Ulcerative colitis (UC) Program in Pharmaceutical Benefits Scheme (PBS) 012-18051140

UC is an inflammatory bowel disease (IBD) in which the lining of the large intestine (colon or bowel) and the rectum become inflamed.

Listing dates:

• infliximab - 1 December 2014
• vedolizumab - 1 August 2015
• adalimumab - 1 December 2016
• golimumab - 1 June 2018
• tofacitinib - 1 July 2021
• ozanimod - 1 May 2023
• upadacitinib - 1 May 2023
• ustekinumab - 1 May 2023
• etrasimod - 1 October 2024

See Written Authority Required Drugs for more details.

Etrasimod

Etrasimod does not have an age restriction. Paediatric patients need to meet adult criteria and apply for treatment using the adult forms.

Treatment cycles

A break in treatment cycles is measured:

• from the date of last approval for PBS-subsidised biological medicine treatment in the most recent cycle
• to the date of the first application for initial treatment with a biological medicine under the new treatment cycle

There is no limit to the number of treatment cycles.

See Treatment breaks and failures for full details.

Acute severe ulcerative colitis in hospital

• Infliximab i.v. can be prescribed for patients suffering from an acute severe episode as a 3 dose course in hospital (first dose is provided by the hospital)
• This is an Authority Required (Streamlined) listing for public and private hospital patients
• The requirements for this authority are not the same as for the moderate to severe program

Prescribers:

• may want their patients to continue treatment under the moderate to severe restriction as there is no continuing available for acute severe ulcerative colitis
• can complete an initial application form for patients who have received PBS-subsidised acute severe treatment in the last 4 months (providing they can demonstrate that the patient is currently responding to treatment)

Patient baselines

When a patient qualifies for treatment, they will have a measured and defined level of disease activity:

• patients qualify on either a Mayo or partial Mayo score as adults, or
• Paediatric Ulcerative Colitis Activity Index (PUCAI) if they are paediatric patients
• this score:
• becomes the patient’s baseline
• is used to demonstrate an initial response to treatment that must be sustained to qualify for continuing treatment

Transfer enquiries about prescription arrangements to PBS Complex Drugs Programs and choose the option relevant to the condition treated.