Eisai gets go ahead for Alzheimer’s appeal

pharmafile | December 10, 2007 | News story | |  Alzheimer's, Eisai, NICE 

Eisai is to make one more legal challenge to NICE by taking its case on Alzheimer’s drugs to the Court of Appeal.

In August the High Court backed the process behind NICE’s decision to restrict patients’ access to Alzheimer’s drugs including Eisai and Pfizer’s Aricept.

The Court of Appeal has agreed to hear arguments from Eisai on one point – the process NICE used when it decided not to recommend the drugs for patients with newly-diagnosed mild Alzheimer’s disease.

Dr Paul Hooper, executive vice-president of Eisai Europe, said: “We are delighted that the court has granted us permission to appeal the decision of the High Court which supported NICE’s lack of transparency over the way that cost effectiveness has been calculated.

“It is disgraceful that NICE can restrict medicines used to treat a most vulnerable group of patients based upon secret calculations.”

Eisai will appeal the High Court ruling on a ‘point of procedural fairness’, questioning NICE’s refusal to disclose a working version of its cost effectiveness model.

“In view of the widespread criticism of NICE expressed during the recent Health Select Committee enquiry, including specific references to a lack of transparency, it is surprising that NICE does not disclose these calculations for proper consultation,” Dr Hooper added. “Such an act would enhance patient, professional and manufacturers’ confidence in NICE and the role it plays in healthcare technology assessments.”

NICE chief executive Andrew Dillon said he was disappointed Eisai was continuing its challenge.

Going back to court will require us to divert energy and tax payers’ money from the work we do to support patients and health professionals and get the most out of the resources available to the NHS.

In August 2007 the High Court found in NICE’s favour on five out of six legal challenges from Eisai’s judicial review.

Mrs Justice Dobbs also ruled it would have been ‘inappropriate’ for NICE to send its economic model to any of the pharmaceutical companies for peer review because they had an interest in the outcome of the process.

The only point found against NICE was one brought by patient group the Alzheimer’s Society. It argued the body had been negligent in not providing specific advice regarding people with learning disabilities and people for whom English is not their first language, and NICE has since updated its guidance to take account of this.

The Court of Appeal will now set a date for an appeal hearing.

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