Court of Appeal criticises NICE

2nd, May 2008

The Court of Appeal has criticised the National Institute of Clinical Excellence (NICE) for not making its decision-making process public.

The criticism was made during an appeal brought by Pfizer and Eisai in relation to decisions made to restrict the Alzheimer’s drug Aricept to those with early or mild forms of the disease.

NICE used an economic model to assess whether the drug would be made available in the NHS. But they would not provide the full model to the drug companies when they questioned NICE’s decision. As part of the ruling NICE has been asked to pass on the full executable model to the drug companies, and they will be able to make a new submission.

Lord Justice Richards, who gave the ruling, said NICE's refusal to give Eisai full details of the economic model used put drug companies "at a significant disadvantage" in challenging the reliability of the models.

Dr Paul Hooper, Executive Vice President of Eisai Europe Ltd said: “It is disgraceful that NICE can restrict medicines used to treat a most vulnerable group of patients based upon secret calculations.

"In view of the widespread criticism of NICE expressed during the recent Health Select Committee enquiry, including specific references to a lack of transparency, it is surprising that NICE does not disclose these calculations for proper consultation.“

NICE is deciding whether they will provide the full executable model as a matter of course as part of their process in future. Speaking to Legal & Medical a NICE spokeswoman said:

“If we do give out the economic model executable version it could increase the complexity of our drug appraisals in some cases and they may take longer.

“If one figure is changed it affects the whole model and it needs to be justified, so we would need to spend time checking this. Assessment has to be based on scientific fact otherwise it is not sensible.”

If the drug company companies’ resubmission is successful it could mean that thousands of people with Alzheimer’s will have access to Aricept.

Neil Hunt, chief executive of the Alzheimer’s Society, said:

“This decision must now be urgently revisited to ensure everyone with Alzheimer's disease is given access to these drug treatments on the NHS, which cost just £2.50 per person per day.”

Court of Appeal criticises NICE

The Court of Appeal has criticised the National Institute of Clinical Excellence (NICE) for not making its decision-making process public.

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