Despite benefits, Merck's Keytruda falls short at NICE in urothelial carcinoma

In an initial review, cost watchdogs in England turned away Merck's Keytruda to treat urothelial carcinoma.

Days after a Roche cancer medication suffered a similar fate, England’s cost watchdogs ruled on a preliminary basis that Merck’s Keytruda isn’t cost effective to treat patients with advanced or metastatic urothelial carcinoma who have had prior platinum-containing chemotherapy.

Even though Keytruda “significantly improves overall survival” versus chemo drugs docetaxel and paclitaxel—the current treatment regimen for the patients—NICE concluded that Keytruda’s cost-effectiveness is “uncertain because the most appropriate methods and assumptions for the economic modelling are unclear.”

In any scenario, the agency’s reviewers estimated that Keytruda’s cost-effectiveness is “higher than what NICE normally considers acceptable for end-of-life treatments, that is, £50,000 per quality-adjusted life year (QALY) gained.” Certain factors could drive the number even higher, the institute wrote in its appraisal consultation document.

And so, NICE had to turn away the Merck blockbuster. The preliminary decision is open for comment until Aug. 24, with another consultation meeting set for Aug. 30, according to NICE’s website. The cost watchdog plans to issue its final determination in November.

According to the review document, Keytruda is likely to extend patient lives by more than three months. Still, the agency says its price is too high, even with a proposed discount from Merck. Keytruda costs £2,630 per 100 mg vial before a discount, according to NICE.

RELATED: NICE turns down Tecentriq in bladder cancer but suggests Roche try again for some patients

The decision comes during the same week Roche’s Tecentriq failed to win over NICE reviewers in metastatic urothelial cancer. The agency said Roche’s med could potentially win inclusion in the revamped Cancer Drugs Fund for patients whose cancer has not yet been treated and who cannot have cisplatin-based chemotherapy. The agency invited Roche to submit a proposal for that route.

In Keytruda’s case, NICE considered the Merck med for CDF inclusion but decided it “cannot be recommended because it does not have the potential to be cost effective.” The Cancer Drugs Fund is a second-line program to fund meds that didn’t make it past an initial review at NICE.

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

Back in March, NICE also rejected Merck’s cancer blockbuster in first-line non small-cell lung cancer, citing high costs. Again in that case, the regulator said Keytruda is too costly for CDF consideration. The drug does however boast a NICE recommendation to treat a select group of patients with advanced lung cancer.

Separately on Thursday, NICE recommended Celgene’s Abraxane to treat patients with pancreatic cancer that has progressed. The deal is contingent on a confidential discount.

NICE has sparred with a who’s who of top drugmakers in recent years as a tough budget situation in the country has forced the agency to get selective on which treatments it can cover.