NICE shoots down Merck's Keytruda in first-line NSCLC—and the med won't be getting any CDF love, either

New Keytruda image
England's cost watchdogs say Merck's Keytruda is too expensive for routine NHS use, even after an agreed-upon discount.

Sure, Merck & Co.’s Keytruda is making waves in the U.S. immuno-oncology market as a newly approved first-line treatment for non-small cell lung cancer. But it won’t be doing so in England—at least not yet.

The National Institute for Health and Clinical Excellence turned down the med in draft guidance, citing its high cost. One 100 mg vial of Keytruda costs £2,630, the agency said, and even with an undisclosed, agreed-to discount by Merck, that’s too pricey for the watchdogs.

What’s more, it’s too pricey for coverage under the Cancer Drugs Fund, which often used to pick up the tab on NICE-excluded meds. The fund recently came under NICE’s control, however, so it’s more difficult to snag a spot on its list—and some drugmakers that once had one have gotten the boot.

It’s a roadblock for Merck, which has been pushing full steam ahead with Keytruda, capturing a critical lead over Bristol-Myers Squibb nemesis Opdivo in the process. Last summer, Opdivo—to that point considered the likely future NSCLC market champ—flopped a first-line monotherapy study, leaving Keytruda a wide-open path to the title. Merck capitalized, scoring a standalone first-line nod not long after, and it’s currently on its way to nabbing a first-line chemo combo FDA green light, too.

If Merck wants to make the most of its market lead in England, though, it has some work to do. NICE is known to change its mind if the price is right, and the body noted in its draft guidance that it’ll look out for forthcoming data over the course of the next year. Plus, Merck already has experience ushering Keytruda past the gatekeepers; in December, it flipped a negative NICE decision on use of the drug in patients who have already received at least one other chemotherapy.

In the meantime, though, Merck doesn’t have to worry too much about the competition. Opdivo suffered its own NICE rejection in lung cancer last October, though NICE Health Technology Evaluation Centre director Carole Longson did say the med could potentially win CDF backing while Bristol gathers more value evidence.