National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 11) (PB 101 of 2016) (Cth)

PB 101 of 2016

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 11)

National Health Act 1953

I, PENNY SHAKESPEARE, First Assistant Secretary, Pharmaceutical Benefits 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 NOVEMBER 2016

PENNY SHAKESPEARE
First Assistant Secretary
Pharmaceutical Benefits Division

Department of Health

1  Name of Instrument

(1)  This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 11).

(2)  This Instrument may also be cited as PB 101 of 2016.

2  Commencement

This Instrument commences on 1 December 2016.

3Amendment of 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 (table item dealing with Ipilimumab, in each of the forms Injection concentrate for I.V. infusion 50 mg in 10 mL; and Injection concentrate for I.V. infusion 200 mg in 40 mL)

omit from the column headed ‘Circumstances’ (all instances): C4254 C4261 substitute (in numerical order): C6562 C6585

2   Schedule 1, Part 2 (table item dealing with Ipilimumab with maximum amount 360 and number of repeats 3)

omit from the column headed ‘Purposes’: P4254 P4261 substitute (in numerical order): P6562 P6585

3   Schedule 4 (table item dealing with Ipilimumab)

omit:

C4254	P4254	Unresectable Stage III or Stage IV malignant melanoma. Treatment Phase: Induction treatment Treatment must be as monotherapy, and must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks. Patient must not have received prior treatment with ipilimumab, and 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 4254
C4261	P4261	Unresectable Stage III or Stage IV malignant melanoma. Treatment Phase: Re‑induction treatment Treatment must be as monotherapy, and must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks. Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re‑induction). An initial objective response to treatment is defined as either: (i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or (ii) a partial or complete response. The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated.	Compliance with Authority Required procedures ‑ Streamlined Authority Code 4261
insert:
C6562	P6562	Unresectable Stage III or Stage IV malignant melanoma Induction treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have received prior treatment with ipilimumab; AND The treatment must not exceed a total of 4 doses at a maximum dose of 3 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 6562
C6585	P6585	Unresectable Stage III or Stage IV malignant melanoma Re-induction treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction); AND The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks. An initial objective response to treatment is defined as either: (i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or (ii) a partial or complete response. The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated.	Compliance with Authority Required procedures - Streamlined Authority Code 6585

4   Schedule 5, table

omit:

Listed Drug	Form	Manner of Administration	Brand	Quantity or Number of Units	Approved Ex‑manufacturer Price	Claimed Ex‑manufacturer Price
Nil entry

insert:

Listed Drug	Form	Manner of Administration	Brand	Quantity or Number of Units	Approved Ex‑manufacturer Price	Claimed Ex‑manufacturer Price
Ondansetron	Wafer 4 mg	Oral	Zofran Zydis	4	$4.17	$6.96
Ondansetron	Wafer 8 mg	Oral	Zofran Zydis	4	$6.54	$9.33