Eisai, its co-promotion partner Pfizer, and the Alzheimer’s Society, are preparing to embark on the next step towards judicial review after being given a nod of approval to pursue their High Court challenge against the UK’s cost-effectiveness body, the National Institute for Health and Clinical Excellence, which ruled in November last year against the use of Alzheimer’s drug treatments for patients who have been newly diagnosed with the early stages of the disease.

A High Court judge agreed that “there are grounds to challenge this decision,” from every aspect applied for – procedural, irrationality and human rights/discrimination - making it the first ever judicial review of the Institute. “Denying people in the early stages of this debilitating disease access to drug treatments is cruel and unethical. Our legal team will also demonstrate that the decision is fundamentally flawed,” argued the Chief Executive of the Alzheimer’s Society, Neil Hunt, in a statement released yesterday.

A potted history of events

NICE backed the use of three Alzheimer’s medications – Aricept, Novartis’ Exelon (rivastigmine) and Shire’s Reminyl (galantamine) in 2001 to combat mild AD, but four years later proposed the withdrawal of this recommendation in newly-diagnosed patients and asked the manufacturers to submit additional data to demonstrate which subsets of the patient population responded best to treatment. Following its review of these data, the Institute then took the controversial decision to only recommend the medicines’ use in moderate disease, a ruling that was appealed by Eisai and Pfizer, as well as the other manufacturers. But, in the October, NICE said all grounds of appeal had been dismissed and one month later issued its final guidance stating that the drugs should not be used on the National Health Service for mild disease, despite Eisai and Pfizer demanding it postpone the guidance and asking it to disclose the calculations used to determine cost-effectiveness. The Alzheimer’s Society claims providing Alzheimer’s therapies for patients with mild disease would only cost the National Health Service £2.50 per day.

The main claimants involved in the case are Eisai and Pfizer, which together market the Alzheimer’s therapy Aricept (donepezil), while the Alzheimer’s Society has been given permission to act as “an interested party” and has recently launched a campaign to raise funds for its independent role during the challenge. The judge also yesterday awarded the charity a degree of cost-protection to ensure it can participate fully in the process.

Separately, the Alzheimer’s Society says it has submitted evidence to the UK’s Health Select Committee, which is conducting an inquiry into the workings of NICE – including why its decisions are increasingly being challenged.

A date for the judicial review process has not yet been set.