A two-year battle to get the National Institute for Health and Clinical Excellence to take a u-turn on its restriction of Alzheimer’s disease drugs to only patients with moderate forms of the condition finally reached the High Court yesterday.

Eisai and Pfizer – which sell Aricept (donepezil) – won the right to challenge NICE in court back in May, and they are being supported by The Alzheimer's Society, which is acting as an interested party in the judicial review to represent the views of people with dementia and their carers.

The four-day, landmark hearing – which is the first ever judicial review of a NICE ruling – marks the climax of an intense campaign involving at least 8,000 objections, five appeals and nationwide protests against NICE’s decision to deny patients with early stages of the disease access to acetyl cholinesterase inhibitors Aricept, Novartis’ Exelon (rivastigmine) and Shire’s Reminyl (galantamine).

Flawed and irrational

NICE’s stance that, at £2.50 per person per day, treatment for early-stage AD patients is not cost-effective has sparked furious criticism from drugmakers, charities, patient groups and carers alike, and Eisai and Pfizer are claiming that the conclusion is flawed and irrational. Furthermore, experts argue that the decision seems to go against the grain of all other treatment strategies that aim to treat a patient as early as possible to prevent disease progession.

“Another 100,000 people will develop dementia this year alone and the result of this case will affect not only them but their families too,” said Neil Hunt, Chief Executive of the Alzheimer’s Society. “We have to fight NICE’s fatally flawed process, which has failed to recognise the benefits these treatments have for carers.”

But Andrew Dillon, Chief Executive of NICE, insists that the “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.”

Furthermore, he argues: “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.”

106m by 2050

But a recent report by researchers Johns Hopkins University in the USA says that delaying disease progression could have a significant impact around the globe. It predicts that worldwide prevalence of AD will cap 106 million cases by 2050 and, by that time, 43% of patients will need high-level care.

The report, published earlier this month in the journal Alzheimer’s and Dementia claims that delaying the onset of AD by as little as one year would reduce its prevalence by 12 million fewer cases in 2050.

There is no doubt that all eyes will be following the case very closely, and health regulators in other regions will be awaiting the court’s decision – which could set a new legal precedent – before making their own conclusions about funding early-stage treatment of AD.

On the advice of legal representatives, Pfizer and Eisai will be not available to comment on the case until the hearing closes on Thursday.