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

Severe Crohn disease

First continuing treatment of Crohn disease in a paediatric patient

Patient must have a documented history of severe Crohn disease; AND

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

Patient must have both: (i) a total PCDAI score of 40 points or less, and (ii) a reduction in PCDAI score by at least 15 points from baseline value; or

Patient must have an adequate response to this drug defined as an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; AND

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

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)]; or

Must be treated by a paediatrician; or

Must be treated by a specialist paediatric gastroenterologist; AND

Patient must be aged 6 to 17 years inclusive.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

The assessment of response must be no more than 4 weeks old at the time of application.

An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course 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.

Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.

Authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction for patients who:

(i) received fewer than 5 repeats at the time of application; and/or

(ii) required changes to their dosing regimen during this treatment phase.