Crohn's disease - fistulising Crohn's disease

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

Patient eligibility

The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with biological medicines under the National Health Act 1953, section 85 and section 100 for patients with complex refractory fistulising Crohn's disease.

Where the term 'biological medicine' appears, it refers to adalimumab, infliximab and ustekinumab.

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

The Schedule of Pharmaceutical Benefits on the PBS website outlines the restrictions for prescribing biological medicines.

Section 100 arrangements

Infliximab i.v. and ustekinumab i.v.

These items are only PBS-subsidised for non-admitted patients, day admitted patients, or patients on discharge who are attending:

  • an approved private hospital
  • a public hospital.

These items aren’t PBS-subsidised for public hospital in-patients. You must include the hospital name and provider number on the authority application form.

Treatment specifics

To be eligible for PBS-subsidised treatment with biological medicines, patients must be treated by one of the following specialists:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology).

Authority applications

Applying for initial treatment

Apply for initial or recommencement (treatment break greater than 5 years) authority approval to prescribe PBS-subsidised biological medicines to treat complex refractory fistulising Crohn's disease in writing and either:

All written applications must include the completed:

Applying for initial grandfather treatment

For patients who received non-PBS-subsidised ustekinumab treatment before 1 January 2024 for complex refractory fistulising Crohn's disease, apply for initial grandfather authority approval in writing and either:

All written applications must include the completed:

Applying for change or recommencement of treatment

Apply to change or recommence (after a treatment break less than 5 years) authority approval to prescribe PBS-subsidised biological medicines to treat complex refractory fistulising Crohn’s disease in writing and either:

All written applications must include the completed:

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

Applying for continuing treatment

Apply for continuing authority approval to prescribe PBS-subsidised biological medicines to treat complex refractory fistulising Crohn's disease in writing and either:

All written applications must include the completed:

After we approve the first application for continuing treatment, subsequent continuing treatment with PBS-subsidised biosimilar brands of biological medicine are Authority Required (Streamlined). You don’t need authority approval from us for the listed quantity and repeats.

More information

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

Page last updated: 1 January 2024.
QC 31861