1.1 Dabrafenib with trametinib is recommended, within its marketing authorisation, as an option for the adjuvant treatment of resected stage III BRAF V600 mutation-positive melanoma in adults. It is recommended only if the company provides dabrafenib and trametinib with the discounts agreed in the commercial arrangements.
Why the committee made these recommendations
There are currently no adjuvant treatments available for stage III BRAF V600 mutation-positive melanoma and there is a substantial risk of the cancer returning and becoming incurable. Dabrafenib with trametinib is a new adjuvant treatment aimed at curing the cancer by reducing the likelihood that it will spread. It is therefore an important development in managing stage III melanoma.
Clinical trial evidence shows that dabrafenib with trametinib extends the length of time people have before their melanoma recurs compared with routine surveillance. Evidence from the trial and from clinical experts strongly suggests that it also increases the overall length of time people live by reducing how many people develop metastatic disease.
Cost-effectiveness estimates for dabrafenib with trametinib are in the range usually considered a cost-effective use of NHS resources. Therefore it can be recommended.