EmailHospital Circular 05/2001
Date Issued: 10 April 2001
Publication: 5/2001
Distribution: Public Hospitals
Subject: Highly Specialised Drugs Program
Purpose: 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 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)
| 6294G | Injection 40 000 units in 1 mL vial, 1 | $660.00 |
For the treatment of anaemia requiring transfusion associated with chronic renal failure.
Effective: 1 May 2001
2. PRICE CHANGES
Tacrolimus
| 6216E | Capsule 1 mg, 100 | $369.60 |
| 6217F | Capsule 5 mg, 50 | $924.00 |
Interferon alfa-2a
| 6210W | Injection 3 million units in 0.5mL single dose pre-filled syringe,1 | $28.11 |
| 6211X | Injection 4.5 million units in 0.5mL single dose pre-filled syringe,1 | $42.17 |
| 6212Y | Injection 6 million units in 0.5mL single dose pre-filled syringe,1 | $56.21 |
| 6213B | Injection 9 million units in 0.5mL single dose pre-filled syringe,1 | $84.32 |
Interferon alfa -2b
| 6233C | Injection
set containing 1 vial powder for injection 30,000,000 i.u. and 1 vial solvent 2 mL |
$281.07 |
| 6244P | Solution for injection 3,000,000 i.u. in 0.5mL single dose vial, 5 | $140.54 |
| 6245Q | Solution for injection 5,000,000 i.u. in 0.5mL single dose vial, 5 | $234.23 |
| 6246R | Solution for injection 10,000,000 i.u. in 1mL single dose vial, 5 | $468.45 |
| 6218G | Solution for injection 18,000,000 i.u. in 3mL multi-dose vial, 5 | $843.21 |
| 6219H | Solution for injection 25,000,000 i.u. in 2.5mL multi-dose vial, 5 | $1,171.13 |
| 6253D | Sol. for injection 18,000,000 i.u. in 1.2mL multi-dose cartridge, 1 | $168.64 |
| 6254E | Sol. for injection 30,000,000 i.u. in 1.2mL multi-dose cartridge, 1 | $281.07 |
| 6255F | Sol. for injection 60,000,000 i.u. in 1.2mL multi-dose cartridge, 1 | $562.14 |
Ribavirin & Interferon
(for relapse patients)
| 6261M | Pack containing 84 capsules ribavirin 200mg and 2 multi-dose cartridges interferon alfa-2b solution for injection 18,000,000 i.u. in 1.2mL, 1 | $ 988.24 |
| 6262N | Pack containing 140 capsules ribavirin 200mg and 2 multi-dose cartridges interferon alfa-2b solution for injection 18,000,000 i.u. in 1.2mL, 1 | $1,450.00 |
| 6263P | Pack containing 168 capsules ribavirin 200mg and 2 multi-dose cartridges interferon alfa-2b solution for injection 18,000,000 i.u. in 1.2mL, 1 | $1,677.06 |
Effective: 1 May 2001
3. CHANGES TO INDICATIONS
Ribavirin & interferon alfa-2b
(patients who have not received previous treatment)
| 6261M | Pack containing 84 capsules ribavirin 200mg and 2 multi-dose cartridges interferon alfa-2b solution for injection 18,000,000 i.u. in 1.2mL, 1 | $988.24 |
| 6262N | Pack containing 140 capsules ribavirin 200mg and 2 multi-dose cartridges interferon alfa-2b solution for injection 18,000,000 i.u. in 1.2mL, 1 | $1,450.00 |
| 6263P | Pack containing 168 capsules ribavirin 200mg and 2 multi-dose cartridges interferon alfa-2b solution for injection 18,000,000 i.u. in 1.2mL, 1 | $1,677.06 |
Caution:
Treatment with interferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicide 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.
Treatment of chronic hepatitis C in patients previously untreated with interferon alfa-2a/2b and who satisfy all of the following criteria:
- Histological evidence of Metavir (or equivalent index) stage 2,3 or 4 fibrosis or stage1 with grade A2 or A3 inflammation, ie moderate to severe inflammation evident on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
- Abnormal serum ALT levels in conjunction with documented chronic hepatitis C infection (repeatedly anti-HCV positive and /or HCV RNA positive);
- Female patients of child bearing age, are not pregnant, not breastfeeding, 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 24 weeks, except for patients with genotype 1 hepatitis C and for patents with hepatic cirrhosis or bridging fibrosis regardless of genotype, for whom the treatment course is limited to 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.
NOTE:
Hospitals 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.
Ganciclovir (Cymevene)
| 6159E | Capsule 250mg, 84 |
| 6272D | Capsule 500mg, 90 |
| 6136Y | Powder for I.V. infusion 500mg, vial, 5 |
Change from:
Primary prophylaxis of cytomegalovirus disease in liver, heart and bone marrow transplant patients at risk of cytomegalovirus disease
Sight-threatening cytomegaloviral retinitis in severely immunocompromised patients. Maintenance therapy after stabilisation with intravenous ganciclovir of sight-threatening cytomegaloviral retinitis in severely immunocompromised patients.
Change to:
Maintenance therapy after stabilisation with intravenous ganciclovir sodium of sight-threatening cytomegaloviral retinitis in severely immunocompromised patients; Prophylaxis of cytomegalovirus disease in bone marrow and solid organ transplant patients at risk of cytomegalovirus disease (for capsule only).
Sight-threatening cytomegalovirus retinitis in severely immunocompromised patients;
Prophylaxis of cytomegalovirus disease in bone marrow and solid organ transplant patients at risk of cytomegalovirus disease (for infusion only).
Please note: Indication for Intravitreal implant remains unchanged as follows:
Sight-threatening cytomegaloviral retinitis in severely immunocompromised patients.
Interferon alfa-2a & interferon alfa -2b
Interferon alfa-2a
| 6210W | Injection 3 million units in 0.5mL single dose pre-filled syringe,1 |
| 6211X | Injection 4.5 million units in 0.5mL single dose pre-filled syringe,1 |
| 6212Y | Injection 6 million units in 0.5mL single dose pre-filled syringe,1 |
| 6213B | Injection 9 million units in 0.5mL single dose pre-filled syringe,1 |
Interferon alfa-2b
| 6233C | Inj. set containing 1 vial powder 30,000,000 i.u. and 1 vial solvent 2 mL |
| 6244P | Solution for injection 3,000,000 i.u. in 0.5 mL single dose vial, 5 |
| 6245Q | Solution for injection 5,000,000 i.u. in 0.5 mL single dose vial, 5 |
| 6246R | Solution for injection 10,000,000 i.u. in 1 mL single dose vial, 5 |
| 6218G | Solution for injection 18,000,000 i.u. in 3 mL multi-dose vial, 5 |
| 6219H | Solution for injection 25,000,000 i.u. in 2.5 mL multi-dose vial, 1 |
| 6253D | Solution for injection 18,000,000 i.u. in 1.2 mL multi-dose cartridge, 1 |
| 6254E | Solution for injection 30,000,000 i.u. in 1.2 mL multi-dose cartridge, 1 |
| 6255F | Solution for injection 60,000,000 i.u. in 1.2 mL multi-dose cartridge, 1 |
Change indication for hepatitis C from:
Use by patients with chronic hepatitis C who satisfy all of the following criteria:
- have evidence of chronic hepatitis on liver biopsy, except in patients with coagulation disorders;
- have a repeatedly positive anti-HCV antibody test;
- have abnormal ALT levels in conjunction with demonstration of viral infection (HCV RNA positive and/or anti-HCV positive);
- do not have cirrhosis or other liver disease;
- are not pregnant, not lactating, or are 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; and
- take no more than 7 standard alcoholic drinks per week;
Conditions of funding for Hepatitis C
The course of treatment is limited to 3 million units subcutaneously 3 times weekly for up to 52 weeks. If the ALT remains greater than the upper limit of the laboratory reference range after 12 weeks, subsidisation through the HSD program is to cease. The course of treatment must be continuous and excludes re-treatment of non-responders or patients who relapse and thus patients eligible for the 12 months course will be new patients and current responding patients who have had less than 12 months continuous interferon treatment.
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.
Change indication for hepatitis C to:
Caution:
Treatment with interferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicide ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored.
Patients with chronic hepatitis C who satisfy all of the following criteria:
- Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
- Abnormal serum ALT levels in conjunction with documented hepatitis C infection(repeatedly anti-HCV positive, and or HCV-RNA positive);
- No other forms of chronic liver disease;
- Female of child bearing age are not pregnant, not breastfeeding, and are using effective form of contraception.
The course of treatment is limited to 3 million units subcutaneously 3 times weekly for up to 52 weeks.
Treatment is to cease if plasma HCV RNA remains detectable by an HCV-RNA qualitative assay after 12 weeks therapy.
The course of treatment must be continuous and excludes re-treatment of non-responders or patients who relapse.
Note:
Hospitals 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.
Ribavirin & interferon alfa-2b
| 6261M | Pack containing 84 capsules ribavirin 200mg and 2 multi-dose cartridges interferon alfa-2b solution for injection 18,000,000 i.u. in 1.2mL, |
| 6262N | Pack containing 140 capsules ribavirin 200mg and 2 multi-dose cartridges interferon alfa-2b solution for injection 18,000,000 i.u. in 1.2mL, 1 |
| 6263P | Pack containing 168 capsules ribavirin 200mg and 2 multi-dose cartridges interferon alfa-2b solution for injection 18,000,000 i.u. in 1.2mL, 1 |
Change indication for relapsed patients from:
Treatment of chronic hepatitis C in patients who have relapsed following interferon alfa-2a/2bmonotherapy where the monotherapy treatment would have complied with the criteria for PBS subsidy. Patients must satisfy all of the following criteria:
- have evidence of 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 an adequate form of birth control;
- have no history of significant 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.
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.
Change indication for relapsed patients to:
Caution:
Treatment with interferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicide 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.
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 and who satisfy all of the following criteria:
- Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
- Abnormal serum ALT levels in conjunction with documented chronic hepatitis C infection (repeatedly anti-HCV positive and /or HCV RNA positive);
- Female patients of child bearing age are not pregnant, not breastfeeding, 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 24 weeks.
Treatment is to cease if plasma HCV RNA remains detectable by an HCV RNA qualitative assay after 12 weeks of therapy.
NOTE:
Hospitals 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: 1 May 2001
4. ADVANCE NOTICE OF DELETION
Filgrastim (Neupogen)
| 6126K | Injection 300 micrograms in 1mL vial, 10 |
| 6127L | Injection 480 micrograms in 1.6mL vial, 10 |
These drug forms have been discontinued by the manufacturer.
Effective: 1 August 2001.
4. CHANGES TO EXPLANATORY NOTES, SECTION 100 PBS SCHEDULE
Change fourth paragraph from:
A patient will be required to pay a contribution for each month's supply of a highly specialised drug at a similar rate to the Pharmaceutical Benefits Scheme. Commonwealth subsidy is not available for hospital inpatients.
Change to:
A patient will be required to pay a contribution for each supply of a highly specialised drug at a similar rate to the Pharmaceutical Benefits Scheme. Commonwealth subsidy is not available for hospital inpatients.
Under " PRIVATE HOSPITALS" change second and third sentence from:
"Highly Specialised Drugs are authority required items and medical practitioners must seek and be granted, approval to prescribe these items as pharmaceutical benefits prior to their dispensing under the PBS. Prescriptions for Highly Specialised Drugs can be dispensed by an approved private hospital's dispensary or by a community pharmacy.
Change second and third sentence to:
"Highly Specialised Drugs are authority required items and medical practitioners must seek by telephone, and be granted, approval to prescribe these items as pharmaceutical benefits prior to their dispensing under the PBS. Prescribers must quote the provider number of the hospital when applying. Not more than two months' supply (one months' supply in the case of Clozapine), with the provision for up to 5 repeats, will be authorised".
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 web site to ensure they are using the correct claim forms or request updated copies by
fax 03-9616 7764.
DR C W BROOK
DIRECTOR, ACUTE HEALTH
