dabrafenib (Tafinlar)

following a full submission considered under the end of life medicine process

dabrafenib (Tafinlar®) is accepted  for restricted use within NHS Scotland.

Indication under review: monotherapy treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

SMC restriction: for use in patients with unresectable or metastatic BRAFV600 mutation-positive metastatic melanoma who have received no prior therapy.

In a phase III randomised open-label study, treatment with dabrafenib extended median progression free survival by 4.2 months compared with chemotherapy.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of dabrafenib. It is contingent upon the continuing availability of the patient access scheme 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.