OBJECTIVES: Since its foundation in 2006, the Institute for Clinical and Economic Review (ICER) has had increasing influence on drug pricing and reimbursement decisions in the US. Such decisions directly affect all stakeholders—insurers, providers, manufacturers, patients, and others—yet there is little synthesis of the effectiveness of engagements by stakeholders on ICER’s assessment of the cost-effectiveness of new interventions. The objective of this study is to evaluate the effectiveness of stakeholder engagement approaches and inform stakeholders of their potential role in collaborating with ICER.
METHODS: ICER evaluations from 2018 (n=12) and 2019 (n=8) were systematically reviewed. Key characteristics were extracted from 172 letters with a total of 1,463 comments documenting interactions between ICER and all stakeholders. Stakeholder engagement approaches were analyzed in terms of their effectiveness indicated by ICER’s modification of its original cost-effectiveness analysis.
RESULTS: 30% of reviewed letters and 5% of comments resulted in a change in ICER’s base-case analysis (49 comments in 2018, 23 in 2019); nearly half of these comments included specific data or a published article to support the stakeholder’s recommendations. Other common types of suggestions that resulted in analysis revisions included comments relating to inconsistent model inputs across treatments (12/49 in 2018, 5/23 in 2019), clinical validity (12/49 in 2018, 0/23 in 2019), and concerns based on patients’ perspectives (1/49 in 2018, 5/23 in 2019). Although these comments led ICER to amend the analysis, the revisions rarely affected ICER’s conclusion on the cost-effectiveness of evaluated interventions. Three out of the 172 letters were associated with a change in the cost-effectiveness conclusion.
CONCLUSIONS: Between 2018 and 2019, stakeholders have leveraged ICER evaluations as an opportunity to promote dialogue about the evidence of the value of technologies. Although stakeholders’ inputs had little influence on ICER assessment’s cost-effectiveness analysis conclusions, actionable, evidence-based recommendations were often accepted.
