UK must change Alzheimer's drug advice
By JILL LAWLESS, Associated Press WriterFri Aug 10, 6:02 PM ET
A judge ruled Friday that Britain's state-run health service must change the way it advises doctors on supplying some Alzheimer's patients with drugs to treat the brain-destroying disease.
However, the judge upheld an argument by the government medicines monitor that the drugs are only cost-effective for patients in later stages of the illness — defeating an attempt to force authorities to prescribe the medicines to those with early-stage Alzheimer's.
The case is the latest in a series of legal challenges to Britain's National Health Service, which offers free health care and low-cost medicines to all Britons, but is regularly accused of rationing access to treatment. The dispute does not concern patients who choose — and can afford — private treatment.
Pharmaceutical companies and Alzheimer's advocates had asked the High Court to overturn a decision by the National Institute for Health and Clinical Excellence, which declined to approve a group of drugs known as acetyl cholinesterase inhibitors for patients in early stages of the disease.
Judge Linda Dobbs said NICE's recommendation that doctors use language-based tests to assess the severity of the disease — and thus whether a patient was eligible for the drugs — "creates confusion and the potential for discrimination" against people with learning disabilities and those whose first language is not English. She ordered NICE to change its guidance.
NICE, which regulates use of prescription drugs, recommended last year that three drugs — donepezil, rivastigmine and galantamine — not be prescribed for patients with early stage Alzheimer's.
It said the treatment was not particularly effective for people with mild Alzheimer's and at about $5 per patient per day was not cost effective. It recommended the drugs for patients with moderate-stage Alzheimer's.
Drug companies Eisai Co. Ltd. and Pfizer Inc., along with the Alzheimer's Society, challenged NICE's decision.
In a statement, Eisai and Pfizer said the court ruling was "a major victory for the many critics of the process by which NICE reaches its often seemingly clinically perverse decisions."
But NICE claimed victory, saying the judge had dismissed five of the six arguments in the case against it.
"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," said chief executive Andrew Dillon.
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