Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Moderate to severe ulcerative colitis

Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form

Must be treated by a gastroenterologist (code 87); or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND

Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; or

Patient must have received this drug in the intravenous form as their most recent course of PBS-subsidised biological medicine for this condition under the vedolizumab intravenous form continuing treatment restriction; AND

Patient must not receive more than 24 weeks of treatment under this restriction; AND

Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or

Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form; AND

Patient must be at least 18 years of age.

Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.

Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.

At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.

Up to a maximum of 5 repeats will be authorised.

An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.