Abilify aripiprazole regulatory update

The U.K.'s NICE issued a preliminary appraisal for Abilify ariprazole from Bristol-Myers and Otsuka to treat schizophrenia in patients ages 15-17 years. In the appraisal, NICE asked the companies to provide more data on the clinical and cost effectiveness of Abilify in the age group compared with each of the antipsychotics routinely used in the U.K., including Zyprexa olanzapine from Eli Lilly and Co. (NYSE:LLY, Indianapolis, Ind.), Seroquel quetiapine from AstraZeneca plc (LSE:AZN; NYSE:AZN, London, U.K.) and the generics risperidone, amisulpride and clozapine.

The committee noted that data in the company's submission were derived mainly from the Phase III 31-03-241 trial, which compared Abilify to placebo and did not provide a head-to-head comparison of Abilify against atypical antipsychotics. Additionally, the committee was concerned that the company's economic model, which estimated an incremental cost-effectiveness ratio (ICER) for first-line Abilifiy vs. Zyprexa at £6,200 ($9,556) per quality-adjusted life year (QALY) gained, contained inappropriate assumptions. The committee said sensitivity analyses suggest the ICER could be as high as £233,000 ($359,123) per QALY gained. ...