National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No.4) (Cth)

PB 43 of 2021

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No.4)

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 and Aged Care, make this Instrument under subsection 100(2) of the National Health Act 1953.

Dated              28 April           2021

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 2021 (No.4).

(2)This Instrument may also be cited as PB 43 of 2021.

1. Commencement

This Instrument commences on 1 May 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. Schedule 1, Part 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL

omit:

Epirubicin ACT JU MP D

1. Schedule 1, Part 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL

omit:

Epirubicin ACT JU MP D

1. Schedule 1, Part 1, entry for Trastuzumab emtansine in each of the forms: Powder for I.V. infusion 100 mg; and Powder for I.V. infusion 160 mg

omit from the column headed “Circumstances”: C10273

1. Schedule 1, Part 2, entry for Trastuzumab emtansine [Maximum Amount: 450; Number of Repeats: 6]

omit from the column headed “Purposes”: P10273

1. Schedule 4, entry for Trastuzumab emtansine

omit:

C10273 P10273 Early HER2 positive breast cancer
Grandfather adjuvant treatment
Patient must have received non‑PBS‑subsidised treatment with this drug as adjuvant treatment of early HER2 positive breast cancer prior to 1 April 2020; AND
The treatment must have been prescribed within 12 weeks after surgery prior to commencing treatment with this drug; AND
Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND
Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane‑based chemotherapy prior to surgery; AND
Patient must not receive PBS‑subsidised treatment with this drug if progressive disease develops while on this drug; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
The treatment must not extend beyond 42 weeks (14 cycles) duration using non‑PBS‑subsidised and PBS‑subsidised drug supply obtained under the grandfather restriction and the continuing treatment restrictions combined.
Authority applications for grandfather treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Early Breast Cancer ‑ PBS Supporting Information Form which includes details from the pathology report from an approved pathology authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery and the number of non‑PBS‑subsidised cycles of treatment received by the patient. Compliance with Written Authority Required procedures