Abstract

Given national scrutiny on rising drug prices in the US, the Institute for Clinical and Economic Review (ICER) is primed to impact formulary decision-making. ICER employs a fixed cost-effectiveness (CE) threshold which guides their appraisal of an intervention’s long-term economic value; ICER deems an intervention to represent low value if the incremental CE ratio falls above the higher bound of ICER’s CE threshold. This study qualitatively assessed the concordance of ICER’s CE findings to published CE models developed by life sciences manufacturers, academics, and government institutions. Disease areas and interventions for comparison were determined based on ICER evaluations conducted between 1/1/2015 – 3/31/2018. A targeted literature search was conducted for non-ICER CE publications using PubMed. Studies were limited to those completed on human subjects, written in English, and published in the same disease area and with the same primary intervention(s) as ICER’s evaluations. Studies also had to: (1) be conducted from the US perspective; (2) include the same population characteristics (e.g., disease severity); (3) incorporate the same comparison group; and (4) express the incremental CE ratio as incremental costs/QALY gained. Concordance was measured as the proportion of findings from other research groups that aligned with ICER’s appraisals. Among the 19 non-ICER studies meeting inclusion criteria, 7 disease areas and 20 primary interventions were assessed. ICER did not recommend 16 of 20 interventions based on incremental CE ratios falling above the higher bound of their CE threshold; 13 of the 16 rejected interventions would have been recommended based on CE findings from other research groups and using ICER’s CE threshold. This represents a 65% (13/20) discordance rate. Our findings indicate high discordance when comparing ICER’s appraisals to CE findings in other research publications. To understand the value of new interventions, evidence from the full universe of CE models should be reviewed.

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