Accelerated Approval, Real World Evidence Pilot From ICER, Aetion Picks HAE As First Therapeutic Area
ICER signals how it will pick other therapies for pilot in interview with Pink Sheet. Aetion believes project will help 'pressure test' the RWE field and show health plans and providers the value of using real world evidence to supplement clinical trial data.
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ICER President Steve Pearson expresses interest in setting drug costs for accelerated approval drugs low with price increases based on confirmatory evidence ahead of upcoming white paper from the group.
Aetion is also working with the US Food and Drug Administration and a number of biopharma companies on projects involving use of real-world evidence.
Process will incorporate real world evidence into future cost effectiveness updates of already reviewed drugs to supplement the information available prior to launch.