Crohn's disease - fistulising Crohn's disease

The PBS subsidises biological agents for patients with complex refractory fistulising Crohn's disease.

Patient eligibility

Treatment with biological agents can be subsidised through the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953, Sections 85 and 100 for a patient with complex refractory fistulising Crohn's disease.

Where the term biological agent appears it refers to adalimumab and infliximab.

Patients must be eligible for the PBS and meet the relevant restriction criteria.

The Schedule of Pharmaceutical Benefits outlines restrictions for prescribing biological agents.

Section 100 arrangements—infliximab

This item is only available for day admitted  patients, non-admitted patients, or patients on discharge who are attending:

  • an approved private hospital
  • a participating public hospital or
  • a public hospital

This item is not PBS benefit for hospital in-patients. You must include the hospital name and provider number on the authority application form.

Applications

All applications must be completed by a treating:

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

Initial treatment

Make all initial applications for authority approval to prescribe PBS subsidised biological agents for the treatment of complex refractory fistulising Crohn's disease in writing and:

All applications must include the completed:

Changing or recommencing treatment

A patient may trial an alternative biological agent while they’re receiving initial or continuing therapy at the time of the application. 
Make all applications for authority approval to change or recommence PBS subsidised biological agents for the treatment of fistulising Crohn’s disease in writing and:

All applications must include the completed:

Continuing treatment

Make all applications for authority approval to continue PBS subsidised biological agents for the treatment of complex refractory fistulising Crohn's disease in writing and:

All applications must include the completed:

You can use this authority application form to submit a demonstration of response to the current PBS subsidised treatment.

After a written authority application for the first continuing treatment with infliximab is approved, subsequent continuing applications for biosimilar brands of infliximab are:

  • S100-HSD (Public) - Authority Required (Streamlined) and don’t need authority approval from us
  • S100-HSD (Private) - Authority Required (Telephone) - you can call the PBS authority approvals line for more information

Further information

Call the PBS Complex Drugs Programs enquiry line for more information.

Page last updated: 1 August 2018