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Appendix 2: Drugs Covered by the Program - Page 1

Note: Drugs funded under the Highly Specialised Drugs Program provide a subsidy for community patients only. Inpatients remain the responsibility of the treating hospital.

Page 1 Abacavir Sulfate to Baclofen (Lioresal Intrathecal)
Page 2 Boceprevir (Victrelis) to Bosentan Monohydrate (Tracleer)
Page 3 Cidofovir (Vistide) to Epoetin lamda (Novicrit)
Page 4 Epoprostenol Sodium (Flolan)
Page 5 Etanercept (Enbrel) to Ibandronate sodium (Bondronat)
Page 6 Iloprost Trometamol (Ventavis) to Indinavir Sulphate (Crixivan)
Page 7 Infliximab (Remicade) to Sevelamer (Renagel)
Page 8 Sildenafil Citrate (Revatio)
Page 9 Sirolimus (Rapamune) to Zoledronic acid (Zometa)

Drug

Date Subsidised

PBAC Clinical Indications and other Restrictions

Abacavir Sulfate (Ziagen)

1 October 1999

Amended 1 February 2004

Amended 1 January 2011

Initial treatment of HIV infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease (3588)

Continuing treatment of HIV infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection (3589)

Abacavir Sulfate with Lamivudine (Kivexa)

1 December 2005

Amended 1 January 2011

Initial treatment of HIV infection in combination with other antiretroviral agents in a patient over 12 years of age, weighing 40kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease (3592)

Continuing treatment of HIV infection in combination with other antiretroviral agents where the patient over 12 years of age, weighing 40kg or more, has previously received PBS-subsidised therapy for HIV infection (3593)

Abacavir Sulfate with Lamivudine and Zidovudine (Trizivir)

1 November 2001

Amended 1 February 2004

Amended 1 January 2011

Amended March 2012

Initial treatment of HIV infection in a patient over 12 years of age, weighing 40kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease (3981)

Continuing treatment of HIV infection where the patient over 12 years of age, weighing 40kg or more, has previously received PBS-subsidised therapy for HIV infection (3982)

Abatacept (Orencia)

1 March 2008

Amended 1 January 2008

This drug needs prior approval by Medicare Australia.
More information and forms are available at http://www.medicareaustralia.gov.au/provider/pbs/highly-specialised-drugs/complex-authority-drugs.jsp

  Abatacept - April 2012

Adalimumab (Humira) 1 November 2010

This drug needs prior approval by Medicare Australia.
More information and forms are available at http://www.medicareaustralia.gov.au/provider/pbs/highly-specialised-drugs/complex-authority-drugs.jsp

PDF Icon Adalimumab - December 2010 (243kb, pdf)

Adefovir Dipivoxil (Hepsera)

1 December 2004

Amended 1 April 2006

Amended 1 April 2007

Amended 1 March 2008

Amended 1 July 2008

Amended 1 March 2012

Chronic hepatitis B in a patient without cirrhosis who has failed antihepadnaviral therapy and who satisfies all of the following criteria:

(a) Repeatedly elevated  serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or

(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a one log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance (3973)

Chronic hepatitis B in a patient with cirrhosis who has failed antihepadnaviral therapy and who has detectable HBV DNA.

Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy. (3974)

NOTE:
Patients may receive treatment in combination with lamivudine but not with other PBS-subsidised antihepadnaviral therapy.

Ambrisentan (Volibris) Added 1 December 2009 This drug needs prior approval by Medicare Australia.
More information and forms are available at http://www.medicareaustralia.gov.au/provider/pbs/highly-specialised-drugs/complex-authority-drugs.jsp

  Ambrisentan - July 2012

Apomorphine Hydrochloride (Apomine, Apomine PFS)

1 Mar 1996

Parkinson's disease in patients severely disabled by motor fluctuations which do not respond to other therapy. (3314)
Atazanavir Sulfate (Reyataz)

1 December 2004

Amended 1 January 2011

Initial treatment of HIV infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease (3588)

Continuing treatment of HIV infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection (3589)
Azacitidine (Vidaza) 1 February 2011

This drug needs prior approval by Medicare Australia.
More information and forms are available at
http://www.medicareaustralia.gov.au/provider/pbs/highly-specialised-drugs/complex-authority-drugs.jsp

PDF Icon Azacitidine (136kb, pdf)

Azithromycin
(Zithromax)

1 December 1997

Prophylaxis against Mycobacterium avium complex infections in HIV positive patients with CD4 cell counts of less than 75per cubic millilitre. (3317)

Baclofen (Lioresal Intrathecal)

Amended 1 February 2003

Severe chronic spasticity, where oral antispastic agents have failed or have caused unacceptable side effects, in patients with chronic spasticity of cerebral origin.   (3318)

Severe chronic spasticity, where oral antispastic agents have failed or have caused unacceptable side effects, in patients with chronic spasticity due to multiple sclerosis. (3319)

Severe chronic spasticity, where oral antispastic agents have failed or have caused unacceptable side effects, in patients with chronic spasticity due to spinal cord injury. (3320)

Severe chronic spasticity, where oral antispastic agents have failed or have caused unacceptable side effects, in patients with chronic spasticity due to spinal cord disease. (3321)

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Last updated: 2 April, 2013
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