Healthy Skepticism Library item: 7221

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.
Eisai, Pfizer to Ask for U.K. Review of Drug Decision
Bloomberg.com 2006 Nov 17
http://www.bloomberg.com/apps/news?pid=20601202&sid=adryq3IOqwtM&refer=healthcare

Abstract:

Eisai Co. and Pfizer Inc. plan to seek judicial review of a decision by a U.K. panel that assesses the cost effectiveness of health treatments, the first such challenge to the agency’s authority.

The companies said they notified the panel, the National Institute for Health and Clinical Excellence, that they will ask a court to examine last month’s decision not to recommend their Aricept medicine for mild Alzheimer’s disease. NICE has 14 days to respond before the case can be filed, the drugmakers said in a statement today.

The appeal would represent the first time a company has legally contested a decision since the panel was established in 1999, NICE spokeswoman Sarita Tamber said today in a telephone interview. The agency’s rulings influence what doctors prescribe and what local health authorities in England and Wales fund. The process NICE uses to determine a drug’s cost-effectiveness is unclear and unfair, Eisai and Pfizer said in a statement.

``They have not allowed us access to a working model so we can check our own conclusions within that,’‘ Paul Hooper, managing director of Eisai’s U.K. unit, said today in an interview broadcast on the British Broadcasting Corp.‘s Radio 4 ``Today’‘ program. ``This is a secret calculation.’‘

NICE said on Oct. 11 that Aricept, along with Johnson & Johnson’s Razadyne and Novartis AG’s Exelon medicines, didn’t ``make enough of a difference’‘ for it to recommend their use in all stages of Alzheimer’s disease. The agency will recommend use of the drug in patients with more advanced forms of the disease.

Tokyo-based Eisai and New York-based Pfizer are asking that the panel its decision, postpone the Nov. 22 publication of the guidance, and develop a new model for judging the cost- effectiveness of a drug.

Economic Model

``We made available a copy of the economic model that we used,’‘ NICE Chief Executive Andrew Dillon said on the ``Today’‘ program. ``What they haven’t got and what they’d like is a copy of the model that allows them to change the numbers.’‘

The agency will respond to the companies’ letter and ``act appropriately’‘ in any court proceedings, Dillon said in a statement. The panel still plans to issue its final guidance on Nov. 22, he said.

If the decision stands, an estimated 72,000 patients will be affected next year, according to the Alzheimer’s Society. The medicines cost an average of 900 pounds ($1,700) a year per patient, the charity has said.

Supporters of the Alzheimer’s Society joined marches and rallies it organized today in more than 30 cities and towns in the U.K., including Liverpool, London and Manchester, to protest against NICE’s decision, the charity said.

``Thousands of people with Alzheimer’s and their carers took part in the events,’‘ spokeswoman Gail Wing said in a telephone interview. ``This is a decision that affects all sorts of vulnerable older people, but they still took to the streets in cold and windy conditions.’‘

Razadyne is sold in the U.K. by Shire Plc under the name Reminyl.