Economic modelling will be in the dock in London's High Court this morning, as a groundbreaking legal challenge over access to dementia drugs get under way.
The case centres on treatments for "mild stage" Alzheimer's disease and pits Eisai, the big Japanese drugmaker, together with The Alzheimer's Society and Shire Pharmaceuticals, against the National Institute for Health and Clinical Excellence, which recommends the treatments the National Health Service should adopt.
Although the number of judicial review challenges to decisions by hospitals or health authorities over the funding of specific drugs or treatments - such as herceptin, the breast cancer drug - has been growing, this is the first time that anyone has taken on NICE directly.
It is also believed to be one of the first cases to challenge the fairness and rationality of underlying economic modelling used to arrive at a cost-benefit decision, and the first in the healthcare field.
"It's never been done before in the health context, as far as I'm aware - this case is very, very novel in many ways," says John Halford at Bindman & Partners, the law firm advising the Alzheimer's Society.
The dispute centres on revised guidance which NICE issued in November, recommending that three drug treatments - all of which involve acetylcholinesterase inhibitors - should no longer be given to people suffering from mild dementia. Instead, NICE recommended these be reserved until individuals reached the "moderate" stage.
Eisai is the licence holder of Aricept, one of these treatments, and is backed in the challenge by co-marketer Pfizer, while Shire supplies another, called Reminyl.
NICE says the new guidance - which is estimated to save £13m a year - follows three years of careful analysis. It stresses that drugs are only part of the care needed by sufferers of Alzheimer's disease. "Non-drug interventions have an important part to play and the evidence indicates that drugs are simply not effective for some patients," said Andrew Dillon, NICE chief executive.
More at the FT
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