EmailHospital Circular 09/2000
Date
Issued: 7 June 2000
Publication: 09/2000
Distribution: Acute Health Circular Registrants
Attention: Public Hospitals, Extended Care Centres, Health Care Networks
Distribution: Public and Private Hospitals
Subject: Highly Specialised Drugs Program
Purpose: The purpose of this circular is to advise hospitals
involved with the Highly Specialised Drugs Program of a number of
changes to the Program.
We have had recent advice from the Commonwealth on a number changes concerning drugs on the Highly Specialised Drugs Program. Details of the changes are set out below.
1. Change in criteria
Ribavirin/Interferon Alfa 2b (Rebetron combination therapy)
To avoid confusion the indication has been changed to:
Treatment of chronic Hepatitis C in patients who have relapsed following interferon alfa-2a/2b monotherapy where the monotherapy treatment would have complied with the criteria for PBS subsidy.
Treatment for patients who satisfy all of the following criteria:
- Have chronic hepatitis evident on liver biopsy, except in patients with coagulation disorders;
- Have a repeatedly positive anti-HCV antibody test;
- Are not pregnant, not lactating, or are practicing and adequate form of birth control;
- Have no sign of psychiatric illness;
- Would be likely to attend regularly for treatment and follow-up;
- Take no more than 7 standard alcoholic drinks per week
Treatment is to cease if plasma HCV RNA remains detectable after 12 weeks therapy. The treatment course is limited to 24 weeks.
Also add:
"States and Territories should adhere to the National Health and Medical Research Council's Taskforce Report on Hepatitis C regarding the facility requirements for the selection of treatment centres".
Effective Date: 1 July 2000
LENOGRASTIM (GRANOCYTE)
Change criteria from:
"who have had a prior episode of severe febrile neutropenia or prolonged severe neutropenia (neutrophil count below 1 x 109 per litre)"
to:
"who have had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count below 1 x 109 per litre)"
Effective Date: 1 July 2000
CLOZAPINE (CLOZARIL)
The recommendation from the PBAC that the sponsor include provision for the recording of patient outcome in its monitoring program will be removed from the guidelines. Details such as percentage of patients "successfully" treated, medium and long term efficacy, relapse rate, movement between different levels of care and usage outside S100 indications are no longer required.
Effective Date: 1 July 2000
HEPATITIS B AND C DRUGS (INTERFERON ALFA 2A (ROFERON A), INTERFERON ALFA 2B (INTRON A) and RIBAVIRIN AND INTERFERON ALFA 2B (REBETRON COMBINATION THERAPY))
All hepatitis B and C criteria have been amended from:
"Use by patients with chronic hepatitis ...who: ..."
To:
"Use by patients with chronic hepatitis.... who satisfy all of the following criteria:
- have evidence of chronic active hepatitis on liver biopsy;
- are E antigen positive and or HBV DNA positive and have had evidence of chronic active hepatitis B for at least 6 months;
- have an ALT greater than twice the upper limit of the laboratory reference range on 3 occasions over a period of 6 months;
- are not pregnant, not lactating, or practicing an adequate form of birth control;
- have no history of significant psychiatric illness;
- would be likely to attend regularly for treatment and follow-up;
- have an alcohol usage of no more than 7 standard drinks per week;
Effective Date: 1 July 2000
LAMIVUDINE (ZEFFIX)
The criteria for the use of Lamivudine (Zeffix) to treat Hepatitis B has been amended to:
"Use by patients with chronic hepatitis B who satisfy all of the following criteria:
- have evidence of chronic hepatitis B on liver biopsy except patients with coagulation disorders;
- are HBe antigen positive and/or HBV DNA positive and have had evidence of chronic hepatitis B for at least 6 months;
- have elevated ALT levels on 2 occasions over a period of 3 months;
- are not pregnant, not lactating, or are practicing an adequate form of birth control;
- would be likely to attend regularly for treatment and follow-up; and
- take no more than 7 standard alcoholic drinks per week.
Persons with Child's Class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin < 30g/L, bilirubin > 30 micromoles/L) should have their treatment discussed with a transplant unit prior to initiating therapy."
Effective Date: 1 July 2000
2. ADVANCE NOTICE OF DELETION
INTERFERON ALFA-2A
6220J Solution for injection 18 million units in single use vial, 3
Effective Date: 1 August 2000
INTERFERON ALFA-2B
6147M Injection 9 million units per vial , 1
6128M Solution for injection 10 million units in 2mL multi-dose vial, 5
Effective Date: 1 August 2000
3. ADDITION OF NEW BRAND
CLOZAPINE (SBPA Clozapine, SL)
6101D Tablet 25mg, 100
6102E Tablet 100mg, 100
Effective Subsidy Date: 1 July 2000
The relevant changes to Appendices 2, 3 and 8 of the Commonwealth/State Highly Specialised Drugs Program Guidelines have been made. Any changes notified by hospital circular will be immediately updated in the Guidelines on the internet. The relevant changes are also attached to this circular by hard copy.
DR C W BROOK
DIRECTOR
