The Association of the British Pharmaceutical Industry has taken the unusual step of speaking out in the wake of the National Institute for Health and Clinical Excellence's recommendation to reject Eisai's advanced breast cancer drug Halaven.

NICE has issued draft guidance saying that it has not been able to recommend Halaven (eribulin) for the treatment of metastatic breast cancer in people whose disease has progressed after at least two chemotherapeutic regimens. NICE chief executive Andrew Dillon said while studies 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 has agreed a patient access scheme with the Department of Health which makes the drug available at a discounted price, though the size of the discount is currently confidential. However, the agency claims that the estimated cost per quality adjusted life year (QALY) gained of eribulin compared with 'treatment of physician's choice' is thought to be in excess of £68,600.

The guidance is now up for public consultation and unsurprisingly Eisai does not agree with NICE's assessment (see the related link for the response given to PharmaTimes by Nick Burgin, European director of market access for the Japan-based firm).

Clinical experts are less than convinced with NICE's stance either, particularly in terms of the adverse events claim. Neville Davidson, a consultant oncologist based at Nuffield Health Brentwood Hospital, said that “having treated patients with eribulin, there were no unexpected side-effects in comparison with other treatment options in heavily pre-treated patients with locally advanced or metastatic breast cancer".

The ABPI has also weighed into the debate, noting in a statement that it "rarely comments on individual NICE decisions and only does so if there is a wider policy consideration to be made". However, the association adds that "coming so soon after the announcement that we will be working with the Department of Health on value-based pricing this is an appropriate moment to re-emphasise why medicines should be considered for their total value and potential savings and not just their cost".

The ABPI goes on to say that "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".

It concludes by noting that "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".