vemurafenib (Zelboraf)

following a resubmission:

vemurafenib (Zelboraf®) is accepted for restricted use within NHS Scotland.

Indication review: as monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

SMC restriction: for use in the first-line treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma.

Vemurafenib significantly increases overall survival and progression-free survival compared with a current standard chemotherapy for patients with previously untreated unresectable stage IIIC or stage IV melanoma with V600 BRAF mutation.

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