Federal Register of Legislation - Australian Government

Primary content

PB 13 of 2019 Arrangements as made
This instrument amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) to add, delete and make changes to drugs, forms, brands, responsible person codes, maximum quantities and repeats and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).
Administered by: Health
Registered 28 Feb 2019

PB 13 of 2019

 

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

 

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 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


 

 

___________________________________________________________________________

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.

2          Commencement

This Instrument commences on 1 March 2019.

3          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

[2]        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

[3]        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

[4]        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

[5]        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