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PB 80 of 2021 Other as made
This instrument amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) to add, delete and make changes to drugs, forms, manners of administration, brands, responsible person codes, authorised prescribers, maximum quantities/amounts and repeats and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).
Administered by: Health
Registered 31 Jul 2021
Tabling HistoryDate
Tabled HR03-Aug-2021
Tabled Senate03-Aug-2021
Date of repeal 19 Oct 2021
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

PB 80 of 2021

 

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No. 7)

 

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.

 

Dated              28 July                                     2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MARIANA CRANK

Assistant Secretary (Acting)

Pharmacy Branch

Technology Assessment and Access Division

Department of Health


___________________________________________________________________________

1          Name of Instrument

(1)          This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No. 7).

(2)          This Instrument may also be cited as PB 80 of 2021.

2          Commencement

This Instrument commences on 1 August 2021.

3          Amendment of National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)

Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).

 

 


Schedule 1     Amendments

[1]        Schedule 1, Part 1, entry for Atezolizumab in the form Solution concentrate for I.V. infusion 1200 mg in 20 mL

omit: C9345

[2]        Schedule 1, Part 1, entry for Blinatumomab

omit: C9878

[3]        Schedule 1, Part 1, entry for Cetuximab  in each of the forms: Solution for I.V. infusion 100 mg in 20 mL; and Solution for I.V. infusion 500 mg in 100 mL

(a)        omit: C4945 C4965

(b)        insert in numerical order in the column headed “Circumstances”: C12016 C12045

[4]        Schedule 1, Part 1, entry for Panitumumab in each of the forms: Solution concentrate for I.V. infusion 100 mg in 5 mL; and Solution concentrate for I.V. infusion 400 mg in 20 mL

(a)        omit: C5439 C5447

(b)        insert in numerical order in the column headed “Circumstances”: C12035 C12066

[5]        Schedule 1, Part 1, entry for Pembrolizumab

insert in numerical order in the column headed “Circumstances”: C11993 C12033 C12065

[6]        Schedule 1, Part 2, entry for Atezolizumab [Maximum Amount:  1200; Number of Repeats: 7]

omit from the column headed “Purposes”: P9345

[7]        Schedule 1, Part 2, entry for Blinatumomab [Maximum Amount: 651; Number of Repeats: 0]

omit from the column headed “Purposes”: P9878

[8]        Schedule 1, Part 2, entry for Cetuximab [Maximum Amount: 550; Number of Repeats: 11]

omit from the column headed “Purposes”: P4945       substitute: P12016

[9]        Schedule 1, Part 2, entry for Cetuximab [Maximum Amount: 880; Number of Repeats: 0]

(a)        omit from the column headed “Purposes”: P4965

(b)        insert in numerical order in the column headed “Purposes”: P12045

[10]      Schedule 1, Part 2, entry for Panitumumab [Maximum Amount: 720; Number of Repeats: 5]

omit from the column headed “Purposes”: P5439 P5447         substitute: P12035 P12066

[11]      Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200; Number of Repeats: 6]

insert in numerical order in the column headed “Purposes”: P11993 P12033 P12065

[12]      Schedule 2, entry for Folinic acid Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL

omit:

 

 

 

Leucovorin Calcium (Hospira Pty Limited)

PF

MP

10

2

[13]      Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg

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

 

 

 

APX-Ondansetron ODT

TY

MP

C5743

 

4

0

C

[14]      Schedule 2, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)

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

 

 

 

APX-Ondansetron

TY

MP

C5778

 

4

0

C

[15]      Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg

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

 

 

 

APX-Ondansetron ODT

TY

MP

C5743

 

4

0

C

[16]      Schedule 2, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate)

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

 

 

 

APX-Ondansetron

TY

MP

C5778

 

4

0

C

[17]      Schedule 4, entry for Atezolizumab

omit:

 

C9345

P9345

Stage IV (metastatic) non‑small cell lung cancer (NSCLC)
Grandfathering treatment
Patient must be undergoing combination treatment with bevacizumab and atezolizumab until disease progression, unless not tolerated.
The condition must be non‑squamous type non‑small cell lung cancer (NSCLC); AND
Patient must have previously received treatment with these drugs for this condition prior to 1 October 2019; AND
Patient must have stable or responding disease; AND
Patient must have a WHO performance status of 0 or 1.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 9345

[18]      Schedule 4, entry for Blinatumomab

omit:

 

C9878

P9878

Acute lymphoblastic leukaemia
Grandfather treatment
Patient must have a documented history of relapsed or refractory B‑precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND
Patient must have a documented history of receiving intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND
Patient must not have received more than 1 line of salvage therapy; AND
Patient must have a documented history of more than 5% blasts in bone marrow; AND
Patient must have received treatment with this drug for this condition prior to 1 October 2019; AND
Patient must not receive PBS‑subsidised treatment with this drug if progressive disease develops while on this drug.
An amount of 651 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 1. An amount of 784 microgram, which may be obtained through a request for an increased maximum amount, will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.
Blinatumomab is not PBS‑subsidised if it is administered to an in‑patient in a public hospital setting.
A patient may qualify for PBS‑subsidised treatment under this restriction once only.
Treatment with this drug for this condition must not exceed 5 treatment cycles in a lifetime.
Patients who have received up to 2 treatment cycles as induction therapy with this drug for this condition prior to 1 October 2019 must have achieved a complete remission or a complete remission with partial haematological recovery in order to continue with PBS‑subsidised treatment with this drug.
Patients who have received at least 1 treatment cycle as consolidation therapy with this drug for this condition prior to 1 October 2019 must have achieved a complete remission or a complete remission with partial haematological recovery in order to continue with PBS‑subsidised treatment with this drug.
Patients who fail to demonstrate a complete remission (CR) or complete remission with incomplete haematological recovery (CRi) after 2 cycles of PBS‑subsidised treatment with this agent must cease PBS‑subsidised treatment with this agent.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application ‑ Supporting Information Form; and
(3) date of the most recent blinatumomab dose, if this was for induction or consolidation therapy, and how many treatment cycle(s) of PBS‑subsidised blinatumomab will be required for completion of induction or consolidation therapy; and
(4) date of most recent chemotherapy prior to receiving non‑PBS subsidised blinatumomab, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and
(5) a copy of the most recent bone marrow biopsy report prior to receiving non‑PBS subsidised blinatumomab.

Compliance with Written Authority Required procedures

[19]      Schedule 4, entry for Cetuximab

(a)        omit:

 

C4945

P4945

Metastatic colorectal cancer
Continuing treatment
Patient must have received an initial authority prescription for this drug for treatment of RAS wild‑type metastatic colorectal cancer after failure of first‑line chemotherapy; AND
Patient must not have progressive disease; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS‑subsidised anti‑EGFR antibody therapy for this condition.
Patients who have progressive disease on panitumumab are not eligible to receive PBS‑subsidised cetuximab.
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS‑subsidised cetuximab.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 4945

 

C4965

P4965

Metastatic colorectal cancer
Initial treatment
Patient must have RAS wild‑type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have failed to respond to first‑line chemotherapy; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS‑subsidised anti‑EGFR antibody therapy for this condition.
Patients who have progressive disease on panitumumab are not eligible to receive PBS‑subsidised cetuximab.
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS‑subsidised cetuximab.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 4965

(b)        insert in numerical order after existing text:

 

C12016

P12016

Metastatic colorectal cancer
Continuing treatment
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; OR
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of treatment with first-line pembrolizumab for dMMR mCRC; AND
Patient must not have progressive disease; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab.
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.

Compliance with Authority Required procedures - Streamlined Authority Code 12016

 

C12045

P12045

Metastatic colorectal cancer
Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have failed to respond to first-line chemotherapy; OR
The condition must have progressed following first-line treatment with pembrolizumab for dMMR mCRC; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab.
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.

Compliance with Authority Required procedures - Streamlined Authority Code 12045

[20]      Schedule 4, entry for Panitumumab

(a)        omit:

 

C5439

P5439

Metastatic colorectal cancer
Initial treatment
Patient must have RAS wild‑type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have failed to respond to first‑line chemotherapy; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS‑subsidised anti‑EGFR antibody therapy for this condition.
Patients who have progressive disease on cetuximab are not eligible to receive PBS‑subsidised panitumumab.
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS‑subsidised panitumumab.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 5439

 

C5447

P5447

Metastatic colorectal cancer
Continuing treatment
Patient must have received an initial authority prescription for this drug for treatment of RAS wild‑type metastatic colorectal cancer after failure of first‑line chemotherapy; AND
Patient must not have progressive disease; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS‑subsidised anti‑EGFR antibody therapy for this condition.
Patients who have progressive disease on cetuximab are not eligible to receive PBS‑subsidised panitumumab.
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS‑subsidised panitumumab.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 5447

(b)        insert in numerical order after existing text:

 

C12035

P12035

Metastatic colorectal cancer
Continuing treatment
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; OR
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of treatment with first-line pembrolizumab for dMMR mCRC; AND
Patient must not have progressive disease; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.

Compliance with Authority Required procedures - Streamlined Authority Code 12035

 

C12066

P12066

Metastatic colorectal cancer
Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have failed to respond to first-line chemotherapy; OR
The condition must have progressed following first-line treatment with pembrolizumab for dMMR mCRC; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.

Compliance with Authority Required procedures - Streamlined Authority Code 12066

[21]      Schedule 4, entry for Pembrolizumab

insert in numerical order after existing text:

 

C11993

P11993

Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer
Transitioning from non-PBS to PBS subsided treatment - Grandfather treatment
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 August 2021; AND
Patient must not have received prior PBS funded treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for colorectal cancer; AND
Patient must have been untreated for this indication (i.e untreated for each of: (i) unresectable disease, (ii) metastatic disease), prior to initiating treatment with this drug; AND
Patient must have stable or responding disease; AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must have deficient mismatch repair (dMMR) colorectal cancer, as determined by immunohistochemistry test; AND
The treatment must not exceed a total of 35 cycles or up to 24 months of treatment in a lifetime for this condition.
A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Authority Required procedures

 

C12033

P12033

Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer
Initial treatment
Patient must be untreated for this PBS indication (i.e untreated for each of: (i) unresectable disease, (ii) metastatic disease); AND
Patient must not have received prior treatment for colorectal cancer with each of: (i) a programmed cell death-1 (PD-1) inhibitor, (ii) a programmed cell death ligand-1 (PD-L1) inhibitor; AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must have deficient mismatch repair (dMMR) colorectal cancer, as determined by immunohistochemistry test; AND
The treatment must not exceed a total of 7 doses under this restriction.

Compliance with Authority Required procedures

 

C12065

P12065

Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must not exceed a total of 35 cycles or up to 24 months of treatment in a lifetime for this condition.

Compliance with Authority Required procedures