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Patient eligibility
The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with biological agents under the National Health Act 1953, sections 85 and 100 for paediatric or adult patients with moderate to severe ulcerative colitis.
Where the term ‘biological agent’ appears in reference to a patient 18 years or older, it refers to:
- adalimumab
- golimumab
- infliximab
- ozanimod
- tofacitinib
- upadacitinib
- ustekinumab
- vedolizumab.
Where the term ‘biological agent’ appears in reference to a patient under the age of 18 years, it refers to:
- adalimumab
- 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., 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 participating 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 ulcerative colitis toxicity and severity descriptors with the authority application.
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)
- paediatrician - paediatric patients only
- specialist paediatric gastroenterologist - paediatric patients only.
Authority applications
Paediatric patients
Applying for initial treatment
Apply for initial authority approval to prescribe PBS-subsidised biological agents to treat moderate to severe ulcerative colitis in writing and either:
- use HPOS Form upload
- mail to PBS Complex Drugs Programs.
All written applications must include the completed:
- authority prescription form or forms
- ulcerative colitis paediatric - initial authority application form
- relevant attachments.
Applying for change or recommencement of treatment
Apply to change or recommence authority approval to prescribe PBS-subsidised biological agents to treat moderate to severe ulcerative colitis in writing and either:
- use HPOS Form upload
- mail to PBS Complex Drugs Programs.
All written applications must include the completed:
- authority prescription form or forms
- ulcerative colitis paediatric - change or recommencement authority application form
- relevant attachments.
Applying for continuing treatment
Applications for continuing authority approval to prescribe PBS-subsidised biological agents to treat moderate to severe ulcerative colitis can be made either:
- in real time using the Online PBS Authorities system
- by calling the PBS Complex Drugs Programs enquiry line.
After we approve the first application for continuing treatment, subsequent continuing treatment with PBS-subsidised biosimilar brands of biological agents are Authority Required (Streamlined). You don’t need authority approval from us for the listed quantity and repeats.
Adult patients
Applying for initial treatment
Apply for initial authority approval to prescribe PBS-subsidised biological agents to treat moderate to severe ulcerative colitis in writing and either:
- use HPOS Form upload
- mail to PBS Complex Drugs Programs.
All written applications must include the completed:
- authority prescription form or forms
- ulcerative colitis - adult - initial authority application form
- relevant attachments.
Applying for initial grandfather treatment
Patients who received non-PBS-subsidised ozanimod, upadacitinib or ustekinumab treatment before 1 May 2023 for moderate to severe ulcerative colitis can apply in writing and either:
- use HPOS Form upload
- mail to PBS Complex Drugs Programs.
All written applications must include the completed:
- authority prescription form or forms
- ulcerative colitis adult - initial grandfather authority application form
- relevant attachments.
Applying for change or recommencement of treatment
Apply to change or recommence authority approval to prescribe PBS-subsidised biological agents to treat moderate to severe ulcerative colitis in writing and either:
- use HPOS Form upload
- mail to PBS Complex Drugs Programs.
All written applications must include the completed:
- authority prescription form or forms
- ulcerative colitis adult - change or recommencement authority application form
- relevant attachments.
Applying for continuing treatment
Applications for continuing authority approval to prescribe PBS-subsidised biological agents to treat moderate to severe ulcerative colitis can be made either:
- in real time using the Online PBS Authorities system
- by calling the PBS Complex Drugs Programs enquiry line.
After we approve the first application for continuing treatment, subsequent continuing treatment with PBS-subsidised biosimilar brands of biological agents 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.