The PBS subsidises infliximab, adalimumab and vedolizumab (adult patients only) for patients with ulcerative colitis.
Treatment with infliximab, adalimumab and vedolizumab (adult patients only) can be subsidised through the Pharmaceutical Benefits Scheme (PBS) under sections 85 and 100 of the National Health Act 1953 for patients with moderate to severe ulcerative colitis.
Section 100 arrangements for infliximab and vedolizumab only
Infliximab and vedolizumab (adult patients only) are available to a patient who is attending:
- an approved private hospital
- a public participating hospital, or
- a public hospital
and is a
- day admitted patient
- non-admitted patient, or
- patient on discharge
The hospital provider number must be included on the application form.
These items aren't available as PBS benefits for hospital in-patients.
Patients must meet the relevant criteria in the restrictions and be eligible for the PBS.
The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing infliximab, adalimumab and vedolizumab (adult patients only).
Interchangeability (adult patients only)
Interchangeability arrangements apply when prescribing the following under the PBS:
- adalimumab, and
- vedolizumab (adult patients only)
Patients are eligible for PBS subsidised treatment for only 1 of these items at a time.
In a treatment cycle, adult patients (aged 18 years or older) can trial each of these agents without having to experience a disease flare, and patients can continue long term treatment if they keep responding to therapy.
If patients either fail or stop responding to treatment 3 times, they’re deemed to have completed a treatment cycle. They must have a minimum 5 year break in PBS subsidised therapy before they’re eligible to start another cycle.
In the same treatment cycle, patients can’t fail or stop responding to the same PBS subsidised agent more than once.
The written application for an adult patient who wants to swap between these agents should include the approved authority prescription for the therapy the patient is stopping.
Demonstration of a response
For second and subsequent courses of PBS subsidised infliximab, adalimumab and vedolizumab (adult patients only), a patient should be reviewed in the month before their current treatment course finishes. You should also make an application for continuing treatment to us before the patient finishes their current treatment course to avoid a break in treatment.
Assessments of response to a course of PBS subsidised therapy must be provided to us no later than 4 weeks from the date that course finished. Not notifying us of the response within these timeframes means the patient is deemed as failing treatment with that agent. It’s important patients are assessed for response to every approved course of treatment within this timeframe to make sure they get the maximum treatment opportunities.
Toxicity and severity descriptors
Use the list of ulcerative colitis toxicity criteria and severity descriptors to make sure the eligibility of patients is fully assessed. This list of descriptors should be used in conjunction with the application when demonstrating a patient’s inability to tolerate prior systemic therapy.
Patients must be treated by a:
- gastroenterologist (code 87)
- consultant physician, internal medicine specialising in gastroenterology (code 81), or
- consultant physician, general medicine specialising in gastroenterology (code 82)
For infliximab and adalimumab applications only, a patient must be treated by a:
- paediatrician, or
- specialist paediatric gastroenterologist
Make all initial applications for authority approval to prescribe PBS subsidised infliximab, adalimumab and vedolizumab (adult patients only) for the treatment of moderate to severe ulcerative colitis in writing and:
- post to the PBS Complex Drugs Programs address
All applications must include a completed:
- authority prescription form(s), and
- Ulcerative colitis (moderate to severe) PBS subsidised authority application form (PB127)
Authority prescription forms – initial treatment
Infliximab – include an authority prescription form for a quantity of vials sufficient for the initial dose and 2 repeats.
Adalimumab – 2 completed authority prescription forms must be submitted with each initial application.
Vedolizumab – Adult patients only. Include an authority prescription form for a quantity of vials sufficient for the initial dose and 2 repeats.
Applications for initial PBS authority approval for grandfathered patients must be made in writing and include a completed:
- authority prescription form, and
- Ulcerative colitis (moderate to severe) grandfather PBS authority application Supporting Information form (PB191)
Make applications for continuing treatment by calling or writing to PBS Complex Drugs Programs.
Recommencement of treatment
Patients who want to start a second or subsequent treatment cycle after a break in PBS subsidised infliximab, adalimumab and vedolizumab (adult patients only) of at least 5 years must requalify for initial treatment and meet the relevant criteria at that time.
To restart treatment, post the Ulcerative colitis PBS subsidised authority application form (PB127) and assessment of response to the PBS Complex Drugs Programs address.
If a patient wants a break in treatment of less than 5 years, provide their assessment of response to us within 4 weeks of stopping treatment.
For more information call the Complex Drugs Programs enquiry line.