The UK’s cost-effectiveness body, the National Institute for Health and Clinical Excellence, has said it is unable to meet any of the requests made by Eisai in its initial judicial review documentation that was triggered by the Institute’s controversial decision not to recommend cholinesterase inhibitors for patients with newly-diagnosed, mild Alzheimer’s disease.
A spokesman for the firm said it did receive a response from NICE by the November 28 deadline, some 14 days after receiving Eisai’s letter, in which it said it was unable to meet any the firm’s demands. These were that NICE withdraw its final recommendations for the treatments – which were due on November 22 – that it disclose its calculations for determining the medicines’ cost-effectiveness and that it develops a new guidance using a “more accurate cost-effectiveness model and data.”
However, on November 22, NICE went ahead with the publication of its so-called final appraisal document – ironically on the same day it announced a decision to plough an additional £40 million into improving the care of Alzheimer’s patients. Neil Hunt, Chief Executive of the Alzheimer's Society, condemned the move, saying: “By releasing these guidelines, NICE is trying to cynically cloak its flawed evaluation of Alzheimer's drug treatments. On the one hand the health body is moving to improve care and services for people with all types of dementia and with the other snatching away the only drugs that can provide them and their carers with a hugely improved quality of life. It's not about care or treatment; people with dementia have the right to both.”
The three main players in the Alzheimer’s arena, Eisai, partner Pfizer, and Shire, have applied for a judicial review of the process - the first time that a NICE decision has been contested at this level. Pfizer and Eisai make and market Aricept (donepezil), one of the cholinesterase inhibitors affected by NICE's action. The others are Shire's Reminyl (galantamine) and Novartis' Exelon (rivastigmine). A fourth drug which works via a different mechanism, Lundbeck's Ebixa (memantine), has been limited to use in clinical trials for patients with moderately severe to severe symptoms only, although it has recently been given the green light of approval in moderate patients and – the firm hopes – it will gain some ground in this particular indication as it falls outside the NICE guidance.
Once its lawyers have reviewed the NICE letter, Eisai says it will then be in a position to take the next steps towards judicial review.