National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2013 (No. 5) (No. PB 56 of 2013)

Link to law: https://www.comlaw.gov.au/Details/F2013L01630

 
PB 56 of 2013
National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2013 (No. 5)
 
National Health Act 1953
___________________________________________________________________________
 
 
I, STEVE DUNLOP, Acting Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Medical Research, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.
Dated   19 August 2013
 
 
 
 
 
 
 
 
 
 
 
 
 
STEVE DUNLOP
Acting Assistant Secretary
Pharmaceutical Access Branch
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 2013 (No.5).
 
(2)                This Instrument may also be cited as PB 56 of 2013.
 
2              Commencement
This Instrument commences on 1 September 2013.
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
Section 3
 [1]           Schedule 1, after entry for Filgrastim in the form Injection 300 micrograms in 0.5 mL single use pre-filled syringe (TevaGrastim)
Insert:
 
Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Zarzio)
Injection
Zarzio
SZ
EMP
C2912 C2913 C2914 C2915 C2916 C2917 C2918 C2919 C2920 C2921 C2922 C2923 C2924 C2925 C2926 C2927 C2928 C2929 C2930 C3087 C3187 C3357 C3358 C3359 C3360 C3361 C3362 C3363 C3364 C3365 C3366 C3367 C3368 C3369 C3370 C3371 C3372 C3373 C3374 C3375 C3376 C3377 C3833 C3834
 
20
11
D
 
[2]            Schedule 1, after entry for Filgrastim in the form Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Nivestim)
Insert:
 
Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Zarzio)
Injection
Zarzio
SZ
EMP
C2912 C2913 C2914 C2915 C2916 C2917 C2918 C2919 C2920 C2921 C2922 C2923 C2924 C2925 C2926 C2927 C2928 C2929 C2930 C3087 C3187 C3357 C3358 C3359 C3360 C3361 C3362 C3363 C3364 C3365 C3366 C3367 C3368 C3369 C3370 C3371 C3372 C3373 C3374 C3375 C3376 C3377 C3833 C3834
 
20
11
D
 
 [3]          Schedule 1, entry for Raltegravir
Substitute:
 

Raltegravir
Tablet 25 mg (as potassium)
Oral
Isentress
MK
EMP
C4273 C4274 C4275 C4276
 
360
5
D

 
Tablet 100 mg (as potassium)
Oral
Isentress
MK
EMP
C4273 C4274 C4275 C4276
 
360
5
D

 
Tablet 400 mg (as potassium)
Oral
Isentress
MK
EMP
C3586 C3587 C3588 C3589
 
120
5
D

 
 
 [4]          Schedule 3, entry for Raltegravir
 
Insert following existing text:
 

 
C4273
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
The treatment must be in combination with other antiretroviral agents,
Patient must be antiretroviral experienced with at least 6 months therapy with 2 alternate classes of anti-retroviral therapy,
Patient must have previously received PBS-subsidised therapy for HIV infection,
Patient must be aged 2 years or older
Compliance with Written or Telephone Authority Required procedures
 

 
C4274
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
The treatment must be in combination with other antiretroviral agents,
Patient must be antiretroviral experienced with at least 6 months therapy with 2 alternate classes of anti-retroviral therapy,
Patient must have previously received PBS-subsidised therapy for HIV infection,
Patient must be aged 2 years or older
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4274

 
C4275
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
The treatment must be in combination with other antiretroviral agents,
Patient must be antiretroviral experienced with at least 6 months therapy with 2 alternate classes of anti-retroviral therapy,
Patient must have a CD4 count of less than 500 per cubic millimetre; OR
Patient must have symptomatic HIV disease,
Patient must be aged 2 years or older
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4275

 
C4276
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
The treatment must be in combination with other antiretroviral agents,
Patient must be antiretroviral experienced with at least 6 months therapy with 2 alternate classes of anti-retroviral therapy,
Patient must have a CD4 count of less than 500 per cubic millimetre; OR
Patient must have symptomatic HIV disease,
Patient must be aged 2 years or older
Compliance with Written and Telephone Authority Required procedures

 
 
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