Crohn's disease - Adult patient

The Pharmaceutical Benefits Scheme (PBS) subsidises biological disease modifying drugs for adult patients with severe Crohn's disease.

Biological disease modifying drugs (bDMDs) can be subsidised through the PBS under Section 85 and Section 100 of the National Health Act 1953 for adult patients with severe Crohn’s disease.

Where the term bDMD appears it refers to adalimumab, infliximab, ustekinumab and vedolizumab only.

Section 100 arrangements  for infliximab, ustekinumab (loading dose) and vedolizumab only

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

  • 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

Infliximab, ustekinumab (loading dose) and vedolizumab are not PBS subsidised for in-patients of the hospital.  The hospital name and provider number must be included on the application form.

Patient eligibility

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

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

Toxicity criteria and severity descriptors

Use our list of Crohn's disease toxicity criteria and severity descriptors to ensure patient eligibility can be fully assessed. This list of descriptors should be used in conjunction with the application when demonstrating a patient’s inability to tolerate prior systemic therapy.

Applications

Initial treatment

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

All applications must include a 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 a 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 bDMD regardless of whether they are receiving initial or continuing therapy at the time of the application. 

Make all applications for authority approval to continue, change or recommence PBS subsidised bDMDs for the treatment of severe Crohn’s disease in writing and:

All applications must include a completed:

This authority application form can also be used to submit a demonstration of response to the current PBS subsidised treatment.

Further information

For more information contact the PBS Complex Drugs Programs enquiry line.

Page last updated: 1 September 2017