Crohn’s disease - adult patient

The PBS subsidises biological agents for adult patients with severe Crohn’s disease.

Patient eligibility

The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with biological agents under the National Health Act 1953, section 85 and section 100 for adult patients with severe Crohn’s disease.

Where the term biological agent appears, it refers to:

  • adalimumab
  • infliximab
  • ustekinumab
  • vedolizumab.

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 agents.

Section 100 arrangements

Infliximab i.v., ustekinumab i.v. and vedolizumab i.v.

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

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

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

Toxicity and severity descriptors

When demonstrating a patient’s intolerance to prior treatment, use the Crohn’s disease toxicity and severity descriptors with the authority application.

Treatment specifics

To be eligible for PBS subsidised treatment with biological agents for severe Crohn’s disease, 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 authority approval to prescribe PBS subsidised biological agents to treat adult patients with severe Crohn’s disease in writing and either:

All written applications must include the completed:

Applying for initial grandfather treatment

For adult patients who received non-PBS subsidised treatment with either infliximab (subcutaneous form) before 1 July 2021 or vedolizumab (subcutaneous form) before 1 September 2021 for severe 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 for authority approval to change or recommence PBS subsidised biological agents to treat adult patients with severe Crohn’s disease in writing and either:

All written applications must include the completed:

  • authority prescription form or forms
  • relevant authority application form
  • relevant attachments.

Select the authority application form relevant to the patient’s circumstances:

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 agents to treat adult patients with severe 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 applications for PBS subsidised biosimilar brands of biological agents are Authority Required (Streamlined). They don’t need authority approval from us for listed quantity and repeats.

Further information

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

Page last updated: 1 September 2021