Tenofovir
Highly Specialised Drugs Program Declaration Form*
| Patient’s Name: | ____________________________________ |
| Medical Record Number: | ____________________________________ |
| Medicare Number: | ____________________________________ |
I certify that the above patient meets the Pharmaceutical Benefits Advisory Committee’s criteria for funding under Section 100 of the National Health Act, 1953.
Criteria
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
Continuing treatment of HIV infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B 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 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.
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who is nucleoside analogue naive 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.
Note: Patients may receive treatment in combination with lamivudine but not with other PBS-subsidised antihepadnaviral therapy.
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.
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.
Note: Patients may receive treatment in combination with lamivudine but not with other PBS-subsidised antihepadnaviral therapy.
Specialist/ Authorised Prescriber
| Signature: | ____________________________________ |
| Name: | ____________________________________ |
| Date: | ____________________________________ |
Additional information to be provided by authorised general practitioners only:
| Provider Number: | ____________________________________ |
| Practice Address: | ____________________________________ |
| Telephone Number: | ____________________________________ |
*To be completed by the specialist or authorised prescriber initiating drug treatment, and retained by the hospital Pharmacy Department.
March 2012