Crohn's disease - adult patient

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

Patient eligibility

Treatment with biological agents can be subsidised through the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953, Section 85 and Section 100 for adult patients with severe Crohn’s disease.

The term biological agent refers to adalimumab, infliximab, ustekinumab and vedolizumab only.

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 for infliximab, ustekinumab (loading dose) and vedolizumab

Infliximab, ustekinumab (loading dose) and vedolizumab are available to a patient who is attending:

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

and is a

  • day admitted patient
  • non-admitted patient, or
  • patient on discharge

These items are not available as a PBS for hospital in-patients. You need to include the hospital name and provider number on the authority application form.

Toxicity criteria and severity descriptors

Use the Crohn's disease toxicity criteria and severity descriptors with the authority application when demonstrating the patient’s intolerance to prior systemic therapy.

Applications

Initial treatment

Make all initial applications for authority approval to prescribe PBS subsidised biological agents for the treatment of severe Crohn’s disease in writing and:

All applications must include the completed:

Initial grandfather treatment

For patients who received non PBS subsidised vedolizumab treatment before 1 August 2015 or ustekinumab treatment before 1 September 2017 for severe Crohn’s disease, make all initial grandfather applications in writing and:

All applications must include the completed:

A patient may qualify for PBS subsidised ustekinumab or vedolizumab under the grandfather restriction once only.

Continuing, 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 continue, change or recommence PBS subsidised biological agents for the treatment of severe 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.

Further information

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

Page last updated: 1 March 2018