Fistulising Crohn disease
Through the Pharmaceutical Benefits Scheme (PBS), under Section 85 and Section 100 arrangements of the National Health Act 1953, authority to supply Tumour Necrosis Factor alfa (TNF a) antagonists (adalimumab and infliximab only) is required for the treatment of:
- patients with complex refractory fistulising Crohn disease
Section 100 arrangements—only for infliximab
This item is only available to a patient:
who is attending either
- an approved private hospital
- a participating public hospital or
- a public hospital
and is either a
- day admitted patient
- non-admitted patient or
- patient on discharge.
This item is 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
View a full transcript of the restriction details
A patient must satisfy the initial restriction before approval will be granted to prescribe a Tumor Necrosis Factor alfa (TNFα) antagonist.
Note: all applications must be completed by:
- a gastroenterologist (code 87), consultant physician in internal medicine specialising in gastroenterology (code 81), or
- consultant physician in general medicine specialising in gastroenterology (code 82).
For continuing PBS subsidised treatment, the patient must demonstrate or sustain an adequate response to treatment with a TNFα antagonist as defined in the restriction.
For more information call 1800 700 270* (option 4) Monday to Friday between 8:00am and 5:00pm EST.
Information relevant to all patients
Initial applications
Applications for initial treatment should be made where patients have received no prior PBS subsidised treatment with a TNFα antagonist.
All applications for initial treatment will be limited to a maximum of:
- 16 weeks of adalimumab
- 14 weeks of infliximab.
Patients must be assessed for a response to any course of PBS subsidised initial TNFα antagonist agent treatment:
- after 12 weeks of adalimumab treatment
- up to 12 weeks after the first dose of infliximab treatment (six weeks following the third dose)
This assessment must be submitted to Medicare Australia no later than four weeks from the date the course is completed. Where a response assessment is not submitted to Medicare Australia within this timeframe, patients will be deemed to have failed to respond to treatment with that TNFα antagonist agent.
Continuing applications
Following the completion of an initial treatment course with a TNFα antagonist, patients may qualify to receive up to 24 weeks of continuing treatment provided they have demonstrated an adequate response to treatment. Patients are eligible to receive further continuing treatment in courses of up to 24 weeks providing they continue to sustain a response.
Patients must be assessed for a response to each course of continuing therapy. The assessment must be submitted to Medicare Australia no later than four weeks from the date the course is completed. Where a response assessment is not submitted to Medicare Australia within this timeframe, patients will be deemed to have failed to respond to treatment.
Swapping therapy—change applications
After an authority for initial treatment with a TNFα antagonist is approved, patients may swap to the alternate treatment—providing they are eligible—without having to requalify with respect to the indices of disease severity.
Patients who have had a break in PBS subsidised treatment with a TNFα antagonist and who wish to recommence treatment, may submit a new baseline assessment, providing they have previously demonstrated a response to treatment.
All applications for change treatment will be limited to a maximum of:
- 16 weeks of adalimumab
- 14 weeks of infliximab.
Patients may swap to the alternate treatment at any time, regardless of whether they are receiving therapy (initial or continuing) at the time of the application. Patients may alternate between TNFα antagonist therapy, provided they have not:
- received PBS subsidised treatment with that particular TNFα antagonist agent previously
or
- trialled and failed, or ceased to respond to, the same PBS subsidised TNF alfa antagonist more than twice.
It is important that patients are assessed for a response for every course of treatment approved within the timeframes specified in the relevant restriction.
To avoid confusion, applications for patients who wish to swap to an alternate TNFα antagonist should be accompanied by the approved authority prescription, or the remaining repeats for the TNFα 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 of the indices of disease severity submitted with the first authority application for a TNFα antagonist.
The lodgement of application must be made within one month of the date of the fistula assessment.
Schedule item details
Dose
Adalimumab (Humira®) is presented as a pre-filled:
- syringe containing 40mg of adalimumab in 0.8mL
- pen containing 40mg of adalimumab in 0.8mL
The dose for adult patients is four injections at week zero, two injections at week two and thereafter one injection every to two weeks.
The form of adalimumab required must be specified on the prescription as either a pre filled syringe or a pre-filled pen.
Infliximab (Remicade®) is available as a vial containing 100mg of lypholised powder.
The dose for adult patients is 5mg per kg given intravenously.
Initially patients are to be treated at week zero, week two and then at week six. Subsequent infusions are at eight week intervals.
Authority prescriptions should be written as the actual number of vials to provide a dose of 5mg per kg and two repeats.
Calculating next assessment dates
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).
Patient eligibility
Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.
Reciprocal Health Care Agreement
Where an eligible patient is a visitor from a country Australia has entered into a Reciprocal Health Care Agreement with, the supply will be limited to the original prescription only. Repeat prescriptions for these patients are not permitted.
Lodgement
The postal address for all written applications is:
Medicare Australia
Prior written approval of specialised drugs
GPO Box 9826
Hobart TAS 7001
(No stamp required if posted in Australia)
For more information call 1800 700 270* (option 4) Monday to Friday 8.00am and 5.00pm EST.
*Call charges apply from mobile or pay phones only.
Application forms (section 100)
Fistulising Crohn disease PBS authority application forms
- Initial PBS subsidised treatment of patients with complex refractory fistulising Crohn disease (Form 4237) [PDF, 312Kb]
This document contains the form you must lodge for a patient starting initial treatment for complex refractory fistulising Crohn disease. The patient and prescriber acknowledgements must be completed. - Continuation of PBS subsidised treatment , or change to an alternate PBS subsidised treatment for which the patient is eligible, or demonstration of response to the current PBS subsidised treatment for patients not continuing treatment at this time (Form 4238) [PDF, 311Kb]
This document contains the form you must lodge for a patient who is:- continuing PBS subsidised treatment or
- changing to the alternate PBS subsidised treatment for which the patient is eligible or
- demonstrating a response to the current PBS subsidised treatment for patients not continuing treatment at this time.
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Last updated: 4 April, 2012