Jean A Gerlach1, Brian Snow2, Katherine M Prioli3, Ronald Vertsman4, Julie Patterson5, Laura T Pizzi6. 1. PharmD Candidate, Ernest Mario School of Pharmacy, Rutgers University, Piscataway, NJ. 2. Biologic Programs Associate, Regeneron Pharmaceuticals, Tarrytown, PA. 3. Senior Research Analyst, Center for Health Outcomes, Policy, & Economics, Rutgers University, Piscataway, NJ. 4. Medical Student, Robert Wood Johnson Medical School, Rutgers University, Piscataway, NJ. 5. Assistant Professor, Virginia Commonwealth University School of Pharmacy, Department of Pharmacotherapy and Outcomes Science. 6. Professor and Director, Center for Health Outcomes, Policy & Economics, Rutgers University, Piscataway, NJ.
Abstract
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.
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.
Keywords:
Institute for Clinical and Economic Review (ICER); decision-making; draft evidence reports; health technology assessment; healthcare stakeholders; value assessment
Authors: Louis P Garrison; Peter J Neumann; Richard J Willke; Anirban Basu; Patricia M Danzon; Jalpa A Doshi; Michael F Drummond; Darius N Lakdawalla; Mark V Pauly; Charles E Phelps; Scott D Ramsey; Adrian Towse; Milton C Weinstein Journal: Value Health Date: 2018-02 Impact factor: 5.725
Authors: George A K van Voorn; Pepijn Vemer; Dominique Hamerlijnck; Isaac Corro Ramos; Geertruida J Teunissen; Maiwenn Al; Talitha L Feenstra Journal: Appl Health Econ Health Policy Date: 2016-04 Impact factor: 2.561