National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No. 4) (No. PB 35 of 2012) (Cth)

Case

PB 35 of 2012

National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No. 4)

National Health Act 1953

___________________________________________________________________________

I, FELICITY MCNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.

Dated     23 May 2012

FELICITY MCNEILL

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health and Ageing

___________________________________________________________________________

1              Name of Instrument

(1)This Instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No.4).

(2)This Instrument may also be cited as PB 35 of 2012.

2             Commencement

This Instrument commences on 1 June 2012.

3              Amendments to PB 116 of 2010

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

Schedule 1                   Amendments

  1. Section 4, definition of medication for the treatment of HIV or AIDS

omit:

(zg) valaciclovir;

(zh) valganciclovir;

(zi) zidovudine.

substitute:

(zg) tenofovir with emtricitabine and rilpivirine;

(zh) valaciclovir;

(zi) valganciclovir;

(zj) zidovudine.

  1. Schedule 1, entry for Mycophenolic Acid

omit from the column headed ‘Section 100 Only’ (all instances):

D

substitute:

C

  1. Schedule 1, entry for Mycophenolic Acid in the form of Capsule containing mycophenolate mofetil 250 mg

insert after entry for the brand Mycophenolate Sandoz:

Pharmacor

Mycophenolate 250

CR EMP C1650 C1651 C3355 C3356 600 5 C
  1. Schedule 1, after entry for Tenofovir with emtricitabine and efavirenz

insert:

Tenofovir with Emtricitabine and Rilpivirine Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and rilpivirine 25 mg (as hydrochloride) Oral Eviplera GI EMP C3983 C3984 C3985 C3986 60 5 D
  1. Schedule 3, after entry for Tenofovir with emtricitabine and efavirenz

insert:

Tenofovir with Emtricitabine and Rilpivirine C3983

Where the patient is receiving treatment at/from a private hospital

Initial treatment of human immunodeficiency virus (HIV) infection in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease

Compliance with Written or Telephone Authority Required procedures
C3984

Where the patient is receiving treatment at/from a private hospital

Continuing treatment of human immunodeficiency virus (HIV) infection where the patient has previously received PBS-subsidised therapy for HIV infection

Compliance with Written or Telephone Authority Required procedures
C3985

Where the patient is receiving treatment at/from a public hospital

Initial treatment of human immunodeficiency virus (HIV) infection in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease

Compliance with Written or Telephone Authority Required procedures Streamlined Authority Code 3985
C3986

Where the patient is receiving treatment at/from a public hospital

Continuing treatment of human immunodeficiency virus (HIV) infection where the patient has previously received PBS-subsidised therapy for HIV infection

Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3986

Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See

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