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Hospital Circular 30/2003

Date Issued: 6 November 2003

Publication: 30/2003

Distribution: Public Hospitals

Subject: Highly Specialised Drugs Program

Purpose: To advise hospitals involved of further changes to the Highly Specialised Drugs Program, addition of infliximab, effective 1 November 2003.

We have had recent advice from the Commonwealth of further changes to the Highly Specialised Drugs Program, effective 1 November 2003.

ADD DRUG

Infliximab

Note:
Any queries concerning the arrangements to prescribe infliximab may be directed to the Health Insurance Commission on 1800 005 750.

Written applications for authority to prescribe infliximab should be forwarded to:
Health Insurance Commission
Prior Written Approval of Specialised Drugs
Reply Paid 9826
GPO Box 9826
HOBART TAS 7001

  1. Initial treatment by a rheumatologist, in combination with methotrexate, of adults with severe active rheumatoid arthritis who have a record of rheumatoid factor positive status;

    AND

    1. who have 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

    1. who have failed to achieve an adequate response to methotrexate, at a dose of at least 20 mg weekly;

    AND

    1. who have failed to achieve an adequate response to methotrexate, in combination with two other disease modifying anti-rheumatic drugs for a minimum of three months;

    AND

    1. have subsequently failed to achieve an adequate response following a minimum of three months' treatment with:
      1. leflunomide alone; or
      2. leflunomide in combination with methotrexate; or
      3. cyclosporin.

If treatment with any of the above-mentioned drugs is contra-indicated according to the relevant TGA-approved product information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, the patient is exempted from demonstrating an inadequate response to the above treatment regimens. Details of the contraindication or intolerance, including the degree of toxicity, must be provided at the time of application.

The following criteria must be met in order to demonstrate failure to achieve an adequate response:

  1. an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm/hr or a C-reactive protein (CRP), greater than 15 mg/L;

    AND either

    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:

      • elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
      • shoulder 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 the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.

The authority application must be in writing and must include sufficient information to determine the patient's eligibility according to the above criteria. The date of joint assessment must be provided.

Where less than three repeats are requested at the time of the initial authority application, authority approvals for sufficient repeats to complete a maximum of four months of treatment may be requested by telephone. Under no circumstances will telephone approvals be granted for initial or continuing authority applications, or for treatment that would otherwise extend the initial treatment period beyond four months.

The assessment of the patient's response to the initial course of treatment should be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated.

Applications for continuing treatment with infliximab should be made prior to the completion of 16 weeks of treatment to ensure continuity for those patients who meet the criteria.

Maximum Qty: 2
Repeats: 3

NOTE: Increased maximum quantities will only be authorised where the listed maximum quantity does not provide sufficient for a single infusion, based on the patient's weight, to achieve a dose of 3 mg per kg. No increased repeats will be authorised.

6397Q Powder for injection 100 mg 1 $875.00 Remicade SH
  1. PBS-subsidised treatment by a rheumatologist, in combination with methotrexate, of adults with severe active rheumatoid arthritis who, at the time of application demonstrate an adequate response to treatment with infliximab as manifested by:

    1. an ESR no greater than 25 mm/hr or a CRP no greater than 15 mg/L or either marker reduced by at least 20% from baseline;

    AND one or more of the following

    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%:

    • elbow, wrist, knee and ankle (assessed as swollen and tender); and/or
    • shoulder and 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 infliximab must be in writing and must include sufficient information to determine the patient's response according to the above criteria. The date of assessment of the patient must be provided.

Patients who fail to demonstrate an adequate response, as specified in the criteria for continuing treatment with infliximab, will not be eligible to re-commence treatment with infliximab within 12 months of the date on which treatment was ceased.

Where re-treatment with infliximab after a break in PBS-subsidised treatment with infliximab is being sought, the reason for and date of cessation of the previous treatment course with infliximab must be included in the application.

  1. Continuing treatment by a rheumatologist, in combination with methotrexate, of adults with severe active rheumatoid arthritis, who have a record of rheumatoid factor positive status, and who were receiving treatment with infliximab prior to 1 March 2003

    AND

    1. who have 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 response as specified in the criteria for continuing PBS-subsidised treatment with infliximab.
Maximum Qty: 2
Repeats: 2

NOTE: Increased maximum quantities will only be authorised where the listed maximum quantity does not provide sufficient for a single infusion, based on the patient's weight, to achieve a dose of 3 mg per kg. No increased repeats will be authorised.

6398R Powder for injection 100 mg 1 $875.00 Remicade 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.

Anna Burgess
Acting Director, Programs
Metropolitan Health & Aged Care Services

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