NICE stuns Eisai with Halaven rejection

The U.K.'s National Institute for Health and Clinical Excellence has issued draft guidance stating it is unable to recommend Eisai's Halaven to treat metastatic breast cancer in patients whose disease has progressed after at least two chemotherapeutic regimens.

NICE determined the drug's price makes it not cost effective. However, the exact price is a secret because of a confidentiality agreement between the drugmaker and the Department of Health. Eisai agreed to a patient access scheme, but the size of this discount remains confidential, as InPharm notes.

In addition, "[t]he majority of the evidence on the effectiveness of eribulin submitted by the manufacturer was based on one study that compared eribulin to a 'treatment of physician's choice'," explains NICE Chief Executive Andrew Dillon in a statement. "Although the study indicated that eribulin could potentially help patients live for a little longer, it also caused more negative side effects than the other treatments and the effects on health-related quality of life had not been adequately assessed."

Eisai and other stakeholders now will be able to comment on the preliminary recommendations, which are available for public consultation, Dillon adds.

But the NICE decision leaves the company is "hugely disappointed," Nick Burgin, European director of market access for Eisai, tells PharmaTimes. The agency has not recommended "an innovative treatment for a vulnerable group of women with heavily pretreated locally advanced or metastatic breast cancer, with a proven overall survival benefit," he adds.

The rejection comes right after Eisai announced it launched the product in Japan. The company introduced Halaven in the U.S. last November and began marketing the agent in the U.K., Germany and other European countries in April. Following the drug's U.S. approval, company CEO Haruo Naito said the drug could reach $1 billion in annual sales--provided it wins additional indications.

- read the NICE statement
- here's the Pharma Times report
- check out the story from InPharm