Thomas A Gaziano1, Gregg C Fonarow2, Brian Claggett3, Wing W Chan4, Celine Deschaseaux-Voinet5, Stuart J Turner4, Jean L Rouleau6, Michael R Zile7, John J V McMurray8, Scott D Solomon3. 1. Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts. 2. UCLA School of Medicine, Los Angeles, California10Associate for Editor for Health Care Quality and Guidelines, JAMA Cardiology. 3. Brigham and Women's Hospital, Boston, Massachusetts. 4. Novartis Pharmaceuticals Corp, East Hanover, New Jersey. 5. Novartis Pharma AG, Basel, Switzerland. 6. Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada. 7. Medical University of South Carolina, Charleston8The Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, South Carolina. 8. University of Glasgow, Glasgow, United Kingdom.
Abstract
IMPORTANCE: The angiotensin receptor neprilysin inhibitor sacubitril/valsartan was associated with a reduction in cardiovascular mortality, all-cause mortality, and hospitalizations compared with enalapril. Sacubitril/valsartan has been approved for use in heart failure (HF) with reduced ejection fraction in the United States and cost has been suggested as 1 factor that will influence the use of this agent. OBJECTIVE: To estimate the cost-effectiveness of sacubitril/valsartan vs enalapril in the United States. DESIGN, SETTING, AND PARTICIPANTS: Data from US adults (mean [SD] age, 63.8 [11.5] years) with HF with reduced ejection fraction and characteristics similar to those in the PARADIGM-HF trial were used as inputs for a 2-state Markov model simulated HF. Risks of all-cause mortality and hospitalization from HF or other reasons were estimated with a 30-year time horizon. Quality of life was based on trial EQ-5D scores. Hospital costs combined Medicare and private insurance reimbursement rates; medication costs included the wholesale acquisition cost for sacubitril/valsartan and enalapril. A discount rate of 3% was used. Sensitivity analyses were performed on key inputs including: hospital costs, mortality benefit, hazard ratio for hospitalization reduction, drug costs, and quality-of-life estimates. MAIN OUTCOMES AND MEASURES: Hospitalizations, quality-adjusted life-years (QALYs), costs, and incremental costs per QALY gained. RESULTS: The 2-state Markov model of US adult patients (mean age, 63.8 years) calculated that there would be 220 fewer hospital admissions per 1000 patients with HF treated with sacubitril/valsartan vs enalapril over 30 years. The incremental costs and QALYs gained with sacubitril/valsartan treatment were estimated at $35 512 and 0.78, respectively, compared with enalapril, equating to an incremental cost-effectiveness ratio (ICER) of $45 017 per QALY for the base-case. Sensitivity analyses demonstrated ICERs ranging from $35 357 to $75 301 per QALY. CONCLUSIONS AND RELEVANCE: For eligible patients with HF with reduced ejection fraction, the Markov model calculated that sacubitril/valsartan would increase life expectancy at an ICER consistent with other high-value accepted cardiovascular interventions. Sensitivity analyses demonstrated sacubitril/valsartan would remain cost-effective vs enalapril.
IMPORTANCE: The angiotensin receptor neprilysin inhibitor sacubitril/valsartan was associated with a reduction in cardiovascular mortality, all-cause mortality, and hospitalizations compared with enalapril. Sacubitril/valsartan has been approved for use in heart failure (HF) with reduced ejection fraction in the United States and cost has been suggested as 1 factor that will influence the use of this agent. OBJECTIVE: To estimate the cost-effectiveness of sacubitril/valsartan vs enalapril in the United States. DESIGN, SETTING, AND PARTICIPANTS: Data from US adults (mean [SD] age, 63.8 [11.5] years) with HF with reduced ejection fraction and characteristics similar to those in the PARADIGM-HF trial were used as inputs for a 2-state Markov model simulated HF. Risks of all-cause mortality and hospitalization from HF or other reasons were estimated with a 30-year time horizon. Quality of life was based on trial EQ-5D scores. Hospital costs combined Medicare and private insurance reimbursement rates; medication costs included the wholesale acquisition cost for sacubitril/valsartan and enalapril. A discount rate of 3% was used. Sensitivity analyses were performed on key inputs including: hospital costs, mortality benefit, hazard ratio for hospitalization reduction, drug costs, and quality-of-life estimates. MAIN OUTCOMES AND MEASURES: Hospitalizations, quality-adjusted life-years (QALYs), costs, and incremental costs per QALY gained. RESULTS: The 2-state Markov model of US adult patients (mean age, 63.8 years) calculated that there would be 220 fewer hospital admissions per 1000 patients with HF treated with sacubitril/valsartan vs enalapril over 30 years. The incremental costs and QALYs gained with sacubitril/valsartan treatment were estimated at $35 512 and 0.78, respectively, compared with enalapril, equating to an incremental cost-effectiveness ratio (ICER) of $45 017 per QALY for the base-case. Sensitivity analyses demonstrated ICERs ranging from $35 357 to $75 301 per QALY. CONCLUSIONS AND RELEVANCE: For eligible patients with HF with reduced ejection fraction, the Markov model calculated that sacubitril/valsartan would increase life expectancy at an ICER consistent with other high-value accepted cardiovascular interventions. Sensitivity analyses demonstrated sacubitril/valsartan would remain cost-effective vs enalapril.
Authors: Pratyaksh K Srivastava; Brian L Claggett; Scott D Solomon; John J V McMurray; Milton Packer; Michael R Zile; Akshay S Desai; Jean L Rouleau; Karl Swedberg; Gregg C Fonarow Journal: JAMA Cardiol Date: 2018-12-01 Impact factor: 14.676
Authors: Thomas A Gaziano; Gregg C Fonarow; Eric J Velazquez; David A Morrow; Eugene Braunwald; Scott D Solomon Journal: JAMA Cardiol Date: 2020-11-01 Impact factor: 14.676