Crohn disease

Authority to supply Tumour Necrosis Factor (TNF) alfa antagonist agents through the Pharmaceutical Benefits Scheme (PBS) for patients under Section 85 and Section 100 of the National Health Act 1953.

Where the term TNF alfa antagonist agent appears it refers to adalimumab and infliximab only.

Adalimumab is available on the PBS as an authority required benefit for:

• adult patients with severe refractory Crohn disease

Infliximab is available on the PBS as an authority required benefit for:

• patients with severe refractory Crohn disease
• paediatric patients (aged 6 to 17 inclusive) with moderate to severe refractory 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 one of the six initial restrictions before approval will be granted to prescribe infliximab.

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) or a paediatrician (for patients aged 6 to 17 years inclusive).

The initial restrictions are:

• Initial PBS subsidised treatment with a TNF alfa antagonist agent of patients with severe refractory Crohn disease with a Crohn Disease Activity Index (CDAI) score greater than or equal to 300.
• Initial PBS subsidised treatment with a TNF alfa antagonist agent of patients with severe refractory Crohn disease with diagnostic imaging or surgical evidence of short gut syndrome or with an ileostomy or colostomy.
• Initial PBS subsidised treatment with a TNF alfa antagonist agent of patients with severe refractory Crohn disease with extensive small intestinal disease and radiological evidence of intestinal inflammation affecting more than 50 cm of the small intestine.
• Initial PBS subsidised treatment with infliximab of paediatric patients aged 6 to 17 years inclusive with moderate to severe refractory Crohn disease.
• Initial PBS subsidised treatment, for continuing treatment of patients with a documented history of severe refractory Crohn disease who started treatment with adalimumab before 9 November 2007 and infliximab before 7 March 2007 and who, at the time of application, have demonstrated an adequate response to treatment.
• Initial PBS subsidised treatment, for continuing treatment of paediatric patients aged 6 to 17 years inclusive with a documented history of moderate to severe refractory Crohn disease who started treatment with infliximab before 4 July 2007 and who, at the time of application, have demonstrated an adequate response to treatment.

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

For more information call 1800 700 270* (option 4) between 8:00am and 5:00pm EST, Monday to Friday.

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 TNF alfa antagonist agent.

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 TNF alfa antagonist agent treatment:

• after 12 weeks of adalimumab treatment
• up to 12 weeks after the first dose for infliximab treatment

This assessment must be submitted to Medicare Australia no later than four weeks from the date that the course completed. 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 alfa antagonist agent.

 Continuing applications

Following the completion of an initial treatment course with a TNF alfa antagonist 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 continuing therapy. The assessment must be submitted to Medicare Australia no later than four weeks from the date that the course is completed. 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.

Swapping therapy—change applications; only for adult patients

Once an authority for initial treatment with a TNF alfa antagonist agent is approved, patients may swap to the alternate treatment, providing they are eligible, without having to requalify with respect to either the:

• indices of disease severity or
• prior therapy requirements.

Patients who have had a break in PBS subsidised treatment with a TNF alfa antagonist agent and who wish to recommence treatment, may submit a new baseline set of measurements.

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 TNF alfa antagonist agent therapy, providing they have:

• not received PBS subsidised treatment with that particular TNF alfa antagonist agent previously
  or
• not trialled and failed, or cease to respond to, the same PBS subsidised TNF alfa antagonist agent more than twice

Therefore, to maximise the choice of TNF alfa antagonist agents patients may alternate between, it is important that they 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 swap to an alternate TNF alfa antagonist agent should be accompanied by the approved authority prescription, or remaining repeats for the TNF alfa antagonist agent 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 TNF alfa antagonist agent.

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

The lodgement of application must be made within one month of the date of all assessments, pathology tests and diagnostic imaging studies.

Schedule item details

 Dose

• 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 four injections at week zero, two injections at week two and thereafter one injection every two weeks.

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

• 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 eight weekly intervals.

Authority prescriptions should be written as follows:
The actual number of vials to provide a dose of 5mg per kg and two repeats.

 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

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.

 Lodgement

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 more information please call 1800 700 270* (option 4) between 8:00am and 5:00pm EST, Monday to Friday.

*Call charges apply from mobile or pay phones only.

 Toxicity and severity descriptors

To ensure that the eligibility of patients can be fully assessed, a comprehensive list of toxicity and severity descriptors which should be used in conjunction with the application when demonstrating a patient’s inability to tolerate prior systemic therapy, is attached.

• Crohn disease PBS toxicity criteria and severity descriptors [PDF, 106Kb]

Additional information

• Adult Crohn Disease Activity Index (CDAI) [PDF, 137Kb]
• Paediatric Crohn Disease Activity Index (PCDAI) [PDF, 148Kb]
• Standard weight chart [PDF, 26Kb]

Application forms (section 85 and section 100)

Crohn disease PBS authority application forms

• Initial PBS subsidised treatment of patients with severe refractory Crohn disease [PDF, 311Kb]
  This document contains the form you must lodge for a patient starting initial treatment for severe refractory Crohn disease. The patient and prescriber acknowledgements must be completed.
• Initial PBS subsidised treatment, for continuing treatment of patients with a documented history of severe refractory Crohn disease who were receiving treatment with adalimumab before 9 November 2007 or infliximab before 7 March 2007 [PDF, 303Kb]
  This document contains the form you must lodge for a patient starting initial PBS subsidised treatment, who was receiving treatment with adalimumab before 9 November 2007 or infliximab before 7 March 2007. The patient and prescriber acknowledgements must be completed.
• Initial PBS subsidised infliximab treatment of patients aged 6 to 17 inclusive with moderate to severe refractory Crohn disease [PDF, 314Kb]
  This document contains the form you must lodge for a paediatric patient starting initial treatment for moderate to severe refractory Crohn disease. The patient acknowledgement must be completed.
• Initial PBS subsidised treatment, for continuing treatment of patients aged 6 to 17 inclusive with a documented history of moderate to severe refractory Crohn disease who were receiving treatment with infliximab for Crohn Disease before 4 July 2007 [PDF, 308Kb]
  This document contains the form you must lodge for a paediatric patient starting initial PBS subsidised treatment, who was receiving treatment with infliximab before 4 July 2007. The patient and prescriber acknowledgements must be completed.
• Continuation of PBS subsidised treatment for all patients, or change to an alternate PBS subsidised treatment for which the adult patient is eligible, or demonstration of response to the current PBS subsidised treatment for all patients not continuing treatment at this time [PDF, 413Kb]
  This document contains the form you must lodge for a patient who is
  • continuing PBS subsidised treatment (all patients)
  • changing to the alternate PBS subsidised treatment for which the patient is eligible
  • demonstrating a response to the current PBS subsidised treatment for all patients not continuing treatment at this time

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Last updated: 9 November, 2009