|Home | About | Journals | Submit | Contact Us | Français|
The National Institute for Health and Clinical Excellence (NICE), the NHS drugs gatekeeper for England and Wales, faces the first legal challenge to one of its decisions restricting the use of a drug by the NHS.
The High Court gave the go ahead this week to a drug company to bring judicial review proceedings over restrictions on the use of donepezil (Aricept), which is used to treat Alzheimer's disease.
Guidance from NICE, which does cost-benefit analyses to decide which drugs should be available on the NHS and for what conditions, is that the drug may be prescribed for moderate Alzheimer's disease but not for early or late stages of the disease.
The Japanese biotechnology company Eisai, the licence holder for Aricept, backed by its co-promotion partner, Pfizer, was this week granted permission to challenge the guidance restricting use of the drug, which costs about £2.50 (€3.68; $4.90) a day.
The company was given the go ahead to challenge the guidance on three grounds—procedural unfairness, irrationality, and discrimination.
The decision was procedurally unfair, the company argues, because NICE has repeatedly refused to disclose a fully working version of the cost effectiveness model used to determine the value of treatment in patients with mild Alzheimer's disease, the process that led to the final appraisal.
Eisai also contends that some of the assumptions made or conclusions drawn in the final appraisal are irrational or cannot be supported, and that the use of mini mental state examination scores as a rigid diagnostic tool discriminates against certain groups of patients.
Neil Hunt, chief executive of the Alzheimer's Society, which was given permission to intervene in the case as an interested party, said, “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.”
Andrew Dillon, chief executive of NICE, said, “We are disappointed that Eisai has taken this step. We consider their claim without foundation, and it will require us to divert energy and funding from the work we do to support patients and health professionals and get the most out of the resources available to the NHS.”
From the archive: Role of cholinesterase inhibitors needs rethinking. (see BMJ 2006;333:491-493).