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NICE guidance on dabrafenib for treating unresectable or metastatic BRAF V600 mutation-positive melanoma

Helen Tucker, Nwamaka Umeweni, Janet Robertson, Jane Adam

The Lancet Oncology, Early Online Publication, 22 October 2014

On Oct 22, 2014, the National Institute for Health and Care Excellence (NICE) published guidance1 recommending the use of dabrafenib as an option for treating unresectable or metastatic BRAF V600 mutation-positive melanoma, but only if companies provide the drug with the discount agreed in the patient access scheme.

Dabrafenib was appraised under the Single Technology Appraisal process. The company that markets dabrafenib (GlaxoSmithKline [GSK], Uxbridge, UK) submitted evidence about the clinical and cost-effectiveness of this drug2 that was reviewed by an independent evidence review group, the Liverpool reviews, and the implementation group.3, 4 An independent appraisal committee met once to develop guidance for the use of dabrafenib and clinical specialists, patient experts, and manufacturer representatives also attended.

Key clinical evidence in the appraisal was from the BREAK-3 trial5 that compared effects of dabrafenib with those of dacarbazine in people with previously untreated, unresectable advanced or metastatic BRAF V600 mutation-positive melanoma. Results from the June, 2012 company analysis (the first of which was presented in December, 2011) for progression-free survival showed that the median length of progression-free survival was 6·9 months for dabrafenib and 2·7 months for dacarbazine (hazard ratio [HR] 0·37, 95% CI 0·24—0·58, p<0·0001). A third analysis (submitted by the company with a cutoff date in December, 2012) for overall survival reported the median overall survival time for patients of 18·2 months in the dabrafenib group and 15·6 months in the dacarbazine group. This difference between overall survival time was not significant (HR 0·76, 95% CI 0·48—1·21). However, when the third analysis was done in December, 2012, 57% of patients who were previously assigned to receive dacarbazine had switched to receive treatment with dabrafenib.