NICE says Merck KGaA's Erbitux falls short in mouth cancer, despite new discount, data

Merck kgaa

Citing “significant uncertainties” about Merck KGaA's Erbitux for head and neck cancer, England’s cost-effectiveness watchdogs have shot down the treatment in a new assessment. Currently available through the country’s Cancer Drugs Fund, Erbitux will see its head-and-neck coverage completely lost in the U.K. if NICE follows up the review with final guidance.

Merck had submitted new evidence and a new discount, but the cost regulator didn’t budge on its negative review from 2009, when it found Erbitux wasn’t cost-effective as a head and neck cancer treatment.

In a further effort to gain NICE approval, Merck had sought coverage only for patients with mouth cancer, rather than a broader approval in head and neck cancers. There are about 2,300 mouth cancer patients in England and Wales. But, NICE said, its experts remained unsure “why it should be more effective in that indication than in others.”

“The company has addressed some of these concerns but significant uncertainties remain,” NICE’s Carole Longson said in a statement. “This decision not to recommend cetuximab as an option for treating mouth cancer will be disappointing for some patients.”

Still, Longson said, the agency needs to assist NHS in ensuring that it “makes the most of its resources by only funding treatments that are both clinically effective and represent good value for money.” Erbitux is NICE-approved in colon cancer, where it's used in combination with chemo.

The Erbitux review is part of an overhaul of the beleaguered Cancer Drugs Fund in which NICE is reexamining meds currently available through the fund.

Merck is far from alone in having its cancer efforts stymied by the cost watchdog. NICE recently spurned Bristol-Myers Squibb’s rival Opdivo in lung cancer. And before that, companies including AstraZeneca, Takeda, Eisai and Roche have each felt the sting of negative cost-effectiveness reviews for cancer meds.

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

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Editor's note: The headline for this story was updated to reflect that Merck KGaA sought NICE approval in mouth cancer.