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Appeal Court rules against NICE

The Court of Appeal in England has ruled that the National Institute for Health and Clinical Excellence was not transparent enough when disclosing why it decided to limit access to Alzheimer's drugs
The Court of Appeal in England has ruled that the National Institute for Health and Clinical Excellence (NICE) was not transparent enough when disclosing why it decided to limit access to Alzheimer's drugs.

NICE had said that four drugs - Aricpet, Exelon, Reminyl and Ebixa - for the treatment of the disease, which affects an estimated 350,000 people, were not cost-effective and should not be funded by the NHS. Lord Justice Richards, presiding over the appeal, said that by not releasing the model used to reach its decision, NICE had put people who wanted to challenge it at a 'significant disadvantage.'

Neil Hunt, chief executive of the UK Alzheimer's Society has called on NICE to change its remit to ensure the wider benefits of medicines are considered when issuing guidance.

"Today's decision is a damming indictment of the fundamentally flawed process used by NICE to deny people with Alzheimer's disease access to drug treatments," said Hunt. "This decision must now be urgently revisited to ensure everyone with Alzheimer's disease is given access to these drug treatments on the NHS, which cost just £2.50 per person per day," he added.

Aricept, one of the drugs at the centre of the case, is manufactured as part of an agreement between Pfizer and Eisai. The two pharmaceutical companies appealed the NICE guidance in 2007 with the support of the Alzheimer's society and Shire.

"We believe that this decision represents a victory for common sense," said Nick Burgin, managing director of Eisai. "We hope that this action will ultimately restore access to anti-dementia medicines for those patients at the mild stages of Alzheimer's disease."

After a recommendation in 2001 that the four drugs be used as standard, NICE published guidance in 2006 stating the treatments did not produce enough of a positive effect in patients with mild Alzheimer's.

In response to the judgement, NICE issued a statement explaining that it will review the findings and reminded people that the ruling does not mean that the drugs will become available. The medications in question remain recommended for use in patients with moderate Alzheimer's disease.

Chief executive of NICE, Andrew Dillon, has said that the ruling could increase and complicate the drug appraisal process. The cost-effectiveness body has said that it will submit full details of the economic model used to make the original decision to Eisai so it can comment on it.

"The failure of NICE to disclose these fundamentally important calculations has impaired the ability of stakeholders to engage fully in the appraisal process," said John Young, managing director of Pfizer.

1st May 2008

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