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Patient eligibility
The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with biological agents under the National Health Act 1953, section 85 and section 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 i.v.
This item is only PBS-subsidised for non-admitted patients, day admitted patients, or patients on discharge who are attending:
- an approved private hospital
- a participating public hospital
- a public hospital.
This item isn’t PBS-subsidised for hospital in-patients. You must include the hospital name and provider number on the authority application form.
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).
Authority applications
Applying for initial treatment
Apply for initial or recommencement (treatment break greater than 5 years) authority approval to prescribe PBS-subsidised biological agents to treat complex refractory fistulising Crohn's disease in writing and either:
- use HPOS Form upload
- post to PBS Complex Drugs Programs.
All written applications must include the completed:
- authority prescription form or forms
- fistulising Crohn’s disease - initial or recommencement (treatment break greater than 5 years) authority application form
- relevant attachments.
Applying for change or recommencement of treatment
Apply to change or recommence (after a treatment break less than 5 years) authority approval to prescribe PBS-subsidised biological agents to treat complex refractory fistulising Crohn’s disease in writing and either:
- use HPOS Form upload
- post to the PBS Complex Drugs Programs.
All written applications must include the completed:
- authority prescription form or forms
- fistulising Crohn’s disease - change, recommencement (treatment break less than 5 years) or demonstration of response authority application form
- relevant attachments.
You can also use this authority application form to submit a demonstration of response to the current PBS-subsidised treatment.
Applying for continuing treatment
Apply for continuing authority approval to prescribe PBS-subsidised biological agents to treat complex refractory fistulising Crohn's disease in writing and either:
- use HPOS Form upload
- post to the PBS Complex Drugs Programs.
All written applications must include the completed:
- authority prescription form or forms
- fistulising Crohn's disease - continuing authority application form
- relevant attachments.
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 need authority approval from us for the listed quantity and repeats.
More information
Call the PBS Complex Drugs Programs enquiry line for more information.