Draft guidance from the National Institute for Clinical Excellence in which it recommends that Eisai’s Aricept (donepezil), Novartis’ Exelon (rivastigmine), Shire and Johnson & Johnson’s Reminyl (galantamine) and Lundbeck’s Exiba (memantine) should not be available on the UK’s NHS for the treatment of Alzheimer’s disease [[01/03/05b]], has been slammed as “heartless and damaging” by the Association of the British Pharmaceutical Industry.

In a statement, the ABPI also said that the draft recommendations were a “devastating blow” to patients and would act as a “significant deterrent” to companies undertaking further research in this area. In addition, it claims that the guidelines put the UK out of step with the rest of Europe, where the medicines are available in all countries where they have a licence.

“NICE’s draft recommendations put small cost savings before the benefit that these medicines can bring to so many people who have Alzheimer’s – and to their family, friends and carers,” said Dr Richard Barker, director general of the ABPI. “It also sends a discouraging message to pharmaceutical companies that are putting major research work into discovering new, innovative medicines to help people with Alzheimer’s and other forms of dementia. How can companies justify investing huge sums in research and development – it costs on average about £550 million to develop a new medicine – if such decisions can be made to withhold medicines from patients despite their benefits?” he added, and called on NICE to reconsider the guidance.

And the ABPI is not the only one to have expressed its shock at the recommendation, which could become official in July this year. The Alzheimer’s Society and AD drug manufacturer, Eisai, have already condemned the decision [[01/03/05b]], while the Royal College of Psychiatrists says it “strongly disagrees” with the preliminary recommendations, which contradict official NICE guidance issued back in 2001 [[22/01/01b]]. It notes that NICE agrees that there is good evidence from clinical trials that the drugs in question are effective, not only for improving memory, but also for beneficial effects on behaviour and daily living tasks. However, it questions NICE’s economic analysis, which concluded that the cost of these drugs (around £2.50 per day) puts them outside the range of cost-effectiveness that might be considered appropriate for the NHS, given the benefits they provide.