Aricept donepezil regulatory update

The U.K.'s NICE said its technology appraisal guidance that reiterated 2006 guidance restricting access to 4 Alzheimer's disease drugs will remain unchanged after consultation with an independent appraisal committee on the cost-effectiveness model used in the appraisal. Upon full review of the comments received after release of the "fully executable" version of the model for comment in November 2008, the committee concluded that amendments made, which included technical inaccuracies, were not sufficient to change the guidance. Last year, the U.K.'s Court of Appeal ruled that procedural fairness requires NICE to release a "fully executable" version of the cost-effectiveness model it used to produce the 2006 guidance (see BioCentury, May 5, 2008). ...