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PB 62 of 2019 Arrangements as made
This instrument amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) to make changes relating to the efficient funding of chemotherapy.
Administered by: Health
Registered 31 Jul 2019

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.

2          Commencement

This Instrument commences on 1 August 2019.

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 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

[2]        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

[3]        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

[4]        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


 

[5]        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

[6]        Schedule 2, omit entry for Aprepitant

[7]        Schedule 4, omit entry for Aprepitant

[8]        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

[9]        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.