Ulcerative colitis

Patient eligibility

The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with biological medicines 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 medicine appears in reference to a patient 18 years or older, it refers to:

• adalimumab
• etrasimod
• golimumab
• infliximab
• ozanimod
• tofacitinib
• upadacitinib
• ustekinumab
• vedolizumab.

Where the term biological medicine 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 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 either:

• 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 ulcerative colitis 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 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

Adult patients

Applying for initial treatment

Please note: You don’t need to complete this application in writing when you request PBS authority online.

Applications for initial authority approval to prescribe PBS-subsidised biological medicines to treat moderate to severe ulcerative colitis can be made:

• using the Online PBS Authorities system
• in writing and use HPOS Form upload
• in writing and mail to PBS Complex Drugs Programs

All written applications must include:

• details of the proposed prescription or prescriptions
• the completed ulcerative colitis adult - initial authority application form
• relevant attachments.

Applying for initial grandfather treatment

Please note: You’ll get an immediate assessment when you request PBS authorities online.

Applications for initial grandfather authority approval to prescribe PBS-subsidised etrasimod to treat moderate to severe ulcerative colitis can be made in:

• real time using the Online PBS Authorities system
• writing and use HPOS Form upload
• writing and mail to PBS Complex Drugs Programs

All written applications must include:

• details of the proposed prescription or prescriptions
• the completed ulcerative colitis - etrasimod - initial grandfather authority application form
• relevant attachments.

Applying for change or recommencement of treatment

Please note: You don’t need to complete this application in writing when you request PBS authority online.

Applications to change or recommence authority approval to prescribe PBS-subsidised biological medicines to treat moderate to severe ulcerative colitis can be made:

• using the Online PBS Authorities system
• in writing and use HPOS Form upload
• in writing and mail to PBS Complex Drugs Programs.

All written applications must include:

• details of the proposed prescription or prescriptions
• the completed 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 medicines 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 treatments with 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.

Paediatric patients

Applying for initial treatment

Please note: You don’t need to complete this application in writing when you request PBS authority online.

Applications to change or recommence authority approval to prescribe PBS-subsidised biological medicines to treat moderate to severe ulcerative colitis can be made:

• using the Online PBS Authorities system
• in writing and use HPOS Form upload
• in writing and mail to PBS Complex Drugs Programs.

All written applications must include:

• details of the proposed prescription or prescriptions
• the completed ulcerative colitis paediatric - initial authority application form
• relevant attachments.

Applying for change or recommencement of treatment

Please note: You don’t need to complete this application in writing when you request PBS authority online.

Applications to change or recommence authority approval to prescribe PBS-subsidised adalimumab or infliximab to treat moderate to severe ulcerative colitis can be made:

• using the Online PBS Authorities system
• in writing and use HPOS Form upload
• in writing and mail to PBS Complex Drugs Programs.

All written applications must include:

• details of the proposed prescription or prescriptions
• the completed ulcerative colitis paediatric - change or recommencement authority application form
• relevant attachments.

Applying for continuing treatment

Applications for continuing authority approval to prescribe PBS-subsidised adalimumab or infliximab 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 treatments with 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.