Incensed by Lenvima shutout, Eisai decries England's 'inequitable' cost-effectiveness decision-making

Weeks of negotiations with England's cost regulators and health officials have yielded no success in making Lenvima available to thyroid cancer patients, Eisai reported Tuesday as it echoed grievances first aired last month. And the Japanese drugmaker is kicking back.

A key cog in Eisai’s turnaround plans, Lenvima provided 18.3 months of progression-free survival versus 3.6 months for a placebo in a pivotal trial for patients with radioiodine refractory differentiated thyroid cancer, a rare form of the disease. But more than a year after its European approval, neither England's cost-effectiveness agency nor its last-resort Cancer Drugs Fund (CDF) allow for its coverage.

As England prepared to relaunch the CDF under the aegis of the National Institute of Health and Care Excellence (NICE), Eisai has been scrambling to persuade health officials that Lenvima should be made available to patients. But the CDF was reborn Friday, and there's still “no clear sign of a resolution,” according to Eisai EMEA CEO Gary Hendler.

The Japanese drugmaker is far from alone in railing against NICE decisions, and more recently, the Cancer Drugs Fund overhaul. Just as the new program began Friday, Roche said it was unhappy with the setup and a related delay for its breast cancer med Perjeta. Stiff-armed on their own cancer meds, Pfizer ($PFE) and AstraZeneca ($AZN) have also joined in with concerns.

Lenvima won European approval in May 2015, but it looks as if patients in England and Wales will have to wait three full years for the medicine; Eisai says NICE doesn’t plan to make a final decision on the med until June 2018. About 250 people per year could use the treatment, Eisai said, adding that it knows of “at least 20 individual funding requests” made by doctors in England for their patients.

“Today we learned that the newly relaunched CDF is still failing people with some rare cancers,” Hendler wrote FiercePharma in an emailed statement. “The process is denying hundreds of people access to a treatment that can delay the progression of advanced thyroid cancer. Our dialogue with NHS England has been unsuccessful to date, with no clear sign of a solution.”

Hendler reiterated that the company, which makes Lenvima in Hertfordshire, is considering legal action and weighing its future investment in the United Kingdom in response to a “backwards process that further denies access in the U.K.”

“We are calling for urgent transitional arrangements to bridge the gap in a new NICE and CDF process where Lenvima (lenvatinib) has been left off the CDF and ignored for review due to its low budget impact,” he wrote.

AstraZeneca, which found support from some government officials in the United Kingdom during its Pfizer takeover defense, has also recently called for CDF reform. The London pharma last month said it was unhappy with a delay on its new lung cancer med Tagrisso.

But coverage decisions aren’t pharma’s only concern with the new CDF overhaul. Going forward, industry will have to pay for budget overruns, adding another layer to price controls and potential discontent.

- here's the release

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