EmailHospital Circular 28/2003
Date Issued: 10 October 2003
Publication: 28/2003
Distribution: Public Hospitals
Subject: To advise hospitals involved of changes to the Highly Specialised Drugs Program, effective 1 November 2003.
We have had recent advice from the Commonwealth of changes to the Highly Specialised Drugs Program, effective 1 November 2003.
1. ADD DRUG
Ribavirin and peginterferon alfa-2a (Pegasys™)
Ribavirin and peginterferon alfa-2b (Pegatron™)
While the listing for ribavirin and peginterferon alfa is effective from 1 November 2003 it missed the publications deadline for the November Schedule of Pharmaceutical Benefits and will therefore be advised in the Schedule of 1 February 2004.
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.
| 6377P | Pack containing 84 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 50 µg with diluent | ‡1 | $1,014.02 | Pegatron | SH |
| 6378Q | Pack containing 112 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 50 µg with diluent | ‡1 | $1,171.51 | Pegatron | SH |
| 6379R | Pack containing 84 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 80 µg with diluent | ‡1 | $1,338.96 | Pegatron | SH |
| 6380T | Pack containing 140 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 80 µg with diluent | ‡1 | $1,496.44 | Pegatron | SH |
| 6381W | Pack containing 168 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 80 µg with diluent | ‡1 | $1,496.44 | Pegatron | SH |
| 6382X | Pack containing 84 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 100 µg with diluent | ‡1 | $1,555.58 | Pegatron | SH |
| 6383Y | Pack containing 112 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 100 µg with diluent | ‡1 | $1,713.07 | Pegatron | SH |
| 6384B | Pack containing 84 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 120 µg with diluent | ‡1 | $1,772.20 | Pegatron | SH |
| 6385C | Pack containing 140 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 120 µg with diluent | ‡1 | $1,929.69 | Pegatron | SH |
| 6386D | Pack containing 84 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 150 µg with diluent | ‡1 | $2,097.14 | Pegatron | SH |
| 6387E | Pack containing 140 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 150 µg with diluent | ‡1 | $2,254.63 | Pegatron | SH |
| 6388F | Pack containing 168 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 150 µg with diluent | ‡1 | $2,254.63 | Pegatron | SH |
| 6389G | Pack containing 84 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a 135 µg | ‡1 | $1,432.08 | Pegasys RBV | RO |
| 6390H | Pack containing 112 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a 135 µg | ‡1 | $1,520.81 | Pegasys RBV | RO |
| 6391J | Pack containing 140 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a 135 µg | ‡1 | $1,609.53 | Pegasys RBV | RO |
| 6392K | Pack containing 168 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a 135 µg | ‡1 | $1,698.26 | Pegasys RBV | RO |
| 6393L | Pack containing 84 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a 180 µg | ‡1 | $1,616.41 | Pegasys RBV | RO |
| 6394M | Pack containing 112 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a 180 µg | ‡1 | $1,705.14 | Pegasys RBV | RO |
| 6395N | Pack containing 140 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a 180 µg | ‡1 | $1,793.86 | Pegasys RBV | RO |
| 6396P | Pack containing 168 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a 180 µg | ‡1 | $1,882.59 | Pegasys RBV | RO |
2. ADD ITEM/DRUG FORM
Efavirenz (Stocrin™)
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.
| 6372J | Oral solution 30 mg per mL, 180 mL | 1 | $135.79 | Stocrin | MK |
NOTE:
These prices are based on special supply arrangements-see Pharmaceutical
Benefits Pricing Authority relativity sheet for full details. For
information on relativity sheets contact the Pharmaceutical Benefits
Pricing Authority Secretariat on (02) 6289 7672.
3. DELETE ITEM/DRUG FORM
Didanosine (Videx™)
| 6119C | Powder for paediatric oral solution 2 g in 120 mL bottle | 1 | $52.77 | Videx | BQ |
Item discontinued by manufacturer.
4. AMEND RESTRICTION
Zoledronic acid (Zometa™)
Change from:
Treatment of hypercalcaemia of malignancy refractory to anti-neoplastic therapy.
Change to:
Multiple myeloma;
Bone metastases from breast cancer;
Bone metastases from hormone-resistant prostate cancer, with demonstration
of biochemical progression of disease despite maximal therapy with
hormonal treatments;
Treatment of hypercalcaemia of malignancy refractory to anti-neoplastic
therapy.
Etanercept (Enbrel™)
The wording of the etanercept listing in the Administrative Arrangements of 1 August 2003 differed slightly from the listing in the Schedule of Pharmaceutical Benefits effective of that date. The replacement wording provided below mirrors that set out in the Schedule. There is no change to the details of the listing.
Change from:
1) Initial treatment by a paediatric rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of patients under 18 years,
a) who have severe active polyarticular course juvenile chronic arthritis;
AND
b) whose parent or authorised guardian has signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if the pre-determined response criteria do not support continuation of PBS-subsidised treatment
AND
c) who have demonstrated:
(i) severe intolerance of, or toxicity due to, methotrexate. (See below for definition of severe intolerance and toxicity.)
OR
(ii) failure to achieve an adequate response to one or more of the following treatment regimens:
- oral or parenteral methotrexate at a dose of at least 20mg/m2 weekly, alone or in combination with oral or intra-articular corticosteroids for a minimum of 3 months;
OR
- oral methotrexate at a dose of at least 10 mg/m2 weekly together with at least one other DMARD, alone or in combination with corticosteroids for a minimum of 3 months; (Note: use of alternative DMARD agents in children is dependent on approval by the Therapeutic Goods Administration as age restrictions may apply).
Severe intolerance is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant NSAIDs on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in two divided doses over 24 hours.
Toxicity is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
The following criteria must be met in order to demonstrate failure to achieve an adequate response to either of the above treatment regimens:
a) an active joint count of at least 20 active (swollen and tender) joints,
OR
b) at least four active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender), and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
If treatment with methotrexate alone, or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, or intolerance develops during the period of use such that permanent withdrawal is necessary and a suitably effective treatment regimen cannot be implemented, this exempts the requirement to demonstrate an inadequate response within the time period specified above for these agents.
The authority application must be in writing and must include the information used to determine the patient's eligibility under the criteria above. The date of the joint assessment must be provided.
The assessment of the patient's response to initial treatment should be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. Only 16 weeks of treatment will be approved under this criterion.
2) Continuing PBS-subsidised treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of severe active polyarticular course juvenile chronic arthritis in patients who have demonstrated an adequate response to treatment with etanercept as manifested by:
a) an active joint count of less than 10 active (swollen and tender) joints,
OR
b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline,
OR
c) a reduction in the number of the following active joints, from at least four, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender), and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All authority applications for continuing treatment with etanercept must be in writing and must include sufficient information to determine the patient's response according to the above criteria. The date of the joint assessment must be provided.
Applications for continuing treatment with etanercept should be made prior to the completion of 16 weeks of treatment to ensure continuity for those patients who meet the criteria. Only six months of treatment per application will be approved under this criterion.
Patients who fail to demonstrate an adequate response, as specified in the criteria for continuing treatment with etanercept, will not be eligible to re-commence treatment with etanercept within 12 months of the date on which treatment was ceased.
Withdrawal of treatment with etanercept should be considered in patients who have achieved and sustained complete remission of disease for 12 months. Subsequent applications for PBS-subsidised re-treatment with etanercept will be subject to the authority conditions applying to initial treatment and will not be authorised within 12 months of the date on which treatment with etanercept was ceased.
Where re-treatment with etanercept after a break in PBS-subsidised treatment with the drug is being sought, the reason for and date of cessation of the previous treatment course with etanercept must be included in the application.
3) Continuing treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of severe active polyarticular course juvenile chronic arthritis in patients receiving treatment with etanercept prior to 1 December 2002
AND
a) whose parent or authorised guardian has signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if the pre-determined response criteria do not support continuation of PBS-subsidised treatment;
AND
b) who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept.
Change to:
Public and private hospital authority required
Initial treatment by a paediatric rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of patients under 18 years who have severe active polyarticular course juvenile chronic arthritis;
AND
a) whose parent or authorised guardian has signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if the predetermined response criteria do not support continuation of PBS-subsidised treatment;
AND
(b) who have demonstrated either:
(i) severe intolerance of, or toxicity due to, methotrexate (see below for definition of severe intolerance and toxicity); or
(ii) failure to achieve an adequate response to 1 or more of the following treatment regimens:
- oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or
- oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other DMARD, alone or in combination with corticosteroids, for a minimum of 3 months. (Note: use of alternative DMARDs in children is dependent on approval by the Therapeutic Goods Administration as age restrictions may apply.)
Severe intolerance is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant NSAIDs on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
The following criteria must be met in order to demonstrate failure to achieve an adequate response to either of the above treatment regimens:
(a) an active joint count of at least 20 active (swollen and tender) joints;
OR
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, or intolerance develops during the period of use such that permanent withdrawal is necessary and a suitably effective treatment regimen cannot be implemented, this exempts the requirement to demonstrate an inadequate response within the time period specified above for these agents.
The authority application must be in writing and must include the information used to determine the patient's eligibility under the criteria above. The date of the joint assessment must be provided.
Only 16 weeks of treatment will be approved. The assessment of the patient's response to initial treatment should be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated.
Initial PBS-subsidised supply for continuing treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of severe active polyarticular course juvenile chronic arthritis in patients receiving treatment with etanercept prior to 1 December 2002;
AND
(a) whose parent or authorised guardian has signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if the predetermined response criteria do not support continuation of PBS-subsidised treatment;
AND
(b) who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept.
The authority application must be in writing and must include sufficient information to determine the patient's eligibility. The date of the joint assessment must be provided.
Only 6 months of treatment will be approved.
Continuing PBS-subsidised treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of severe active polyarticular course juvenile chronic arthritis in patients who have demonstrated an adequate response to treatment with etanercept as manifested by:
(a) an active joint count of fewer than 10 active (swollen and tender) joints;
OR
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline;
OR
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All authority applications for continuing treatment with etanercept must be in writing and must include sufficient information to determine the patient's response according to the above criteria. The date of the joint assessment must be provided.
Only 6 months of treatment per application will be approved. Applications for continuing treatment with etanercept should be made prior to the completion of 16 weeks of treatment to ensure continuity for those patients who meet the criteria.
Patients who fail to demonstrate an adequate response, as specified in the criteria for continuing treatment with etanercept, will not be eligible to recommence treatment with etanercept within 12 months of the date on which treatment was ceased.
Withdrawal of treatment with etanercept should be considered in patients who have achieved and sustained complete remission of disease for 12 months. Subsequent applications for PBS-subsidised re-treatment with etanercept will be subject to the authority conditions applying to initial treatment and will not be authorised within 12 months of the date on which treatment with etanercept was ceased.
Where re-treatment with etanercept after a break in PBS-subsidised treatment with the drug is being sought, the reason for and date of cessation of the previous treatment course with etanercept must be included in the application.
5. PRICE DECREASE
Doxorubicin hydrochloride, pegylated lipsomal (Caelyx™)
| 6249X | Suspension for I.V. infusion 20 mg in 10 mL vial | 1 | $614.84 | Caelyx | SH |
Zoledronic Acid (Zometa™)
| 6343W | Powder for I.V. infusion 4 mg vial with diluent ampoule | 1 | $450.00 | Zometa | NV |
| 6371H | Injection concentrate for I.V. infusion 4 mg in 5 mL | 1 | $450.00 | Zometa | NV |
NOTE:
These prices are based on special supply arrangements-see Pharmaceutical
Benefits Pricing Authority relativity sheet for full details.
6. PRICE INCREASE
Didanosine (Videx EC™)
| 6298L | Capsule 125 mg (containing enteric coated beadlets) | 30 | $102.12 | Videx EC BQ | |
| 6299M | Capsule 200 mg (containing enteric coated beadlets) | 30 | $163.40 | Videx EC BQ | |
| 6300N | Capsule 250 mg (containing enteric coated beadlets) | 30 | $204.24 | Videx EC BQ | |
| 6301P | Capsule 400 mg (containing enteric coated beadlets) | 30 | $326.79 | Videx EC BQ |
7. OTHER AMENDMENTS - CHANGE IN MANUFACTURER
The following Faulding Pharmaceuticals (FA) and David Bull Laboratories (BL) items have been replaced by Mayne Pharma (MX).
Apomorphine hydrochloride (Apomine™)
| 6104G | Injection 10 mg in 1 mL | 5 | $27.72 | Apomine | MX |
Clozapine (Clopine™)
| 6101D | Tablet 25 mg | 100 | $72.00 | Clopine | MX |
| 6102E | Tablet 100 mg | 100 | $270.00 | Clopine | MX |
Cyclosporin (Cysporin™)
| 6352H | Capsule 25 mg | 30 | $43.54 | Cysporin | MX |
| 6111P | Capsule 25 mg | 50 | $73.55 | Cysporin | MX |
| 6353J | Capsule 50 mg | 30 | $88.53 | Cysporin | MX |
| 6112Q | Capsule 50 mg | 50 | $148.53 | Cysporin | MX |
| 6354K | Capsule 100 mg | 30 | $178.38 | Cysporin | MX |
| 6114T | Capsule 100 mg | 50 | $298.38 | Cysporin | MX |
Desferrioxamine mesylate
| 6113R | Powder for injection 500 mg vial | 10 | $99.00 | MX | |
| 6270B | Powder for injection 2 g vial | 1 | $39.60 | MX |
Disodium pamidronate (Pamisol™)
| 6286W | Concentrated injection 15 mg in 5 mL | 1 | $56.89 | Pamisol | MX |
| 6287X | Concentrated injection 30 mg in 10 mL | 1 | $113.79 | Pamisol | MX |
| 6288Y | Concentrated injection 60 mg in 10 mL | 1 | $227.57 | Pamisol | MX |
| 6289B | Concentrated injection 90 mg in 10 mL | 1 | $341.36 | Pamisol | MX |
| 6289B | Concentrated injection 90 mg in 10 mL | 1 | $341.36 | Pamisol | MX |
8. ADVANCE NOTICE - DELETE
Zoledronic acid (Zometa™)
| 6343W | Powder for I.V. infusion 4 mg vial with diluent ampoule | 1 | $450.00 | Zometa | NV |
Item to be deleted effective 1 February 2003. Item is being discontinued by the manufacturer.
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.
Trevor Sutherland
Acting Director, Programs
Metropolitan Health & Aged Care Services
