Reason for request

First listing

Summary of opinion

Favourable opinion for reimbursement in the treatment of adult patients with unresectable or
metastatic melanoma with a BRAF V600 mutation in combination with encorafenib.

No clinical added value of the MEKTOVI 45 mg film-coated tablet form compared to the proprietary medicinal product containing binimetinib already available.


Clinical Benefit

Moderate

The Committee considers that the clinical benefit of the BRAFTOVI/MEKTOVI 45 mg film-coated tablet (encorafenib/binimetinib) combination is moderate in the MA indication.


Clinical Added Value

no clinical added value

This medicinal product is a range supplement that does not provide any clinical added value (CAV V) compared to the form already listed.


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