UK Court Rules Against language issue in NICE Alzheimer's Policy

Harold Schiffman hfsclpp at
Sat Aug 11 13:49:59 UTC 2007

UPDATE:UK Court Rules Against Detail Of NICE Alzheimer's Policy

August 10, 2007: 01:19 PM EST

LONDON -(Dow Jones)- Japanese drugmaker Eisai Co. Ltd. (ESALY) Friday
said it had partly won its legal case against the U.K. National
Institute for Health and Clinical Excellence, or NICE, over the
prescription of drugs used to treat Alzheimer's disease.

The High Court in London earlier Friday ruled that NICE's
recommendation that language-based tests be used to restrict the
prescription of the drugs could be discriminatory. The judge said the
tests failed to take into account the needs of patients with learning
disabilities or whose first language was not English, Associated Press
news agency reported.

The judge ruled that NICE must therefore review the way it decides
which Alzheimer's patients may be prescribed the drugs, known as
acetyl cholinesterase inhibitors.

However to the disappointment of some medical experts and the drugs
companies, the court upheld NICE's argument that these medicines are
only cost-effective for patients with moderate stages of the illness
and shouldn't be prescribed to those with mild Alzheimer's.

NICE Chief Executive Andrew Dillon said in a statement that "Our
guidance stands, and the drugs continue to be recommended for people
with moderate Alzheimer's disease, but the court has asked us to
clarify our guidance when it is used for certain groups."

Eisai for its part said the ruling marks "a major victory for the many
critics of the process by which NICE reaches its often seemingly
clinically perverse decisions."

Eisai, which developed the Alzheimer's treatment Aricept, had
challenged in court the way NICE reached its decision not to recommend
the reimbursement of the medicines to patients with a mild form of the
disease. It was joined in the legal challenge by its marketing partner
Pfizer Inc. (PFE) of the U.S.

Eisai said it was disappointed that NICE hasn't been required by the
court to reveal details of the calculations used to determine the
value of treatment for patients with mild Alzheimer's.

It said it will continue to pursue access to these calculations
through the courts. And it later confirmed that it will also appeal
against the High Court's decision to uphold the ban on the drugs being
used to treat mild Alzheimer's.

NICE determines which drugs are provided by the National Health
Service in England and Wales. This is the first time the
cost-effectiveness regulator has been challenged in court.

U.K. pharmaceutical company Shire PLC (SHPGY), which markets
Alzheimer's treatment Reminyl - one of the drugs whose use was
restricted - said separately it was disappointed that the judgment in
effect upholds NICE's guidance that the majority of patients
newly-diagnosed with a mild stage of Alzheimer's shouldn't receive
drug treatments on the NHS.

Alzheimer's disease is the most common form of dementia among older
people, seriously affecting a person's ability to carry out daily
activities. Drugs can help reduce the symptoms of the disease, but
cannot stop its course.

The Alzheimer's Society estimates that there are 700,000 people with
dementia in the U.K.

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