September 18, 2014
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NICE recommends melanoma therapy after GSK agrees to offer at discounted price

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The United Kingdom’s National Institute for Health and Care Excellence published its final appraisal determination recommending Tafinlar to treat unresectable or metastatic BRAF V600 mutation-positive melanoma.

In the guidance, NICE stated it would recommend Tafinlar (dabrafenib, GlaxoSmithKline) only under the stipulation that the company provides the drug at a discount agreed upon in the patient access scheme.

GlaxoSmithKline has agreed to a patient access discount; however, the scope of the discount is commercial in confidence, according to the appraisal, and was not disclosed.

Key evidence of the drug’s effectiveness came from the BREAK-3 trial, an international, multicenter, randomized, open-label, active-controlled trial comparing dabrafenib with dacarbazine in patients with previously untreated, unresectable, advanced or metastatic BRAF V600 mutation-positive melanoma.