Peginterferon Alfa-2b (Peg-Intron®)
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
CAUTION: Treatment with peginterferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored.
Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C and have a contraindication to ribavirin, who satisfy all of the following criteria:
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Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
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Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.
The treatment course is limited to up to 48 weeks.
Patients may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop.
NOTE: Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24 hour access by patients to medical advice; and
(c) an established liver clinic; and(d) facilities for safe liver biopsy.
Specialist Prescriber
| Signature: | ____________________________________ |
| Name: | ____________________________________ |
| Date: | ____________________________________ |
*To be completed by the specialist initiating drug treatment, and retained by the hospital Pharmacy Department.
April 2007