Eisai shocked at Halaven decision

Eisai has revealed its surprise over NICE’s decision not to recommend its breast cancer drug Halaven (eribulin) in draft guidance.

NICE raised worries over the side-effects Halaven caused and the data supplied by Eisai which compared the drug with a ‘treatment of physician’s choice’ (TPC).

But Nick Burgin, European Director of Market Access, Eisai, says NICE’s “unwillingness” to recommend the treatment comes as a “real surprise”.

Eisai say the side-effect profile of Halaven was “expected and manageable”, and that serious adverse events and adverse events leading to therapy discontinuation actually occurred more in those on TPC than its injection.

The draft guidance is based on Phase III data which showed a median overall survival benefit of 13.1 months for patients receiving Halaven, compared to 10.6 months for those using a TPC. Before its approval in Europe, Eisai claims that no single treatment demonstrated a “statistically significant prolongation of median overall survival” than its clinical trial.

“We are hugely disappointed with the draft guidance issued by NICE,” said Nick Burgin. “It has not recommended an innovative treatment for a vulnerable group of women with heavily pre-treated locally advanced or metastatic breast cancer, with a proven overall survival benefit.”

Halaven is approved in the EU, USA, Switzerland, Japan, and Singapore. It was launched in the UK in April 2011 and Eisai say that patients have already started to benefit from the treatment.

A Patient Access Scheme had also been agreed with DH making the price of Halaven in the UK the lowest in the world. The ABPI says the example of Halaven highlights the need to switch to a value-based pricing approach to improve access of medicines to patients.

“There is serious concern in the research-based pharmaceutical industry about delay in new and innovative medicines reaching patients which potentially denies access to proven effective drugs for urgent clinical needs,” a statement said.

“The UK has amongst the lowest prices in Europe for our medicines but our uptake is both slow and low. The new pricing and reimbursement system needs to reduce bureaucracy and get the right medicines to patients as quickly as possible.”