Background:
Sacubitril–valsartan therapy reduces cardiovascular mortality compared with enalapril therapy in patients with heart failure with reduced ejection fraction.
Objective:
To evaluate the cost-effectiveness of sacubitril–valsartan versus angiotensin-converting enzyme inhibitor therapy in patients with chronic heart failure.
Design:
Markov decision model.
Data Sources:
Clinical trials, observational analyses, reimbursement data from the Centers for Medicare & Medicaid Services, drug pricing databases, and Centers for Disease Control and Prevention life tables.
Target Population:
Patients at an average age of 64 years, New York Heart Association (NYHA) class II to IV heart failure, and left ventricular ejection fraction of 0.40 or less.
Time Horizon:
Lifetime.
Perspective:
Societal.
Intervention:
Treatment with sacubitril–valsartan or lisinopril.
Outcome Measures:
Life-years, quality-adjusted life-years (QALYs), costs, heart failure hospitalizations, and incremental cost-effectiveness ratios.
Results of Base-Case Analysis:
The sacubitril–valsartan group experienced 0.08 fewer heart failure hospitalization, 0.69 additional life-year, 0.62 additional QALY, and $29 203 in incremental costs, equating to a cost per QALY gained of $47 053. The cost per QALY gained was $44 531 in patients with NYHA class II heart failure and $58 194 in those with class III or IV heart failure.
Results of Sensitivity Analysis:
Sacubitril–valsartan treatment was most sensitive to the duration of improved outcomes, with a cost per QALY gained of $120 623 if the duration was limited to the length of the trial (median, 27 months). No variations in other parameters caused the cost to exceed $100 000 per QALY gained.
Limitation:
The benefit of sacubitril–valsartan is based on a single clinical trial.
Conclusion:
Treatment with sacubitril–valsartan provides reasonable value in reducing cardiovascular mortality and morbidity in patients with NYHA class II to IV heart failure.
Primary Funding Source:
U.S. Department of Veterans Affairs and Institute for Clinical and Economic Review.
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Author, Article and Disclosure Information
From Veterans Affairs Palo Alto Health Care System, Palo Alto, California; Center for Health Policy and Center for Primary Care and Outcomes Research, Stanford University, and Stanford University School of Medicine, Stanford, California; and Institute for Clinical and Economic Review, Boston, Massachusetts.
Disclaimer: The findings and conclusions in this article are those of the authors and do not necessarily represent the views of the U.S. Department of Veterans Affairs.
Acknowledgment: The authors thank Iris Ma, MD, for her thoughtful comments on the draft manuscript.
Financial Support: This study was funded in part by the U.S. Department of Veterans Affairs (Drs. Sandhu and Heidenreich) and the Institute for Clinical and Economic Review (Drs. Ollendorf, Chapman, and Pearson).
Disclosures: Drs. Ollendorf and Pearson report grants from the Blue Shield of California Foundation, the California Health Care Foundation, and the Laura and John Arnold Foundation during the conduct of the study; a grant from the National Pharmaceutical Council outside the submitted work; and dues from Aetna, AHIP, Anthem, Blue Shield of California, CVS Caremark, Express Scripts, Harvard Pilgrim Health Care, OmedaRx, UnitedHealthcare, Kaiser Permanente, Premera Blue Cross, AstraZeneca, Genentech, GlaxoSmithKline, Johnson & Johnson, Merck, the National Pharmaceutical Council, Takeda Pharmaceuticals, Pfizer, Novartis, and Eli Lilly and Company outside the submitted work. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-0057.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol: See the Supplement. Statistical code: The model is available from Dr. Sandhu (e-mail, [email protected]
Corresponding Author: Alexander T. Sandhu, MD, MS, Stanford University Center for Primary Care and Outcomes Research, 117 Encina Commons, Stanford, CA 94305; e-mail, [email protected]
Current Author Addresses: Dr. Sandhu: Stanford University Center for Primary Care and Outcomes Research, 117 Encina Commons, Stanford, CA 94305.
Drs. Ollendorf, Chapman, and Pearson: Institute for Clinical and Economic Review, Two Liberty Square, 9th Floor, Boston, MA 02109.
Dr. Heidenreich: Palo Alto VA Medical Center, 3801 Miranda Avenue, Palo Alto, CA 94304.
Author Contributions: Conception and design: A.T. Sandhu, D.A. Ollendorf, S.D. Pearson, P.A. Heidenreich.
Analysis and interpretation of the data: A.T. Sandhu, D.A. Ollendorf, S.D. Pearson, P.A. Heidenreich.
Drafting of the article: A.T. Sandhu.
Critical revision of the article for important intellectual content: A.T. Sandhu, D.A. Ollendorf, R.H. Chapman, S.D. Pearson, P.A. Heidenreich.
Final approval of the article: A.T. Sandhu, D.A. Ollendorf, R.H. Chapman, S.D. Pearson, P.A. Heidenreich.
Provision of study materials or patients: A.T. Sandhu.
Statistical expertise: A.T. Sandhu.
Obtaining of funding: D.A. Ollendorf, S.D. Pearson.
Administrative, technical, or logistic support: A.T. Sandhu, D.A. Ollendorf, R.H. Chapman.
Collection and assembly of data: A.T. Sandhu.
This article was published at www.annals.org on 30 August 2016.
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