NICE Issues Technology Appraisal Guidance on Encorafenib with Binimetinib

They are recommended as an option for treatment of adults with unresectable or metastatic BRAF V600 mutation-positive melanoma

On 27 February 2019, NICE issued Technology appraisal guidance [TA562] with evidence-based recommendations on encorafenib (Braftovi, Pierre Fabre) with binimetinib (Mektovi, Pierre Fabre) for treating unresectable or metastatic BRAF V600 mutation-positive melanoma in adults.

Encorafenib with binimetinib is recommended, within its marketing authorisation, as an option for treating unresectable or metastatic BRAF V600 mutation-positive melanoma in adults. It is recommended only if the company provides encorafenib and binimetinib according to the commercial arrangement.

For encorafenib, the recommended dose is 450 mg (6×75‑mg capsules) taken orally, once daily. For binimetinib, the recommended dose is 45 mg (3×15‑mg tablets) taken orally, twice daily, 12 hours apart.

The list price for 42 capsules of encorafenib 75 mg is 1,400 GBP and for 84 tablets of binimetinib 15 mg is 2,240 GBP (company submission).

The company has a commercial arrangement for each drug. This makes encorafenib with binimetinib available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

Why the appraisal committee made these recommendations?

Current treatments for unresectable or metastatic BRAF V600 mutation-positive melanoma include targeted therapy, usually using a combination of a BRAF and MEK inhibitor (dabrafenib with trametinib) or sometimes monotherapy with a BRAF inhibitor (vemurafenib or dabrafenib).

Clinical trial evidence shows that, compared with vemurafenib, encorafenib with binimetinib extends progression-free and overall survival. There are no trials directly comparing it against dabrafenib with trametinib. But compared indirectly, encorafenib with binimetinib appears to be as effective as dabrafenib with trametinib.

When the commercial arrangements for encorafenib, binimetinib, dabrafenib and trametinib are taken into account, encorafenib with binimetinib is considered to be a cost-effective use of NHS resources. It is therefore recommended.

Next review of this guidance is foreseen for February 2022.