Judicial review on Alzheimer’s drugs to go ahead
pharmafile | March 26, 2007 | News story | Sales and Marketing |Â Â Â
The decision to restrict access to Alzheimer's drugs for some patients is to be scrutinised in a UK court, it was announced today, the first time such a challenge will be heard.
Pfizer and Eisai, the two pharma companies which market the leading Alzheimer's drug Aricept have made the legal challenge to NICE, the UK's clinical and cost-effectiveness body.
The two companies and the charity The Alzheimer's Society have been awaiting a decision on the unprecedented judicial review since January, but have now heard that it will go ahead.
A High Court judge has agreed there are grounds to challenge this decision, and the review will consider the soundness of NICE's decision-making process, which campaigners say was badly flawed.
Pfizer and Eisai have appealed on three grounds:
* Procedural: The companies say 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. They say this means the process leading to the Final Appraisal Determination (FAD) and the new treatment guidance breached the principles of procedural fairness.
* Irrationality: The companies also claim some of the assumptions made or conclusions drawn in the FAD are irrational or cannot be supported.
* Human Rights/Discrimination: Pfizer and Eisai also dispute the use of MMSE (Mini Mental State Examination) scores, saying the test is a rigid diagnostic tool which discriminates against certain patient groups.
Commenting on the High Court's decision to grant permission, Dr Paul Hooper, Managing Director of Eisai Limited said: "We welcome the fact that the High Court has given us permission to launch this unprecedented legal challenge, and await confirmation of a date for the hearing."
John Young, Pfizer's UK Managing Director said: "We accept that NICE has an important role to play on behalf of the NHS and our issue is not what NICE do, but how it has reached this decision."
Neil Hunt, chief executive of the Alzheimer's Society added his views. "Today is an important step forward in our fight for the rights of people with Alzheimer's disease and their carers who have been forgotten in this decision," he said.
"We are delighted that the judge has recognised the importance of hearing their voices in court. 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."
The Alzheimer's Society has been allowed to act as an interested party in the judicial review, and the judge has also made a special guarantee to limit the legal costs for the charity to ensure it can play a full part in the legal challenge.
Andrew Dillon, NICE's chief executive has always maintained that the decision to restrict access to the drug was sound and based on clinical evidence. In November, he said: "We have to be honest and say the evidence [suggests] these drugs do not make enough of a difference for us to recommend their use for treating all stages of the disease."
NICE's guidance said only patients with moderate Alzheimer's disease, the middle stage of the progressive disease should receive the drugs on the NHS.
