National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (September Update) Instrument 2023 (Cth)

PB 84 of 2023

National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (September Update) Instrument 2023

National Health Act 1953

I, NIKOLAI TSYGANOV, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, delegate of the Minister for Health and Aged Care, make this Instrument under subsection 100(2) of the National Health Act 1953.

Dated               30 August 2023              

NIKOLAI TSYGANOV

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Contents

1......... Name............................................................................................................................... 1

2......... Commencement............................................................................................................... 1

3......... Authority......................................................................................................................... 1

4......... Schedules......................................................................................................................... 1

Schedule 1—Amendments  2

National Health (Highly Specialised Drugs Program) Special Arrangement 2021
(PB 27 of 2021)   2

1. Name

(1)This instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (September Update) Instrument 2023.

(2)This instrument may also be cited as PB 84 of 2023.

1. Commencement

(1)Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1.  The whole of this instrument	1 September 2023	1 September 2023

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

1. Authority

This instrument is made under subsection 100(2) of the National Health Act 1953.

1. Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021)

1. Part 1, Division 1, Section 6, definition for “medication for the treatment of HIV or AIDS”

substitute:

medication for the treatment of HIV or AIDS means any of the following:

(a)   abacavir;

(b)   abacavir with lamivudine;

(c)   abacavir with lamivudine and zidovudine;

(d)   atazanavir;

(e)   atazanavir with cobicistat;

(f)   azithromycin;

(g)   bictegravir with emtricitabine with tenofovir alafenamide;

(h)   cabotegravir;

(i)   cabotegravir and rilpivirine;

(j)   darunavir;

(k)   darunavir with cobicistat;

(l)   darunavir with cobicistat, emtricitabine and tenofovir alafenamide;

(m)   dolutegravir;

(n)   dolutegravir with abacavir and lamivudine;

(o)   dolutegravir with lamivudine;

(p)   dolutegravir with rilpivirine;

(q)   doxorubicin ‑ pegylated liposomal;

(r)   efavirenz;

(s)   emtricitabine with rilpivirine with tenofovir alafenamide;

(t)   emtricitabine with tenofovir alafenamide;

(u)   etravirine;

(v)   fosamprenavir;

(w)   ganciclovir;

(x)   lamivudine;

(y)   lamivudine with zidovudine;

(z)   lopinavir with ritonavir;

(aa)   maraviroc;

(bb)   nevirapine;

(cc)   raltegravir;

(dd)   rifabutin;

(ee)   rilpivirine;

(ff)   ritonavir;

(gg)   tenofovir;

(hh)   tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat;

(ii)   tenofovir with emtricitabine;

(jj)   tenofovir with emtricitabine and efavirenz;

(kk)   valganciclovir;

(ll)   zidovudine.

1. Schedule 1, entry for Apomorphine

omit:

Injection containing apomorphine hydrochloride hemihydrate 20 mg in 2 mL Injection Movapo C11385 C11445 360 5

1. Schedule 1, entry for Entecavir in the form Tablet 1 mg (as monohydrate)

omit:

Entecavir GH C5037 C5044 60 5

1. Schedule 1, omit entry for Saquinavir

1. Schedule 3, omit entry for Saquinavir