Authority to prescribe TNF α antagonists (adalimumab, etanercept, golimumab 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.
These items are only available to a patient who is attending:
- an approved private hospital
- a public participating hospital
- a public hospital
and is either a
- day admitted patient
- non-admitted patient
- 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.
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.
All applications must be completed by the treating rheumatologist, with expertise in the management of active ankylosing spondylitis.
The restrictions are:
- Initial PBS subsidised treatment, with a TNF α antagonist.
- Initial PBS subsidised treatment for continuing treatment, with golimumab for patients who commenced treatment before 1 March 2010. Contact Medicare Australia for advice about which form(s) to complete.
- Continuing PBS subsidised treatment, with a TNF α antagonist.
- Recommencement or change to an alternate TNF α antagonist.
Patients are eligible for PBS subsidised treatment with only one of the 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, golimumab 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.
Adalimumab (Humira®) is presented as either:
- a prefilled syringe containing 40 mg adalimumab in 0.8 mL
- 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 prefilled syringes or prefilled autoinjectors.
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 a week.
Etanercept (Enbrel®) 50 mg is presented as either:
- a pack of four single use prefilled syringes containing etanercept 50 mg in 1 mL
- a pack of four single use prefilled autoinjectors containing etanercept 50 mg in 1 mL.
The dose for adult patients is one subcutaneous injection once a week.
The form of etanercept 50 mg required must be specified on the prescription as a pack of either prefilled syringes or prefilled autoinjectors.
Golimumab (Simponi®) 50mg is presented as:
- a prefilled syringe
- a prefilled pen
The form of golimumab 50 mg required must be specified on the prescription as a pack of either prefilled syringes or prefilled pens.
The dose for adult patients is one subcutaneous injection every 4 weeks.
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 week six. Subsequent infusions are at six weekly intervals.
To assist with calculating the next assessment for patients continuing on the same biological agent:
- The first assessment of the patient after starting treatment must be after the patient has had at least 12 weeks of treatment. This date can be calculated by adding 12 weeks to the patient’s first dispensing of the approved authority prescription.
- Patients should then be assessed at 24 week intervals (assuming continuous treatment)
Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.
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 assessment.
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, 282Kb]
Please fax your completed form to 1300 154 019 so that it can be included in the patient's treatment history.
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.
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 treatment. The intolerance must be of a severity to necessitate permanent treatment withdrawal.
This list has been prepared in consultation with the Australian Rheumatology Association.
- NSAID toxicity criteria and severity descriptors for the listing of TNF α antagonists for ankylosing spondylitis under the PBS [PDF, 41Kb]
Where an eligible patient is a visitor from a country with which Australia has entered into a Reciprocal Health Care Agreement, the supply of infliximab will be limited to the original prescription only. Repeat prescriptions for infliximab are not permitted.
- Chest expansion normal data [PDF, 21Kb]
A uniform method of measuring chest expansion and age adjusted normal limits.
- Bath Ankylosing Spondylitis Metrology Index (BASMI) [PDF, 49Kb]
The BASMI consists of five clinical measurements to reflect axial status. Two of these five measurements are required for initial application for PBS-subsidised treatment with a TNF α antagonist for ankylosing spondylitis.
- Exercise program [PDF, 97Kb]
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.
The address for all written applications is:
Prior written approval of specialised drugs
Reply Paid 9826
Hobart TAS 7001
(No stamp required if posted in Australia)
For more information call 1800 700 270** (option 2) between 8.00am and 5.00pm EST Monday to Friday.
- Initial PBS subsidised treatment (no prior treatment) (Form 4154) [PDF, 369Kb]
Lodge this form for a patient starting initial treatment for active ankylosing spondylitis. The patient and prescriber acknowledgements form must be completed. It also includes certification of exercise program and BASDAI.
- Continuing, change or recommencement of PBS subsidised treatment (Form 4156) [PDF, 282Kb]
Lodge this form for a patient continuing, changing to an alternate agent, or demonstrating a response to PBS subsidised treatment with a TNF α antagonist.
** Call charges apply from mobile and pay phones only.
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Last updated: 3 May, 2012