The National Institute for Health and Clinical Excellence is sticking by its original decision to reject the use of Alzheimer’s disease drugs in patients with mild forms of the condition, as it claims they are not a cost-effective use of NHS resources.

The Institute first ruled against the use of the acetyl cholinesterase inhibitors Aricept (donezepil), marketed by Pfizer and Eisai, Novartis’ Exelon (rivastigmine) and Shire’s Reminyl (galantamine) on the National Health Service in March 2005, acknowledging that they were clinically effective but stating that, at £2.50 a day per patient, they do not provide value for money.

Widespread public condemnation, however, lead to this decision being partly overturned in November 2006, allowing patients with moderate disease access to the drugs, but a subsequent unsuccessful appeal to extend this to patients with mild Alzheimer’s drove Eisai/Pfizer as the lead claimant to pursue the first-ever judicial review against a NICE decision.

Although in the end the court largely sided with the Institute, it did agree that NICE “breached the principle of procedural fairness” because it refused to allow the drugs’ manufacturers access to the economic model used to draw up its guidance, and so the Institute was forced to hand it over for scrutiny.

However, following consultation with stakeholders on the model underpinning its recommendations for Alzheimer’s treatment on the NHS, the Institute has this morning said its draft guidance remains unchanged.

“We have complied with the Court of Appeal’s ruling to release the executable version of the economic model used in this appraisal for consultation and to consider the comments made by consultees. Although these comments resulted in minor changes to the model, our Independent Advisory Committee concluded that these were not enough to make these treatments a cost-effective use of NHS resources in the mild stages of the disease,” explained NICE chief executive Andrew Dillon.

Disappointment and frustration
Commenting on the decision, Neil Hunt, chief executive of the Alzheimer’s Society, said he is “extremely disappointed to see that the NICE guidance is essentially unchanged, despite what we feel are fundamental flaws in the economic model they have used to inform their recommendations”.

There is, however, still a glimmer of hope for campaigners as Dillon also said that, provided no appeals are received against this latest decision, NICE can start a new review of its guidance “as soon as possible” to take into account any new evidence regarding the use of these drugs in patients with mild forms of the illness.

“This will be little consolation for the thousands of people who will develop Alzheimer’s disease this year but provides hope for the future that this incomprehensible decision will be changed,” Hunt said.

In a statement, Eisai and Pfizer said they "remain frustrated that patients suffering from mild Alzheimer’s disease will continue to be denied treatment after such a lengthy process", but have welcomed NICE's recommendation for new review which, they stress, should be started "as a matter of urgency".