gefitinib (Iressa)

following a second re-submission

gefitinib (Iressa®) is accepted for restricted use within NHS Scotland.

Indication under review: the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of epidermal growth factor receptor tyrosine kinase (EGFR-TK).

SMC restriction: in patients with previously untreated locally advanced or metastatic NSCLC with activating EGFR-TK mutations i.e. as a first-line therapy.

In patients with EGFR mutation-positive, advanced NSCLC, randomised controlled studies demonstrated an improvement in the progression-free survival and tumour response rates for those treated with gefitinib compared with platinum-doublet chemotherapy. There was no overall survival benefit demonstrated.

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