ICER Will Assess Real World Evidence On Accelerated Approvals After Two Years
Process will incorporate real world evidence into future cost effectiveness updates of already reviewed drugs to supplement the information available prior to launch.
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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.
Biopharma’s funding support for the Institute for Clinical and Economic Review has been slightly above that of payers and providers for the past three to four years.
To aid its value assessments, ICER is interested in helping FDA understand the importance of patient-relevant outcomes and consistent endpoints across trials of drugs for the same disease.