National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (October Update) Instrument 2022 (Cth)

PB 89 of 2022

National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (October Update) Instrument 2022

National Health Act 1953

I, NIKOLAI TSYGANOV, Assistant Secretary (Acting), 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.

Date     29 September 2022                    

NIKOLAI TSYGANOV

Assistant Secretary (Acting)

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 (October Update) Instrument 2022.

(2)This instrument may also be cited as PB 89 of 2022.

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 October 2022	1 October 2022

Note:          This table relates only to the provisions of this instrument as originally made.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)  saquinavir;

(hh)  tenofovir;

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

(jj)  tenofovir with emtricitabine;

(kk)  tenofovir with emtricitabine and efavirenz;

(ll)  tipranavir;

(mm)  valganciclovir;

(nn)  zidovudine.

1. Schedule 1, omit entry for Enfuvirtide

1. Schedule 1, entry for Plerixafor

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

Plerixafor ARX C4549 C9329 1 1

1. Schedule 1, entry for Pomalidomide in each of the forms: Capsule 3 mg; and Capsule 4 mg

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

Pomalidomide Sandoz C13144 C13145 See Schedule 2 See Schedule 2

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

Pomolide C13141 C13144 C13145 C13252 See Schedule 2 See Schedule 2

1. Schedule 3, omit entry for Enfuvirtide