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Medicare Australia - Australian Government
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June 2008
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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 for infliximab only

This item is only available to a patient who is attending an approved private hospital or public participating hospital or public hospital and is a day admitted patient, a non-admitted patient or a patient on discharge. This is not a PBS benefit for inpatients of the hospital.

The hospital provider number must be included on the application form.

Schedule restriction details

An adult patient must satisfy one of the four restrictions, before approval will be granted to prescribe a TNF α antagonist.

All applications must be completed by the treating rheumatologist, with expertise in the management of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis.

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 commenced 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 of patients who, at the time of application have demonstrated an adequate response to treatment with the PBS-subsidised TNF α antagonist requested during the interchangeability cycle.
  4. Recommencement or change to an alternate TNF α antagonist, where the patient has already received PBS-subsidised TNF α antagonist treatment within this interchangeability cycle.

Notes on interchangeability

The following information applies to prescribing under the PBS of TNF α antagonists (infliximab, etanercept and adalimumab only) for adult patients with active ankylosing spondylitis.

Patients are eligible for PBS-subsidised treatment with only one of the three TNF α antagonists above at any one time.

Schedule item details

Dose

Adalimumab (Humira®) is presented as:

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

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?

Reciprocal Health Care Agreement (infliximab only)

Where an eligible patient is a visitor from a country with which Australia has entered into a Reciprocal Health Care Agreement, the supply will be limited to the original prescription only. Repeat prescriptions for these patients are not permitted.

Test requirements

  • Erythrocyte Sedimentation Rate (ESR), C-Reactive Protein (CRP) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) measurements must be within one month of the application date.
  • The same acute phase reactant measured in the initial treatment application must be measured in all subsequent continuing treatment applications.

Demonstration of response

It is recommended that patients who wish to have a temporary break in treatment be reviewed in the month before completing their course of treatment. Patients must be assessed after a minimum of 12 weeks of treatment and no later than four weeks after the treatment has ceased. Failure to notify Medicare Australia of response means that this patient is deemed to have failed that particular TNF α antagonist.

Assessment must be completed before starting an alternate TNF α antagonist.

For assessment purposes, please use form 4156. [PDF, 69Kb]PDF reader required

Please fax your completed form to 03 6215 5519 so that it can be included in the patient's treatment history.

Treatment failure—re-treatment

Patients may only fail a maximum of three treatment courses in any one interchangeability cycle. Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS subsidised TNF α antagonist more than once.

Patients may only commence a new interchangeability cycle after a minimum of five years has elapsed from the date of the final approval of the most recent PBS subsidised TNF α antagonist.

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 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

See the attached list of toxicity descriptors to use when:

  • assessing a patient’s eligibility
  • demonstrating a patient’s inability to tolerate non-steroidal anti-inflammatory drugs.

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

Additional information

This is a guide for physicians and patients as to what constitutes an appropriate minimum exercise program for the purposes of administering the PBS restriction for TNF α antagonist for ankylosing spondylitis.

Application forms (sections 85 and 100)

Information relevant to all patients

Initial treatment

Applications for initial treatment should be made where:

  • patients have received no prior PBS-subsidised TNF α antagonist treatment and wish to commence such therapy,
  • patients have received prior PBS-subsidised (initial or continuing) TNF α antagonist therapy and wish to trial an alternate agent.
  • patients wish to re-commence treatment with a specific TNF α antagonist following a break in PBS-subsidised therapy with that specific agent.

All applications for initial treatment will be limited to provide for a maximum of 16 weeks of therapy for etanercept and adalimumab, and 18 weeks of therapy for infliximab.

Assessment for the first continuing application should be made following a minimum of 12 weeks of therapy and this assessment must be submitted to Medicare Australia no later than four weeks from the date that course was ceased.

Where a response assessment is not submitted to Medicare Australia within these time frames, patients will be deemed to have failed to respond to treatment with that TNF α antagonist.

Continuing treatment

Following the completion of an initial treatment course with a TNF α antagonist, patients may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment. Patients are eligible to receive continuing TNF α antagonist treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response.

Patients must be assessed for response to a course of continuing therapy, and the assessment must be submitted to Medicare Australia no later than 4 weeks from the date that course was ceased. Where a response assessment is not submitted to Medicare Australia within these time frames, patients will be deemed to have failed to respond to treatment with that TNF α antagonist.

Calculating next assessment dates

To assist with calculating the next assessment date for patients continuing on the same biological agent:

  • A letter confirming the application approval will always be sent for patients commencing on a program and when a patient changes to an alternate agent.
  • The next assessment date will be provided in that letter (this assumes continuous treatment).
  • To calculate subsequent dates for assessment, assuming continuous treatment, add 24 weeks to the previous assessment date.

Changing therapy

Once an authority for initial treatment with the first PBS-subsidised TNF α antagonist is approved, patients may change to an alternate TNF α antagonist without having to re-qualify with respect to the indices of disease severity (i.e Erythrocyte Sedimentation Rate (ESR) or C-Reactive Protein (CRP) levels and BASDAI) or the prior non- TNF α antagonist therapy requirements.

Patients may swap to an alternate TNF α antagonist at any time, regardless of whether they are receiving therapy (initial or continuing) with a TNF α antagonist at the time of the application or not.

Patients may alternate between therapy with any TNF α antagonist (one at a time) providing:

  • they have not received PBS-subsidised treatment with that particular TNF α antagonist previously
    or
  • they have demonstrated an adequate response to that particular TNF α antagonist if they have previously trialled it under the PBS

Therefore, to maximise the choice of TNF α antagonist treatment it is important that patients are assessed for response to every course of treatment approved, within the timeframes specified in the relevant restriction.

To avoid confusion, applications for patients who wish to change to the alternate TNF α antagonist should be accompanied by the approved authority prescription or remaining repeats for the TNF α antagonist the patient is ceasing.

Baseline measurements to determine response

Medicare Australia will determine whether a response to treatment has been demonstrated based on the baseline measurements submitted with the first authority application for a TNF α antagonist. However, prescribers may provide new baseline measurements any time that an initial treatment authority is submitted within a treatment cycle and Medicare Australia will assess response according to these revised baseline measurements.

To ensure consistency in determining response, the same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications. Therefore, where only an ESR or CRP level is provided at baseline, an ESR or CRP level respectively must be provided to determine response.

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.

Patients who have received no prior PBS-subsidised TNF α antagonist treatment at 1 March 2007

From 1 March 2007, the arrangements for prescribing the three TNF α antagonists (infliximab, etanercept and adalimumab) under the PBS have been amended. Patients can be treated with an alternate TNF α antagonist within a single cycle of treatment, without having to experience a disease flare when swapping between TNF α antagonists.

Within a single treatment cycle, patients may continue to receive long-term treatment with a TNF α antagonist while they continue to show a response to therapy.

Once patients have either failed, or ceased to respond to, treatment three times they are deemed to have completed an interchangeability treatment cycle. They must have, at minimum, a five-year break in PBS-subsidised TNF α antagonist therapy before they are eligible to commence the next cycle. The five-year period will be measured from the date the last prescription for PBS-subsidised TNF α antagonist treatment was approved in the most recent cycle, and the date of the application for initial treatment with a TNF α antagonist under the new cycle.

Patients who have failed treatment with fewer than the three TNF α antagonist treatment courses as outlined above, and where a period of less than five years has elapsed since the patient's previous course of PBS-subsidised TNF α antagonist treatment, may commence a further course of TNF α antagonist treatment within that same treatment cycle.

Patients who have failed treatment with fewer than the three TNF α antagonist treatment courses as outlined above, and who have had a break in PBS-subsidised therapy of five years or more, are eligible to commence a new treatment cycle.

There is no limit to the number of treatment cycles a patient may undertake in their lifetime.

If a patient fails to respond to a particular TNF α antagonist within a single treatment cycle, they are not eligible to receive further PBS-subsidised treatment with that drug until they commence the next cycle.

Patients who have received PBS-subsidised TNF α antagonist treatment before 1 March 2007

Patients who commenced PBS-subsidised TNF α antagonist therapy before1 March 2007 are considered to be in their first cycle of TNF α antagonist treatment as of 1 March 2007.

Patients who have failed to respond to prior PBS-subsidised treatment with fewer than the 3 TNF α antagonist treatment courses outlined above, at the time the first application for treatment is made on or after 1 March 2007, will be subject to the same conditions applying to new patients detailed above.

Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised TNF-alfa antagonist more than once.  A patient, who, before 1 March 2007, was authorised to receive PBS-subsidised initial treatment for ankylosing spondylitis with the same agent twice, is exempt from this condition in respect of applications approved before 1 March 2007.

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Last updated: 5 August, 2008

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