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

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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.
 
[2]    Schedule 1, entry for Mycophenolic Acid
omit from the column headed ‘Section 100 Only’ (all instances):
D
 
substitute:
C
 
[3]    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
 
[4]    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
 
 
[5]    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 http://www.frli.gov.au.