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Hospital Circular 16/2001

Date Issued: 17 July 2001

Publication: 16/2001

Distribution: Public Hospitals

Subjects: Highly Specialised Drugs Program

Purpose: To advise hospitals involved of a number of changes to the Highly Specialised Drugs Program.

We have had recent advice from the Commonwealth on a number of changes concerning drugs on the Highly Specialised Drugs Program. Details of the changes are set out below.

1. Add Pack Size

Epoetin alfa (Eprex)

For the treatment of anaemia requiring transfusion, associated with chronic renal failure.

6302Q Injection 5,000 units in 0.5mL pre-filled syringe, 6 $556.50
6303R Injection 6,000 units in 0.6mL pre-filled syringe, 6 $660.60
6304T Injection 7,000 units in 0.7mL pre-filled syringe, 6 $756.00
6305W Injection 8,000 units in 0.8mL pre-filled syringe, 6 $856.80
6306X Injection 9,000 units in 0.9mL pre-filled syringe, 6 $953.10

Didanosine (Videx)

Treatment of HIV infection in patients with CD4 cell counts of less than 500 per cubic millimetre, or viral load of greater than 10,000 copies per mL.

6298L Capsule 125mg (containing enteric coated beadlets), 30 $98.95
6299M Capsule 200mg (containing enteric coated beadlets), 30 $158.31
6300N Capsule 250mg (containing enteric coated beadlets), 30 $197.89
6301P Capsule 400mg (containing enteric coated beadlets), 30 $316.62

Effective 1 August 2001

2. Amend Indication

Interferon alfa - 2a and 2b (Roferon-A, Intron A and Intron A Redipen)

Change from:
Patients with chronic hepatitis B who satisfy all of the following criteria:
  1. Have evidence of chronic hepatitis on liver biopsy, except in patients with coagulation disorders;
  2. Are HBe antigen positive and/or HBV DNA positive and have had evidence of chronic hepatitis B for at least 6 months;
  3. Have an ALT greater than twice the upper limit of the laboratory reference range on 3 occasions over a period of 6 months;
  4. Are not 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);
  5. Are not pregnant, not lactating, or are practising an adequate form of birth control;
  6. Have no history of significant psychiatric illness;
  7. Would be likely to attend regularly for treatment and follow-up;
  8. Take no more than 7 standard alcoholic drinks per week;
Change to:
Patients with chronic hepatitis B who satisfy all of the following criteria:
  1. Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
  2. Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection (repeatedly HBe antigen positive and/or HBV DNA positive);
  3. Are not 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);
  4. Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception;

Lamivudine (Zeffix)

Change from:
Patients with chronic hepatitis B who satisfy all of the following criteria:
  1. Have evidence of chronic hepatitis on liver biopsy, except in patients with coagulation disorders;
  2. Are HBe antigen positive and/or HBV DNA positive and have had evidence of chronic hepatitis B for at least 6 months;
  3. Have elevated ALT levels on 2 occasions over a period of 3 months;
  4. Are not pregnant, not lactating, or are practising an adequate form of birth control;
  5. Would be likely to attend regularly for treatment and follow-up;
  6. Take no more than 7 standard alcoholic drinks per week.

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.

Change to:
Patients with chronic hepatitis B who satisfy all of the following criteria:
  1. Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
  2. Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection (repeatedly HBe antigen positive and/or HBV DNA positive);
  3. Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.

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.

Effective: 1 August 2001

3. Deletion

Filgrastim (Neupogen)

6224N Inj. 300 micrograms in 1mL single use pre-filled syringe, 10 $1,504.00
6225P Inj. 480 micrograms in 1.6mL single use pre-filled syringe, 10 $2,407.00

The manufacturer has discontinued these drug forms.

Effective: 1 August 2001

Any changes notified by hospital circular will be updated in the Guidelines on the internet and the relevant claim forms amended. Pharmacists are encouraged to check Victoria's Highly Specialised Drugs Program website to ensure they are using the correct claim forms or to request updated copies by Fax on 03-9616 7764.

End of Financial Year Audit of Highly Specialised Drugs Program

Please note that certified statements of Hospital Audits for the 2000/2001 HSD Program are due by 30 September 2001. Please ensure that the audit is completed by the due date to secure your continued access to the program.

Please send Audit Certifications to:
Sue Merritt, HSD Project Officer
Acute Health, 17/555 Collins Street, Melbourne, VIC 3000.
Ph 9616 8673 Email: sue.merritt@dhs.vic.gov.au

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