osimertinib (Tagrisso)

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

osimertinib (Tagrisso®) is accepted for restricted use within NHS Scotland.

Indication under review: the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer (NSCLC).

SMC Restriction: in patients who have received previous treatment with an EGFR tyrosine kinase inhibitor.

Osimertinib was associated with an overall response rate of 66% in the pooled analysis of two phase II single-arm studies of patients with EGFR T790M advanced NSCLC who had received previous treatment with an EGFR tyrosine kinase inhibitor.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of osimertinib. 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 views from a Patient and Clinician Engagement (PACE) meeting.