afatinib (Giotrif)

following a full submission

afatinib (Giotrif®) is accepted for use within NHS Scotland.

Indication under review: As monotherapy, for the treatment of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s).

In two phase III studies, in patients with EGFR mutation positive adenocarcinoma of the lung, afatinib was significantly superior to the chemotherapy regimen comparators for the primary endpoint of progression free survival. Overall survival data are immature. A mixed treatment comparison provides indirect comparative data versus other tyrosine kinase inhibitors.

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