Following consultation with stakeholders, the National Institute for Health and Clinical Excellence (NICE) has announced that its 2006 guidance on the use of drugs to treat Alzheimer’s disease remains unchanged.
This resulted from a judicial review brought against NICE in 2007 by Eisai and supported by Pfizer, with the Alzheimer’s Society and Shire Pharmaceuticals listed as interested parties.
Eisai appealed against the judge’s ruling that “NICE did not breach principles of procedural fairness by providing a ‘read only’ version of the economic model”.
In October 2008, NICE was refused permission to lodge an appeal with the House of Lords.
The healthcare watchdog was instructed to release the executable version of the economic model it used to conclude that the use of Eisai’s Aricept (donepezil) (co-marketed by Pfizer), Novartis’s Exelon (rivastigmine), and Reminyl (galantamine), which is co-developed by Shire and Janssen, as well as memantine (marketed by Merz, Forest, Lundbeck and Unipharm) in patients with mild stages of Alzheimer’s disease was not cost effective.
Andrew Dillon, NICE CEO said: “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.”
Dillon added that as part of NICE’s standard operating processes, a review of the guidance would be carried out as soon as possible.
Neil Hunt, CEO of the Alzheimer’s Society, said: “We are 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.”
“The glimmer of hope is that NICE has finally committed to a full review to address these concerns, as soon as possible. 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.”