EmailHospital Circular 17/2000
Date
Issued:
19 September 2000
Publication: 17/2000
Distribution: Public
and Participating Private 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 changes concerning drugs on the Highly Specialised Drugs Program. Details of the changes are set out below.
1. NEW DRUGS ON PROGRAM (PUBLIC HOSPITALS)
Baclofen (Lioresal Intrathecal)
| Code | Pack size | Price | |
|---|---|---|---|
| 6284R | Intrathecal injection 10mg in 5mL. | 1 | $140.00 |
| 6285T | Intrathecal injection 10mg in 20mL. | 1 | $140.00 |
Indication:
Patients with severe chronic spasticity due to multiple sclerosis or spinal cord injury or disease where oral antispastic agents have failed or have caused unacceptable side effects.
Effective date: 1 October 2000
Disodium Pamidronate (Aredia)
| 6286W | Concentrated injection 15mg in 5mL. | 1 | $63.21 |
| 6287X | Concentrated injection 30mg in 10mL. | 1 | $126.43 |
| 6288Y | Concentrated injection 60mg in 10mL. | 1 | $252.86 |
| 6289B | Concentrated injection 90mg in 10mL. | 1 | $379.29 |
Indication:
Treatment of hypercalcemia of malignancy refractory to anti-neoplastic therapy.
Effective date: 1 October 2000
Valaciclovir Hydrochloride (Valtrex)
| 6280M | Tablet 500mg (base). | 240 | $1,160.72 |
Indication:
Prophylaxis of cytomegalovirus (CMV) infection and disease following renal transplantation in patients at risk of CMV disease.
Effective date: 1 October 2000
2. ADD PACK SIZE
Disodium Pamidronate (Aredia)
| 6289B | Concentrated injection 90mg in 10mL. | 1 | $379.29 |
Indication:
Multiple
myeloma.
Bone
metastases from breast cancer.
Effective date: 1 October 2000
Efavirenz (Stocrin)
| 6283Q | Capsule 200mg. | 90 | $271.59 |
Effective date: 1 October 2000
Filgrastim (Neupogen)
| 6291D | Injection 300 micrograms in 0.5mL single use pre-filled syringe. | 10 | $1,504.00 |
| 6292E | Injection 480 micrograms in 0.5mL single use pre-filled syringe. | 10 | $2,407.00 |
Effective date: 1 October 2000
3. PATIENT ELIGIBILITY
Add "Where a patient is entitled to be treated as an eligible person under section 7 of the Health Insurance Act 1973 (i.e. a visitor from a country with which Australia has entered into a Reciprocal Health Care Agreement), the supply will be limited to the original prescription only. Repeat prescriptions are not permitted."
Effective date: 1 October 2000
4. CHANGE IN INDICATION
Dornase alfa (Pulmozyme)
Change "Use by cystic fibrosis patients who" to "Use by cystic fibrosis patients who satisfy all of the following criteria."
Change "The following conditions must be adhered to in order to be eligible for Commonwealth funding" to "In order for patients to be eligible for participation in the HSD program, the following conditions must be met."
Change "Patients must be assessed at cystic fibrosis clinics/centres which are under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis and the prescribing of dornase alfa under this program is limited to such physicians. If attendance at such units is not possible because of geographical location, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit" to "Patients must be assessed at cystic fibrosis clinics/centres which are under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis and the prescribing of dornase alfa under the HSD program is limited to such physicians. If attendance at such units is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit."
Change "The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel, at established lung function testing laboratories, unless this is not possible because of geographical location" to from "The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel, at established lung function testing laboratories, unless this is not possible because of geographical isolation."
Change "Patients who fail to meet a 10% or greater improvement in FEV1 after the four weeks' treatment at the approved daily dose, may have one further trial in the next twelve months but not before 3 months after the initial trial" to "Patients who fail to meet a 10% or greater improvement in FEV1 after the four weeks' treatment at a dose of 2.5mg daily, may have one further trial in the next twelve months but not before 3 months after the initial trial."
Change "The approved daily dose is 2.5mg" to "Initial therapy is limited to 4 weeks' treatment with dornase alfa at a dose of 2.5mg daily."
Change "Where there is documented evidence that a patient already receiving dornase alfa treatment would have met the criteria for subsidy (i.e. Satisfied the criteria for the 4 week trial and achieved a 10% or greater improvement in FEV1) then the patient is eligible to continue treatment under this program." to "Where there is documented evidence that a patient already receiving dornase alfa treatment would have met the criteria for subsidy (i.e. Satisfied the criteria for the 4 week trial and achieved a 10% or greater improvement in FEV1) then the patient is eligible to continue treatment under the HSD program."
Effective date: 1 October 2000
Tacrolimus (Prograf)
Change "Prevention and treatment of rejection in primary liver and renal transplant recipients" to "Prevention and treatment of rejection in liver and renal transplant recipients."
Effective date: 1 October 2000
Interferon alfa-2a (Roferon-A) and Interferon alfa-2b (Intron A)
Change "Use by patients with chronic active hepatitis B who satisfy all of the following criteria" to "Use by patients with chronic hepatitis B who satisfy all of the following criteria."
Change "have chronic hepatitis on liver biopsy, except in patients with coagulation disorders" to "have evidence of chronic hepatitis on liver biopsy, except in patients with coagulation disorders."
Effective date: 1 October 2000
Octreotide Acetate (Sandostatin LAR)
Change "Subsidisation through the HSD program is to cease in patients previously treated with radiotherapy where there is biochemical evidence of remission (normal IGF 1) after octreotide withdrawal for at least 4 weeks (8 weeks after the last dose). Octreotide should be withdrawn for assessment of remission every 2 years in the 10 years after radiotherapy" to "Subsidisation through the HSD program is to cease in patients previously treated with radiotherapy where there is biochemical evidence of remission (normal IGF 1) after octreotide acetate withdrawal for at least 4 weeks (8 weeks after the last dose). Octreotide acetate should be withdrawn for assessment of remission every 2 years in the 10 years after radiotherapy."
Effective date: 1 October 2000
Rivavirin and interferon alfa-2b (Rebetron Combination Therapy)
Change "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" 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. Patients must satisfy all of the following criteria:"
Effective date: 1 October 2000
Lamivudine (Zeffix)
The paragraph order only, of this criterion, has been changed, after reports of confusion with the layout, to:
Use by patients with chronic hepatitis B who satisfy all of the following criteria:
- have evidence of chronic hepatitis on liver biopsy except in 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 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 date: 1 October 2000
Cidofovir (Vistide)
Change "Treatment of sight-threatening cytomegalovirus retinitis in patients aged twelve years and over with AIDS" to "Treatment of sight-threatening cytomegalovirus retinitis in patients with AIDS."
Effective date: 1 October 2000
5. ADD BRAND
Desferrioxamine Mesylate (Desferal) David Bull
| 6270B | Powder for injection 2g vial. | 1 | $40.00 |
Indication:
Disorders of erythropoiesis associated with treatment related chronic iron overload.
Effective date: 1 October 2000
Following private hospitals administration of HSDs becoming a Commonwealth responsibility, future amendments to the administrative arrangements will be at the same time as the publishing dates of the "Schedule of Pharmaceutical Benefits" i.e. 1 February, 1 May, 1 August and 1 November. This change is necessary to ensure that listing, delistings and variations for HSDs are in-line for both the private and public sectors. With a claims transmission system between the pharmacy and the Health Insurance Commission being mandatory, following the Third Community Pharmacy Agreement, it is unavoidable and essential to align the HSD Program and the PBS publishing dates.
It is expected that private hospitals will start accessing HSDs through the Health Insurance Commission on 1 November 2000. After this date, claim forms sent to the Department of Human Services will be returned to the hospital.
The relevant changes to Appendices 2, 3 and 8 of the Commonwealth/State Highly Specialised Drugs Program Guidelines have been made to the Department's website at http://www.health.vic.gov.au/hsdp/.
Any changes notified by hospital circular will be immediately updated in the Guidelines on the internet.
Please note that certified statements of Hospital Audits 1999/2000 for the HSD Program are due by 30 September 2000. 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, Acute Health, 17/555 Collins Street, Melbourne, VIC 3000.
If you have any questions please phone Sue on 9616 8673.
DR C W
BROOK
DIRECTOR
