treatment' authority application will be compared against the baseline value(s) submitted in this application.
A stable parenteral support regimen is defined as a minimum of 3 days of parenteral support (parenteral nutrition with or without IV fluids) per week for 4 consecutive weeks to meet caloric, fluid or electrolyte needs.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

 

C12186

 

Type III Short bowel syndrome with intestinal failure
Subsequent continuing treatment
Must be treated by a gastroenterologist; OR
Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
Patient must have received PBS-subsidised first-continuing treatment with this drug for this condition and achieved a treatment response in the preceding treatment period; OR
Patient must have received PBS-subsidised recommencement of treatment following a trial cessation period and not have previously experienced a failure to respond to treatment with this drug for this condition.
Treatment response
Adult:
In a subsequent continuing treatment application, treatment response in a patient aged at least 18 years is one of:
(i) a reduction in the mean number of days of parenteral support of at least 1 day per week since the last assessment for PBS-subsidised treatment; or
(ii) parenteral support completely ceasing (due to clinical benefit from this drug) for a period of at least 4 consecutive weeks
Child (yet to turn 18 years of age):
In a subsequent continuing treatment application, treatment response in a child is one of:
(iii) a reduction in the mean number of days of parenteral support of at least 1 day per week since the last assessment for PBS-subsidised treatment; or
(iv) a reduction in the mean weekly volume of parenteral support (mL per kg of body weight) of at least 20% since the last assessment for PBS-subsidised treatment; or
(v) parenteral support completely ceasing (due to clinical benefit from this drug) for a period of at least 4 consecutive weeks.
A patient who has turned 18 years of age since their last authority application may be assessed for response using either the mean number of days of parenteral support or mean volume of parenteral support. Any subsequent authority application after this application must be assessed using the mean number of days of parenteral support.
The current mean number of days of parenteral support is calculated as the mean number of days in which any parenteral support is required (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over the immediately preceding 4 week treatment period
The current mean weekly parenteral support volume is calculated as the mean mL per kg of body weight of parenteral support (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over the immediately preceding 4 week treatment period.
Treatment failure
Adult:
In a subsequent continuing treatment application, treatment failure is defined as an increase in the mean number of days per week in parenteral support (parenteral nutrition with or without IV fluids) to meet caloric, fluid or electrolyte needs, compared to the most recent authority application.
Child (yet to turn 18 years of age):
In a subsequent continuing treatment application, treatment failure is defined as at least one of the following occurring:
(i) an increase in the mean number of days per week in parenteral support (parenteral nutrition with or without IV fluids) to meet caloric, fluid or electrolyte needs, compared to the most recent authority application; or
(ii) an increase of 20% or more in the mean weekly volume of parenteral support (mL per kg of body weight; parenteral nutrition with or without IV fluids) to meet caloric, fluid or electrolyte needs, compared to most recent authority application.
Patients who experience failure of treatment must permanently discontinue treatment.
Treatment stability
A patient who neither demonstrates a treatment response as defined above nor a treatment failure as defined above since the last assessment for PBS-subsidised treatment is considered to have 'treatment stability'.
Trial cessation period
A patient with treatment stability must undertake a trial cessation period. A patient who re-commences treatment after a trial cessation period is exempt from further trial cessation periods.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

[21]      Schedule 3, entry for Tocilizumab

(a)        omit:

 

C9496

 

Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA‑approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
If methotrexate is contraindicated according to the TGA‑approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L; AND either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application ‑ Supporting Information Form.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.
An assessment of a patient’s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

(b)        insert in numerical order after existing text:

 

C12163

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; OR
Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

[22]      Schedule 3, entry for Vedolizumab

(a)        omit:

 

C9682

 

Moderate to severe ulcerative colitis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
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 previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient’s condition; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.
A partial Mayo clinic assessment of the patient’s response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient’s most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient’s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.

Compliance with Written Authority Required procedures

 

C9683

 

Moderate to severe ulcerative colitis
Continuing treatment
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 previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose.
Up to a maximum of 2 repeats will be authorised.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Authority Required procedures

 

C9708

 

Severe Crohn disease
Initial treatment ‑ Initial 1 (new patient)
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 be aged 18 years or older.
Patient must have confirmed severe 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 failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR
Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR
Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient’s condition if relevant; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iv) the date of the most recent clinical assessment.
Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:
(a) patient must have evidence of intestinal inflammation;
(b) patient must be assessed clinically as being in a high faecal output state;
(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 1 month following cessation of the most recent prior treatment
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA‑approved Product Information, please provide details at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS‑subsidised therapy.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
The assessment of the patient’s response to this initial course of treatment must be made up to 12 weeks after the first dose (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 the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

(b)        omit:

 

C9739

 

Moderate to severe ulcerative colitis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
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 received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient’s condition if relevant; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose.
Up to a maximum of 2 repeats will be authorised.
Authority approval for sufficient therapy to complete a maximum of 3 initial doses of treatment may be requested by telephone by contacting the Department of Human Services.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient’s most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, an assessment of a patient’s response must have been conducted following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in 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:

 

C9792

 

Moderate to severe ulcerative colitis
Initial treatment ‑ Initial 1 (new patient)
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 failed to achieve an adequate response to a 5‑aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Application for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient’s condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.
A partial Mayo clinic assessment of the patient’s response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.
If treatment with any of the above‑mentioned drugs is contraindicated according to the relevant TGA‑approved Product Information, details must be provided at the time of application.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.

Compliance with Written Authority Required procedures

 

C9796

 

Severe Crohn disease
Continuing treatment
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 be aged 18 years or older.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment.
All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.
If the application is the first application for continuing treatment with this drug, an assessment of the patient's response to the initial course of treatment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide sufficient for a single infusion of 300 mg vedolizumab per dose. Up to a maximum of 2 repeats will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.

Compliance with Written Authority Required procedures

 

C9815

 

Severe Crohn disease
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
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 received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form, which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of assessment of the patient’s condition if relevant; or
(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment; and
(iv) the details of prior biological medicine treatment including the details of date and duration of treatment.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient’s most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab or ustekinumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
The assessment of the patient’s response to this initial course of treatment must be made up to 12 weeks after the first dose (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 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 the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9825

 

Severe Crohn disease
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
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 received prior PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
Patient must have confirmed severe 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 a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; OR
Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR
Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND
Patient must have evidence of intestinal inflammation; OR
Patient must be assessed clinically as being in a high faecal output state; OR
Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient’s condition if relevant; and
(ii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iii) the date of the most recent clinical assessment.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS‑subsidised therapy.
The assessment of the patient’s response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

(d)        insert in numerical order after existing text:

 

C12080

 

Moderate to severe ulcerative colitis
Initial treatment - Initial 1 (new patient)
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 failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Application for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.
A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
Details of the accepted toxicities including severity can be found on the Services Australia website.

Compliance with Written Authority Required procedures

 

C12083

 

Severe Crohn disease
Initial treatment - Initial 1 (new patient)
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 be aged 18 years or older.
Patient must have confirmed severe 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 failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR
Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR
Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iv) the date of the most recent clinical assessment.
Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:
(a) patient must have evidence of intestinal inflammation;
(b) patient must be assessed clinically as being in a high faecal output state;
(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 1 month following cessation of the most recent prior treatment
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Services Australia website.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C12135

 

Moderate to severe ulcerative colitis
Continuing treatment
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 received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; OR
Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the vedolizumab subcutaneous form continuing restriction; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose.
Up to a maximum of 2 repeats will be authorised.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Authority Required procedures

 

C12137

 

Severe Crohn disease
Continuing treatment
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 be aged 18 years or older.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; OR
Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the vedolizumab subcutaneous form continuing restriction; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment.
All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide sufficient for a single infusion of 300 mg vedolizumab per dose. Up to a maximum of 2 repeats will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.

Compliance with Written Authority Required procedures

 

C12179

 

Moderate to severe ulcerative colitis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
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 received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose.
Up to a maximum of 2 repeats will be authorised.
Authority approval for sufficient therapy to complete a maximum of 3 initial doses of treatment may be requested by telephone by contacting the Department of Human Services.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab and submitted no later than 4 weeks from the date of completion of treatment.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in 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

 

C12219

 

Moderate to severe ulcerative colitis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
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 previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.
A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
Details of the accepted toxicities including severity can be found on the Services Australia website.

Compliance with Written Authority Required procedures

 

C12220

 

Severe Crohn disease
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
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 received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form, which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of assessment of the patient's condition if relevant; or
(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment; and
(iv) the details of prior biological medicine treatment including the details of date and duration of treatment.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab or ustekinumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted no later than 4 weeks from the date that course was ceased.
If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C12221

 

Severe Crohn disease
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
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 received prior PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
Patient must have confirmed severe 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 a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; OR
Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR
Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND
Patient must have evidence of intestinal inflammation; OR
Patient must be assessed clinically as being in a high faecal output state; OR
Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iii) the date of the most recent clinical assessment.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures