ceritinib (Zykadia)

following a full submission assessed under the end of life and ultra orphan process

ceritinib (Zykadia®) is accepted for use within NHS Scotland.

Indication under review: Treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.

In two non-comparative studies (one phase I and one phase II) of patients with advanced ALK-positive NSCLC previously treated with crizotinib, treatment with ceritinib was associated with clinically meaningful tumour responses and median overall survival of approximately 15 to 17 months. Controlled data with clinical outcomes are currently lacking.

This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of ceritinib. 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.