National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2022 (No. 3) (Cth)

PB 28 of 2022

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2022 (No. 3)

National Health Act 1953

I, DAVID LAFFAN, Assistant Secretary, 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 29 March 2022

DAVID LAFFAN

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

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

1. Name

(1)This instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2022 (No. 3).

(2)This instrument may also be cited as PB 28 of 2022.

1. 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 April 2022	1 April 2022

Note:          This table relates only to the provisions of this instrument as originally made.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.

1. Authority

This instrument is made under subsection 100(2) of the National Health Act 1953.

1. 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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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)

1. Schedule 1, Part 1, entry for Pembrolizumab

(a)omit from the column headed “Circumstances”: C10678

(b)omit from the column headed “Circumstances”: C10809 C10888

1. Schedule 1, Part 1, entry for Raltitrexed

omit from the column headed “Circumstances”: C6228

1. Schedule 1, Part 1, after entry for Trastuzumab in the form Powder for I.V. infusion 420 mg

insert:

Powder for I.V. infusion 440 mg with diluent Injection Herzuma EW MP C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296 PB

1. Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200; Number of Repeats: 6]

omit from the column headed “Purposes”: P10678

1. Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200; Number of Repeats: 7]

omit from the column headed “Purposes”: P10888

1. Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 400; Number of Repeats: 3]

omit from the column headed “Purposes”: P10809

1. Schedule 2, after entry for Mesna in the form Solution for I.V. injection 1 g in 10 mL ampoule

insert:

Mycobacterium bovis (Bacillus Calmette and Guerin (BCG)) Danish 1331 strain Single dose pack containing powder for irrigation 30 mg, 4 vials Intravesical BCG Culture SSI LM MP C5597 3 1 C

1. Schedule 2, entry for Palonosetron

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

Palonosetron Dr.Reddy's RZ MP C5805 1 0 C

1. Schedule 4, after entry for Methotrexate

insert:

Mycobacterium bovis (Bacillus Calmette and Guerin (BCG)) Danish 1331 strain C5597 Primary and relapsing superficial urothelial carcinoma of the bladder

1. Schedule 4, entry for Pembrolizumab

(a)omit:

C10678 P10678 Relapsed or refractory primary mediastinal B‑cell lymphoma
Grandfather treatment (initial treatment of a patient commenced on non‑PBS‑subsidised treatment)
Patient must have received treatment with this drug for this condition prior to 1 September 2020; AND
The condition must be diagnosed as primary mediastinal B‑cell lymphoma through histological investigation combined with at least one of: (i) positron emission tomography ‑ computed tomography (PET‑CT) scan, (ii) PET scan, (iii) CT scan, with the results retained in the patient's medical records; AND
Patient must have been treated with rituximab‑based chemotherapy prior to initiating treatment with this drug for this condition; AND
Patient must have been experiencing relapsed/refractory disease prior to initiating treatment with this drug for this condition; AND
Patient must have been autologous stem cell transplant (ASCT) ineligible following a single line of treatment prior to initiating treatment with this drug for this condition; OR
Patient must have undergone an autologous stem cell transplant (ASCT) prior to initiating treatment with this drug for this condition; OR
Patient must have been treated with at least 2 chemotherapy treatment lines for this condition, one of which must have included rituximab‑based chemotherapy, prior to initiating treatment with this drug for this condition; AND
Patient must not have received treatment with a programmed cell death‑1 (PD‑1) inhibitor or a programmed cell death ligand‑1 (PD‑L1) inhibitor for this condition 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 not exceed a total of 35 cycles in a lifetime; AND
The treatment must not exceed a total of 7 doses 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 primary mediastinal B‑cell lymphoma pembrolizumab PBS Authority Application for Grandfathered patients, which includes:
(i) confirmation that histology results and PET/CT scans support a diagnosis of primary mediastinal B‑cell lymphoma and are retained on the patient's medical records;
(ii) details of prior treatments for this condition Compliance with Written Authority Required procedures

(b)omit:

C10809	P10809	Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma Grandfather treatment ‑ 6 weekly treatment regimen Patient must have previously received non‑PBS‑subsidised drug for adjuvant treatment following complete surgical resection prior to 1 September 2020; AND Patient must have a WHO performance status of 1 or less prior to starting non‑PBS treatment with this drug; AND Patient must not have evidence of recurrence; AND The treatment must be the sole PBS‑subsidised therapy for this condition; AND Patient must not have received prior PBS‑subsidised treatment for this condition; AND Patient must have commenced non‑PBS‑subsidised treatment within 12 weeks of complete surgical resection; AND Patient must not receive more than 12 months of combined PBS‑subsidised and non‑PBS‑subsidised adjuvant therapy. A 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.	Compliance with Authority Required procedures
C10888	P10888	Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma Grandfather treatment ‑ 3 weekly treatment regimen Patient must have previously received non‑PBS‑subsidised drug for adjuvant treatment following complete surgical resection prior to 1 September 2020; AND Patient must have a WHO performance status of 1 or less prior to starting non‑PBS treatment with this drug; AND Patient must not have evidence of recurrence; AND The treatment must be the sole PBS‑subsidised therapy for this condition; AND Patient must not have received prior PBS‑subsidised treatment for this condition; AND Patient must have commenced non‑PBS‑subsidised treatment within 12 weeks of complete surgical resection; AND Patient must not receive more than 12 months of combined PBS‑subsidised and non‑PBS‑subsidised adjuvant therapy. A 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.	Compliance with Authority Required procedures

1. Schedule 4, omit entry for Raltitrexed