Ulcerative colitis

The PBS subsidises adalimumab, infliximab and vedolizumab (adults only) for patients with moderate to severe ulcerative colitis.

Treatment with adalimumab, infliximab 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 name and provider number must be included on the application form. These items are not available as PBS benefits for inpatients of the hospital. 

Patient eligibility

Patients must meet the relevant criteria in the restrictions and be eligible for the Pharmaceutical Benefits Scheme.

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing adalimumab, infliximab and vedolizumab (adult patients only).

Interchangeability (adult patients only)

Interchangeability arrangements apply when prescribing the following under the PBS:

  • adalimumab
  • infliximab, and
  • vedolizumab (adult patients only)

Interchangeability (paediatric patients aged 6 to 17 years)

Interchangeability arrangements apply when prescribing the following under the PBS:

  • adalimumab
  • infliximab

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) and paediatric patients (aged 6 to 17 years) 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 biological agent more than once.

Demonstration of a response

For second and subsequent courses of PBS subsidised adalimumab, infliximab 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 is important patients are assessed for response to every approved course of treatment within this timeframe to make sure they get 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.

Applications

All applications must be made by the treating:

  • gastroenterologist (code 87)
  • consultant physician, internal medicine specialising in gastroenterology (code 81), or consultant physician, general medicine specialising in gastroenterology (code 82) or paediatrician (paediatric patients only), or
  • specialist paediatric gastroenterologist (paediatric patients only)

Initial treatment (adult patients)

Make all initial applications for authority approval to prescribe PBS subsidised adalimumab, infliximab and vedolizumab (adult patients only) for the treatment of moderate to severe ulcerative colitis in writing and:

All applications must include a completed:

Initial treatment (paediatric patients)

Make all initial applications for authority approval to prescribe PBS subsidised adalimumab and infliximab for the treatment of moderate to severe ulcerative colitis in writing and:

All applications must include a completed:

Grandfathered treatment

Applications for initial PBS authority approval for grandfathered patients must be made in writing and include a completed:

A patient may qualify for PBS subsidised treatment under this restriction once only.  

Continuing treatment

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 adalimumab, infliximab or vedolizumab (adult patients only) of at least 5 years must requalify for initial treatment and meet the relevant criteria at that time.

Change or recommencement of treatment (adult patients)

To change or recommence treatment with adalimumab, infliximab or vedolizumab, the application must be made in writing and:

All applications must include a completed:

Change or recommencement of treatment (paediatric patients)

To change or recommence treatment with adalimumab or infliximab the application must be made in writing and:

All applications must include a completed:

Patients can have a break in treatment of less than 5 years, providing an assessment demonstrating a response is submitted within 4 weeks of treatment cessation.

Patients can swap to an alternate biological agent once an authority for initial treatment with the first PBS subsidised biological agent is approved.

Further information

For more information call the Complex Drugs Programs enquiry line.

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Page last updated: 3 July 2017

This information was printed Thursday 17 August 2017 from humanservices.gov.au/health-professionals/enablers/ulcerative-colitis It may not include all of the relevant information on this topic. Please consider any relevant site notices at humanservices.gov.au/siteinformation when using this material.