dasatinib (Sprycel)

following an abbreviated submission:

dasatinib (Sprycel®) is accepted for use within NHSScotland.

Indication under review: for the treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.

SMC has previously accepted dasatinib for use in the treatment of adult patients with newly diagnosed Ph+ CML-CP (SMC No. 1170/16) and Ph+ CML-CP resistant or intolerant to prior therapy including imatinib (SMC No. 370/07).

Dasatinib was accepted for use in the treatment of adult patients with Ph+ CML-CP resistant or intolerant to prior therapy including imatinib (SMC No. 370/07) following a submission under the orphan process.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of dasatinib. This SMC advice is contingent upon the continuing availability of the patient access scheme or a list price that is equivalent or lower.