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Ankylosing spondylitis

Authority to prescribe TNF α antagonists (adalimumab, etanercept and infliximab only) through the Pharmaceutical Benefits Scheme (PBS) for adults under Section 100 and Section 85 of the National Health Act 1953.

TNF α antagonists are available under the PBS as an authority required benefit for adult patients with active ankylosing spondylitis.

Guide to prescribing biological agents

Section 100 arrangements only for infliximab

These items are only available to a patient who is attending:

  • an approved private hospital
  • a public participating hospital
    or
  • a public hospital

    and is either a

  • day admitted patient
  • non-admitted patient
    or
  • patient on discharge.

These items are not available as a PBS benefit for in-patients of the hospital. The hospital provider number must be included on the application form.

Restriction details

Adult patients must satisfy the initial treatment criteria to be eligible to start an interchangeability cycle. Applications to change, recommence or continue PBS subsidised treatment will only be considered after an initial treatment course.

View a full transcript of the restriction detailsExternal link

All applications must be completed by the treating rheumatologist, with expertise in the management of active ankylosing spondylitis.

The restrictions are:

  1. Initial PBS subsidised treatment, with a TNF α antagonist.
  2. Initial PBS subsidised treatment for continuing treatment, with a TNF α antagonist for patients who started treatment with infliximab before 1 March 2004, etanercept before 1 July 2004 or adalimumab before 1 November 2006.
  3. Continuing PBS subsidised treatment, with a TNF α antagonist.
  4. Recommencement or change to an alternate TNF α antagonist.

Notes on interchangeability

Patients are eligible for PBS subsidised treatment with only one of the three TNF α antagonists for ankylosing spondylitis at any one time. Patients can start a TNF α antagonist treatment cycle where they may trial adalimumab, etanercept or infliximab without the need to experience a disease flare before swapping to an alternate agent. Within a single cycle, patients may receive long term treatment with a TNF α antagonist as long as they sustain a response to therapy.

Once patients have either failed or ceased to sustain a response to treatment three times, they are deemed to have completed a single cycle and must have a minimum five year break in PBS subsidised TNF α antagonist therapy before they are eligible to start another cycle.

Within the same cycle, patients cannot fail or cease to respond to the same PBS subsidised TNF α antagonist more than once. If a patient fails to meet the response criteria for any TNF α antagonist, they must change to an alternate agent they have not previously failed.

Item details

Dose

Adalimumab (Humira®) is presented as:

  • a prefilled syringe containing 40 mg adalimumab in 0.8 mL
    or
  • a prefilled pen containing 40 mg adalimumab in 0.8 mL.

 The dose for adult patients is one subcutaneous injection fortnightly.

The form of adalimumab 40 mg required must be specified on the prescription as either a prefilled syringe or a prefilled pen.

Etanercept (Enbrel®) 25 mg is presented as:

  • a set of four vials of powder for injection 25 mg and four prefilled syringes of solvent 1 ML.

The dose for adult patients is one subcutaneous injection twice weekly.

Etanercept (Enbrel®) 50 mg is presented as:

  • a set of four vials of powder for injection 50 mg and four prefilled syringes of solvent 1 mL
    or
  • a pack of four single use prefilled syringes containing etanercept 50 mg in 1 mL.

The dose for adult patients is one subcutaneous injection once weekly.

The form of etanercept 50 mg required must be specified on the prescription as either an injection set or a pack of prefilled injections.

Infliximab (Remicade®) is presented as:

  • a vial containing 100 mg of lypholised powder.

The dose for adult patients is 5 mg per kg given intravenously.

Initially, patients are to be treated at week zero, week two and then at week six. Subsequent infusions are at six weekly intervals.

Calculating next assessment dates

Patients who start treatment with a TNF α antagonist, or who have changed treatment to an alternate agent, will receive a confirmation letter of approval, which will provide the approximate date of the next assessment of the patient.

To calculate subsequent dates for assessment, assuming continuous treatment, add 24 weeks to the previous assessment date.

Patient eligibility

Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.

Who is eligible for the PBS?

Test requirements

To ensure consistency in determining response, the same indices of disease severity used to establish baseline at the start of treatment with each initial treatment application, must be provided for all subsequent continuing treatment applications. All assessments must be within one month of application.

  • Prescribers should provide Erythrocyte Sedimentation Rate (ESR) and C-Reactive Protein (CRP) measurements with the initial application. Prescribers may choose to provide only one acute phase reactant measurement with continuing treatment applications. Where only an ESR or CRP level is provided at baseline, an ESR or CRP level respectively must be provided to determine response.
  • The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) measurements must be completed by the patient. The patient must not have access to any previous BASDAI assessments when completing the new assessmentDemonstration of response

It is recommended that patients who have had a minimum of 12 weeks of treatment, and who wish to have a temporary break in treatment for any reason, be reviewed immediately before, and no later than four weeks after stopping treatment. Failure to notify Medicare Australia of response means that this patient is deemed to have failed that particular TNF α antagonist.

For assessment purposes, please use form 4156. [PDF, 737Kb]PDF reader required

Please fax your completed form to 1300 154 019 so that it can be included in the patient's treatment history.

Recommencement of treatment after a five year break in PBS subsidised therapy

Patients who wish to trial a second or subsequent treatment cycle, following a break in PBS subsidised TNF α antagonist therapy of at least five years, must requalify for initial treatment with respect to the indices of disease severity. Patients must have received treatment with at least one non-steroidal anti-inflammatory drugs (NSAID), at an adequate dose, for a minimum of three consecutive months immediately before the time the BASDAI, ESR and/or CRP levels are measured.

Toxicity and severity descriptors

To make sure the eligibility of patients can be fully assessed, a comprehensive list of toxicity descriptors is available. This should be used in conjunction with the application when demonstrating a patient's inability to tolerate NSAID. The intolerance must be of a severity to necessitate permanent treatment withdrawal.

This list has been prepared in consultation with the Australian Rheumatology Association.

Additional information

Lodgement details

The postal address for all written applications is:

Medicare Australia
Prior written approval of specialised drugs
Reply paid 9826
GPO Box 9826
Hobart TAS 7001

(No stamp required if posted in Australia)

For assistance please call 1800 700 270* and select option 2 (8 am to 5 pm EST Monday to Friday).

*Call charges apply from mobile or pay phones only.

Application forms (Section 85 and Section 100)

Some documents on this page may require the free Adobe PDF reader.

Last updated: 15 December, 2008

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