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NICE Recommends Novartis' Tafinlar-Mekinist as Frontline Treatment for BRAF-Mutant NSCLC

NEW YORK – The UK's National Institute for Health and Care Excellence (NICE) on Thursday recommended Novartis' BRAF/MEK inhibitor combination, Tafinlar plus Mekinist (dabrafenib plus trametinib), as a first-line option for advanced non-small cell lung cancer patients in England whose tumors harbor BRAF V600 mutations.

In a final draft guidance, which NICE is expected to publish on June 14, barring any appeals, the agency estimated that the drug combination's cost-effectiveness likely falls within the range it considers acceptable. Tafinlar costs £1,400 ($1,752.71) for a 28-day supply of 75 mg capsules, and Mekinist costs £4,800 for a 30-day supply of 2 mg tablets. However, the National Health Service has struck a confidential agreement with Novartis, through which the drugmaker will provide Tafinlar plus Mekinist at an undisclosed discounted price. 

The drug combination has been available through the National Health Service since 2020, when it became available as an interim treatment during the COVID-19 pandemic.

In recommending the combination treatment, NICE considered evidence from various sources: the Phase II BRF113928 clinical trial; the Flatiron Health database; and the KEYNOTE-189 clinical trial of Merck's checkpoint inhibitor Keytruda (pembrolizumab) plus chemo for newly diagnosed advanced NSCLC. The latter trial provided a cohort that NICE could indirectly compare against the cohort in BRF113928 in lieu of a head-to-head trial.

Tafinlar plus Mekinist has the US Food and Drug Administration's approval as a treatment for metastatic NSCLC patients whose cancers harbor BRAF V600E mutations. Last year, Novartis also netted a tumor-agnostic accelerated approval for the drug combination to treat patients with any type of refractory solid tumor harboring BRAF V600E mutations.