National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2013 (No. 8) (No. PB 78 of 2013)

Link to law: https://www.comlaw.gov.au/Details/F2013L02011

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PB 78 of 2013
National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2013 (No. 8)
 
National Health Act 1953
___________________________________________________________________________
 
 
I, KIM BESSELL, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.
Dated   27 November 2013
 
 
 
 
 
 
 
 
 
 
 
 
 
 
KIM BESSELL
Assistant Secretary
Pharmaceutical Access Branch
Pharmaceutical Benefits Division
Department of Health
___________________________________________________________________________
 
 
1              Name of Instrument
 
(1)                This Instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2013 (No.8).
 
(2)                This Instrument may also be cited as PB 78 of 2013.
 
2              Commencement
This Instrument commences on 1 December 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, entry for Darunavir in the form Tablet 400mg (as ethanolate), brand Prezista
Substitute:
Tablet 400mg (as ethanolate)
Oral
Prezista
JC
EMP
C4313 C4346
 
120
5
D
 
[2]            Schedule 1, after entry for Darunavir in the form Tablet 600mg (as ethanolate), brand Prezista
Insert:
 
Tablet 800mg (as ethanolate)
Oral
Prezista
JC
EMP
C4313 C4346
 
60
5
D
[3]           Schedule 3, entry for Darunavir
Omit:
 
 
C3940
 
Where the patient is receiving treatment at/from a private hospital
 
Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co‑administered with 100 mg ritonavir in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance, and who has not demonstrated darunavir resistance associated mutations detected on resistance testing.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity
Compliance with Written or Telephone Authority Required procedures
 

 
C3941
 
Where the patient is receiving treatment at/from a public hospital
 
Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co‑administered with 100 mg ritonavir in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance, and who has not demonstrated darunavir resistance associated mutations detected on resistance testing.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3941
 

 
[4]     Schedule 3, entry for Darunavir
 
Insert in numerical order:
 
 
C4313
 
Where the patient is receiving treatment at/from a public hospital
 
Human immunodeficiency virus (HIV) infection
The treatment must be in addition to optimised background therapy
The treatment must be in combination with other antiretroviral agents
The treatment must be co-administered with 100 mg ritonavir
Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen
Patient must not have demonstrated darunavir resistance associated mutations detected on resistance testing.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4313

 
C4346
 
Where the patient is receiving treatment at/from a private hospital
 
Human immunodeficiency virus (HIV) infection
The treatment must be in addition to optimised background therapy
The treatment must be in combination with other antiretroviral agents
The treatment must be co-administered with 100 mg ritonavir
Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen
Patient must not have demonstrated darunavir resistance associated mutations detected on resistance testing.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity
Compliance with Written or Telephone Authority Required procedures