National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 2) (PB 13 of 2019) (Cth)

PB 13 of 2019

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 2)

National Health Act 1953

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I, BEN SLADIC, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.

Dated  26 February 2019

BEN SLADIC

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

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1. Name of Instrument

(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 2).

(2)This Instrument may also be cited as PB 13 of 2019.

1. Commencement

This Instrument commences on 1 March 2019.

1. Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)

Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

Schedule 1       Amendments

1. Part 1, Division 1, Section 4, definition for ‘medication for the treatment of HIV or AIDS’

insert in alphabetical order:            (fa)     bictegravir with emtricitabine with tenofovir alafenamide

1. Schedule 1, after entry for Benralizumab

insert:

Bictegravir with emtricitabine with tenofovir alafenamide Tablet containing bictegravir 50 mg with emtricitabine 200 mg with tenofovir alafenamide 25 mg Oral Biktarvy GI EMP C4470 C4522 60 5 D

1. Schedule 1, entry for Valaciclovir

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

Valaciclovir APOTEX GX EMP C5939 C5975 500 2 C

1. Schedule 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

omit:

DEZTRON DZ EMP C5605 C5606 C5676 C5677 C5703 C5704 C5735 C5736 1 11 PB

1. Schedule 3, after entry for Benralizumab

insert:

Bictegravir with emtricitabine with tenofovir alafenamide	C4470	HIV infection Continuing Patient must have previously received PBS-subsidised therapy for HIV infection.	Compliance with Authority Required procedures - Streamlined Authority Code 4470
	C4522	HIV infection Initial Patient must be antiretroviral treatment naive.	Compliance with Authority Required procedures - Streamlined Authority Code 4522