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

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