Shire says NICE Alzheimer’s decision is a “grave error”

Shire, Britain’s third largest pharmaceuticals company, has criticised NICE’s final appraisal determination (FAD) which leaves the draft guidance for drug treatments for Alzheimer’s disease (AD) unaltered.

The judgement means that people with newly diagnosed, mild AD will not have access to prescription drug treatments on the NHS – something described by Shire as “hard to reconcile” with the Scottish Intercollegiate Guidelines Network’s recommendation that cholinesterase inhibitors should be used on AD patients in all stages of the disease.

Shire currently markets two such drugs, Reminyl and Reminyl XL.

Dr Ian Howe, Shire’s medical director, said: “Withdrawing drug treatments on the NHS for people diagnosed with mild AD is a grave error as clinical trials demonstrate that mild AD patients benefit significantly with measurable improvements in cognition and the ability to continue to participate in activities of daily living.”

John Freeman, the company’s managing director, added: “Shire Pharmaceuticals is considering all options following the issue of this FAD, including the option to appeal.

“Shire will continue to press for newly diagnosed mild AD patients to receive these drugs on the NHS in England and Wales and challenge the inequality of care that will be generated by this NICE recommendation.”

He concluded: “NICE’s recommendation will result in those diagnosed with mild AD missing out on effective treatment – a treatment that costs less than 2.50 pounds a day.”

The UK’s Alzheimer’s Society was also critical of NICE’s decision. Neil Hunt, of the Action on Alzheimer’s Drugs Alliance, stated: “This decision is outrageous. Where is the clinical excellence in a decision that puts cost cutting and flawed calculations ahead of care and quality of life?”

A NICE statement said that a committee reviewed additional data submitted by pharmaceutical companies and stakeholders before it concluded that the use of such drugs was “both clinically and cost effective” in patients with moderate Alzeheimer’s disease.

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