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Patient eligibility
The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with adalimumab under the National Health Act 1953, section 85 for paediatric patients with severe refractory Crohn’s disease.
The PBS subsidises treatment with infliximab under the National Health Act 1953, section 100 for paediatric patients with moderate to severe refractory Crohn’s disease.
Where the term biological medicine 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 medicines.
Section 100 arrangements
Infliximab
This item is only PBS-subsidised for non-admitted patients, day admitted patients, or patients on discharge who are attending either:
- an approved private hospital
- a public hospital.
This item isn’t PBS-subsidised for public 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 medicines for severe or moderate to severe refractory 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 medicines to treat severe or moderate to severe refractory Crohn’s disease in writing and either:
- use HPOS Form upload
- mail to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed 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 medicines to treat severe or moderate to severe refractory Crohn’s disease in writing and either:
- use HPOS Form upload
- mail to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed Crohn’s disease paediatric - change, recommencement or demonstration of response authority application form (PB239)
- 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 medicines to treat severe or moderate to severe refractory Crohn’s disease in writing and either:
- use HPOS Form upload
- mail to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed Crohn’s disease paediatric - continuing authority application form (PB161)
- relevant attachments.
After we approve the first application for continuing treatment, subsequent continuing applications for PBS-subsidised biosimilar brands of biological medicines are Authority Required (Streamlined). You 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.