OBJECTIVES: Since its foundation in 2006, the Institute for Clinical and Economic Review (ICER) had increased its capacity for evaluating the value of health technologies in the United States. However, despite the potential significant impact of assessment outcomes on the perceived value of new products, best practices for engaging with ICER have not been established. The objective of this presentation is to outline the evolution of ICER review processes and to recommend how to best leverage evaluations as opportunities to communicate the value of health technologies.
METHODS: Based on a systematic review of publicly available ICER evaluation materials for assessments performed from 2008 to 2018, we summarized ICER’s evaluation framework and highlight key procedural changes. Reviews conducted in 2018 were critically assessed to summarize the influence of stakeholder comments on ICER’s reporting and conclusions.
RESULTS: During the 10 years, the number of ICER evaluations increased from 1 to 12 per year, and the stakeholder engagement approach shifted; opportunities for public comments (1) and “open input” (2) were introduced in 2011 and 2016, respectively. Evaluations in rare indications were introduced in 2016, comprising 50% of evaluations in 2018. In 2018, 6 of 12 assessments reported ≥1 evaluated intervention to be cost-effective under the incremental costeffectiveness ratio threshold of $150,000. A higher proportion of rare indications were concluded not cost-effective (4/6 vs. 2/6). Although all 40 participating manufacturers had at least one comment addressed by ICER, only 7 participants experienced change in conclusions from the draft to final report. Comments that influenced model results included specific recommendations on alternative approaches.
CONCLUSIONS: Although ICER has expanded and clarified its process for collaborating with stakeholders, stakeholder comments had little influence on assessment outcomes. It is critical for stakeholders to provide explicit recommendations in order to leverage the evaluations as opportunities to promote active dialogue.
