Fistulising Crohn disease
The Pharmaceutical Benefits Scheme subsidises tumour necrosis factor alfa antagonists for patients with complex refractory fistulising Crohn disease.
For patients with complex refractory fistulising Crohn disease, treatment with tumour necrosis factor alfa (TNFα) antagonists (adalimumab and infliximab only) can be subsidised through the Pharmaceutical Benefits Scheme (PBS) under Sections 85 and 100 of the National Health Act 1953.
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.
The Schedule of Pharmaceutical Benefits on the PBS website outlines the initial restriction that a patient must satisfy before approval will be granted to prescribe a Tumor Necrosis Factor alfa (TNFα) antagonist.
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.
Information relevant to all patients
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 us no later than four weeks from the date the course is completed. Where a response assessment is not submitted to us within this timeframe, patients will be deemed to have failed to respond to treatment with that TNFα antagonist agent.
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 us no later than four weeks from the date the course is completed. Where a response assessment is not submitted to us 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 without having to requalify, providing they are eligible 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
We 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 0.8 mL
- pen containing 40mg of adalimumab in 0.8 mL
The dose for adult patients and paediatric patients (≥ 30Kg) is four injections at week zero, 2 injections at week two and thereafter 1 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.
Dose - Infliximab (Remicade®) is available as a vial containing 100 mg of lypholised powder.
The dose for 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 eight week intervals.
Authority prescriptions should be written as the actual number of vials to provide a dose of 5 mg per kg and 2 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
Patients must meet the relevant criteria as indicated in the restrictions and be eligible for the Pharmaceutical Benefits Scheme.
Lodging an application
Send all written applications to the Complex drugs address on the contact us page.
- lodge Fistulising Crohn disease Initial PBS authority application and Supporting information form (PB092) for a patient starting initial treatment for complex refractory fistulising Crohn disease. The patient and prescriber acknowledgements must be completed
- lodge Fistulising Crohn's Disease Continuing PBS authority application Supporting information form (PB093) 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
For more information contact us on the Complex Drugs enquiry line.