Hospital Circulars

 

Hospital Circular 15/2003

Date Issued: 3 July 2003

Publication: 15/2003

Distribution: Public Hospitals

Subject: Pharmaceuticals - Etanercept (Enbrel ®)

Purpose: To advise hospitals of arrangements for the prescribing and supply of Etanercept, effective 1 July 2003.

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We have had recent advice from the Commonwealth of arrangements for the prescribing and supply of etanercept (Enbrel ®) for the treatment of patients under 18 years of age with severe polyarticular course juvenile chronic arthritis, effective 1 July 2003.

Advice from the Commonwealth:

From 1 July 2003, etanercept will be available as part of the Section 100 Highly Specialised Drugs Program (HSDP) as an 'Authority Required' pharmaceutical benefit, for treatment of patients under the age of 18 years with severe polyarticular course juvenile chronic arthritis who are being treated by a paediatric rheumatologist or under the supervision of a paediatric rheumatology treatment clinic.

Prescribers will be required to make written application to the HIC for approval to prescribe etanercept as a pharmaceutical benefit.

Application forms are available from the HIC by telephoning 1800 005 750 or can be downloaded from the HIC website.

Applications to prescribe etanercept must be mailed to:

HIC
Prior Written Approval of Specialised Drugs
Reply Paid 9826
GPO Box 9826
HOBART TAS 7001

WHO CAN ACCESS ETANERCEPT?

1. Initial treatment by a paediatric rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of patients under 18 years,

1. who have severe active polyarticular course juvenile chronic arthritis;
   AND
2. 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
3. who have demonstrated
   1. severe intolerance of, or toxicity due to, methotrexate (see below for definition of severe intolerance and toxicity)
      OR
   2. failure to achieve an adequate response to one or more of the following treatments 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 a least one other disease modifying anti-rheumatic drug (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 regimes:

1. an active joint count of at least 20 active (swollen and tender) joints,
   OR
2. at least four active joints from the following list:
   1. elbow, wrist, knee and/or ankle (assessed as swollen and tender), and/or
   2. shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation or 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 contra-indicated 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 chromic arthritis in patients who have demonstrated an adequate response to treatment with etanercept as manifested by:

1. an active joint count of less than 10 active (swollen and tender joints),
   OR
2. a reduction in the active (swollen and tender) joint count by at least 50% from baseline,
   OR
3. a reduction in the number of the following active joints, from at least four, by at least 50%:
   1. elbow, wrist, knee and/or ankle (assessed as swollen and tender), and/or
   2. 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 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 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 authority conditions applying to initial treatment and will not be authorised within 12 months of the date on which treatment with etanercept was ceased.

When 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 prior to 1 December 2002

AND

1. 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
2. who have demonstrated a response as specified in the criteria for continuing PBS?subsidised treatment.

Contact HIC on 1800 005 750 for advice on prescribing etanercept or go to the HIC website.

WHO CAN PRESCRIBE ETANERCEPT?

• Paediatric rheumatologist or doctor under the supervision of a paediatric rheumatology treatment centre.
• All prescribers will require a PBS prescriber number available from the HIC.

Contact HIC on 132 150 for information on obtaining a PBS prescriber number.

HOW DO PRESCRIBERS APPLY FOR ETANERCEPT AUTHORITY APPROVAL?

• Prescribers need to make written application to HIC for authority approval by completing the appropriate forms.
• Prescribers will be required to provide to the HIC a completed authority prescription form, the appropriate completed etanercept PBS authority application supporting information form, and a completed etanercept patient agreement form (for initial treatment of juveniles and continuing treatment of juveniles who commenced treatment before 1 December 2002).
• The HIC etanercept PBS authority application supporting information form and the Patient Agreement form can be downloaded from the HIC website. Prescribers can receive faxed copies of the forms by telephoning the HIC on 1800 005 750
• Once approved, the authorised prescription will be returned to the prescriber or sent direct to the patient, as indicated by the prescriber on the authority prescription form.
• Please allow at least one week for return of authorised prescriptions from the HIC.
• Doctors working in hospitals that are participating in Pharmaceutical Reform can use a normal PBS hospital prescription form.

Prescriptions written in hospitals participating in Pharmaceutical Reform on a hospital PBS prescription can be dispensed by the hospital pharmacy or a community pharmacy

• Hospitals that are not participating in the PBS Pharmaceutical Reforms should complete a PBS-RPBS Authority form that can be downloaded from the HIC website.

This form will be retained by the HIC and an approved authority prescription generated by the HIC will be returned the prescriber. The prescriber must sign this prescription prior to dispensing. The approved HIC prescription may be dispensed by the hospital pharmacy or a community pharmacy.

• Authority applications to prescribe etanercept as a pharmaceutical benefit must be posted to -

  HIC
  Prior Written Approval of Specialised Drugs
  Reply Paid 9826
  GPO Box 9826
  HOBART TAS 7001

HOW OFTEN WILL HIC APPLICATION FORMS NEED TO BE COMPLETED AND SUBMITTED?

• For initial treatment of a patient under the age of 18 years with severe active polyarticular course juvenile chronic arthritis, sufficient repeats will be approved for four months of treatment.
  • In cases where less than four months supply has been approved at the time of the initial authority application, subsequent authority approvals may be granted to complete a maximum of four months treatment, and may be requested by telephone (Phone number: 1800 005 750)
  • Under no circumstances will telephone approvals be granted for complete initial authority applications, or for treatment that would otherwise extend the continuing treatment period beyond four months.
• For continuing treatment of a patient under the age of 18 years with severe active course juvenile chronic arthritis, sufficient repeats will be approved for six months treatment
  • In cases where less than six months supply has been approved at the time of the authority application, subsequent authority approvals may be granted to complete a maximum of six months treatment, and may be requested by telephone (Phone number: 1800 005 750)

DISPENSING ARRANGEMENTS FOR HOSPITALS

• Etanercept dispensed by hospital pharmacies will be funded under the normal Section 100 Highly Specialised Drug Program for outpatients, day-admitted or discharge patients. The listing does not cover inpatient use.
• Only etanercept that has been approved by HIC via the authority system will be subsidised as a pharmaceutical benefit under the Section 100 Highly Specialised Drug Program. Approved prescriptions will have been stamped and signed by HIC staff.

PATIENT COPAYMENT

• PBS general and concession patient co?payments will apply to etanercept as for other Section 100 Highly Specialised Drugs.

HOW WILL PHARMACIES OBTAIN SUPPLIES OF ETANERCEPT?

• Hospital pharmacies with an existing account with Wyeth Australia Pty Ltd can order Enbrel ® directly from the manufacturer. Otherwise, orders for Enbrel ® should be placed with pharmaceutical wholesalers.
• Etanercept (Enbrel ®) is available as an injection set containing four 25 mg vials of powder for injection and four pre-filled syringes of solvent (1 mL).

PAYMENT ARRANGEMENTS FOR PUBLIC HOSPITALS

• Etanercept dispensed by a hospital pharmacy for an outpatient, day-admitted patient or discharge patient will be funded under the normal Section 100 Highly Specialised Drug Program, provided that it has HIC authority approval.
• Hospitals will be required to complete a quarterly claim form for etanercept. The claim procedures will be similar to that for other highly specialised drugs, however, as additional information is required for etanercept, a separate spreadsheet will be used. Hospital pharmacies will need to keep a record of the HIC authority prescription approval number, the date of dispensing, and whether the dispensing is an original or repeat supply (the number of the repeat is also required).
• The Commonwealth will reconcile HIC authorisations with the HSDP quarterly claim.

ETANERCEPT FOR ADULTS

Etanercept for the treatment of adult patients with severe active rheumatoid arthritis who have a record of rheumatoid factor positive status and meet further criteria will receive listing under Section 85 (general pharmaceutical benefits) effective 1 August 2003. Information on patient eligibility and prescribing requirements will be available in the August 2003 Schedule of Pharmaceutical Benefits and application forms will be available on the HIC website. Until August 1, hospitals should continue to supply and fund etanercept for adult patients on a case-by-case basis through the hospital drug committee.

Please note that only etanercept for patients under 18 will be claimable under the Section 100 Highly Specialised Drug Program. The adult listing, as a general pharmaceutical benefit, will be claimed through the HIC.

Further information concerning arrangements to prescribe and supply etanercept (Enbrel ®) is available from the HIC website.

For information regarding payment for etanercept (Enbrel ®) via the Section 100 Highly Specialised Drug Program contact Alicia Segrave on (03) 9616 2586 or Email: alicia.segrave@dhs.vic.gov.au

Noreen Dowd
Director, Programs Branch
Metropolitan Health and Aged Care Services