Analysis of Stakeholder Engagement in the Public Comments of ICER Draft Evidence Reports.

backgroundHealth technology assessment is becoming increasingly important to healthcare payers' decision-making. The Institute for Clinical and Economic Review (ICER) is the most established US-based research group performing value assessments. ICER provides opportunities for stakeholder engagement, including a window of opportunity for public comments on the draft evidence report. Those public comments were reviewed in this study.

objectivesTo determine which stakeholders are most often commenting on ICER technology appraisal reports and to examine what aspects of the reports are the topics of these comments.

methodWe reviewed 7 ICER reports, which were used to extract stakeholder comments. All the identified comments were evaluated by 2 trained reviewers independently for stakeholder type, comment nature (positive or negative), and focus of comments (eg, methodology, data, real-world experience). Statistical analyses were used to analyze the reports for any associations between the frequency of the comments and the stakeholder type by therapeutic area.

resultsA total of 463 comments were identified within the 55 letter submissions identified across the 7 ICER reviews that were included in the study. The quantity of the comments generally reflected the quantity of therapies that were included in the review. Drug manufacturers (63.1%), patients or patient advocacy groups (18.1%), and providers or provider groups (9.7%) were the stakeholders most often engaged in the public comments. The comments most often addressed the methodology of the value assessment (53.8%). Comments about missing data (14%), general criticism (8.2%), and general support (2.2%) were less common.

conclusionICER is committed to engaging stakeholders in their value assessment process and adapting their strategies to improve such communications. Although ICER aims to influence payer decision-making, drug manufacturers were the most involved stakeholder in the assessment process, and they were most concerned with ICER's methodology. These results show the impact that ICER may have on decision-making in healthcare, emphasize the incentives that ICER drives for certain stakeholders, and highlight areas for further investigation.