Crohn's disease - fistulising Crohn's disease

The PBS subsidises biological agents for patients with complex refractory fistulising Crohn's disease.

Patient eligibility

The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with biological agents under the National Health Act 1953, sections 85 and 100 for patients with complex refractory fistulising Crohn's disease.

Where the term biological agent appears, it refers to adalimumab and 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

This item is only PBS subsidised for day admitted patients, non-admitted patients, or patients on discharge who are attending either:

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

You must include the hospital name and provider number on the authority application form. This item isn’t PBS subsidised for hospital in-patients.

Treatment specifics

To be eligible for PBS subsidised treatment with biological agents, patients must be treated 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).

A patient who has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered to have failed treatment with that PBS subsidised biological agent.

A demonstration of response must be conducted while the patient is on or within 4 weeks of cessation to the most recent course of PBS subsidised treatment.

Applications

Initial treatment

Apply for authority approval to prescribe initial PBS subsidised biological agents to treat complex refractory fistulising Crohn's disease in writing and either:

All applications must include the completed:

Changing or recommencing treatment


Apply for authority approval to change or recommence PBS subsidised biological agents to treat complex refractory fistulising Crohn’s disease in writing and either:

All applications must include the completed:

Continuing treatment

Apply for authority approval to continue PBS subsidised biological agents to treat complex refractory fistulising Crohn's disease in writing and either:

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.

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 require 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: 28 October 2019