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

Background: Health 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.

Objectives: To 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.

Method: We 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.

Results: A 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.

Conclusion: ICER 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.