Eisai Europe Limited

Eisai Announce Application to Appeal NICE Judicial Review Verdict

    London (ots/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

ots Originaltext: Eisai Europe Limited
Im Internet recherchierbar: http://www.presseportal.ch

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



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