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The regulatory body that decides which treatments the NHS should pay for was accused of “irrational” decision making in the High Court this week for denying drugs to patients in the mild stage of Alzheimer's disease.
The National Institute for Health and Clinical Excellence (NICE), which issues its guidance on the basis of cost benefit analyses, is facing its first legal challenge to a decision to restrict a drug's availability on the NHS.
The unprecedented case was brought to the High Court in London this week by two drug companies and by the Alzheimer's Society, representing patients and carers.
NICE's guidance last year meant that nearly 100000 patients a year in England, Wales, and Northern Ireland with mild Alzheimer's disease were no longer entitled to certain drugs on the NHS. The drugs are the acetyl cholinesterase inhibitors donepezil (Aricept), rivastigmine (Exelon), and galantamine (Reminyl). Eisai, the Japanese manufacturer of donepezil, and Pfizer, which distributes it in Britain, asked the court to force NICE to reconsider its decision.
A key plank of NICE's case is that its decisions are too technical and complex to be examined in a judicial review application. It also says that when its appraisal committee first looked at acetyl cholinesterase inhibitors for “the whole cohort of mild to moderate AD [Alzheimer's disease] sufferers, it did not even come close to achieving the levels of cost effectiveness generally required before NICE could recommend such use within the NHS.”
David Pannick QC, for Eisai, told Mrs Justice Dobbs that the drugs could “buy time and quality of life” for patients with mild symptoms. But NICE, backed by an appeal panel, had decided that the drugs should no longer be made available on the NHS in the early stages of Alzheimer's disease, on the grounds that the daily cost of £2.50 (€3.70; $5) was too high given their “small clinical effect.”
Mr Pannick argued that the decision making approach was “procedurally flawed and irrational.” He said his clients had been unlawfully denied access to a computer model that would have enabled it to test NICE's assessments.
He added that the cognition test prescribed by NICE for distinguishing between the various stages of the disease—the mini-mental state examination (MMSE)—produced arbitrary and inconsistent scores, making the decision to rely on it irrational.
He said that the consequence of removing funding of drugs for people with mild Alzheimer's disease “is that the opportunity is lost for delaying the onward march of this appalling disease and maintaining a relatively good quality of life for patients for as long as possible.”
The Alzheimer's Society accuses NICE of ignoring the benefits of the drugs for carers and of relying on outdated studies that seriously underestimate the savings to the state of keeping patients at home longer. The society also says that the exclusive use of the MMSE unlawfully discriminates against patients with learning disabilities or with less than fluent English.
Andrew Dillon, chief executive of NICE, said, “Our consultation, decision making, and appeals processes are transparent and fair.
“The recommendations on the use of drugs for treating Alzheimer's disease were developed over a three year period in which careful analysis and detailed discussions with patient groups, doctors, and the drug manufacturers demonstrated our commitment to involving those whom our decisions affect.
“The reality is that, for Alzheimer's disease, drugs are only part of the care that needs to be offered. Non-drug interventions have an important part to play, and the evidence indicates that drugs are simply not effective for some patients.”
The judge was expected to finish hearing the case this week, after the BMJ went to press, and to deliver judgment in July.