A British court has ruled that the country's drugs cost-effectiveness watchdog can restrict access to medicines for Alzheimer's disease to only the neediest patients, rejecting an appeal by drugmakers and charities.
By Michael Kahn
LONDON, Aug 10 (Reuters) - A British court has ruled that the country's drugs cost-effectiveness watchdog can restrict access to medicines for Alzheimer's disease to only the neediest patients, rejecting an appeal by drugmakers and charities.
Although the court said on Friday that the National Institute for Health and Clinical Excellence (NICE) had breached its duties towards some patients, both sides in the case said this would affect very few people.
The case was the first time that the agency in charge of deciding which medicines are offered in the state health system in England and Wales had faced a legal action.
Its outcome was closely watched because Britain is pioneering attempts to measure the value of drugs, in addition to their safety and efficacy, and other countries may follow suit as they seek to control soaring health budgets.
NICE sparked fury among drug companies and care groups by denying access to medicines costing around $5 a day for National Health Service (NHS) patients newly diagnosed with mild Alzheimer's disease. It argued they were only cost-effective for patients with moderate or severe forms of the disease.
Japan's Eisai Co. Ltd., which markets top-selling Alzheimer's medicine Aricept with Pfizer Inc. (PFE), and the Alzheimer's Society, representing patients and their carers, took NICE to court claiming it was being unfair.
"The legal challenge to our recommendation that drugs for Alzheimer's disease should only be prescribed to those in the moderate stage of the disease has failed," NICE said in a statement. "Our guidance stands and the drugs continue to be recommended only for people with moderate Alzheimer's disease."
Neil Hunt, chief executive of the Alzheimer's Society, said: "This is not satisfactory and the Society is considering whether to pursue an appeal."
The court also ruled, however, that NICE had breached its duties by not offering specific advice for people with learning disabilities and people for whom English is not their first language.
NICE said it had always been its intention to make sure such people had equal access to the drugs in the moderate stage of Alzheimer's disease and it would reissue our guidance to the NHS to make this "crystal clear".
Anti-cholinesterase drugs such as Aricept can help but not cure some Alzheimer's patients. Other products affected by NICE's decision are Exelon from Novartis AG (NOVN.VX: Quote, Profile , Research), Ebixa from Lundbeck A/S (LUN.CO: Quote, Profile , Research) and Reminyl from Shire Plc (SHP.L: Quote, Profile , Research), which is sold elsewhere by Johnson & Johnson (JNJ.N: Quote, Profile , Research) as Razadyne.
Such drugs are widely used in other countries, but NICE calculates their cost -- about 1,000 pounds ($2,023) per patient a year -- means they are not cost-effective for most patients.
The Association of the British Pharmaceutical Industry (ABPI) was disappointed by the court's decision.
"NICE's decisions rely very heavily on...using healthcare costs and benefits only, and do not properly acknowledge the full "value" of medicines to patients, their carers and society at large," it said in a statement.
The medical director of Shire in the UK said the decision was "better than nothing" but fell short of what was needed.
"The tragedy is mild patients are still not recommended for treatment under the NHS," Ian Howe said.
However, the Science Media Centre, which aims to promote science, said NICE was working well.
"There has been a huge escalation in the costs of drug treatments and no health system in the world can afford to pay for every new drug that comes along," it said.
"It is essential that such decisions are based on the best scientific evidence and not influenced by the industry's PR machine or by their heavyweight lawyers."