Novartis melanoma combination wins key thumbs-up from cost watchdog NICE after Opdivo shut out

Just one week after Bristol-Myers Squibb failed to gain a recommendation for coverage in the U.K. for Opdivo in adjuvant melanoma, Novartis has one-upped its rival with an approval in the same setting.

The National Institute for Health and Care Excellence (NICE) has given its blessing to the combination of Novartis’ Tafinlar and Mekinist in patients with stage III BRAF V600 mutation-positive melanoma after surgery. The agency cited a lack of adjuvant treatment options and the effectiveness of the combination in lowering the chance of the cancer spreading. The decision comes two years after NICE recommended the combination as a first-line treatment for advanced melanoma patients who are not eligible for surgery.



Sanofi blockbuster-to-be skin drug Dupixent fails to win gatekeeper’s backing

Sanofi’s new atopic dermatitis launch Dupixent has hit a roadblock with the influential cost-effectiveness gatekeepers in England. The National Institute for Health and Care Excellence rejected the blockbuster hopeful, despite finding that it’s an innovative drug for patients who have a strong need for new treatments.

The obstacle? It’s likely price, if NICE history holds. The agency found that Dupixent is a “step change” in managing the disease, Sanofi said Tuesday, but couldn’t sign off on its use because of cost-effectiveness concerns. The guidance isn’t final, and the process now goes to a consultation period until April 24.