Ribavirin and Peginterferon Alfa-2b (Pegatron®)
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.
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.
CAUTION: Ribavirin 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 during the 6 months period after cessation of treatment.
Criteria
Treatment, managed by an accredited treatment centre, of chronic 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 or patients who have failed one prior attempt at interferon based therapies (non-pegylated or pegylated) and who satisfy all of the following criteria:
Patients naive to interferon based therapies (non-pegylated or pegylated).
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 who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and both patient and their partner are using effective forms of contraception (one for each partner). Male patients and their partners are using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant.
For patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 24 weeks. For hepatitis C patients with genotype 1, 4, 5 or 6 and those genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 48 weeks.
Patients with genotype 1, 4, 5 or 6 who are eligible for 48 weeks of treatment 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. (An HCV RNA assay at week 12 is unnecessary for genotype 2 and 3 patients because of the high likelihood of early viral response by week 12).
Patients with genotype 1, 4, 5 or 6 who are viral positive at week 12 but have attained at least a 2 log drop in viral load may only continue treatment after the first 24 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. Similarly, genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis may only continue treatment after the first 24 weeks if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. An HCV RNA qualitative assay at week 24 is unnecessary for those patients with genotype 1, 4, 5 or 6 who became viral negative at week 12.
Patients who have failed one prior attempt at interferon based therapies (non-pegylated or pegylated).
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 more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C and who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and both patient and their partner are using effective forms of contraception (one for each partner). Male patients and their partners are using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant.
The treatment course is limited to 48 weeks. Patients may only continue treatment after the first 12 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 12.
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 nurse educator/counsellor for patients; and
- 24 hour access by patients to medical advice; and
- an established liver clinic; and
- facilities for safe liver biopsy.
Specialist Prescriber
| Signature: | ____________________________________ |
| Name: | ____________________________________ |
| Date: | ____________________________________ |
Accredited Medical Practitioner
| Signature: | ____________________________________ |
| Name: | ____________________________________ |
| Date: | ____________________________________ |
| Practice Address: | ____________________________________ |
| Provider Number: | ____________________________________ |
| Phone Number: | ____________________________________ |
*To be completed by the specialist initiating drug treatment and when prescribing maintenance drug treatment under shared care arrangements to be completed by the accredited medical practitioner and retained by the hospital Pharmacy Department.
December 2008