trametinib (Mekinist)

following an abbreviated submission:

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

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: after first line treatment

Trametinib in combination with dabrafenib offers an additional treatment choice in the therapeutic class of BRAF/ mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors.

Another medicine combination within this therapeutic class has been accepted via the end of life and orphan medicine process.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/list price that is equivalent or lower.

SMC has previously accepted trametinib for restricted use in combination with dabrafenib for first-line treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (SMC 1161/16). The current advice now extends use after first line treatment.

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