|Home | About | Journals | Submit | Contact Us | Français|
Campaigners and drug makers failed last week in their High Court bid to overturn guidance recommending only limited coverage on the NHS of drugs to treat Alzheimer's disease. This was the first major legal challenge to guidance issued by the National Institute for Health and Clinical Excellence (NICE), the body that recommends which drugs are available on the NHS in England and Wales.
Mrs Justice Dobbs ordered NICE to amend the existing guidance, having ruled that its diagnostic criteria breached the Disability Discrimination Act and the Race Relations Act. NICE undertook to make the relevant changes within 28 days—but the core of the guidance will remain unchanged.
The guidance recommends against the use of donepezil (Aricept), rivastigmine (Exelon), and galantamine (Reminyl) in patients with mild to moderate Alzheimer's disease and against the use of memantine (Ebixa) in moderately severe to severe disease.
The court's decision means that the NHS will not typically cover the costs of acetylcholinesterase inhibitors for patients who are given a new diagnosis of Alzheimer's disease. Patients already taking the drugs, however, will continue to receive them under an arrangement made in 2006, when NICE reversed its previous recommendation that the drugs be covered.
The judge rejected claims by the Alzheimer's Society that NICE's deliberative process failed to take adequately into account the potential benefits to carers and failed to reflect the full costs of long term care. The court also dismissed a claim from the manufacturer of donepezil, Eisai, and its UK distributor, Pfizer, alleging that NICE acted unfairly in releasing a “read only” version of its economic model document in which changes could not be tracked. Mrs Justice Dobbs also rejected a claim that NICE's assessment of data from research into Alzheimer's disease was irrational.
But she upheld the claim of the Alzheimer's Society that the questionnaire NICE recommends for diagnosing the severity of Alzheimer's disease, the mini-mental state examination, potentially discriminates against non-English speakers and people with learning disabilities.
The claimants were ordered to pay 60% of the case's legal costs and were denied leave to appeal. Neil Hunt, chief executive of the Alzheimer's Society, called the judgment “deeply disappointing for everyone in the early stages of Alzheimer's and their carers.”
Andrew Dillon, chief executive of NICE, said the ruling had strengthened NICE by endorsing its evaluative approach. He said, “Our goal is always to address the core arguments of consultees, using the best available evidence. We believe we have done that, and this ruling supports that.”
He said NICE had always expected legal challenges to its decisions. “Actually, we expected to get some in our first year. The fact that we've gone over eight years before the first case shows, I think, that our consultative process has worked very well.”
But Harriet Millward, deputy chief executive of the Alzheimer's Research Trust, said, “We are devastated that these drugs will remain unavailable on the NHS to people with early stage Alzheimer's, when they might benefit from them.”
Paul Hooper, managing director of Eisai, called the guidance “disgraceful” and “morally reprehensible,” adding, “This is about patients, not profits.”
David Anderson, who chairs the faculty of the psychiatry of old age at the Royal College of Psychiatrists, said he was “astonished that the NICE process has been found to be rational and without perversity in this case.”