Eisai considers legal action over NICE delay of Lenvima

Lenvima

Drug execs have railed against the U.K.’s drug cost watchdog’s denial of many new drugs, often novel cancer treatments, because of their price tags, not their effectiveness. Eisai, which is confronting a delay by the regulator over one of its cancer drugs, has indicated it is mad as hell and not going to take it anymore.

The top exec in Europe for the Japanese drugmaker told Reuters Eisai is considering legal action against the National Health Service for not including the company's thyroid cancer drug Lenvima for coverage by its revamped Cancer Drugs Fund (CDF) and delaying a reconsideration until next year. Lenvima was approved by the European Commission in May 2015, but it will not receive a recommendation from the National Institute for Health and Care Excellence (NICE) until at least April 2017, the news service said.

Gary Hendler, Eisai EMEA head, told Reuters that the drugmaker is looking at all it options, including rethinking its commitment to the U.K. because of the delay for a drug which Eisai actually manufactures there.

"Eisai may be forced to consider its level of investment in the UK because it is unacceptable that drugs which are manufactured in England cannot be provided to people in England, without delays of many years," Hendler said.

The EU had approved the med last year just weeks after an FDA approval. The drugmaker, which has been struggling in recent years after patent losses on key drugs, is counting on Lenvima to be a significant part of its financial turnaround. The company is projecting blockbuster sales by 2020, but that effort will be hampered if it can’t get it approved in the U.K.

Eisai earlier this year sent out a press release lambasting the NHS for it changes in the cancer fund and its exclusion of Lenvima, calling it devastating news for thyroid cancer patients and “an utterly disgraceful situation.”

Eisai far from alone in raising concerns about U.K.’s system, which the country has said is imperative to keeping healthcare costs under control. Johnson & Johnson’s Janssen unit last month lashed out at NICE for its handling of chronic lymphocytic leukemia med Imbruvica. The Association of the British Pharmaceutical Industry (ABPI), an outspoken critic, has claimed the changes to the CDF move will turn the clock “back 5 years” and potentially set back patient access.

-read the Reuters story

Related Articles:
Novartis joins Eisai to push Lenvima and Afinitor combo in U.S.
Look out, drugmakers: NICE is taking the reins of England's Cancer Drugs Fund
NICE invites angry J&J to make a Cancer Drugs Fund case for Imbruvica

Read more on