UK reviews controversial curbs on Alzheimer drugs
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British healthcare experts meet on Tuesday to review a planned ban on the new use of Alzheimer’s drugs within the state health service, which has outraged both patients and drug companies.
The deliberations of the National Institute of Clinical Excellence (NICE) committee will resonate with governments around the world, who increasingly have to weigh up the benefits of modern medicines against their price.
A negative opinion from NICE could deter other countries from using the drugs, which cost around 1,000 pounds ($1,765) per patient a year, some experts believe.
Alzheimer’s is a growing problem around the globe, with a team of international researchers predicting last week the number of people suffering from dementia was set to double every 20 years and could reach more than 81 million worldwide by 2040.
NICE decided in a preliminary ruling earlier this year that so-called anti-cholinesterase drugs—which offer no cure but can help some patients—were not cost effective.
But it put off implementing the ban on using the pills in newly diagnosed Alzheimer’s patients pending more evidence on their potential benefits in certain patients.
“We’ve don’t think these drugs are clinically cost effective, based on the evidence we have seen,” said NICE spokeswoman Lucy Betterton.
“But if drug manufacturers have got additional data that might identify sub-groups of patients that particularly benefit, we would like to see it and we have asked them to submit it.”
The agency, which was founded in 1999 to examine the cost-benefit of drugs and surgical procedures, is expected to announce its final decision in January.
The ongoing debate leaves in limbo the future of four drugs, including Pfizer Inc and Eisai Co Ltd’s market leader Aricept, which are currently reimbursed on the National Health Service.
The other medicines affected are Reminyl, from Johnson & Johnson and Shire Pharmaceuticals Group Plc, and Novartis AG’s Exelon, both of which are used like Aricept to treat mild to moderate Alzheimer’s.
The fourth drug, Ebixa, is made by Lundbeck and is given to patients with more serious disease.
DRUG FIRMS FIGHTS BACK
Drug manufacturers have come out fighting.
Pfizer and Eisai said in a statement that a re-analysis of data undertaken for NICE suggested Aricept was actually more cost effective than previously thought, because even “non-responders” maintained cognition levels after six months on the drug, while those on placebo saw a decline.
But clinical trial results showed it was not possible to accurately predict in advance which patients would benefit, as NICE had hoped, the companies added.
As a result, Pfizer and Eisai said all patients should be offered the chance of benefiting from medication.
Britain’s Alzheimer’s Society said it would be “outrageous” if anti-cholinesterase drugs—already licensed as safe and effective by regulators—were not reimbursed.
The Association for the British Pharmaceutical Industry said rejection of the medicines by NICE would be a major blow.
“What is the point of investing further money into this area of research if the end result of your labours, which satisfied the licensing agency, is not going to be prescribed?” said spokesman Richard Ley.
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