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PB 92 of 2021 Arrangements as made
This instrument amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 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 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To be repealed 11 Feb 2022
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003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 92 of 2021

 

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No. 8)

 

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 (Efficient Funding of Chemotherapy) Special Arrangement 2011
(PB 79 of 2011)
                                                                                                                                      2

 

 

 


1        Name

(1)          This instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No. 8).

(2)          This instrument may also be cited as PB 92 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 (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)

[1]        Schedule 1, Part 1, entry for Brentuximab vedotin

(a)        omit from the column headed “Circumstances”: C4675 C7616

(b)        insert in numerical order in the column headed “Circumstances”: C12085 C12087 C12088 C12141

[2]        Schedule 1, Part 2, entry for Brentuximab vedotin

substitute:

Brentuximab vedotin

P8722

180

3

 

P8736

180

11

 

P12088

200

1

 

P10811 P10902 P12085

200

3

 

P12087

200

5

 

P10519 P10524 P12141

200

11

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

[4]        Schedule 4, entry for Brentuximab vedotin

(a)        omit:

 

C4675

P4675

CD30 positive systemic anaplastic large cell lymphoma
Continuing treatment
Patient must not have progressive disease; AND
Patient must have previously been issued with an authority prescription for this drug.
The treatment must not exceed a lifetime total of 16 cycles.

Compliance with Authority Required procedures

 

C7616

P7616

CD30 positive systemic anaplastic large cell lymphoma
Initial treatment
The treatment must be for curative intent; AND
Patient must have undergone appropriate prior front‑line curative intent chemotherapy; AND
Patient must demonstrate relapsed or chemotherapy‑refractory disease.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Systemic anaplastic large cell lymphoma Brentuximab PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) a histology report including evidence of the tumour's CD30 positivity;
(ii) The date of initial diagnosis of systemic anaplastic large cell lymphoma;
(iii) Dates of commencement and completion of front‑line curative intent chemotherapy; and
(iv) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory.
A maximum quantity and number of repeats to provide for an initial course of brentuximab vedotin of 4 cycles will be authorised as part of the initiating restriction.

Compliance with Written Authority Required procedures

(b)        insert in numerical order after existing text:

 

C12085

P12085

CD30 positive systemic anaplastic large cell lymphoma
Initial treatment
The treatment must be for curative intent; AND
Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND
Patient must demonstrate relapsed or chemotherapy-refractory disease; AND
Patient must have responded to PBS-subsidised treatment with this drug if previously used for initial treatment of CD30 positive peripheral T-cell lymphoma, non-cutaneous type.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Systemic anaplastic large cell lymphoma Brentuximab PBS Authority Application - Supporting Information Form which includes the following:
(i) a histology report including evidence of the tumour's CD30 positivity;
(ii) The date of initial diagnosis of systemic anaplastic large cell lymphoma;
(iii) Dates of commencement and completion of front-line curative intent chemotherapy; and
(iv) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory.
A maximum quantity and number of repeats to provide for an initial course of brentuximab vedotin of 4 cycles will be authorised as part of the initiating restriction.

Compliance with Written Authority Required procedures

 

C12087

P12087

CD30 positive peripheral T-cell lymphoma, non-cutaneous type
Initial treatment
Patient must have histological confirmation of CD30 expression in at least 3% of malignant cells; AND
The treatment must be for first line therapy for this condition; AND
The treatment must be for curative intent; AND
The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND
The treatment must not be more than 6 treatment cycles under this restriction in a lifetime.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Peripheral T-cell lymphoma Brentuximab PBS Authority Application - Supporting Information Form which includes the following:
(i) a histology report including evidence of the tumour's CD30 positivity;
(ii) The date of initial diagnosis of Peripheral T-cell lymphoma cell lymphoma.

Compliance with Written Authority Required procedures

 

C12088

P12088

CD30 positive peripheral T-cell lymphoma, non-cutaneous type
Continuing treatment
The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND
Patient must have completed 6 initial cycles of PBS-subsidised treatment with this drug for this indication; AND
Patient must have achieved at least a partial response to the 6 initial cycles of treatment with a combination of this drug and cyclophosphamide, doxorubicin and prednisone for this indication; AND
The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.
Partial response is defined using Lugano Response Criteria for Non-Hodgkin Lymphoma as:
(a) Positron emission tomography-based response: lymph nodes and extralymphatic sites - a score of 4 (uptake moderately > liver), or 5 (uptake markedly higher than liver and/or new lesions), with reduced uptake compared with baseline and residual mass(es) of any size; nonmeasured lesions - not applicable; organ enlargement - not applicable; new lesions - none; bone marrow - residual uptake higher than uptake in normal marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). If there are persistent focal changes in the marrow in the context of a nodal response, consideration should be given to further evaluation with MRI or biopsy or an interval scan; OR
(b) Computed tomography-based response: lymph nodes and extralymphatic sites -
greater than or equal to 50% decrease in the sum of the product of the perpendicular diameters for multiple lesions, of up to six (6) target measurable nodes and extranodal sites; non-measured lesions - absent/normal, regressed but no increase; new lesions - none; bone marrow - not applicable.

Compliance with Authority Required procedures

 

C12141

P12141

CD30 positive systemic anaplastic large cell lymphoma
Continuing treatment
Patient must not have progressive disease; AND
Patient must have previously been issued with an authority prescription for this drug.
The treatment must not be more than 12 treatment cycles under this restriction in a lifetime.

Compliance with Authority Required procedures

[5]        Schedule 4, omit entry for Interferon alfa‑2a