National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 3) (PB 21 of 2017) (Cth)

Case

PB 21 of 2017

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 3)

National Health Act 1953

I, JULIANNE QUAINE, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health and Minister for Sport, make this Instrument under subsection 100(2) of the National Health Act 1953.

Dated 30 MARCH 2017

JULIANNE QUAINE

Assistant Secretary

Pharmaceutical Access Branch

Pharmaceutical Benefits Division

Department of Health

1  Name of Instrument

(1)  This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 3).

(2)  This Instrument may also be cited as PB 21 of 2017.

2  Commencement

This Instrument commences on 1 April 2017.

3Amendment of 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. Section 60(1)

omit:

1 April 2017

substitute:

1 March 2019

  1. Schedule 1, Part 1 (table item dealing with Brentuximab Vedotin)

substitute:

Brentuximab Vedotin Powder for I.V. Infusion 50 mg Injection Adcetris TK MP C4675
C4719
C6800
C6816
C6826
C6838 		D

  1. Schedule 1, Part 1 (table item dealing with Epirubicin, in the form ‘Solution for injection containing epirubicin hydrochloride 200 mg in 25 mL, and after brand DBL Epirubicin Hydrochloride Injection)

insert:

Epirubicin Accord

OC

MP

 D

  1. Schedule 1, Part 1 (table item dealing with Irinotecan, in the form ‘I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL’, manner of administration ‘Injection’

omit:

Irinotecan Alphapharm AF MP D

  1. Schedule 1, Part 1 (table item dealing with Methotrexate, after the form Injection 50 mg in 2 mL vial, manner of administration Injection, and brand Methaccord)

insert:

Methotrexate Accord

 OD D

  1. Schedule 1, Part 1 (table item dealing with Methotrexate, after the form ‘Solution concentrate for I.V. infusion 1000 mg in 10 mL vial’, manner of administration ‘Injection’, and brand Methaccord)

insert:

Methotrexate Accord

 OD D

  1. Schedule 1, Part 1 (table item dealing with Pembrolizumab)

substitute:

Pembrolizumab Powder for injection 50 mg Injection

Keytruda

 MK C6801
C6806
C6817
C6828
C6829 		D

  1. Schedule 1, Part 2 (table item dealing with Brentuximab vedotin)

substitute:

Brentuximab Vedotin P4675
P6800
P6816 		200 11
P4719
P6826
P6838 		200  3

  1. Schedule 1, Part 2 (table item dealing with Pembrolizumab)

substitute:

Pembrolizumab P6806 P6817 P6828 P6829 240 5
P6801 240 7

10  Schedule 4 (table item dealing with Bretuximab vedotin)

substitute:

Brentuximab vedotin 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
C4719 P4719

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 from a biopsy subsequent to the most recently delivered prior treatment with radiation, chemotherapy, biologics, immunotherapy or other agents;

(ii) The date of initial diagnosis of systemic anaplastic large cell lymphoma;

(iii) Dates of commencement and completion of front-line curative intent chemotherapy;

(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;

(v) a declaration of whether the patient has had, or is planned to have, a transplant

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
C6800 P6800

Relapsed or Refractory Hodgkin lymphoma

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

Patient must not receive more than 12 cycles of treatment under this restriction.

Authority applications for continuing treatment may be made by telephone to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday)

The treatment must not exceed a total of 16 cycles in a lifetime

 Compliance with Authority Required procedures
C6816 P6816

Relapsed or Refractory Hodgkin lymphoma

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

Patient must not receive more than 12 cycles of treatment under this restriction.

Authority applications for continuing treatment may be made by telephone to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday)

The treatment must not exceed a total of 16 cycles in a lifetime

 Compliance with Authority Required procedures
C6826 P6826

Relapsed or Refractory Hodgkin lymphoma

Initial treatment

Patient must have undergone a primary autologous stem cell transplant (ASCT); AND

Patient must have experienced a relapsed CD30+ Hodgkin lymphoma post ASCT; OR

Patient must have experienced a refractory CD30+ Hodgkin lymphoma post ASCT; AND

Patient must not receive more than 4 cycles of treatment under this restriction.

Applications for authorisation of initial treatment must be in writing and must include:

(a) a completed authority prescription form;

(b) a completed Hodgkin lymphoma brentuximab PBS Authority Application; and

(c) a signed patient acknowledgement.

 Compliance with Written Authority Required procedures
C6838 P6838

Relapsed or Refractory Hodgkin lymphoma

Initial treatment

Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND

Patient must not be suitable for ASCT for this condition; OR

Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND

Patient must have experienced a relapsed CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; OR

Patient must have experienced a refractory CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; AND

Patient must not receive more than 4 cycles of treatment under this restriction.

Applications for authorisation of initial treatment must be in writing and must include:

(a) a completed authority prescription form;

(b) a completed Hodgkin lymphoma brentuximab PBS Authority Application; and

(c) a signed patient acknowledgement.

 Compliance with Written Authority Required procedures

11  Schedule 4 (table item dealing with Pembrolizumab)

substitute:

Pembrolizumab C6801 P6801

Unresectable Stage III or Stage IV malignant melanoma

Continuing treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have previously been issued with an authority prescription for this drug for this condition; AND

Patient must have stable or responding disease; AND

The treatment must not exceed a maximum dose of 2 mg per kg every 3 weeks.

 Compliance with Authority Required procedures - Streamlined Authority Code 6801
C6806 P6806

Unresectable Stage III or Stage IV malignant melanoma

Initial treatment 1

The condition must be positive for a BRAF V600 mutation; AND

The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) unless contraindicated or not tolerated according to the TGA approved Product Information; AND

Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

The treatment must not exceed a total of 6 doses at a maximum dose of 2 mg per kg every 3 weeks.

The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6806
C6817 P6817

Unresectable Stage III or Stage IV malignant melanoma

Initial treatment 2

The condition must be negative for a BRAF V600 mutation; AND

Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

The treatment must not exceed a total of 6 doses at a maximum dose of 2 mg per kg every 3 weeks.

The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6817
C6828 P6828

Unresectable Stage III or Stage IV malignant melanoma

Grandfathering treatment 2

The condition must be negative for a BRAF V600 mutation; AND

Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 September 2015; AND

Patient must not have received prior treatment with ipilimumab or any other PD-1 (programmed cell death-1) inhibitor for this condition; AND

Patient must have stable or responding disease; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

The treatment must not exceed a maximum dose of 2 mg per kg every 3 weeks.

 Compliance with Authority Required procedures - Streamlined Authority Code 6828
C6829 P6829

Unresectable Stage III or Stage IV malignant melanoma

Grandfathering treatment 1

The condition must be positive for a BRAF V600 mutation; AND

The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) unless contraindicated or not tolerated according to the TGA approved Product Information; AND

Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 September 2015; AND

Patient must not have received prior treatment with ipilimumab or any other PD-1 (programmed cell death-1) inhibitor for this condition; AND

Patient must have stable or responding disease; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

The treatment must not exceed a maximum dose of 2 mg per kg every 3 weeks.

 Compliance with Authority Required procedures - Streamlined Authority Code 6829
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