National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 3) (PB 23 of 2018) (Cth)

PB 23 of 2018

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 3)

National Health Act 1953

________________________________________________________________________

I, KAREN HALL, Assistant Secretary (Acting), Private Health Insurance and 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   26 March 2018

KAREN HALL

Assistant Secretary (Acting)

Private Health Insurance and 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 2018 (No. 3).

(2)This Instrument may also be cited as PB 23 of 2018.

1. Commencement

This Instrument commences on 1 April 2018.

1. Amendment of National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)

This Instrument amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).

Schedule 1— Amendments

1. Schedule 1, Part 1, after entry for Arsenic

insert:

Atezolizumab Solution concentrate for I.V. infusion 1200 mg in 20 mL Injection Tecentriq RO MP C6999 C7539 C7572 D

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

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

Fludarabine AMNEAL JU MP PB

1. Schedule 1, Part 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL

(a)omit from the column headed “Circumstances”: C6996

(b)insert in numerical order in the column headed “Circumstances”: C7567

1. Schedule 1, Part 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium); and Powder for I.V. infusion 500 mg (as disodium)

omit:

Pemetrexed Juno JU MP C4792 C7195 D

1. Schedule 1, Part 1, after entry for Pertuzumab

insert:

Pralatrexate Solution for I.V. infusion 20 mg in 1 mL Injection Folotyn MF MP C7526 C7558 D

1. Schedule 1, Part 2, after entry for Arsenic [Maximum Amount: 18; Number of Repeats: 140]

insert:

Atezolizumab	P7539	1200	5
P6999 P7572	1200	7

1. Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 360; Number of Repeats: 8]

omit from the column headed “Purposes”: P6996                   substitute: P7567

1. Schedule 1, Part 2, after entry for Pertuzumab [Maximum Amount: 840; Number of Repeats: 1]

insert:

Pralatrexate	P7558	80	5
P7526	80	11

1. Schedule 4, after entry for Arsenic

insert:

Atezolizumab	C6999	P6999	Locally advanced or metastatic non-small cell lung cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised treatment for this condition; AND Patient must have stable or responding disease.	Compliance with Authority Required procedures - Streamlined Authority Code 6999
	C7539	P7539	Locally advanced or metastatic non-small cell lung cancer Initial treatment Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised treatment for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy.	Compliance with Authority Required procedures - Streamlined Authority Code 7539
	C7572	P7572	Locally advanced or metastatic non-small cell lung cancer Grandfathering treatment Patient must have received treatment with this drug for this condition prior to 1 April 2018; AND The treatment must be the sole PBS-subsidised treatment for this condition; AND Patient must have stable or responding disease; AND Patient must have had a WHO performance status of 0 or 1 at the time non PBS-subsidised treatment with this drug for this condition was initiated. 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 - Streamlined Authority Code 7572

1. Schedule 4, entry for Nivolumab

(a)omit:

C6996 P6996 Locally advanced or metastatic non-small cell lung cancer Initial treatment Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.
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 6996

(b)insert in numerical order after existing text:

C7567 P7567 Locally advanced or metastatic non-small cell lung cancer Initial treatment Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.
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 7567

1. Schedule 4, after entry for Pertuzumab

insert:

Pralatrexate	C7526	P7526	Relapsed or chemotherapy refractory Peripheral T-cell Lymphoma Continuing treatment The condition must be relapsed or chemotherapy refractory; AND Patient must not develop progressive disease whilst receiving PBS-subsidised treatment with this drug for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures
	C7558	P7558	Relapsed or chemotherapy refractory Peripheral T-cell Lymphoma Initial treatment The condition must be relapsed or chemotherapy refractory; AND Patient must have undergone appropriate prior front-line curative intent chemotherapy.	Compliance with Authority Required procedures