EmailHospital Circular 02/2004
Date Issued: 27 January 2004
Distribution: Public Hospitals
Subject: Highly Specialised Drugs Program
Purpose: To advise hospitals of changes to the Highly Specialised Drugs Program, effective 1 February 2004.
We have had recent advice from the Australian Government of changes to the Highly Specialised Drugs Program, effective 1 February 2004.
1. ADD DRUG
Deferiprone
Iron overload in patients with thalassaemia major who are unable to take
desferrioxamine therapy;
Iron overload in patients with thalassaemia major in whom desferrioxamine
therapy has proven ineffective.
| 6416Q | Tablet 500 mg | 100 | $400.00 | Ferriprox | OA |
2. ADD ITEM/DRUG FORM
Clozapine
Schizophrenia in patients who are:
- non-responsive to other neuroleptic agents; or
- intolerant of other neuroleptic agents.
| 6417R | Tablet 50 mg | 100 | $144.00 | Clopine 50 | MX |
| 6418T | Tablet 200 mg | 100 | $540.00 | Clopine 200 | MX |
Lanreotide acetate
Active acromegaly in patients with persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre AND
- after failure of other therapy including dopamine agonists; or
- as interim treatment in patients awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or
- where surgery and radiotherapy are contraindicated.
Treatment is to cease in patients previously treated with radiotherapy where there is biochemical evidence of remission (normal IGF1) after lanreotide acetate withdrawal for at least 4 weeks (8 weeks after the last dose). Lanreotide acetate should be withdrawn for assessment of remission every 2 years in the 10 years after radiotherapy.
Treatment is to cease if there has been failure to lower IGF1 after 3 months treatment.
| 6423C | Injection 60 mg (base) in single dose pre-filled syringe | 1 | $1,345.00 | Somatuline Autogel | IS |
| 6424D | Injection 90 mg (base) in single dose pre-filled syringe | 1 | $1,790.00 | Somatuline Autogel | IS |
| 6425E | Injection 120 mg (base) in single dose pre-filled syringe | 1 | $2,240.00 | Somatuline Autogel | IS |
Octreotide acetate
Patients with acromegaly who are controlled on Sandostatin subcutaneous injections.
Treatment is to cease in patients previously treated with radiotherapy where there is biochemical evidence of remission (normal IGF1) 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 Octreotide acetate should be withdrawn for assessment of remission every 2 years in the 10 years after radiotherapy.
Treatment is to cease if there has been failure to lower IGF1 after 3 months of treatment;
Patients with a histologically-confirmed diagnosis of a functional carcinoid tumour or vasoactive intestinal peptide secreting tumour (VIPoma) and who are controlled on Sandostatin subcutaneous injections.
Treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with Sandostatin subcutaneous injections. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.
| 6426F | Injection (modified release) 10 mg (base) vial and diluent syringe | 1 | $1,390.00 | Sandostatin LAR | NV |
| 6427G | Injection (modified release) 20 mg (base) vial and diluent syringe | 1 | $1,850.00 | Sandostatin LAR | NV |
| 6428H | Injection (modified release) 30 mg (base) vial and diluent syringe | 1 | $2,315.00 | Sandostatin LAR | NV |
Peginterferon alfa-2b
CAUTION:
Treatment with peginterferon alfa has been associated with depression
and suicide in some patients. Patients with a history of suicidal ideation
or depressive illness should be warned of the risks. Psychiatric status
during therapy should be monitored.
Chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no prior interferon alfa therapy and have a contraindication to ribavirin, 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);
- No other forms of chronic liver disease;
- Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.
The treatment course is limited to 0.5 to 1 microgram per kilogram weekly for up to 52 weeks.
Treatment is to cease if plasma HCV RNA remains detectable by an HCV RNA qualitative assay after 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.
| 6411K | Powder for injection 50 micrograms with diluent in single use injection pen | 4 | $920.00 | PEG-Intron Redipen | SH |
| 6412L | Powder for injection 80 micrograms with diluent in single use injection pen | 4 | $1,472.00 | PEG-Intron Redipen | SH |
| 6413M | Powder for injection 100 micrograms with diluent in single use injection pen | 4 | $1,840.00 | PEG-Intron Redipen | SH |
| 6414N | Powder for injection 120 micrograms with diluent in single use injection pen | 4 | $2,208.00 | PEG-Intron Redipen | SH |
| 6415P | Powder for injection 150 micrograms with diluent in single use injection pen | 4 | $2,760.00 | PEG-Intron Redipen | SH |
Ribavirin and Peginterferon alfa-2b
CAUTION:
Treatment with interferon alfa has been associated with depression and
suicide in some patients. Patients with a history of suicidal 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 18 years or older who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment and who satisfy all of the following criteria:
- Histological evidence of Metavir (or equivalent index) stage 2, 3 or 4 fibrosis or stage 1 with grade A2 or A3 inflammation, i.e. 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 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.
For patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 24 weeks. For hepatitis C patients with genotype 1, 4, 5 or 6 and those genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 48 weeks.
Patients with genotype 1, 4, 5 or 6 who are eligible for 48 weeks of treatment may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop. (An HCV RNA assay at week 12 is unnecessary for genotype 2 and 3 patients because of the high likelihood of early viral response by week 12).
Patients with genotype 1, 4, 5 or 6 who are viral positive at week 12 but have attained at least a 2 log drop in viral load may only continue treatment after the first 24 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. Similarly, genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis may only continue treatment after the first 24 weeks if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. An HCV RNA qualitative assay at week 24 is unnecessary for those patients with genotype 1, 4, 5 or 6 who became viral negative at week 12.
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.
| 6399T | Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent | ‡1 | $1,014.02 | Pegatron | SH |
| 6400W | Pack containing 112 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent | ‡1 | $1,171.51 | Pegatron | SH |
| 6401X | Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent | ‡1 | $1,338.96 | Pegatron | SH |
| 6402Y | Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent | ‡1 | $1,496.44 | Pegatron | SH |
| 6403B | Pack containing 168 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent | ‡1 | $1,496.44 | Pegatron | SH |
| 6404C | Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent | ‡1 | $1,555.58 | Pegatron | SH |
| 6405D | Pack containing 112 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent | ‡1 | $1,713.07 | Pegatron | SH |
| 6406E | Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 120 micrograms with diluent | ‡1 | $1,772.20 | Pegatron | SH |
| 6407F | Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 120 micrograms with diluent | ‡1 | $1,929.69 | Pegatron | SH |
| 6408G | Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent | ‡1 | $2,097.14 | Pegatron | SH |
| 6409H | Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent | ‡1 | $2,254.63 | Pegatron | SH |
| 6410J | Pack containing 168 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent | ‡1 | $2,254.63 | Pegatron | SH |
3. DELETE ITEM/DRUG FORM
Cyclosporin
| 6111P | Capsule 25 mg | 50 | $73.55 | Cysporin | MX |
| 6112Q | Capsule 50 mg | 50 | $148.53 | Cysporin | MX |
| 6114T | Capsule 100 mg | 50 | $298.38 | Cysporin | MX |
Items discontinued by manufacturer. No advance notice given.
Zoledronic acid
| 6343W | Powder for I.V. infusion 4 mg vial with diluent ampoule | 1 | $389.25 | Zometa | NV |
Item discontinued by manufacturer.
4. BENCHMARK PRICE DECREASE AND APPLICATION OF BRAND PRICE PREMIUM
Cyclosporin
There has been a decrease in the benchmark price for cyclosporin 25 mg pack size 30, cyclosporin 50 mg pack size 30, cyclosporin 100 mg pack size 30 and a brand premium applied to Neoral 25, Neoral 50 and Neoral 100.
| 6352H | Capsule 25 mg | 30 | $41.63 | Cicloral | HX |
| Cysporin | MX | ||||
| Neoral 25 | NV |
NOTE:
A brand price premium of $1.91 applies to Neoral 25 brand. All 3 brands
may not be available in all hospitals.
| 6353J | Capsule 50 mg | 30 | $86.61 | Cicloral | HX |
| Cysporin | MX | ||||
| Neoral 50 | NV |
NOTE:
A brand price premium of $1.92 applies to Neoral 50 brand. All 3 brands
may not be available in all hospitals.
| 6354K | Capsule 100 mg | 30 | $176.46 | Cicloral | HX |
| Cysporin | MX | ||||
| Neoral 100 | NV |
NOTE:
A brand price premium of $1.92 applies to Neoral 100 brand. All 3 brands
may not be available in all hospitals.
5. OTHER AMENDS - CHANGE IN DESCRIPTION OF RESTRICTION
Please be advised that there have been changes in the wording/description of the restrictions of: HIV/AIDS Antiretroviral Agents, ganciclovir (several forms), and clozapine. The restrictions in substance are unchanged. There has also been an update of the wording for infliximab to allow treatment by either a rheumatologist or a clinical immunologist with expertise in the management of rheumatoid arthritis. Full details will be available at HSDP website from February 1, 2004.
6. OTHER AMENDS - CHANGE IN DESCRIPTION OF FORM
Amend description of form for the following items as shown (from 'cartridge' to 'injection pen').
Interferon alfa-2b
Change from:
| 6253D | Solution for injection 18,000,000 i.u. in 1.2 mL multi-dose cartridge | 1 | $168.64 | Intron A Redipen | SH |
| 6254E | Solution for injection 30,000,000 i.u. in 1.2 mL multi-dose cartridge | 1 | $281.07 | Intron A Redipen | SH |
| 6255F | Solution for injection 60,000,000 i.u. in 1.2 mL multi-dose cartridge | 1 | $562.14 | Intron A Redipen | SH |
Change to:
| 6253D | Solution for injection 18,000,000 i.u. in 1.2 mL multi-dose injection pen | 1 | $168.64 | Intron A Redipen | SH |
| 6254E | Solution for injection 30,000,000 i.u. in 1.2 mL multi-dose injection pen | 1 | $281.07 | Intron A Redipen | SH |
| 6255F | Solution for injection 60,000,000 i.u. in 1.2 mL multi-dose injection pen | 1 | $562.14 | Intron A Redipen | SH |
Ribavirin and interferon alfa-2b
Change from:
| 6261M | Pack containing 84 capsules ribavirin 200 mg and 2 multi-dose cartridges interferon alfa-2b solution for injection 18,000,000 i.u. in 1.2 mL | ‡1 | $988.24 | Rebetron Combination Therapy | SH |
| 6262N | Pack containing 140 capsules ribavirin 200 mg and 2 multi-dose cartridges interferon alfa-2b solution for injection 18,000,000 i.u. in 1.2 mL | ‡1 | $1,450.00 | Rebetron Combination Therapy | SH |
| 6263P | Pack containing 168 capsules ribavirin 200 mg and 2 multi-dose cartridges interferon alfa-2b solution for injection 18,000,000 i.u. in 1.2 mL | ‡1 | $1,677.06 | Rebetron Combination Therapy | SH |
Change to:
| 6261M | Pack containing 84 capsules ribavirin 200 mg and 2 multi-dose injection pens interferon alfa-2b solution for injection 18,000,000 i.u. in 1.2 mL | ‡1 | $988.24 | Rebetron Combination Therapy | SH |
| 6262N | Pack containing 140 capsules ribavirin 200 mg and 2 multi-dose injection pens interferon alfa-2b solution for injection 18,000,000 i.u. in 1.2 mL | ‡1 | $1,450.00 | Rebetron Combination Therapy | SH |
| 6263P | Pack containing 168 capsules ribavirin 200 mg and 2 multi-dose injection pens interferon alfa-2b solution for injection 18,000,000 i.u. in 1.2 mL | ‡1 | $1,677.06 | Rebetron Combination Therapy | SH |
Changes notified by hospital circular will be updated in the Guidelines on the Commonwealth/State Highly Specialised Drugs Program Guidelines website and the claim form amended.
Noreen Dowd
Director, Programs
Metropolitan Health & Aged Care Services
