Eisai wins NICE backing for older Halaven but still isn't happy about Lenvima


After weighing new data and a discount, England’s drug-cost watchdogs backed Eisai’s Halaven to treat advanced breast cancer, making it the first drug to win a green light in breast cancer in nearly a decade.

Since NICE’s initial rejection four years ago on concerns about Halaven’s cost, side effects and effectiveness, Eisai worked to vouch for the drug. It added quality-of-life data and updated trial results to show that the med helped patients live longer on average than those on other treatments. The recommendation, specific to patients whose disease has advanced locally or metastasized, is contingent on a “discount agreed in the patient access scheme,” the National Institute for Health and Care Excellence said in a statement.

While Halaven is set to get coverage by NHS England, other breast cancer meds, including Roche's Perjeta and Kadcyla, have encountered obstacles at the hands of the country's cost watchdogs. Last September, when the Cancer Drugs Fund threw out coverage for Kadcyla and a host of other treatments, Roche CEO Severin Schwan described it as "stupid from a cost point of view." In May, NICE rejected Perjeta.

Eisai said it "welcomes" the Halaven decision, but the Japanese drugmaker still isn't happy with the drug's tortuous path through the NICE approval process. Eisai EMEA CEO Gary Hendler said in a statement that patients “will finally now have routine access” to a med that was approved in 2011 “after years of uncertainty for patients and poor management” in the country’s beleaguered Cancer Drugs Fund.

NICE recently tweaked its review process as it took over that fund--but didn't change it enough, Hendler said. The company's thyroid cancer drug Lenvima is still languishing in NICE's queue.

So far, he said “an unacceptable process has again taken precedence over patients," given the delayed review for Lenvima. Over the summer, Eisai said it would consider legal action--and its commitment to the U.K.--over the delay.

Halaven will be available to patients with locally advanced breast cancer or breast cancer that has spread after two chemo treatments. The regulator looked at data showing that women on Halaven lived about 3 months longer on average compared with patients on other treatments.

According to NICE, about 45,000 women are diagnosed with breast cancer each year in England, making it the most common cancer in the country.

Even with the NICE backing, Eisai isn’t alone in expressing discontent about the agency’s review process. Larger pharmas AstraZeneca and Roche have each lashed out over delays for their own 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.