Crohn's disease - Adult patient

The Pharmaceutical Benefits Scheme (PBS) subsidises tumour necrosis factor alpha antagonist agents for patients with severe refractory Crohn's disease.

Information to apply for PBS subsidised biological disease modifying drugs for adult patients with severe refractory Crohn's disease.

Authority to provide PBS subsidised biological disease modifying drugs (bDMDs) for adult patients with severe refractory Crohn's disease is available under Section 85 and Section 100 of the National Health Act 1953.

Where the term bDMD appears it refers to adalimumab, infliximab and vedolizumab only.

All applications must be made and completed by a:

  • gastroenterologist (code 87), or
  • consultant physician in internal medicine specialising in gastroenterology (code 81), or
  • consultant physician in general medicine specialising in gastroenterology (code 82)

Patients must meet the relevant criteria as indicated in the PBS restrictions and be eligible for the PBS

Section 100 arrangements only for infliximab and vedolizumab

Infliximab and vedolizumab are only available to a patient who is attending either:

  • an approved private hospital
  • a public participating hospital, or
  • a public hospital
The hospital provider number must be included on the application form.

The patient must either be:

  • a day admitted patient
  • a non-admitted patient, or
  • a patient on discharge
Infliximab and vedolizumab are not PBS subsidised for in-patients of the hospital.

Restriction details

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing adalimumab and infliximab to patients.

For continuing PBS subsidised treatment, the patient must demonstrate or sustain an adequate response to treatment with a bDMD as defined in each restriction.

Information relevant to all patients

All patients receiving treatment with vedolizumab must be appropriately assessed for the risk of developing multifocal leukoencephalopathy whilst on this treatment.

Treatment

Initial treatment

Applications for initial treatment should be made where patients have received no prior PBS subsidised treatment with a bDMD.

All applications for initial treatment will be limited to a maximum of:

  • 16 weeks of adalimumab
  • 14 weeks of infliximab
  • 14 weeks of vedolizumab

Patients must be assessed for a response to any course of PBS subsidised bDMD treatment:

  • after 12 weeks of adalimumab treatment
  • up to 12 weeks after the first dose for infliximab treatment
  • up to 12 weeks after the first dose of vedolizumab treatment
This assessment must be submitted to us no later than 4 weeks from the date that the course completed. Where a response assessment is not submitted to us within this timeframe, patients will be found to have failed to respond to treatment with that bDMD agent.

Continuing treatment

After an initial treatment course with a bDMD agent, patients may qualify to receive up to 24 weeks of continuing treatment providing 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 continued treatment. The assessment must be submitted to us no later than 4 weeks from the date that the course is completed. Where a response assessment is not submitted to us within this timeframe, patients will be found to have failed to respond to treatment.

Recommencement treatment

Once an authority for initial treatment with a bDMD agent is approved, patients may recommence treatment with the same bDMD agent. A response to treatment must be submitted to us within the relevant timeframes set out in the restrictions, listed on the PBS website

All applications to recommence will be limited to a maximum of:

  • 16 weeks of adalimumab
  • 14 weeks of infliximab
  • 14 weeks of vedolizumab

Changing treatments

Once an authority for initial treatment with a bDMD agent is approved, patients may change to the alternative treatment, providing they are eligible, without having to requalify with respect to either the:

  • indices of disease severity, or
  • previous therapy requirements

All applications for a change treatment will be limited to a maximum of:

  • 16 weeks of adalimumab
  • 14 weeks of infliximab
  • 14 weeks of vedolizumab

Patients may change to an alternative treatment at any time, regardless of whether they are receiving initial or continuing treatment at the time of the application. Patients may alternate between bDMD agent therapies, providing they have not:

  • trialled and failed, or ceased to respond to, the PBS subsidised bDMD agent requested more than twice, or
  • failed 3 bDMD agent treatment courses

To maximise the choice of bDMD agents patients may alternate between, it is important that they are assessed for a response to every course of treatment. Assessments must be submitted to us no later than 4 weeks from the date that the course is completed to authorise treatment change.

To avoid confusion, applications for patients changing to an alternative bDMD agent should be accompanied by the approved authority prescription or remaining repeats for the TNF alpha antagonist agent the patient is ceasing.

Baseline measurements to determine response

We will determine whether a response to treatment has been demonstrated. This will be based on the baseline measurements of the indices of disease severity submitted with the first authority application.

Where applicable, any one of the baseline criteria may be used to determine a response to an initial course of treatment and eligibility for continued treatment, according to the continuing treatment restriction. To determine eligibility for continuing PBS subsidised treatment, any criterion used to demonstrate a response must have been supplied with the initial application.

Schedule item details

Adalimumab (Humira®) is presented as:

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

The dose for adult patients is 4 injections at week zero, 2 injections at week 2 and 1 injection thereafter.

You will be required to make 2 authority prescriptions. The first authority prescription will be for the induction pack of 6 doses of 40 mg and no repeats. The second prescription should be written for 2 doses of 40 mg and 2 repeats.

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

Infliximab (Remicade®) is presented as a vial containing 100 mg of lyophilised powder.

The dose for patients is 5 mg/kg given intravenously.

Initially, patients are to be treated at week zero, week 2 and week 6. Subsequent infusions are at 8 weekly intervals.

Authority prescriptions should be written as the actual number of vials to provide a dose of 5 mg/kg and 2 repeats.

Vedolizumab, Entyvio®, is presented as a vial containing 300 mg.

The dose is 300 mg per infusion.

Initially patients are to be treated at week zero, week 2 and then at week 6. Subsequent infusions are at 8 weekly intervals.

Authority prescriptions should be written as Vedolizumab – one vial of 300 mg and 2 repeats.

Toxicity criteria and severity descriptors

Use our list of Crohn's disease toxicity criteria and severity descriptors to ensure patient eligibility can be fully assessed. This list of descriptors should be used in conjunction with the application when demonstrating a patient’s inability to tolerate prior systemic therapy.

Lodging an application

All applications for authority to provide initial or continued PBS subsidised treatment for severe refractory Crohn's disease must be provided in writing.

Applications must be made within 1 month of the date of all assessments, pathology tests and diagnostic imaging studies.

Initial treatment

Complete and return the Crohn's disease Initial PBS authority application and Supporting information form (PB087)

We will not consider an application for initial treatment unless the patient and prescriber acknowledgements are completed.

Continuing or changing treatment

Complete and return the Crohn's disease Continuing PBS authority application and Supporting information form (PB088)

This form can also be used to advise when your patient is demonstrating a response to the current PBS subsidised treatment but not continuing treatment at this time.

Send all written applications to the Complex Drugs Programs address on the contact us page.

Further information

For more information contact the Complex Drugs Programs enquiry line.

Page last updated: 8 November 2016

This information was printed Friday 9 December 2016 from humanservices.gov.au/health-professionals/enablers/crohns-disease-adult-patient It may not include all of the relevant information on this topic. Please consider any relevant site notices at humanservices.gov.au/siteinformation when using this material.