NICE says no to breast cancer treatment Halaven
pharmafile | July 20, 2011 | News story | Sales and Marketing | Eisai, Halaven, NICE
Eisai’s Halaven has been rejected by NICE in draft guidance for locally advanced or metastatic breast cancer.
Halaven (eribulin) is a new chemotherapy treatment for patients whose disease has progressed after at least two chemotherapy regimens for advanced and metastatic disease.
Halaven is the first single treatment to show a statistically significant increase in median overall survival in these patients, extending lives by an average of two and a half months.
But NICE says the drug’s price makes it not cost effective – although what exactly the price is remains secret because of a confidentiality agreement between Eisai and the Department of Health.
The company has agreed a patient access scheme with the DH, discounting the list price of £313 per vial of Halaven, but the size of this discount remains confidential.
NICE’s initial judgement also emphasised the frequency and severity of the side-effects patients experience on Halaven, and says Eisai did not incorporate the drug’s full toxicity profile in its submission.
Adverse events include alopecia, febrile neutropenia and peripheral neuropathy, and NICE has concluded these make it less favourable compared to existing alternatives.
Eisai argues that Halaven provides a new option for women who do not respond or become refractory to treatments such as anthracyclines and taxanes and, in many cases, capecitabine.
The company must now try to persuade NICE to change its decision benefits before it finalises its appraisal later this year.
“We are hugely disappointed with the draft guidance issued by NICE. 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,” commented Nick Burgin, European Director of Market Access, Eisai.
“Despite the UK price of eribulin currently being the lowest in the world, and a further patient access scheme agreement with the Department of Health which makes eribulin available at a discounted price, and unique real-world comparative data that has demonstrated overall survival, NICE’s unwillingness to approve this treatment is a real surprise.”
One oncologist also disagreed that Halaven’s side-effect profile was a downside. Professor Neville Davidson, Consultant Oncologist commented: “Having treated patients with eribulin, there were no unexpected side-effects in comparison with other treatments options in heavily pre-treated patients with locally advanced or metastatic breast cancer.”
ABPI speaks out
In a highly unusual move, the ABPI has entered into the discussion. In a prepared statement the industry association said:
“The ABPI rarely comments on individual NICE decisions and only does so if there is a wider policy consideration to be made, but 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.
It added that there was serious concern in the industry about delay in new and innovative medicines reaching patients “which potentially denies access to proven effective drugs for urgent clinical needs.” Reiterating the point that the UK has one of the lowest prices in Europe and ‘slow and low’ uptake, it concluded: “The new pricing and reimbursement system needs to reduce bureaucracy and get the right medicines to patients as quickly as possible.”
Andrew McConaghie
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