National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 7) (PB 62 of 2019) (Cth)

PB 62 of 2019

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 7)

National Health Act 1953

___________________________________________________________________________

I, BEN SLADIC, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under subsection 100(2) of the National Health Act 1953.

Dated                   29 July 2019

BEN SLADIC

Assistant Secretary

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 2019 (No. 7).

(2)This Instrument may also be cited as PB 62 of 2019.

1. Commencement

This Instrument commences on 1 August 2019.

1. 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 Bevacizumab in each of the forms: Solution for I.V. infusion 100 mg in 4 mL; and Solution for I.V. infusion 400 mg in 16 mL

insert in numerical order in the column headed “Circumstances”: C9102 C9149 C9166

1. Schedule 1, Part 1, entry for Pembrolizumab in each of the forms: Powder for injection 50 mg; and Solution concentrate for I.V. infusion 100 mg in 4 mL

(a)omit from the column headed “Circumstances”: C6801 C6806 C6817

(b)insert in numerical order in the column headed “Circumstances”: C9044 C9127 C9178

1. Schedule 1, Part 1, entry for Trastuzumab in the form Powder for I.V. infusion 150 mg

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

Ogivri AF MP C4083 C4093 C4104 C4142 C4143 C4156 C5024 C5032 C5041 C5834 C5844 C7718 C7746 PB

1. Schedule 1, Part 2, entry for Bevacizumab

substitute:

Bevacizumab	P4814	900	5
P4584 P4587 P4594 P4939 P4968	900	11
P9166	1800	3
P9102 P9149	1800	5
P6337 P6353	1800	7

1. Schedule 1, Part 2, entry for Pembrolizumab

substitute:

Pembrolizumab	P9127 P9178	200	5
P7606 P7610 P7773 P8122 P8123 P8124 P8542 P8543 P8563	200	6
P9044	200	7

1. Schedule 2, omit entry for Aprepitant

1. Schedule 4, omit entry for Aprepitant

1. Schedule 4, entry for Bevacizumab

insert in numerical order after existing text:

C9102	P9102	Relapsed or recurrent glioblastoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed further symptomatic progression while being treated with this drug for this condition; AND The treatment must not exceed a dose of 10 mg per kg every 2 weeks; OR The treatment must not exceed a dose of 15 mg per kg every 3 weeks. Symptomatic progression is defined as: i) Deterioration of neurologic function which may include motor dysfunction, seizures, lack of co-ordination, changes to personality, reduced ability to communicate, neurocognitive decline; OR ii) Increasing symptoms of raised intracranial pressure which may include headache, nausea, vomiting or poorly controlled vasogenic oedema.	Compliance with Written Authority Required procedures
C9149	P9149	Relapsed or recurrent glioblastoma Grandfathering treatment Patient must have confirmed glioblastoma; AND Patient must have had radiologic evidence of evaluable disease at the time non-PBS subsidised treatment with this drug for this condition was initiated; AND Patient must have had evidence of symptomatic progression at the time non-PBS subsidised treatment with this drug for this condition was initiated; AND Patient must have failed to achieve an adequate response to, or be intolerant to, temozolomide; AND Patient must have been receiving non-PBS subsidised treatment with this drug for this condition prior to 1 August 2019; AND Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less at the time non-PBS subsidised treatment with this drug for this condition was initiated; AND Patient must not have developed further symptomatic progression while being treated with this drug for this condition; AND The treatment must not exceed a dose of 10 mg per kg every 2 weeks; OR The treatment must not exceed a dose of 15 mg per kg every 3 weeks. A Grandfathered 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. The authority application must be made in writing and must include: (1) a completed authority prescription form; (2) a completed Glioblastoma PBS Authority Application - Supporting Information Form, which includes the following: (a) evidence of confirmed glioblastoma confirmed by radiology report; and (b) confirmation that the patient has failed to achieve an adequate response to, or is intolerant to, temozolomide. Symptomatic progression is defined as: i) Deterioration of neurologic function which may include motor dysfunction, seizures, lack of co-ordination, changes to personality, reduced ability to communicate, neurocognitive decline; OR ii) Increasing symptoms of raised intracranial pressure which may include headache, nausea, vomiting or poorly controlled vasogenic oedema.	Compliance with Written Authority Required procedures
C9166	P9166	Relapsed or recurrent glioblastoma Initial treatment Patient must have confirmed glioblastoma; AND Patient must have radiologic evidence of evaluable disease; AND Patient must have evidence of symptomatic progression; AND Patient must have failed to achieve an adequate response to, or be intolerant to, temozolomide; AND Patient must not receive more than 8 weeks of treatment per initial treatment course authorised under this restriction; AND Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND Patient must not have received prior treatment with this drug for this condition; AND The treatment must not exceed a dose of 10 mg per kg every 2 weeks; OR The treatment must not exceed a dose of 15 mg per kg every 3 weeks. The authority application must be made in writing and must include: (1) a completed authority prescription form; (2) a completed Glioblastoma PBS Authority Application - Supporting Information Form, which includes the following: (a) evidence of confirmed glioblastoma confirmed by radiology report; and (b) confirmation that the patient has failed to achieve an adequate response to, or is intolerant to, temozolomide. Symptomatic progression is defined as: i) Deterioration of neurologic function which may include motor dysfunction, seizures, lack of co-ordination, changes to personality, reduced ability to communicate, neurocognitive decline; OR ii) Increasing symptoms of raised intracranial pressure which may include headache, nausea, vomiting or poorly controlled vasogenic oedema.	Compliance with Written Authority Required procedures

1. Schedule 4, entry for Pembrolizumab

(a)omit:

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

(b)insert in numerical order after existing text:

C9044	P9044	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 administered every 3 weeks fixed at 200 mg.	Compliance with Authority Required procedures - Streamlined Authority Code 9044
C9127	P9127	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 administered every 3 weeks, with each maximum dose fixed at 200 mg. 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 9127
C9178	P9178	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 administered every 3 weeks, with each maximum dose fixed at 200 mg. The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.