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Patient eligibility
The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with ‘biological medicines’ under the National Health Act 1953, section 85 and section 100 for adult patients with severe Crohn’s disease.
Where the term biological medicine appears it refers to:
- adalimumab
- infliximab
- upadacitinib
- ustekinumab
- vedolizumab.
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 i.v., ustekinumab i.v. and vedolizumab i.v.
These items are only PBS-subsidised for non-admitted patients, day admitted patients, or patients on discharge who are attending:
- an approved private hospital
- a public hospital.
These items aren’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, patients must be treated by either a:
- gastroenterologist
- consultant physician (internal medicine specialising in gastroenterology)
- consultant physician (general medicine specialising in gastroenterology).
Authority applications
Applying for initial treatment
Apply for initial authority approval to prescribe PBS-subsidised biological medicines to treat adult patients with severe 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 adult - initial authority application form
- relevant attachments.
Applying for initial grandfather treatment
For patients who received non-PBS-subsidised upadacitinib treatment before 1 December 2023 for severe Crohn’s disease, apply for initial grandfather authority approval 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 adult - upadacitinib - initial grandfather authority application form
- relevant attachments.
Applying for extended induction period (optional)
Applications for authority approval to prescribe PBS-subsidised upadacitinib or vedolizumab i.v. for (optional) extended induction period to treat Crohn’s disease can be made either:
- in real time using the Online PBS Authorities system
- by calling the PBS Complex Drugs Programs enquiry line.
Applying for change or recommencement of treatment
Apply to change or recommence authority approval to prescribe PBS-subsidised biological medicines to treat adult patients with severe 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 adult - change, recommencement 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 medicines to treat adult patients with severe 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 adult - continuing authority application form
- relevant attachments.
After we approve the first application for continuing treatment, subsequent continuing treatments with PBS-subsidised biosimilar brands of biological medicine 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.