NICE Alzheimer's Treatment Decision Subject to Judicial Review

High Court judgement clears the way for landmark legal challenge

LONDON, March 27, 2007 - Eisai Limited, the licence holder of Aricept® (donepezil hydrochloride), announced today that the High Court has granted permission to proceed to a Judicial Review challenging the process by which the National Institute for Health and Clinical Excellence (NICE) reached its decision to ban anti-dementia medicines for NHS patients with newly diagnosed mild Alzheimer's disease.

Eisai, with the full support and backing of Pfizer Limited, its co-promotion partner, applied for permission to proceed to Judicial Review on the following three grounds:
  • Procedural:  since 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 leading to the Final Appraisal Determination (FAD) and the new treatment guidance breached the principles of procedural fairness
  • Irrationality:  some of the assumptions made or conclusions drawn in the FAD are irrational or cannot be supported
  • Human Rights/Discrimination:  the use of MMSE (Mini Mental State Examination) scores as a rigid diagnostic tool 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.”

Mr John Young, Managing Director of Pfizer Limited, 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.”




Background

January 2001 NICE approved the use of these medicines (donepezil, rivastigmine and galantamine) for treatment of mild Alzheimer's disease for use by the NHS.

March 2005 NICE first proposed banning NHS prescription of the medicines to newly diagnosed Alzheimer's patients.

July 2005 NICE postponed ratifying the ban but instead asked the manufacturers to supply extra data showing which patients responded best to the medication.

December 2005    NICE considered the data supplied by the manufacturers.

23 January 2006 NICE proposed that moderate AD be treated on the NHS, but not mild. Moderate is being defined as starting at 20 on the MMSE scale. A consultation period followed this announcement.

26 June 2006 NICE announced that despite the views of patients and doctors, it planned to stick to its ban on using the treatments for mild AD.

13/14 July 2006 Eisai and Pfizer appealed this decision, along with other manufacturers and organisations including the Alzheimer's Society and the Royal College of Psychiatrists.

11 October 2006 NICE announced that all grounds of appeal from all parties had been dismissed.

14 November 2006    Eisai and Pfizer called on NICE to:
  • withdraw the current FAD and postpone issuing the new guidance
  • disclose a fully transparent working version of the calculations used in the cost-effectiveness model for independent evaluation and comment
  • develop a new FAD using both a more accurate cost-effectiveness model and data.
22 November 2006 NICE issued new Guidance banning the use of medicines for NHS patients with newly diagnosed mild Alzheimer's disease.

05 January 2007 Eisai and Pfizer confirmed Eisai's application for Judicial Review submission, fully supported by Pfizer.

23 March 2007 Following consideration of documents lodged, the High Court grants permission to proceed to judicial review on all grounds (procedural, irrationality and human rights/discrimination.)

Posted: March 2007


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