NICE claims victory in Alzheimer’s court case
pharmafile | August 10, 2007 | News story | Sales and Marketing | Alzheimer's
NICE will have to issue new guidance on Alzheimer's drugs, but claims the ruling in the judicial review vindicates its approach to evaluating drugs.
The High Court verdict is a blow to pharma, which had hoped to show NICE's guidance was fundamentally flawed when it found a number of treatments weren't cost-effective for some Alzheimer's sufferers.
Instead the judge, Mrs Justice Dobbs, found in NICE's favour on five out of the six counts brought against it, but said its guidance discriminated against people with learning disabilities and those for whom English is not their first language.
She said: "The extent of the amendment and the way in which this is to be achieved will be clarified following further submissions by the parties."
The institute will now have to reassess the guidance to ensure it complies with anti-discrimination legislation, but restrictions on drug access to patients with moderate Alzheimer's disease remains.
NICE chief executive, Andrew Dillon said the ruling strengthens NICE by endorsing its approach to evaluating drugs.
He said: "Our guidance stands and the drugs continue to be recommended only for people with moderate Alzheimer's disease, but the court has asked us to clarify our guidance when it is used for certain groups.
"It was always our intention that people with learning disabilities or people whose first language is not English should have equal access to the drugs in the moderate stage of Alzheimer's disease. We will reissue our guidance to the NHS to make this crystal clear."
Pharma company Eisai launched the unprecedented court challenge earlier this year in response to guidance restricting access to Aricept (which it co-markets with Pfizer), Novartis' Exelon and Shire's Reminyl. A third drug, Lundbeck's Ebixa, was blocked altogether.
It was joined in court by the Alzheimer's Society, which was responsible for arguing NICE's guidance was discriminatory in its use of a standard assessment test for the disease.
The patient group said this was failing to pick up false results in certain groups, such as people with learning difficulties, preventing them from receiving drug treatment, even if they have the moderate form of the disease.
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