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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ICON survey finds payers increasingly use ICER reports at multiple ‘touchpoints’ during the drug evaluation and decision-making process and the most common use reported in 2020 was as a reference in rebate and pricing negotiations.
With a remdesivir analysis pushing cost-recovery models and lower thresholds for cost-effectiveness, ICER's COVID-19 pricing framework will likely result in lower pricing benchmarks for drugs than the group would have issued under its typical analysis framework. Critics say this is the opposite of what should be incentivized in an emergency.
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.