An appeals court on Thursday ruled the country's healthcare cost-effectiveness watchdog had acted unfairly in the way it decided to curb access to Alzheimer's drugs, in a victory for drugmakers and patients.
The move will let manufacturers renew their challenge to National Institute for Health and Clinical Excellence (NICE) limits on the use of drugs on the state health service to treat the mild early stages of Alzheimer's disease.
Japan's Eisai Co, which markets the top-selling treatment Aricept with Pfizer and has been waging a legal fight against the NICE decision, welcomed the news.
Three judges said NICE had been procedurally wrong in the run-up to its recommendation that the National Health Service should cease funding the 2.50 pounds-a-day drugs for early-stage patients, because it failed to share details of its economic modelling.
The ruling does not oblige NICE to make the drugs more widely available but Eisai will now get full details of NICE's computer model and be able to make a new submission.
"As soon as we have reviewed their cost-effectiveness calculations we will submit any new findings to NICE," Nick Burgin, managing director of Eisai's UK business, said.
"We hope that this action will ultimately restore access to anti-dementia medicines for those patients at the mild stages of Alzheimer's disease."
Eisai had lost an earlier High Court fight last August.
LONGER APPRAISALS?
NICE Chief Executive Andrew Dillon said the organisation was considering its position but would supply Eisai with a version of its model and take its comments into account.
"The ruling will increase the complexity of our drug appraisals in some cases and they may take longer as a result," he added.
Anti-cholinesterase drugs such as Aricept can help but not cure some Alzheimer's patients. Other products affected by NICE's decision include Exelon from Novartis, Ebixa from Lundbeck and Reminyl from Shire, which is sold elsewhere by Johnson & Johnson as Razadyne.
Neil Hunt, chief executive of the Alzheimer's Society, said: "Today's decision is a damning indictment of the fundamentally flawed process used by the NICE to deny people with Alzheimer's disease access to drug treatments."
Curbs on drug access should now be urgently reviewed, he added.
Since 1999, NICE has led the world in measuring the cost-effectiveness of new treatments, and its actions are closely watched by other governments and insurers.
The organisation plays a key role in rationing healthcare but its decisions have often proved controversial. Drug manufacturers see NICE as a fourth barrier for drugs that have already been proved safe, effective and of good quality.
NICE, as a general rule, recommends that medicines costing more than 30,000 pounds per quality-adjusted life year, or QALY, should not be used.
A QALY is a statistical measure of a person's state of health, with one QALY equal to one year of perfect health or two years of half-perfect health.
