trametinib (Mekinist)

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

trametinib (Mekinist®) is accepted for restricted use within NHS Scotland.

Indication under review: in combination with dabrafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

SMC restriction: to first-line treatment.

In two phase III studies, trametinib in combination with dabrafenib improved progression-free survival and overall survival compared with BRAF inhibitor monotherapy for the first-line treatment of unresectable or metastatic melanoma with BRAF V600 mutation in adults.

This advice takes account of the benefits of Patient Access Schemes (PAS) that improve the cost-effectiveness of trametinib and dabrafenib. This advice is contingent upon the continuing availability of these patient access schemes in NHS Scotland or list prices that are equivalent or lower.

This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.

Trametinib is also licensed as monotherapy. As the company submission related only to combination therapy, SMC cannot recommend use as monotherapy.