Pharma won a "stunning victory" over the National Institute for Health and Clinical Excellence, or NICE, which a UK Court of Appeal ruled had acted unfairly in refusing to allow Pfizer and Eisai full access to a computer model that was used to assess cost-effectiveness of their Aricept drug for Alzheimer's,The Times of London reports.
NICE had decided that the drug shouldn't be prescribed on the NHS to patients with mild Alzheimer’s disease, because it wasn't worth the $5-a-day price tag. But Eisai and Pfizer, which jointly market Aricept, were put at a disadvantage during their appeal because NICE refused access to the data. The ruling doesn't require NICE to make Aricept more widely available, but the drugmakers will now get full details of the computer model so they can a new submission.
"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," Neil Hunt of the Alzheimer's Society tells Reuters, adding that curbs on drug access should now be urgently reviewed.
But NICE ceo Andrew Dillon warns that longer approval times may be in store. "The ruling will increase the complexity of our drug appraisals in some cases and they may take longer as a result," he tells Reuters. Since 1999, NICE has measured the cost-effectiveness of new treatments, and its actions are closely watched by other governments and insurers, the wire service notes.
The organization plays a key role in rationing healthcare, but its decisions have often proved controversial. Drugmakers see NICE as a fourth hurdle for drugs that have already been proved safe, effective and of good quality. Generally, NICE recommends that med costing more than $60,000 per quality-adjusted life year, or QALY, shouldn't 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.