Merck impresses NICE with Keytruda data—and discounts—cueing up a CDF switch

After making headlines at this year’s American Society of Clinical Oncology annual meeting, Merck’s Keytruda had a big week on the other side of the pond, too.

On Wednesday, England’s cost-effectiveness gatekeepers at the National Institute for Health and Care Excellence recommended the drug in draft guidance for routine use as a treatment for previously untreated lung cancer.

Previously, Keytruda was available for first-line use, but only for patients who applied for special funding through England’s Cancer Drugs Fund. Now, though—assuming the recommendation holds when NICE publishes final guidance later this month—about 1,800 patients per year will no longer have to jump through those hoops.

What changed minds at the cost watchdog? A couple of things. For one, new data showing the cancer-fighter could improve survival by 16 months over standard chemo for patients whose tumors bear protein marker PD-L1.

"Recent changes to the CDF mean we have more flexibility in our process so we can grant early access to promising drugs whilst more data is gathered on their long-term benefits," Meindert Boysen, director of the NICE center for health technology evaluation, said in a statement, adding that Keytruda "is one of the first new cancer drugs to benefit from this flexible approach."

A discount from Merck on the £84,000-per-treatment-course product didn’t hurt, either. Price breaks are known to swing NICE opinions in drug companies’ favor, and Merck served up a confidential one to secure the switch.

The guidance follows less than a week after a big showing at ASCO, where Keytruda posted stellar data in squamous cell patients. Analysts were iffier on its new monotherapy results in patients with low levels of PD-L1, pointing out that they may leave an entry for competitors, but they still expect regulators to widen the drug’s label based on the showing.

Meanwhile, NICE was busy this week releasing guidance on other cancer drugs, too. It shot down front-line use of Ipsen kidney cancer drug Cabometyx, and it rejected Zytiga from Johnson & Johnson Janssen in early prostate cancer, too.

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