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

Moderate to severe Crohn disease

Subsequent continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND

Patient must have both: (i) a total PCDAI score of 30 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.

Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment, unless the patient has experienced 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 at a dose of 5 mg per kg per dose providing they continue to sustain the response.

At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.

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 2 repeats at the time of application; and/or

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