National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 4) (PB 38 of 2020) (Cth)
PB 38 of 2020
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (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, make this Instrument under subsection 100(2) of the National Health Act 1953.
Dated 29 April 2020
BEN SLADIC
Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division
Department of Health
___________________________________________________________________________
Name of Instrument
(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 4).
(2)This Instrument may also be cited as PB 38 of 2020.
Commencement
This Instrument commences on 1 May 2020.
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
Schedule 1, Part 1, entry for Pertuzumab
(a)omit from the column headed “Circumstances”: C9517 C9579
(b)insert in numerical order in the column headed “Circumstances”: C10414
Schedule 1, Part 1, entry for Trastuzumab in each of the forms: Powder for I.V. infusion 60 mg; and Powder for I.V. infusion 150 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Trazimera | PF | MP | C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296 | PB |
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”: C9577
Schedule 1, Part 2, entry for Pertuzumab [Maximum Amount: 420; Number of Repeats: 3]
omit from the column headed “Purposes”: P9579 substitute: P10414
Schedule 1, Part 2, entry for Pertuzumab
omit:
| P9517 | 840 | 1 |
Schedule 1, Part 2, entry for Trastuzumab emtansine [Maximum Amount: 450; Number of Repeats: 8]
omit from the column headed “Purposes”: P9577
Schedule 2, entry for Folinic acid
omit:
| Injection containing calcium folinate equivalent to 1000 mg folinic acid in 100 mL | Injection | Calcium Folinate Ebewe | SZ | MP | 1 | 1 |
Schedule 4, entry for Pertuzumab
(a)omit:
| C9517 | P9517 | HER2 positive breast cancer Grandfathering treatment Patient must have previously received non‑PBS‑subsidised treatment with this drug for this condition before 1 July 2015; OR Patient must have received non‑PBS‑subsidised trastuzumab for this condition before 1 July 2015; AND Patient must not have received non‑PBS‑subsidised treatment with trastuzumab for this condition before 1 July 2014; AND Patient must not have received prior therapy with trastuzumab emtansine or lapatinib for this condition; AND The treatment must be in combination with trastuzumab; 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. Authority applications for treatment must be made in writing and must include a completed authority prescription form. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA) during treatment. | Compliance with Written Authority Required procedures |
| C9579 | P9579 | Metastatic (Stage IV) HER2 positive breast cancer Continuing treatment Patient must have previously been issued with an authority prescription for this drug for this condition; AND Patient must not receive PBS‑subsidised treatment with this drug if progressive disease develops while on this drug; AND The treatment must be in combination with trastuzumab; 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. A patient who has progressive disease when treated with this drug is no longer eligible for PBS‑subsidised treatment with this drug. The treatment must not exceed a lifetime total of one continuous course. However, short treatment breaks are permitted. A patient who has a treatment break of less than 6 weeks in PBS‑subsidised treatment with this drug for reasons other than disease progression is eligible to continue to receive PBS‑subsidised treatment with this drug. A patient who has a treatment break of more than 6 weeks in PBS‑subsidised treatment with this drug is not eligible to receive PBS‑subsidised treatment with this drug. Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment. | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C10414 | P10414 | Metastatic (Stage IV) HER2 positive breast cancer Continuing treatment Patient must have previously been issued with an authority prescription for this drug for this condition; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND The treatment must be in combination with trastuzumab; 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. A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. The treatment must not exceed a lifetime total of one course. However, treatment breaks are permitted. A patient who has a treatment break in PBS-subsidised treatment with this drug for reasons other than disease progression is eligible to continue to receive PBS-subsidised treatment with this drug. Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment. | Compliance with Authority Required procedures |
Schedule 4, entry for Trastuzumab emtansine
omit:
| C9577 | P9577 | Metastatic (Stage IV) HER2 positive breast cancer Grandfathering treatment Patient must have previously received non‑PBS‑subsidised treatment with this drug for this condition before 1 July 2015; OR Patient must have received non‑PBS‑subsidised trastuzumab for this condition before 1 July 2015; OR Patient must have received PBS‑subsidised lapatinib for this condition before 1 July 2015; AND Patient must not receive PBS‑subsidised treatment with this drug if progressive disease develops while on this drug; AND The treatment must be as monotherapy; 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. Authority applications for treatment must be made in writing and must include a completed authority prescription form. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA) during treatment. | Compliance with Written Authority Required procedures |
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