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

Severe Crohn disease

Subsequent continuing treatment of Crohn disease in a paediatric patient

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

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

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

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.