The hopes of people with mild Alzheimer’s disease of having access to acetylcholinesterase inhibitors through the NHS were boosted last week when three appeal court judges ruled that a key step in the process for appraising the drugs for NHS use was “procedurally unfair.”
The court unanimously overturned a High Court ruling that the National Institute for Health and Clinical Excellence (NICE) acted fairly when it refused to supply the drug company Eisai with a full version of the computer model it used to decide that the treatment would not be cost effective for the early stages of the illness (BMJ 2007;335:319; doi: 10.1136/bmj.39307.630347.DB).
The drugs cost £2.50 (€3.17; $4.90) a day. In 2004 NICE decided that they were not cost effective for mild Alzheimer’s disease. It will now have to give Eisai the “fully executable” version of the model in place of the read only model it previously supplied and reconsider its decision in the light of any further submissions by Eisai, the UK licence holder for donepezil (Aricept), one of this group of drugs.
The case, the first to be lost in court by NICE, will have repercussions for future cost-benefit analyses of new drugs, which will have to become more transparent. Drug companies that ask for the fully executable model will have to be given it to enable them to carry out their own analyses.
Nick Burgin, managing director of Eisai, said, “We believe that this decision represents a victory for common sense. As soon as we have reviewed their cost effectiveness calculations we will submit any new findings to NICE.
“We hope that this action will ultimately restore access to antidementia medicines for those patients at the mild stages of Alzheimer’s disease.”
David Pannick, Eisai’s QC, told the appeal court last month, “The evidence suggests that when the guidance takes full effect—for no mild Alzheimer’s sufferer will have current treatment discontinued as a result of the guidance—annually 96 600 patients with mild Alzheimer’s will be refused treatment with acetylcholinesterase inhibitors that would have been made available.”
The appeal court judges heard arguments by NICE that it was bound by confidentiality not to hand over the fully executable model, which was developed by academics, and that doing so would add another two or three months to the appraisal process.
But Lord Justice Richards, giving the court’s judgment, said that NICE’s refusal to hand over the full version put drug companies at a disadvantage in challenging the reliability of the model. “The possibility cannot be excluded that work done by them on the fully executable version would bring to light hitherto unrecognised weaknesses in the model,” he added.
NICE’s chief executive, Andrew Dillon, said, “The ruling will increase the complexity of our drug appraisals in some cases, and they may take longer as a result. In the meantime, and in accordance with the judges’ ruling, we will provide Eisai with an executable version of the economic model used in our appraisal so that they can comment on it. We will then take those comments into account.
“It is important to recognise that we have not been asked to amend or withdraw our current guidance on the use of these drugs to treat Alzheimer’s disease: the drugs continue to be recommended only for people with moderate Alzheimer’s disease.”