NICE, the National Institute for Curbing Expenditure, had acted unfairly in refusing to allow Eisai and Pfizer full access to a computer model used to assess the cost-effectiveness of Aricept, an Alzheimer’s drug, the court ruled.

NICE had decided that the drug should not be prescribed on the NHS to patients with mild Alzheimer’s disease.

But Eisai and Pfizer, which market Aricept in a partnership, were disadvantaged in appealing against this guidance by NICE’s refusal to let them have a “fully executable” version of the economic model it had used.

Had the companies had the full version, they could have tested it using a variety of assumptions and be in a better position to challenge the guidance. The Court of Appeal decision means that NICE must now make such a version available.

Lord Justice Richards, giving the ruling of the appeal judges, said NICE had supplied a spreadsheet of the economic model used to evaluate the drugs and had refused an Eisai request for full details.

“The view I have come to is that, notwithstanding NICE’s considered position to the contrary (to which in itself I am prepared to give some weight), procedural fairness does require release of the fully executable version of the model.”

Refusal to do so, said the judge, put drugs companies at “a significant disadvantage” in challenging the reliability of the model.

He allowed the appeal by Eisai, who will now receive the full details and make new representations to NICE, which will then make a new appraisal of the drugs.

NICE is now considering whether to appeal to the House of Lords. It has always believed that the full details of the computer programs are the intellectual property of the academic teams who developed them, and who are entitled to have them protected.

Andrew Dillon, chief executive of NICE, said: “We will be considering very carefully the findings and the implications for the time it takes us to provide advice to patients and the NHS on the use of new treatments.

“The ruling will increase the complexity of our drug appraisals in some cases and they may take longer as a result. In the meantime, and in accordance with the judges’ ruling, we will provide Eisai with an executable version of the economic model used in our appraisal, so that they comment on it.”

From:
http://www.timesonline.co.uk/tol/news/uk/health/article3854121.ece

Health Direct notes that the ruling – the first time that NICE has been successfully challenged in court – could open the door to other companies seeking access to the economic models on the same basis. NICE often uses computer models developed for it by outside teams.

The ruling will not make Aricept available to Alzheimer’s sufferers. It will simply enable Eisai and Pfizer to review the model and see if doing so reveals any flaws in NICE’s reasoning. If it does, they will be able to appeal against the guidance.

Neil Hunt, chief executive of the Alzheimer’s Society, said: “The decision is a damming indictment of the fundamentally flawed process used by NICE to deny people with Alzheimer’s disease access to drug treatments.