Ulcerative colitis

Patient eligibility

The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with biological agents under the National Health Act 1953, sections 85 and section 100 for adult or paediatric 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
• tofacitinib
• vedolizumab.

Where the term biological agent appears in reference to a patient under the age of 18 years, 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 i.v. and vedolizumab i.v.

These items are 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.

These items aren’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 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:

• upload through Health Professionals Online Service (HPOS)
• post 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 for authority approval to change or recommence PBS subsidised biological agents to treat moderate to severe ulcerative colitis 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
• 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.

Continuing PBS subsidised treatment for a paediatric patient with biosimilar brands of biological agents is Authority Required (Streamlined). It doesn’t need prior authority approval from us for 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:

• upload through HPOS
• post 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

For patients who received non-PBS subsidised treatment for moderate to severe ulcerative colitis with either:

• infliximab (subcutaneous form) before 1 July 2021
• tofacitinib before 1 July 2021
• vedolizumab (subcutaneous form) before 1 September 2021.

Apply for initial grandfather authority approval 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
• ulcerative colitis – adult - initial grandfather authority application form
• relevant attachments.

Applying for change or recommencement of treatment

Apply for authority approval to change or recommence PBS subsidised biological agents to treat moderate to severe ulcerative colitis 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
• relevant authority application form
• relevant attachments.

Select the authority application form relevant to the patient’s circumstances:

• ulcerative colitis - adult change or recommencement (treatment break less than 5 years) authority application form
• ulcerative colitis - adult recommencement (treatment break greater than 5 years) authority application form.

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.

Continuing PBS subsidised treatment with PBS listed biosimilar brands of biological agents are Authority Required (Streamlined). They don’t need prior authority approval from us for listed quantity and repeats.

Further information

Find out more about ulcerative colitis toxicity and severity descriptors.

Call the PBS Complex Drugs Programs enquiry line for further information.