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

The measurement of response to the prior course of therapy must be documented in the patient's medical notes.

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.