National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No. 8) (Cth)
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
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.
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Note: This table relates only to the provisions of this instrument as originally made.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.
Authority
This instrument is made under subsection 100(2) National Health Act 1953.
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 (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)
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
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 |
Schedule 2, omit entry for Interferon alfa‑2a
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 |
Schedule 4, omit entry for Interferon alfa‑2a
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