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

Case

PB 113 of 2021

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

National Health Act 1953

I, DAVID LAFFAN, Assistant Secretary, 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     28 October 2021

DAVID LAFFAN

Assistant Secretary

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 (November Update) Instrument 2021.

(2)This instrument may also be cited as PB 113 of 2021.

  1. 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 November 2021 1 November 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Note:          This table relates only to the provisions of this instrument as originally made.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.

  1. Authority

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

  1. 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 1—Amendments

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

  1. Schedule 1, entry for Abatacept

insert in numerical order in the column headed “Circumstances”: C12372 C12375 C12384

  1. Schedule 1, entry for Adalimumab

substitute:

Adalimumab Injection 20 mg in 0.2 mL pre-filled syringe Injection Humira C12111 C12112 C12114 C12117 C12120 C12166 C12169 C12355 C12373 See Schedule 2 See Schedule 2
Injection 20 mg in 0.4 mL pre-filled syringe Injection Amgevita C11526 C12111 C12112 C12114 C12116 C12117 C12120 C12166 C12169 C12355 C12373 See Schedule 2 See Schedule 2
Injection 40 mg in 0.4 mL pre-filled pen Injection Humira C12111 C12112 C12114 C12117 C12120 C12166 C12169 C12355 C12373 See Schedule 2 See Schedule 2
Injection 40 mg in 0.4 mL pre-filled syringe Injection Humira C12111 C12112 C12114 C12117 C12120 C12166 C12169 C12355 C12373 See Schedule 2 See Schedule 2
Injection 40 mg in 0.8 mL pre-filled pen Injection Amgevita C11526 C12111 C12112 C12114 C12116 C12117 C12120 C12166 C12169 C12355 C12373 See Schedule 2 See Schedule 2
Hadlima C11526 C12111 C12112 C12114 C12116 C12117 C12120 C12166 C12169 C12355 C12373 See Schedule 2 See Schedule 2
Hyrimoz C11526 C12111 C12112 C12114 C12116 C12117 C12120 C12166 C12169 C12355 C12373 See Schedule 2 See Schedule 2
Idacio C11526 C12111 C12112 C12114 C12116 C12117 C12120 C12166 C12169 C12355 C12373 See Schedule 2 See Schedule 2
Injection 40 mg in 0.8 mL pre-filled syringe Injection Amgevita C11526 C12111 C12112 C12114 C12116 C12117 C12120 C12166 C12169 C12355 C12373 See Schedule 2 See Schedule 2
Hadlima C11526 C12111 C12112 C12114 C12116 C12117 C12120 C12166 C12169 C12355 C12373 See Schedule 2 See Schedule 2
Hyrimoz C11526 C12111 C12112 C12114 C12116 C12117 C12120 C12166 C12169 C12355 C12373 See Schedule 2 See Schedule 2
Idacio C11526 C12111 C12112 C12114 C12116 C12117 C12120 C12166 C12169 C12355 C12373 See Schedule 2 See Schedule 2

  1. Schedule 1, entry for Azacitidine

omit:

Vidaza C6132 C6143 C6144 C6177 C6186 C6199 See Schedule 2 See Schedule 2

  1. Schedule 1, entry for Darunavir

omit:

Tablet 150 mg (as ethanolate) Oral Prezista C5094 240 5

  1. Schedule 1, entry for Etanercept in each of the forms: Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes solvent 1 mL; Injections 50 mg in 1 mL single use pre‑filled syringes, 4; and Injection 50 mg in 1 mL single use auto‑injector, 4

insert in numerical order in the column headed “Circumstances”: C12357 C12358

  1. Schedule 1, omit entry for Grazoprevir with elbasvir

  1. Schedule 1, entry for Infliximab

insert in numerical order in the column headed “Circumstances” (all instances): C12361 C12362

  1. Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 500 mg in 50 mL

insert in numerical order in the column headed “Circumstances” (all instances): C12379

  1. Schedule 1, after entry for Tocilizumab in the form Concentrate for injection 80 mg in 4 mL

insert:

Concentrate for injection 80 mg in 4 mL s19A Injection RoActemra C10532 C10535 C10536 C10567 C10570 C10571 See Schedule 2 See Schedule 2

  1. Schedule 1, after entry for Tocilizumab in the form Concentrate for injection 200 mg in 10 mL

insert:

Concentrate for injection 200 mg in 10 mL s19A Injection RoActemra C10532 C10535 C10536 C10567 C10570 C10571 See Schedule 2 See Schedule 2

  1. Schedule 1, after entry for Tocilizumab in the form Concentrate for injection 400 mg in 20 mL

insert:

Concentrate for injection 400 mg in 20 mL s19A Injection RoActemra C10532 C10535 C10536 C10567 C10570 C10571 See Schedule 2 See Schedule 2

  1. Schedule 2, entry for Abatacept

substitute:

Abatacept C8638, C11806 1 dose Sufficient for treatment for 16 weeks
C8748, C11795 1 dose 4
C12384 1 dose 5
C8627, C8655, C12372, C12375 1 dose Sufficient for treatment for 24 weeks

  1. Schedule 2, entry for Adalimumab

substitute:

Adalimumab C12111, C12117, C12120, C12169 2 doses 3
C11526, C12112, C12114, C12116, C12166, C12355, C12373 2 doses 5

  1. Schedule 2, entry for Etanercept

substitute:

Etanercept C9417, C10548, C10578, C10599 Sufficient for treatment for 4 weeks 3
C9384, C10579, C12357, C12358 Sufficient for treatment for 4 weeks 5

  1. Schedule 2, entry for Infliximab

substitute:

Infliximab C8800, C8801, C8885, C8886, C8983, C9110, C9111, C9169, C9191, C9400, C9401, C9402, C9558, C9559, C9587, C9877, C9994 1 dose of 5 mg per kg of patient weight 3
C8646, C8886, C9111, C12024, C12039, C12061, C12361 1 dose of 3 mg per kg of patient weight 3
C7777, C8296, C8745, C8844, C8940, C9068, C9188, C9472, C9481, C9487, C9584, C9602, C9621, C9668, C9669, C12004, C12058, C12067, C12075, C12362 1 dose of 3 mg per kg of patient weight 2
C4524, C7777, C8296, C8745, C8881, C8883, C8941, C8962, C9065, C9067, C9068, C9487, C9669, C9677, C9719, C9721, C9732, C9751, C9752, C9754, C9775, C9779, C9783, C9787, C9799, C9803, C9900, C12003, C12007, C12025, C12042, C12043, C12049, C12051, C12059, C12063, C12069, C12074, C12076, C12313 1 dose of 5 mg per kg of patient weight 2

  1. Schedule 2, entry for Rituximab

substitute:

Rituximab C7021, C7022, C9344, C9511, C9448, C9450, C9340, C11749, C11812 2 doses Sufficient for treatment for 4 weeks
C12379 2 doses 0
C9446, C9611 2 doses 1
C9336, C9539, C9641, C9640 3 doses 5

  1. Schedule 3, entry for Abatacept

insert in numerical order after existing text:

C12372 Severe active rheumatoid arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab) - Balance of Supply
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 received insufficient therapy with this drug for this condition under the Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab) restriction to complete 24 weeks treatment, depending on the dosage regimen; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. 		Compliance with Authority Required procedures
C12375 Severe active rheumatoid arthritis
First continuing treatment - Critical shortage of tocilizumab - Temporary listing
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 received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); 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; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
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 including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The 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 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 has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. 		Compliance with Written Authority Required procedures
C12384

Severe active rheumatoid arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab)

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 been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
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 including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
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).
If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided.
If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion.
Up to a maximum of 5 repeats will be authorised.

 Compliance with Written Authority Required procedures

  1. Schedule 3, entry for Adalimumab

insert in numerical order after existing text:

C12355 Severe active juvenile idiopathic arthritis
First continuing treatment - Critical shortage of tocilizumab - Temporary listing
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 under Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); 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.
Patient must be under 18 years of age.
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) 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 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 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 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.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. 		Compliance with Written Authority Required procedures
C12373 Severe active juvenile idiopathic arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab)
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 been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 24 weeks of treatment under this restriction; 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.
Patient must be under 18 years of age.
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).
If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided.
If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab.
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 5 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.
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.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. 		Compliance with Written Authority Required procedures

  1. Schedule 3, entry for Etanercept

insert in numerical order after existing text:

C12357 Severe active juvenile idiopathic arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab)
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 been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 24 weeks of treatment under this restriction; 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.
Patient must be under 18 years of age.
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 to provide sufficient for four weeks of treatment. Up to a maximum of 5 repeats will be authorised.
If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided.
If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab.
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).
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. 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.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. 		Compliance with Written Authority Required procedures
C12358 Severe active juvenile idiopathic arthritis
First continuing treatment - Critical shortage of tocilizumab - Temporary listing
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 under Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); 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.
Patient must be under 18 years of age.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
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) 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 injections to provide sufficient for four weeks of treatment. Up to a maximum of 5 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. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
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.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. 		Compliance with Written Authority Required procedures

  1. Schedule 3, omit entry for Grazoprevir with elbasvir

  1. Schedule 3, entry for Infliximab

insert in numerical order after existing text:

C12361 Severe active rheumatoid arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab)
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 been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 22 weeks of treatment under this restriction; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
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 including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
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).
If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided.
If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.
Up to a maximum of 3 repeats will be authorised. 		Compliance with Written Authority Required procedures
C12362 Severe active rheumatoid arthritis
First continuing treatment - Critical shortage of tocilizumab - Temporary listing
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 received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; 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.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
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 including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
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 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 has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.
Up to a maximum of 2 repeats will be authorised.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. 		Compliance with Written Authority Required procedures

  1. Schedule 3, entry for Rituximab

insert in numerical order after existing text:

C12379 Severe active rheumatoid arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab)
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 been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must have failed to respond to at least 1 PBS-subsidised tumour necrosis factor (TNF) alfa antagonist for this condition; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND
Patient must not receive more than 2 infusions of this drug 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 including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
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).
If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided.
If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
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.
A patient may qualify to receive a further course of treatment (every 24 weeks) with this drug provided they have demonstrated an adequate response to treatment following a minimum of 12 weeks after the first infusion of their most recent treatment with this drug. The demonstration of response must be submitted within 4 weeks of assessment.
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.
A patient whose most recent course of PBS-subsidised therapy was with this drug and whose response to this treatment is demonstrated at 12 weeks, may apply for a further course of this drug under the First continuing treatment restriction.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
If a patient fails to demonstrate a response to this drug and who qualifies to trial an alternate biological medicine according to the interchangeability arrangements for biological medicines for the treatment of severe rheumatoid arthritis, may do so without having to have a 22 week treatment-free period. 		Compliance with Written Authority Required procedures
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