on this page
Patient eligibility
The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with biological agents under the National Health Act 1953, section 85 and section 100 for paediatric patients with moderate to severe 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 public participating 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.
Toxicity and severity descriptors
When demonstrating a patient’s intolerance to prior treatment, use the Crohn's disease toxicity and severity descriptors with the authority application.
Treatment specifics
To be eligible for PBS-subsidised treatment with biological agents for moderate to severe Crohn’s disease, 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)
- paediatrician
- specialist paediatric gastroenterologist.
Authority applications
Applying for initial treatment
Apply for initial authority approval to prescribe PBS-subsidised biological agents to treat paediatric patients with moderate to severe Crohn's disease in writing and either:
- upload through Health Professional Online Services (HPOS)
- post to PBS Complex Drugs Programs.
All written applications must include the completed:
- authority prescription form or forms
- Crohn's disease paediatric initial authority application form (PB085)
- relevant attachments.
Applying for change or recommencement of treatment
Apply to change or recommence authority approval to prescribe PBS-subsidised biological agents to treat paediatric patients with moderate to severe Crohn’s disease in writing and either:
- upload through HPOS
- post to PBS Complex Drugs Programs.
All written applications must include the completed:
- authority prescription form or forms
- Crohn’s disease paediatric change or recommencement authority application form (PB239)
- relevant attachments.
Applying for continuing treatment
Apply for continuing authority approval to prescribe PBS-subsidised biological agents to treat paediatric patients with moderate to severe Crohn’s in writing and either:
- upload through HPOS
- post to PBS Complex Drugs Programs.
All written applications must include the completed:
- authority prescription form or forms
- Crohn's disease paediatric continuing authority application form (PB161)
- relevant attachments.
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 need authority approval from us for listed quantity and repeats.
Further information
Call the PBS Complex Drugs Programs enquiry line for further information.