Eisai Announce Application to Appeal NICE Judicial Review Verdict

LONDON, Oct. 1, 2007 /PRNewswire/ -- Eisai Limited, the licence holder of Aricept(R) (donepezil hydrochloride) and Pfizer Limited, its co-promotion partner, announced today that Eisai has applied to the Court of Appeal for permission to appeal the recent High Court ruling on 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 has lodged an application to appeal on the point of procedural fairness based on NICE's repeated refusal to disclose a working version of the cost effectiveness model they used to determine the value of treatment in patients with mild Alzheimer's disease.

Dr Paul Hooper, Managing Director of Eisai Limited said: "We are sad that we are having to take this further action. We maintain our belief that NICE should be required to be fully transparent in the way in which they reach their decisions surrounding the cost effectiveness of medicines."

Notes to Editors

Earlier this year the High Court granted permission to proceed to a Judicial Review on three grounds:

- Procedural: since NICE had 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

- Discrimination: the use of MMSE (Mini Mental State Examination) scores as a rigid diagnostic tool discriminates against certain patient groups

    
    Background


 
    January 2001      NICE approved the use of these medicines by
                      the NHS (donepezil, rivastigmine and
                      galantamine) for the treatment of mild and
                      moderate Alzheimer's disease.
 
    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 was 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.
 
    23 March 2007     Following consideration of documents lodged,
                      the High Court grants permission to proceed
                      to judicial review on all grounds (procedural
                      fairness, irrationality and discrimination).
 
    25 June 2007      Judicial Review hearing commences at High
                      Court.
 
    10 August 2007    High Court upholds claim of discrimination.
 
    28 September 2007 Eisai and Pfizer announce Eisai's application
                      to the Court of Appeal on the ground of
                      procedural fairness
Eisai Europe Limited

For further information contact: Andrew Day, Eisai Europe Corporate Affairs Department, +44-(0)208-600-1400, Andrew_Day@eisai.net

Posted: October 2007


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