Healthy Skepticism Library item: 7301

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Gerlin A.
U.K. Panel Rejects Four Drugs for Mild Alzheimer's
Bloomberg.com 2006 Oct 11
http://www.bloomberg.com/apps/news?pid=20601102&sid=aWB1DS6qFn0M&refer=uk

Abstract:

A U.K. government panel that assesses the cost effectiveness of health treatments won’t recommend the use of Eisai Co.‘s Aricept, Johnson & Johnson’s Razadyne and Novartis AG’s Exelon for mild Alzheimer’s disease.

A fourth drug, H. Lundbeck A/S’s Ebixa, should be used only in clinical trials in people with ``moderately severe to severe’‘ disease, the panel, called the National Institute for Health and Clinical Excellence, said in an e-mailed statement today. The panel’s recommendations influence what doctors prescribe and what local health authorities in England and Wales fund.

``Our experts have concluded that these drugs do not make enough of a difference for us to recommend their use for treating all stages of Alzheimer’s disease,’‘ Andrew Dillon, NICE’s chief executive officer, said in the statement. The decision confirmed the agency’s proposal last year to limit use of the drugs in patients with mild forms of the disease.

The decision will affect an estimated 72,000 patients next year, according to the Alzheimer’s Society. The medicines cost an average of 900 pounds ($1,670) a year per patient, Hannah Clack, a spokeswoman for the charity, said in a telephone interview.

Court Appeal

The group estimates the NHS will save about 9.4 million pounds a year from the decision, based on the number of people in the disease’s mild stage and the proportion on drug treatment, about 13 percent.

Today’s action is ``going to set back Alzheimer’s disease treatment and support 10 years,’‘ Clive Evers, the Alzheimer Society’s director of information and education, said in a telephone interview.

The charity, which was among the groups that had appealed last year’s proposal, said it would ask the Department of Health to exert influence on NICE and might take the matter to the U.K.‘s High Court. NICE, which was established by the Department of Health and is funded by it, acts independently, Matthew Barker, a health department spokesman, said in a telephone interview.

``We can’t affect their decision-making process,’‘ Barker said.

The U.K.‘s two largest opposition political parties said the cost-effectiveness panel’s appraisals should include the indirect costs that patients, their families and the health-care system incur without treatment, such as nursing-home care.

``NICE always has difficult decisions to make, but their process should take into account the wider benefits to society — and the potential for these drugs to reduce social care costs,’‘ Sandra Gidley, a member of parliament and spokeswoman for the Liberal Democrats on health issues, said in an e-mailed statement.

``We should aim to give NICE a wider remit to take into account all social care costs and benefits in deciding on access to drugs,’‘ John Baron, a member of parliament and spokesman for the Conservative Party on health issues, said in an e-mailed statement.

`In Shock’

Eisai and partner Pfizer Inc. said in a statement they were evaluating whether to seek an appeal in court.

``I’m in shock that this committee has not found in favor of us or any of the patient groups’‘ that supported a recommendation covering mild Alzheimer’s, Paul Hooper, managing director of Eisai’s U.K. unit, said in a telephone interview. NICE used a flawed methodology to measure quality of life in people with Alzheimer’s in its cost-effectiveness calculations, he said.

People with moderate Alzheimer’s disease should get Aricept, Razadyne and Exelon from the NHS, NICE said. Patients with milder forms of the disease who already take the drugs will continue receiving them, the health department said.

Razadyne is sold in the U.K. by Shire Plc. Shire and Lundbeck also disagree with the ruling, the companies said in separate press releases.