Ulcerative colitis

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

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 moderate to severe ulcerative colitis.

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

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

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

Treatment with golimumab and vedolizumab is only available to adult patients.

Section 100 arrangements

Infliximab and vedolizumab 

These items are only available for a day admitted patient, non-admitted patient, or patients on discharge who are attending:

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

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

Toxicity and severity descriptors

Use the ulcerative colitis toxicity and severity descriptors with the authority application when demonstrating a patient’s intolerance to prior treatments.

Treatment specifics

All applications must be completed by one of the following specialists: 

  • gastroenterologist - code 87
  • consultant physician, internal medicine specialising in gastroenterology - code 81
  • consultant physician, general medicine specialising in gastroenterology - code 82
  • paediatrician - paediatric patients only
  • specialist paediatric gastroenterologist - paediatric patients only

Applications

Adult patients

Initial treatment

Make all initial applications for authority approval to prescribe PBS subsidised biological agents for the treatment of moderate to severe ulcerative colitis in writing and:

All applications must include the completed:

Initial grandfather treatment

Initial grandfather treatment is available for patients who received:

  • non-PBS subsidised vedolizumab treatment before 1 August 2015 for the treatment of moderate to severe ulcerative colitis or
  • non-PBS subsidised golimumab treatment before 1 June 2018 for the treatment of moderate to severe ulcerative colitis

Make all initial grandfather applications in writing and:

All applications must include the completed:

A patient may qualify for PBS subsidised treatment under this restriction once only.

Changing and recommencing treatment

Make all applications for authority approval to change or recommence PBS subsidised biological agents for the treatment of moderate to severe ulcerative colitis in writing and:

All applications must include the completed:

Continuing treatment

To make continuing applications for the treatment of moderate to severe ulcerative colitis with PBS subsidised biological agents call the PBS Complex Drugs Programs enquiry line.

Continuing treatment with biosimilar brands of infliximab is S100-HSD (Public) - Authority Required (Streamlined). It does not need prior authority approval from us for listed quantities and repeats.

Paediatric patients

Initial treatment

Make all initial applications for authority approval to prescribe or recommence PBS subsidised adalimumab or infliximab for the treatment of moderate to severe ulcerative colitis in writing and:

All applications must include the completed:

Changing and recommencing treatment


Make all applications for authority approval to change or recommence PBS subsidised biological agents for the treatment of moderate to severe ulcerative colitis in writing and:

All applications must include the completed:

Continuing treatment

To make continuing applications for the treatment of moderate to severe ulcerative colitis with biological agents call the PBS Complex Drugs Programs enquiry line.

Continuing treatment with biosimilar brands of infliximab is S100-HSD (Public) - Authority Required (Streamlined) and it doesn’t need prior authority approval from us for listed quantities and repeats.

Further information

For more information call the Complex Drugs Programs enquiry line.

Page last updated: 2 October 2018