dasatinib (Sprycel)

following a re-submission assessed under the orphan process:

dasatinib (Sprycel®) is accepted for use within NHS Scotland.

Indication under review: for the treatment of adult patients with chronic, accelerated or blast phase chronic myelogenous leukaemia (CML) with resistance or intolerance to prior therapy including imatinib mesilate.

In patients with chronic, accelerated or blast phase CML, dasatinib produced haematological and cytogenetic responses in two phase III dosing ranging studies. In a phase II study dasatinib was associated with higher haematological and cytogenetic responses relative to another tyrosine kinase inhibitor in patients with chronic phase CML.

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

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.