Ulcerative colitis

The PBS subsidises biological agents for patients with moderate to severe ulcerative colitis.

Patient eligibility

The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with biological agents under the National Health Act 1953, sections 85 and 100 for adult or paediatric patients with moderate to severe ulcerative colitis.

Where the term ‘biological agent’ appears in reference to a patient 18 years or older, it refers to:

  • adalimumab
  • golimumab
  • infliximab
  • tofacitinib
  • vedolizumab.

Where the term ‘biological agent’ appears in reference to a patient under the age of 18 years, it refers to:

  • adalimumab
  • infliximab.

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. and vedolizumab i.v.

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

  • 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 ulcerative colitis toxicity and severity descriptors with the authority application.

Treatment specifics

To be eligible for PBS-subsidised treatment with biological agents, 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)
  • paediatrician - paediatric patients only
  • specialist paediatric gastroenterologist - paediatric patients only.

Authority applications

Paediatric patients

Applying for initial treatment

Apply for initial authority approval to prescribe PBS-subsidised biological agents to treat moderate to severe ulcerative colitis in writing and either:

All written applications must include the completed:

Applying for change or recommencement of treatment

Apply to change or recommence authority approval to prescribe PBS-subsidised biological agents to treat moderate to severe ulcerative colitis in writing and either:

All written applications must include the completed:

Applying for continuing treatment

Applications for continuing authority approval to prescribe PBS-subsidised biological agents to treat moderate to severe ulcerative colitis can be made either:

Continuing PBS-subsidised treatment with PBS listed biosimilar brands of biological agents is Authority Required (Streamlined). It doesn’t need prior authority approval from us for the listed quantity and repeats.

Adult patients

Applying for initial treatment

Apply for initial authority approval to prescribe PBS-subsidised biological agents to treat moderate to severe ulcerative colitis in writing and either:

All written applications must include the completed:

Applying for initial grandfather treatment

For patients who received non-PBS-subsidised vedolizumab (subcutaneous form) treatment before 1 September 2021 for moderate to severe ulcerative colitis, 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 authority approval to prescribe PBS-subsidised biological agents to treat moderate to severe ulcerative colitis in writing and either:

All written applications must include the completed:

Applying for continuing treatment

Applications for continuing authority approval to prescribe PBS-subsidised biological agents to treat moderate to severe ulcerative colitis can be made either:

Continuing PBS-subsidised treatment with PBS listed biosimilar brands of biological agents is Authority Required (Streamlined). It doesn’t need prior 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 August 2022