National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No.5) (Cth)

Case

PB 51 of 2021

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No. 5)

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.

Dated          27 May 2021

MARIANA CRANK

Assistant Secretary (Acting)

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 2021 (No.5).

(2)This Instrument may also be cited as PB 51 of 2021.

  1. Commencement

This Instrument commences on 1 June 2021.

  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. Part 1, Division 1, Section 3, definition for “HSD hospital authority”

substitute:

HSD hospital authority means a public hospital authority approved under section 10 the National Health (Highly specialised drugs program) Special Arrangement of 2021

  1. Part 4, Division 1, Section 37 (1)(b)

substitute:

(b) a reference to a number allotted to an approval under section 16 of the Regulations includes a reference to a number allotted to an approval under section 10 of the National Health (Highly specialised drugs program) Special Arrangement 2021 for a HSD hospital authority; and

  1. Schedule 1, Part 1, entry for Bevacizumab

substitute:

Bevacizumab Solution for I.V. infusion 100 mg in 4 mL Injection Mvasi AN MP D
Solution for I.V. infusion 400 mg in 16 mL Injection Mvasi AN MP D

  1. Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 1 mg

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

Bortezomib Juno JU MP C11099 D

  1. Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 3.5 mg

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

Bortezomib Juno JU MP C11099 D

  1. Schedule 1, Part 1, entry for Epirubicin

omit:

Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL Injection/
intravesical 		Epirubicin ACT JU MP D

  1. Schedule 1, Part 1, entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg

omit:

Fludarabine AMNEAL JU MP PB

  1. Schedule 1, Part 1, entry for Obinutuzumab

(a)omit from the column headed “Circumstances”: C7935 C7936 C7950 C7959 C7968 C7981

(b)insert in numerical order in the column headed “Circumstances”: C11755 C11785 C11787 C11815

  1. Schedule 1, Part 2, entry for Bevacizumab

substitute:

Bevacizumab 1800 7

  1. Schedule 1, Part 2, entry for Obinutuzumab [Maximum Amount: 1000; Number of Repeats: 5]

omit from the column headed “Purposes”: P7935 P7950 substitute: P11785 P11787

  1. Schedule 1, Part 2, entry for Obinutuzumab [Maximum Amount: 1000; Number of Repeats: 7]

(a)omit from the column headed “Purposes”: P7959 P7968

(b)insert in numerical order in the column headed “Purposes”: P11755

  1. Schedule 1, Part 2, entry for Obinutuzumab [Maximum Amount: 1000; Number of Repeats: 9]

omit from the column headed “Purposes”: P7936 P7981 substitute: P11815

  1. Schedule 4, omit entry for Bevacizumab

  1. Schedule 4, entry for Obinutuzumab

(a)omit:

C7935 P7935 Stage II bulky or Stage III/IV follicular lymphoma
Maintenance therapy
Patient must have previously received PBS‑subsidised treatment with this drug under the previously untreated initial restriction; OR
Patient must have previously received PBS‑subsidised treatment with this drug under the previously untreated grandfather restriction; AND
The condition must be CD20 positive; AND
Patient must have demonstrated a partial or complete response to PBS‑subsidised induction treatment with this drug for this condition; AND
The treatment must be maintenance therapy; AND
The treatment must be the sole PBS‑subsidised treatment for this condition; AND
The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND
Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition. 		Compliance with Authority Required procedures
C7936 P7936 Stage II bulky or Stage III/IV follicular lymphoma
Grandfather treatment ‑ previously untreated setting
Patient must have received non‑PBS subsidised treatment with this drug for this condition prior to 1 October 2018; AND
The condition must be CD20 positive; AND
The condition must have been untreated prior to initiating non‑PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must be in combination with chemotherapy for induction treatment; AND
The treatment must not exceed 10 doses for induction treatment with this drug for this condition; OR
Patient must have demonstrated a partial or complete response to induction treatment with this drug for this condition for maintenance treatment; AND
The treatment must be the sole PBS subsidised treatment for maintenance treatment; AND
The treatment must not exceed 12 doses or 2 years duration of maintenance treatment, whichever comes first.
A patient may only qualify for PBS subsidised initiation treatment once in a lifetime under:
i) the previously untreated induction treatment restriction; or
ii) the rituximab‑refractory re‑induction restriction; or
iii) the previously untreated grandfather restriction; or
iv) the rituximab‑refractory grandfather restriction. 		Compliance with Authority Required procedures
C7950 P7950 Follicular lymphoma
Maintenance therapy
Patient must have previously received PBS‑subsidised treatment with this drug under the rituximab refractory initial restriction; OR
Patient must have previously received PBS‑subsidised treatment with this drug under the rituximab refractory grandfather restriction; AND
The condition must be CD20 positive; AND
The condition must have been refractory to treatment with rituximab; AND
Patient must have demonstrated a partial or complete response to PBS‑subsidised re‑induction treatment with this drug for this condition; AND
The treatment must be maintenance therapy; AND
The treatment must be the sole PBS‑subsidised treatment for this condition; AND
The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND
Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition. 		Compliance with Authority Required procedures
C7959 P7959 Follicular lymphoma
Re‑induction treatment
Patient must not have previously received PBS subsidised obinutuzumab; AND
The condition must be CD20 positive; AND
The condition must be refractory to treatment with rituximab for this condition; AND
The condition must be symptomatic; AND
The treatment must be for re‑induction treatment purposes only; AND
The treatment must be in combination with bendamustine; AND
The treatment must not exceed 8 doses for re‑induction treatment with this drug for this condition.
The condition is considered rituximab‑refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab‑containing regimen.
A patient may only qualify for PBS subsidised initiation treatment once in a lifetime under:
i) the previously untreated induction treatment restriction; or
ii) the rituximab‑refractory re‑induction restriction; or
iii) the previously untreated grandfather restriction; or
iv) the rituximab‑refractory grandfather restriction. 		Compliance with Authority Required procedures
C7968 P7968 Follicular lymphoma
Grandfather treatment ‑ rituximab refractory
Patient must have received non‑PBS subsidised treatment with this drug for this condition prior to 1 October 2018; AND
The condition must be CD20 positive; AND
The condition must have been refractory to treatment with rituximab prior to initiating non‑PBS treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must be in combination with bendamustine for re‑induction treatment; AND
The treatment must not exceed 8 doses for re‑induction treatment with this drug for this condition; OR
Patient must have demonstrated a partial or complete response to re‑induction treatment with this drug for this condition; AND
The treatment must be the sole PBS subsidised treatment for maintenance treatment; AND
The treatment must not exceed 12 doses or 2 years duration of maintenance treatment, whichever comes first.
The condition is considered rituximab‑refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab‑containing regimen.
A patient may only qualify for PBS subsidised initiation treatment once in a lifetime under:
i) the previously untreated induction treatment restriction; or
ii) the rituximab‑refractory re‑induction restriction; or
iii) the previously untreated grandfather restriction; or
iv) the rituximab‑refractory grandfather restriction. 		Compliance with Authority Required procedures
C7981 P7981 Stage II bulky or Stage III/IV follicular lymphoma
Induction treatment
The condition must be CD20 positive; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
The treatment must be in combination with chemotherapy; AND
The treatment must not exceed 10 doses for induction treatment with this drug for this condition.
A patient may only qualify for PBS subsidised initiation treatment once in a lifetime under:
i) the previously untreated induction treatment restriction; or
ii) the rituximab‑refractory re‑induction restriction; or
iii) the previously untreated grandfather restriction; or
iv) the rituximab‑refractory grandfather restriction. 		Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C11755 P11755 Follicular lymphoma
Re-induction treatment
Patient must not have previously received PBS-subsidised obinutuzumab; AND
The condition must be CD20 positive; AND
The condition must be refractory to treatment with rituximab for this condition; AND
The condition must be symptomatic; AND
The treatment must be for re-induction treatment purposes only; AND
The treatment must be in combination with bendamustine; AND
The treatment must not exceed 8 doses for re-induction treatment with this drug for this condition.
The condition is considered rituximab-refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab-containing regimen.
A patient may only qualify for PBS-subsidised initiation treatment once in a lifetime under:
i) the previously untreated induction treatment restriction; or
ii) the rituximab-refractory re-induction restriction. 		Compliance with Authority Required procedures
C11785 P11785 Follicular lymphoma
Maintenance therapy
Patient must have previously received PBS-subsidised treatment with this drug under the rituximab refractory initial restriction; AND
The condition must be CD20 positive; AND
The condition must have been refractory to treatment with rituximab; AND
Patient must have demonstrated a partial or complete response to PBS-subsidised re-induction treatment with this drug for this condition; AND
The treatment must be maintenance therapy; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition. 		Compliance with Authority Required procedures
C11787 P11787 Stage II bulky or Stage III/IV follicular lymphoma
Maintenance therapy
Patient must have previously received PBS-subsidised treatment with this drug under the previously untreated initial restriction; AND
The condition must be CD20 positive; AND
Patient must have demonstrated a partial or complete response to PBS subsidised induction treatment with this drug for this condition; AND
The treatment must be maintenance therapy; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition. 		Compliance with Authority Required procedures
C11815 P11815 Stage II bulky or Stage III/IV follicular lymphoma
Induction treatment
The condition must be CD20 positive; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
The treatment must be in combination with chemotherapy; AND
The treatment must not exceed 10 doses for induction treatment with this drug for this condition.
A patient may only qualify for PBS-subsidised initiation treatment once in a lifetime under:
i) the previously untreated induction treatment restriction; or
ii) the rituximab-refractory re-induction restriction. 		Compliance with Authority Required procedures
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