U.K. cost gatekeeper says 'OK' to Merck's Keytruda for advanced skin cancer

Merck's ($MRK) Keytruda got a green light from the U.K.'s cost effectiveness gatekeeper to treat patients with advanced skin cancer, chalking up another victory as it picks up steam in its head-to-head battle with Bristol-Myers Squibb's ($BMY) Opdivo.

NICE director Carole Longson

The National Institute of Health and Care Excellence (NICE) gave its thumbs-up to the med for individuals who have already taken BMS' melanoma drug Yervoy, and whose cancer is spreading or can't be removed, Pharmafile reports. NICE's OK comes months after a new program in the U.K., the Early Access to Medicines Scheme (EAMS), selected Keytruda as its first therapy under the scheme, which fast-tracks products to help patients with serious illnesses who have no other treatment options.

"We are pleased to be able to recommend (Keytruda), the first EAMS drug, in final guidance," NICE director Carole Longson said, as quoted by Pharmafile. "There were over 13,000 people diagnosed with malignant melanoma in the U.K. in 2011, and melanoma accounts for more deaths than all other skin cancers combined. This will be welcome news to patients and healthcare professionals alike."

The U.K. cost watchdog's decision also comes as welcome news to Merck, which is fighting tooth and nail for its share of the market with BMS. BMS arrived second to market with Opdivo, but leaped ahead in March with quick FDA approval for Opdivo in advanced squamous non-small cell lung cancer (NSCLC).

But Merck recently bounced back with its own lightning-fast approval for Keytruda in advanced NSCLC, even though the FDA restricted the label drug's label to patients who test positive for a PD-L1 biomarker. Nailing indications for lung cancer could be the key to winning the PD-1/PD-L1 crown. Lung cancer represents a lucrative opportunity for the class, with $21 billion in potential sales by 2022. And some analysts are betting that BMS will emerge the winner with Opdivo, which is expected to gain a broad label for second-line use.

But the FDA's recent label decision for Keytruda "may not matter as much as investors think," Bernstein & Co. analyst Tim Anderson said in a recent note to investors. Opdivo could lose its labeling advantage if and when both drugs are approved for first-line use. And overseas, price-wary payers are likely to limit drugs to biomarker-positive patients, anyway, he added. Who remains the victor in the PD-1/PD-L1 showdown is anyone's best guess.

- read the Pharmafile story

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