Merck's Keytruda wins NICE backing in lung cancer with new data, discount

Merck's Keytruda won a coverage recommendation from England's cost watchdogs following an earlier rejection.

Reversing a previous denial, the U.K.'s cost watchdogs have endorsed Merck’s Keytruda for some patients with advanced lung cancer after weighing new data and a new discount. The move will affect about 1,700 patients who are set to have routine access through NHS England.

Merck submitted a “fairly priced proposal” to win the coverage nod, according to Carole Longson, director of the NICE (National Institute for Health and Care Excellence) center for health technology evaluation. Keytruda costs £29,114 ($36,802) for an average course but the NICE discount is confidential. The company also provided a newer data analysis on its immuno-oncology contender after a recent rejection by NICE experts.

The new recommendation states that treatment should be stopped after two years if a patient has no documented disease progression. NICE’s concern about extended treatment was one factor in its decision against the immuno-oncology blockbuster-to-be back in October. NICE expects to review its recommendation in two years after more data about Keytruda’s long-term benefits are available.

Longson added in a statement that “it is great that pembrolizumab will now be routinely available” for patients who don’t have many options. Keytruda will be available to PD L1-positive non-small-cell lung cancer patients who have had a previous treatment with chemotherapy.

NICE's decision gives Merck and Keytruda a boost in its competition with Bristol-Myers Squibb's Opdivo, which was rejected in lung cancer treatment by NICE in October.

Merck joins a handful of other top pharma companies to initially have new cancer meds turned away by the tough cost watchdogs but win a reversal after further talks. Roche’s breast cancer med Perjeta finally made it through the agency last month after a rejection in May, and AstraZeneca’s lung cancer drug Tagrisso won coverage through the Cancer Drugs Fund in October after a NICE rejection this summer.

“If companies work with us to price drugs reasonably and manage any uncertainties in the evidence base, we can continue to recommend patients have routine access to the treatments they need,” Longson said on Friday.

Only a small number of patients had previously had access to Keytruda in the U.K. through the Early Access to Medicines Scheme. Keytruda won EU approval in August.

NICE decisions only directly affect patients in the U.K., but other countries use the agency’s assessments to shape their own coverage, giving added importance to judgments by the U.K. agency.