nilotinib (Tasigna)

Advice

following a full submission:

nilotinib 150mg hard capsules (Tasigna®) is accepted for use within NHS Scotland.

Indication under review: for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase.

First-line treatment with nilotinib in newly diagnosed patients has resulted in significantly higher molecular and cytogenetic response rates compared to the standard tyrosine kinase inhibitor. Further longer term follow-up data are needed to confirm the duration of this response and assess the impact on disease progression and overall survival.

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