LONDON, May 9 /PRNewswire/ -- Eisai Limited, the licence holder of Aricept(R) (donepezil hydrochloride)
and Pfizer Limited, its co-promotion partner, announced today that the Court
of Appeal has released its decision on the consequential issues arising from
Court of Appeal's recent ruling that the process by which the National
Institute for Health and Clinical Excellence (NICE) decided to restrict
anti-dementia medicines for newly diagnosed patients with mild Alzheimer's
disease was procedurally unfair. The decision today will now be reflected in
a Court order.
The Court has decided that
- NICE must make available to all consultees, within 14 days of
the end of the period for appealing to the House of Lords, a copy of the
fully executable version (FEV) of the cost-effectiveness model used to
produce guidance for the treatment of patients with Alzheimer's
- Eisai and other consultees have a period of 42 days from receipt
of the FEV in which to review the model and make representations to NICE
- NICE is to pay 60% of Eisai's costs resulting from the original
Judicial Review
- NICE is to pay the costs of Eisai's appeal
- NICE has been refused permission to appeal to the House of Lords
We believe this now brings the prospect of restored access to
anti-dementia medicines for those patients at the mild stages of Alzheimer's
disease one stage closer.
Should Eisai find that the calculations relied on by NICE to determine
the cost-efficacy of anti-dementia medicines in mild Alzheimer's to contain
errors or to be unreliable, they will submit their findings to the NICE
Appraisal Committee who will be required to review their recommendations in
light of any such fresh evidence.
Eisai and Pfizer remain fully committed to working with NICE to ensure
that all patients in the UK with mild to moderate Alzheimer's disease will
have access to these medicines.
Notes to Editors
- As with all cases heard by the Court of Appeal, the Courts
decision can be challenged by further appeal to the House of Lords. The
House of Lords will only usually allow appeal on points of law
- In this case, the Court of Appeal went as far as stating in
its judgment that "...this case depends not on the resolution of any real
dispute about the legal principles, but on the application of well
established principles to the particular context and particular
circumstances of NICE's appraisal process"
- In its decision announced today, the Court of Appeal has
refused NICE permission to appeal to the House of Lords, although NICE
may apply directly to the House of Lords should they wish
- NICE is on public record as stating "...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 comment on it. We will then take those comments into account"
- NICE have not yet confirmed a date for when they plan to
release the fully executable version of the model
- Eisai has now won two out of the three points of its original
appeal; discrimination and procedural fairness
For further information please contact
Alison MacKenzie, Reynolds Andrew Day, Eisai Andrew Thomas, Pfizer
MacKenzie
+44(0)20-7031-4360 +44(0)7973-411-419 +44(0)7814-528-928
+44(0)7989-353-779
Eisai Limited
