EmailHospital Circular 08/2001
Date Issued: 10 May 2001
Publication: 8/2001
Distribution: Public Hospitals
Subject: Highly Specialised Drugs Program
Purpose: To inform hospitals of advice from the Commonwealth regarding compassionate use of Ribavirin in the Highly Specialised Drugs Program.
On 1 May 2001, the Commonwealth advised of arrangements to allow patients accessing ribavirin with subsidised interferon to continue their treatment with the new indication for Rebetron Combination Therapy as 'patients previously untreated with interferon alfa-2a/2b' (refer Hospital Circular 6/2001 dated 2/5/01).
Subsequently, it has been brought to the Commonwealth's attention that a small number of this patient group may not meet all the criteria for Rebetron Combination Therapy, in particular, criterion one in relation to fibrosis. As this criterion had not, prior to 1 May 2001, applied to Rebetron Combination Therapy or the monotherapy restrictions, the Commonwealth has further agreed to subsidise these patients under the restrictions that applied to them prior to 1 May 2001. Therefore, those patients accessing ribavirin and subsidised interferon alfa-2b prior to 1 May are to continue to comply with the monotherapy restrictions as indicated in the Schedule of Pharmaceutical Benefits (PBS) at the time of commencement of therapy.
There are two exceptions to the monotherapy restrictions:
- The treatment
course is limited to a single course of 24 weeks, except for patients
with genotype 1 hepatitis C and patients with hepatic cirrhosis or bridging
fibrosis regardless of genotype, for whom the treatment course is limited
to a single course of 48 weeks. Patients eligible for 48 weeks treatment
may only continue therapy if plasma HCV RNA is not detectable by an
HCV RNA qualitative assay after the first 24 weeks of therapy.
Those patients who were receiving ribavirin and interferon alfa-2b prior to the change in indication should complete their course on subsidised Rebetron Combination Therapy and not restart the treatment duration from 1 May.
- That 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.
Please note: This is a transitional arrangement. Any new patient commencing ribavirin and interferon alfa-2b from 1 May 2001 will need to comply with all the restrictions listed in the Schedule of Pharmaceutical Benefits May 2001.
DR
C W BROOK
DIRECTOR, ACUTE HEALTH
