Note: Drugs funded under the Highly Specialised Drugs Program provide
a subsidy for community patients only. Inpatients remain the responsibility
of the treating hospital.
Drug |
Date Subsidised |
PBAC Clinical
Indications and other Restrictions |
| Sirolimus (Rapamune) |
1 April 2004 |
Management of rejection, under the supervision
and direction of a transplant unit, in patients receiving this
drug for prophylaxis and treatment of renal allograft rejection.
Management includes initiation, stabilisation and review of therapy
as required.
CAUTION:
Careful monitoring of patients is mandatory. |
Sitaxentan Sodium
(Thelin) |
1 April 2008
Amended 1 July 2008
Amended 1 August 2008 |
This drug needs prior approval by Medicare Australia.
More information and forms are available at www.medicare.gov.au/provider/pbs/drugs/index.shtml
Sitaxentan Sodium - amended August 2009 (PDF file 134KB) |
Stavudine
(Zerit)
|
1 July 1996
Amended 1 February 2004 |
Treatment of HIV infection in patients with:
(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10 000 copies per mL. |
Tacrolimus
(Prograf)
|
1 October 1997
Amended 1 February 2003
Amended 1 April 2008
Amended 1 June 2008
Amended 1 March 2009 |
Management of rejection in patients following organ or tissue transplantation, under supervision and direction of a transplant unit. Management includes initiation, stabilisation and review of therapy as required.
|
Tenofovir
Disoproxil Fumarate (Viread)
|
1 October 2002
Amended 1 February 2004
Amended
1 April 2005 |
Treatment, in combination with other antiretroviral
drugs, of HIV infection in patients who have:
(a) failed treatment with their current antiretroviral regimen
and for whom an effective regimen, including a regimen containing
amprenavir, cannot otherwise be constructed; or
(b) experienced treatment-limiting toxicity with their current
antiretroviral regimen and for whom an effective regimen, including
a regimen containing amprenavir, cannot otherwise be constructed.
Treatment of HIV infection in patients with:
(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL. |
| Telbivudine (Serbivo) |
1 August 2008
Amended 1 December 2008 |
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B infection who is nucleoside analogue naïve and satisfies all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
(2) (a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection;
(3) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.
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. |
Tenofovir
Disoproxil Fumarate with Emtricitabine
(Truvada) |
1 February 2006 |
Treatment of HIV infection in patients with:
(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load of greater than 10,000 copies per mL |
Thalidomide
(Thalidomide Pharmion) |
1 February 2006
1 September 2009 |
CAUTION: Thalidomide is a category X drug and must not be given to pregnant women. Pregnancy in female patients or in the partners of male patients must be avoided during treatment and for 1 month after cessation of treatment.
Multiple myeloma .
NOTE: Patients receiving thalidomide under the PBS listing must be registered in the Pharmion Risk Management Program. |
| Tipranavir (Aptivus) |
1 August 2007 |
Treatment, in combination with other antiretroviral
agents, and co-administered with 200 mg ritonavir twice daily,
of
HIV infection in antiretroviral experienced adults with:
(a) evidence of HIV replication (viral load greater than 10,000 copies
per mL); and/or
(b) CD4 cell counts of less than 500 per cubic millimetre.
Patients must have failed previous treatment with, or have resistance
to, 3 different antiretroviral regimens which
have included:
(i) at least 1 non-nucleoside reverse transcriptase inhibitor; and
(ii) at least 1 nucleoside reverse transcriptase inhibitor; and
(iii) at least 2 protease inhibitors. |
Valaciclovir Hydrochloride
(Valtrex)
|
1 October 2000
Amended 1 February 2003 |
Prophylaxis of cytomegalovirus (CMV) infection
and disease following renal transplantation in patients at risk
of CMV disease. |
Valganciclovir
hydrochloride (Valcyte)
|
1 November 2002
Amended 1 May 2004 |
Cytomegalovirus retinitis in patients with acquired
immunodeficiency syndrome.
Prophylaxis of cytomegalovirus infection and disease in solid
organ transplant patients at risk of cytomegalovirus disease. |
Zidovudine
(AZT) (Retrovir) |
1 July 1992
Amended 1 February 2004 |
Treatment of HIV infection in patients with:
(a) CD4 cell counts of less than 500 per cubic millimetre; or
(b) viral load greater than 10,000 copies per mL. |
Zoledronic acid
(Zometa)
|
1 May 2002
Last revision: February 2004 |
Multiple myeloma;
Bone metastases from breast cancer;
Bone metastases from hormone -resistant prostate cancer, with demonstration
of biochemical progression of disease despite maximal therapy with
hormone treatments;
Treatment of hypercalcaemia of malignancy refractory to anti-neoplastic
therapy. |
