Eisai ‘dismayed’ at Halaven decision

NICE has failed to recommend the use of breast cancer drug Halaven (eribulin) in final draft guidance after raising concerns over the side effects of the treatment.

Its independent Advisory Committee indicated the medication may help patients live longer but, when compared to existing treatments, there were more  “undesirable side effects”.

Nick Burgin, European Director of Market Access, Eisai, says the company is “dismayed” and the decision “denies women access to a treatment that is proven to prolong life”.

Halaven, which NICE claims to have adverse effects including fatigue, alopecia, peripheral neuropathy, nausea, neutropenia, leukopenia and anaemia, is the second breast cancer drug that has failed to be recommended in the space of seven days after the effectiveness of Faslodex

(fulvestrant) was questioned by the Institute.

The medication was launched in April this year in the UK for the treatment of patients with locally advanced or metastatic breast cancer whose disease h
as progressed

after at least two chemotherapeutic regimens for advanced disease.

But NICE claim that experts stressed it would be “unlikely” to replace Roche’s Xeloda (capecitabine) and Navelbine (vinorelbine) in the established sequential pathway if approved for use on the NHS.

A Patient Access Scheme had been agreed between Eisai and the DH for the use of Halaven, which the pharma company says is the lowest price in the world for this compound. It now plans to assess the appraisal to determine the grounds for appeal.

“Eribulin is an innovative agent currently being offered to the NHS at the lowest price in the world,” said Nick Burgin. “Eisai has tried to make eribulin affordable in England and Wales and has offered a discount on the price of the new drug.  We feel that patients should not be unable to access a life-prolonging drug like eribulin on the basis of an arbitrary threshold of cost per quality adjusted life year (QALY) used by NICE and we plan to appeal this decision.”

Patients can still access Halaven through the Cancer Drugs Fund, where it has been approved in four of the 10 regions across England.