Quantifying Patient Preferences About Features of Nonstatin Lipid-Lowering Therapies: A Discrete Choice Experiment in the United States.
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2025-08
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Background
Despite the growing number of nonstatin lipid-lowering treatments (NS-LLTs), data are lacking on how patients value their various features and outcomes. Study objectives were to quantify patients' preferences across levels of efficacy, treatment regimens, side effects, and out-of-pocket costs of NS-LLTs and compare approaches with framing treatment efficacy.Methods
A discrete choice experiment survey was administered to US adults aged ≥40 years with medical claims indicating statin use and atherosclerotic cardiovascular disease. Each participant was administered 12 sets of experimentally designed pairs of add-on NS-LLT profiles that varied in efficacy, administration regimen, injection-site reaction, joint pain, out-of-pocket cost, and a no-additional treatment option. Random-parameter logit models were used to estimate preference weights, and tradeoffs across attributes were reported as willingness-to-pay estimates.Results
A total of 1193 participants completed the survey (36% female; 90% White; mean age, 68.2±9.7 years). Across treatment features assessed, out-of-pocket cost ranging from $0 to $200 per month was the most important factor. All else being equal, a daily oral dosing regimen was the most preferred regimen. Among injectable regimens, participants preferred dosing every 6 months versus every 2 weeks (P<0.001) or every month (P<0.001). Efficacy presented as 25% to 60% reductions in LDL-C (low-density lipoprotein-cholesterol) levels was valued greater than equivalent reductions in 5-year cardiovascular risks. Among those reporting annual household incomes <$150 000 (93.5%), the average maximum willingness to pay for an add-on NS-LLT as a daily, oral medication without side effects ranged from $131 to $175 per month with efficacy framed as a 25% reduction in LDL-C levels versus $89 to $124 with efficacy framed as corresponding reductions in 5-year cardiovascular risk.Conclusions
Among treatment features assessed, out-of-pocket costs were the primary factor driving choices. Those opting for an add-on NS-LLT were willing to trade off additional efficacy for less frequent injections or a daily oral medication.Type
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Reed, Shelby D, Jessie Sutphin, Juan Marcos Gonzalez, Matthew J Wallace, Judith J Stephenson, Batul Electricwala, Hayden B Bosworth, Neha Pagidipati, et al. (2025). Quantifying Patient Preferences About Features of Nonstatin Lipid-Lowering Therapies: A Discrete Choice Experiment in the United States. Circulation. Cardiovascular quality and outcomes, 18(8). p. e011804. 10.1161/circoutcomes.124.011804 Retrieved from https://hdl.handle.net/10161/33907.
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Scholars@Duke
Shelby Derene Reed
Shelby D. Reed, PhD, is Professor in the Departments of Population Health Sciences and Medicine at Duke University’s School of Medicine. She is the director of the Center for Informing Health Decisions and Therapeutic Area leader for Population Health Sciences at the Duke Clinical Research Institute (DCRI). She also is core faculty at the Duke-Margolis Center for Health Policy. Dr. Reed has over 20 years of experience leading multidisciplinary health outcomes research studies. Dr. Reed has extensive expertise in designing and conducting trial-based and model-based cost-effectiveness analyses of diagnostics, drugs and patient-centered interventions. In 2016, she co-founded the Preference Evaluation Research (PrefER) Group at the DCRI, and she currently serves as its director. She and the group are frequently sought to conduct stated-preference studies to inform regulatory decisions, health policy, care delivery, value assessment and clinical decision making with applied projects spanning a wide range of therapeutic areas. She served as President for ISPOR in 2017-2018, and she currently is Past-Chair of the Society’s Health Science Policy Council.
Areas of expertise: Health Economics, Health Measurement, Stated Preference Research, Health Policy, and Health Services Research
Juan Marcos Gonzalez
Dr. Gonzalez is an Associate Professor in the Department of Population Health Sciences. He is an expert in the design of stated-preference survey instruments and the use of advanced statistical tools to analyze stated-preference data. His research has focused on the transparency in benefit-risk evaluations of medical interventions, and the elicitation of health preferences from multiple stakeholders to support shared decision making.
Dr. Gonzalez co-led the first FDA-sponsored preference study which was highlighted in FDA’s recent precedent-setting guidance for submitting patient-preference evidence to inform regulatory benefit-risk evaluations of new medical devices. More recently, Dr. Gonzalez collaborated with the Medical Devices Innovation Consortium (MDIC) to prepare the first catalog of preference-elicitation methods (part of the Patient-Centered Benefit-Risk Assessment Framework) suitable for benefit-risk assessments of medical devices. As a core group member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Conjoint Analysis Task Force, Dr. Gonzalez helped draft good-practice recommendations for statistical analysis, interpretation, and reporting of health preference data. Currently, he is working with the Center for Devices and Radiological Health at FDA to support the Center’s capabilities for the review of stated-preference data in regulatory decisions.
Areas of expertise: Clinical Decision Sciences and Health Measurement
Hayden Barry Bosworth
Dr. Bosworth is a health services researcher and Deputy Director of the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) at the Durham VA Medical Center. He is also Vice Chair of Education and Professor of Population Health Sciences. He is also a Professor of Medicine, Psychiatry, and Nursing at Duke University Medical Center and Adjunct Professor in Health Policy and Administration at the School of Public Health at the University of North Carolina at Chapel Hill. His research interests comprise three overarching areas of research: 1) clinical research that provides knowledge for improving patients’ treatment adherence and self-management in chronic care; 2) translation research to improve access to quality of care; and 3) eliminate health care disparities.
Dr. Bosworth is the recipient of an American Heart Association established investigator award, the 2013 VA Undersecretary Award for Outstanding Achievement in Health Services Research (The annual award is the highest honor for VA health services researchers), and a VA Senior Career Scientist Award. In terms of self-management, Dr. Bosworth has expertise developing interventions to improve health behaviors related to hypertension, coronary artery disease, and depression, and has been developing and implementing tailored patient interventions to reduce the burden of other chronic diseases. These trials focus on motivating individuals to initiate health behaviors and sustaining them long term and use members of the healthcare team, particularly pharmacists and nurses. He has been the Principal Investigator of over 30 trials resulting in over 400 peer reviewed publications and four books. This work has been or is being implemented in multiple arenas including Medicaid of North Carolina, private payers, The United Kingdom National Health System Direct, Kaiser Health care system, and the Veterans Affairs.
Areas of Expertise: Health Behavior, Health Services Research, Implementation Science, Health Measurement, and Health Policy
Neha Pagidipati
Neha J. Pagidipati, MD, MPH, is an Assistant Professor of Medicine and cardiovascular disease prevention specialist. Since 2011, she has conducted research on cardiometabolic disease prevention, lifestyle modification and weight management. She is currently an NIH K12 scholar in Implementation and Dissemination Science.
Dr. Pagidipati is building the Duke Cardiometabolic Disease Prevention Program, which focuses on behavior change and risk factor management in patients with high risk of cardiovascular and metabolic diseases such as diabetes and obesity. The program’s multi-disciplinary team of cardiologists, endocrinologists, nephrologists, and hepatologists will work together to provide coordinated, team-based care to the most high-risk and complex patients in the health system.
Dr. Pagidipati’s research grants include the COORDINATE-Diabetes Trial, to improve the quality of care for patients with diabetes and cardiovascular disease across the U.S., and QuBBD: Deep Poisson Methods for Biomedical Time-to-Event and Longitudinal Data. She served as a study clinician on the large, longitudinal EXSCEL (Exenatide Study of Cardiovascular Event Lowering) trial. She is currently conducting a nation-wide study of obesity management using real-world data sources, and is a site investigator for the Baseline Health Study in collaboration with Verily Life Sciences. In addition, she is leading a large study within the Duke Health System to study heterogeneity within cardiovascular disease risk and response to weight loss interventions among individuals with obesity.
Dr. Pagidipati graduated from Harvard College and Harvard Medical School. She completed her internal medicine residency at Brigham and Women’s Hospital. During a two-year research fellowship in Global Women’s Health at the Brigham, she obtained an MPH from the Harvard School of Public Health and studied cardiovascular disease prevention in women in India. Dr. Pagidipati completed a four-year cardiology fellowship at the Duke University School of Medicine and served as Chief Research Fellow at the Duke Clinical Research Institute. In 2017, she became a faculty member of the Duke University School of Medicine School.
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