Drug

Date Subsidised

PBAC Clinical Indications and other Restrictions

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. (3355)

CAUTION:
Careful monitoring of patients is mandatory.

Stavudine (Zerit)

1 July 1996

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)

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. (3328)

http://www.medicareaustralia.gov.au/provider/pbs/highly-specialised-drugs/complex-authority-drugs.jsp

 Tadalafil - April 2012

1 August 2008

Amended 1 December 2008

Amended 1 December 2008

Amended 1 November 2011

Amended 1 March 2012

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis who is nucleoside analogue naïve and satisfies all of the following criteria:

(1) Elevated HBV DNA levels – greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative – in conjunction with documented hepatitis B infection;

(2) Evidence of chronic liver injury as determined by:

(a) Confirmed elevated serum ALT; or;

(b) Liver biopsy. (3969)

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who is nucleoside analogue naïve and who has detectable HBV DNA. (3970)

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 (Viread)

1 October 2002

Amended 1 February 2004

Amended
1 April 2005

Amended 1 December 2009

Amended 1 January 2011

Amended 1 November 2011

Amended 1 March 2012

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)

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis  who is nucleoside analogue naive and satisfies all of the following criteria;

(1) Elevated HBV DNA levels – greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or 2,000 IU/mL (10,000 copies/mL) if HBeAG negative – in conjunction with documented hepatitis B infection;

(2)Evidence of chronic liver injury as determined by:

(a) Confirmed elevated serum ALT; or;

(b) Liver biopsy (3969)

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who is nucleoside analogue naïve and who has detectable HBV DNA. (3970)

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 1 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. (3974)

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

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

1 February 2006

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)

Tenofovir with Emtricitabine and Efavirenz (Atripla)

1 January 2010

Amended 1 January 2011

Amended 1 March 2012

Initial treatment of HIV infection in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease (3985)

1 February 2006

1 September 2009

Amended 1 August 2010

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. (3342)

1 August 2007

1 August 2010

Amended 1 January 2011

Treatment of HIV infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 200 mg ritonavir twice daily in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.
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. (3601)

Treatment of HIV infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with ritonavir in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.
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

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 

 Tocilizumab - April 2012

 Tocilizumab (under 18 years) May 2012

Valaciclovir Hydrochloride (Valtrex, APO-Valaciclovir, Zelitrex, Valaciclovir RBX, Valvala)

1 October 2000

Amended 1 February 2003

Prophylaxis of cytomegalovirus (CMV) infection and disease following renal transplantation in patients at risk of CMV disease. (3419)

1 November 2002

Amended 1 May 2004

Cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome. (3420)

Prophylaxis of cytomegalovirus infection and disease in solid organ transplant patients at risk of cytomegalovirus disease. (3421)

Zidovudine (AZT) (Retrovir)

1 July 1992

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)

1 May 2002

Last revision: February 2004

Amended 1 November 2011

Multiple myeloma; (3342)

Bone metastases from breast cancer;(3343)

Bone metastases from hormone -resistant prostate cancer, with demonstration of biochemical progression of disease despite maximal therapy with hormone treatments;(3882)

Treatment of hypercalcaemia of malignancy refractory to anti-neoplastic therapy.(3341)

Note:

Special Pricing Arrangements apply.