Cost-effectiveness of sacubitril-valsartan in patients with heart failure with reduced ejection fraction

Annals of Internal Medicine

Volumn 165, Issue 10, 2016, Pages 681-689

  Sandhu, Alexander T ^a   Ollendorf, Daniel A ^b   Chapman, Richard H ^b   Pearson, Steven D ^b   Heidenreich, Paul A ^c  

^a STANFORD UNIVERSITY   (United States)

^b INSTITUTE FOR CLINICAL AND ECONOMIC REVIEW   (United States)

^c VA PALO ALTO HEALTH CARE SYSTEM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

LISINOPRIL; LOSARTAN; SACUBITRIL PLUS VALSARTAN; AMINOBUTYRIC ACID DERIVATIVE; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; TETRAZOLE DERIVATIVE;

ARTICLE; CARDIOVASCULAR MORTALITY; COST EFFECTIVENESS ANALYSIS; DRUG COST; HEALTH CARE COST; HEART EJECTION FRACTION; HEART FAILURE; HIDDEN MARKOV MODEL; HOSPITALIZATION; HUMAN; NEW YORK HEART ASSOCIATION CLASS; PRIORITY JOURNAL; QUALITY ADJUSTED LIFE YEAR; TREATMENT OUTCOME; ANGIONEUROTIC EDEMA; CHEMICALLY INDUCED; COST BENEFIT ANALYSIS; ECONOMICS; HEART STROKE VOLUME; MARKOV CHAIN; MIDDLE AGED; MORTALITY; PATHOPHYSIOLOGY; PHYSIOLOGY;

AMINOBUTYRATES; ANGIOEDEMA; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; COST-BENEFIT ANALYSIS; HEART FAILURE; HOSPITALIZATION; HUMANS; LISINOPRIL; MARKOV CHAINS; MIDDLE AGED; QUALITY-ADJUSTED LIFE YEARS; STROKE VOLUME; TETRAZOLES; TREATMENT OUTCOME;

EID: 84995933518     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/M16-0057     Document Type: Article

References (54)

1. Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, et al; American Heart Association Advocacy Coordinating Committee. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013;6:606-19. [PMID: 23616602] doi:10.1161/HHF .0b013e318291329a
2. Sayer G, Bhat G. The renin-Angiotensin-Aldosterone system and heart failure. Cardiol Clin. 2014;32:21-32. [PMID: 24286576] doi:10 .1016/j.ccl.2013.09.002
3. Lillyblad MP. Dual angiotensin receptor and neprilysin inhibition with sacubitril/valsartan in chronic systolic heart failure: understanding the new PARADIGM. Ann Pharmacother. 2015;49:1237-51. [PMID: 26175499] doi:10.1177/1060028015593093
4. McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, et al; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371:993-1004. [PMID: 25176015] doi:10.1056/NEJMoa1409077
5. Packer M, McMurray JJ, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, et al; PARADIGM-HF Investigators and Coordinators. Angiotensin receptor neprilysin inhibition compared with enalapril on the risk of clinical progression in surviving patients with heart failure. Circulation. 2015;131:54-61. [PMID: 25403646] doi:10.1161/CIRCULATIONAHA.114.013748
6. Red Book Online [online database]. Greenwood Village, CO: Truven Health Analytics; 2015. Accessed at http://micromedex.com/products/product-suites/clinical-knowledge/redbook on 8 August 2015.
7. Center for Drug Evaluation and Research. Medical Review(s). Application review: 207620Orig1s000. 2014. Accessed at www.access data.fda.gov/drugsatfda-docs/nda/2015/207620Orig1s000MedR .pdf on 15 July 2016.
8. Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, et al; American College of Cardiology Foundation. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013; 62:e147-239. [PMID: 23747642] doi:10.1016/j.jacc.2013.05.019
9. Tu K, Mamdani M, Kopp A, Lee D. Comparison of angiotensinconverting enzyme inhibitors in the treatment of congestive heart failure. Am J Cardiol. 2005;95:283-6. [PMID: 15642572]
10. Anderson JL, Heidenreich PA, Barnett PG, Creager MA, Fonarow GC, Gibbons RJ, et al. ACC/AHA statement on cost/value methodology in clinical practice guidelines and performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures and Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63:2304-22. [PMID: 24681044] doi:10.1016/j.jacc.2014.03.016
11. Neumann PJ, Cohen JT, Weinstein MC. Updating cost-effectiveness-the curious resilience of the $50,000-per-QALY threshold. N Engl J Med. 2014;371:796-7. [PMID: 25162885] doi:10.1056/NEJMp1405158
12. Weinstein MC, Siegel JE, Gold MR, Kamlet MS, Russell LB. Recommendations of the Panel on Cost-effectiveness in Health and Medicine. JAMA. 1996;276:1253-8. [PMID: 8849754]
13. Caro JJ, Briggs AH, Siebert U, Kuntz KM; ISPOR-SMDM Modeling Good Research Practices Task Force. Modeling good research practices-overview: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force-1. Med Decis Making. 2012;32:667-77. [PMID: 22990082]
14. Heran BS, Musini VM, Bassett K, Taylor RS, Wright JM. Angiotensin receptor blockers for heart failure. Cochrane Database Syst Rev. 2012:CD003040. [PMID: 22513909] doi:10.1002/14651858 .CD003040.pub2
15. Desai AS, McMurray JJ, Packer M, Swedberg K, Rouleau JL, Chen F, et al. Effect of the angiotensin-receptor-neprilysin inhibitor LCZ696 compared with enalapril on mode of death in heart failure patients. Eur Heart J. 2015;36:1990-7. [PMID: 26022006] doi:10 .1093/eurheartj/ehv186
16. Jaagosild P, Dawson NV, Thomas C, Wenger NS, Tsevat J, Knaus WA, et al. Outcomes of acute exacerbation of severe congestive heart failure: quality of life, resource use, and survival. SUPPORT Investigators. The Study to Understand Prognosis and Preferences for Outcomes and Risks of Treatments. Arch Intern Med. 1998;158: 1081-9. [PMID: 9605779]
17. Centers for Medicare & Medicaid Services. Physician Fee Schedule. Baltimore: Centers for Medicare & Medicaid Services; 2016. Accessed at www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html?redirect=/PhysicianFee Sched on 16 February 2015.
18. Ollendorf DA, Sandhu AT, Chapman R, Heidenreich PA, Russo E, Shore KK, et al. CardioMEMS™ HF System (St. Jude Medical, Inc.) and Sacubitril/Valsartan (Entresto™, Novartis AG) for Management of Congestive Heart Failure: Effectiveness, Value, and Value-Based Price Benchmarks. Boston: Institute for Clinical and Economic Review; 2015. Accessed at https://icer-review.org/wp-content/uploads/2016/01/CHF-Final-Report-120115.pdf on 31 July 2016.
19. Swedberg K. Patient and Physician Reported Outcomes. Presented at the European Society of Cardiology World Congress on Acute Heart Failure, London, United Kingdom, 29 August-2 September 2015. Accessed at www.escardio.org/Congresses-&-Events/Upcoming-congresses/Heart-Failure/Congress-resources/Slides on 1 November 2015.
20. Ziaeian B, Sharma PP, Yu TC, Johnson KW, Fonarow GC. Factors associated with variations in hospital expenditures for acute heart failure in the United States. Am Heart J. 2015;169:282-289. [PMID: 25641538] doi:10.1016/j.ahj.2014.11.007
21. Gustafsson F, Torp-Pedersen C, Seibaek M, Burchardt H, Køber L; DIAMOND study group. Effect of age on short and long-term mortality in patients admitted to hospital with congestive heart failure. Eur Heart J. 2004;25:1711-7. [PMID: 15451149]
22. Arias E, Heron M, Tejada-Vera B. United States life tables eliminating certain causes of death, 1999-2001. Natl Vital Stat Rep. 2013; 61:1-128. [PMID: 24968617]
23. Congressional Budget Office. Prescription drug pricing in the private sector. 2007. Accessed at www.cbo.gov/sites/default/files/110th-congress-2007-2008/reports/01-03-prescriptiondrug.pdf on 16 April 2016.
24. Centers for Medicare & Medicaid Services. FY 2015 Hospital Inpatient PPS Final Rule. Baltimore: Centers for Medicare & Medicaid Services; 2014. Accessed at www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/AcuteInpatientPPS/FY2015-IPPS-Final-Rule-Home-Page.html on 8 August 2015.
25. Dunlay SM, Shah ND, Shi Q, Morlan B, VanHouten H, Long KH, et al. Lifetime costs of medical care after heart failure diagnosis. Circ Cardiovasc Qual Outcomes. 2011;4:68-75. [PMID: 21139091] doi:10 .1161/CIRCOUTCOMES.110.957225
26. Göhler A, Geisler BP, Manne JM, Kosiborod M, Zhang Z, Weintraub WS, et al. Utility estimates for decision-Analytic modeling in chronic heart failure-health states based on New York Heart Association classes and number of rehospitalizations. Value Health. 2009; 12:185-7. [PMID: 18647251] doi:10.1111/j.1524-4733.2008.00425.x
27. Claggett B, Packer M, McMurray JJ, Swedberg K, Rouleau J, Zile MR, et al; PARADIGM-HF Investigators. Estimating the long-term treatment benefits of sacubitril-valsartan [Letter]. N Engl J Med. 2015;373:2289-90. [PMID: 26630151] doi:10.1056/NEJMc1509753
28. Shah MR, Lauer MS. Striking the right balance in heart failure. Ann Intern Med. 2016;164:125-6. [PMID: 26720859] doi:10.7326/M15-2587
29. Packer M. Unbelievable folly of clinical trials in heart failure: the inconvenient truth about how investigators and guidelines weigh evidence. Circ Heart Fail. 2016;9. [PMID: 27009552] doi:10.1161/CIRCHEARTFAILURE.116.002837
30. Packer M. Love of angiotensin-converting enzyme inhibitors in the time of cholera. JACC Heart Fail. 2016. [PMID: 27107555] doi:10 .1016/j.jchf.2016.02.012
31. Kaplinsky E. PARADIGM-HF trial: will LCZ696 change the current treatment of systolic heart failure? J Geriatr Cardiol. 2015;12:470-3. [PMID: 26512236] doi:10.11909/j.issn.1671-5411.2015.05.010
32. King JB, Bress AP, Reese AD, Munger MA. Neprilysin inhibition in heart failure with reduced ejection fraction: a clinical review. Pharmacotherapy. 2015;35:823-37. [PMID: 26406774] doi:10.1002/phar .1629
33. Braunwald E. The path to an angiotensin receptor antagonistneprilysin inhibitor in the treatment of heart failure. J Am Coll Cardiol. 2015;65:1029-41. [PMID: 25766951] doi:10.1016/j.jacc.2015.01 .033
34. Califf RM. LCZ696: too good to be true? [Editorial]. Eur Heart J. 2015;36:410-2. [PMID: 25549727] doi:10.1093/eurheartj/ehu501
35. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. The SOLVD Investigators. N Engl J Med. 1991;325:293-302. [PMID: 2057034]
36. Kjekshus J, Swedberg K, Snapinn S. Effects of enalapril on longterm mortality in severe congestive heart failure. CONSENSUS Trial Group. Am J Cardiol. 1992;69:103-7. [PMID: 1729857]
37. Packer M, Poole-Wilson PA, Armstrong PW, Cleland JG, Horowitz JD, Massie BM, et al. Comparative effects of low and high doses of the angiotensin-converting enzyme inhibitor, lisinopril, on morbidity and mortality in chronic heart failure. ATLAS Study Group. Circulation. 1999;100:2312-8. [PMID: 10587334]
38. Nanas JN, Alexopoulos G, Anastasiou-Nana MI, Karidis K, Tirologos A, Zobolos S, et al. Outcome of patients with congestive heart failure treated with standard versus high doses of enalapril: a multicenter study. High Enalapril Dose Study Group. J Am Coll Cardiol. 2000;36:2090-5. [PMID: 11127445]
39. Gaziano TA, Fonarow GC, Claggett B, Chan WW, Deschaseaux-Voinet C, Turner SJ, et al. Cost-effectiveness analysis of sacubitril/valsartan vs enalapril in patients with heart failure and reduced ejection fraction. JAMA Cardiol. 2016. doi:10.1001/jamacardio.2016 .1747
40. King JB, Shah RU, Bress AP, Nelson RE, Bellows BK. Costeffectiveness of sacubitril-valsartan combination therapy compared with enalapril for the treatment of heart failure with reduced ejection fraction. JACC Heart Fail. 2016;4:392-402. [PMID: 27039128] doi:10 .1016/j.jchf.2016.02.007
41. Ollendorf DA, Sandhu AT, Pearson SD. Sacubitril-valsartan for the treatment of heart failure: effectiveness and value. JAMA Intern Med. 2016;176:249-50. [PMID: 26720832] doi:10.1001/jamainternmed.2015.7661
42. Solomon SD, McMurray J, Desai A, Zile M, Swedberg K, Shi V, et al. Benefit of sacubitril/valsartan therapy in clinically stable patients with heart failure and reduced ejection fraction. J Am Coll Cardiol. 2016;67:1349. doi:10.1016/S0735-1097(16)31350-X
43. Poole-Wilson PA, Swedberg K, Cleland JG, Di Lenarda A, Hanrath P, Komajda M, et al; Carvedilol Or Metoprolol European Trial Investigators. Comparison of carvedilol and metoprolol on clinical outcomes in patients with chronic heart failure in the Carvedilol Or Metoprolol European Trial (COMET): randomised controlled trial. Lancet. 2003;362:7-13. [PMID: 12853193]
44. Swedberg K, Kjekshus J, Snapinn S. Long-term survival in severe heart failure in patients treated with enalapril. Ten year follow-up of CONSENSUS I. Eur Heart J. 1999;20:136-9. [PMID: 10099910]
45. Feldman AM, Haller JA, DeKosky ST. Valsartan/sacubitril for heart failure: reconciling disparities between preclinical and clinical investigations. JAMA. 2016;315:25-6. [PMID: 26641736] doi:10 .1001/jama.2015.17632
46. Ahmed A. A propensity matched study of New York Heart Association class and natural history end points in heart failure. Am J Cardiol. 2007;99:549-53. [PMID: 17293201]
47. Rogers JK, McMurray JJ, Pocock SJ, Zannad F, Krum H, van Veldhuisen DJ, et al. Eplerenone in patients with systolic heart failure and mild symptoms: analysis of repeat hospitalizations. Circulation. 2012;126:2317-23. [PMID: 23042980] doi:10.1161/CIRCULATIONAHA.112.110536
48. Stout NK, Knudsen AB, Kong CY, McMahon PM, Gazelle GS. Calibration methods used in cancer simulation models and suggested reporting guidelines. Pharmacoeconomics. 2009;27:533-45. [PMID: 19663525] doi:10.2165/11314830-000000000-00000
49. Jhund PS, Fu M, Bayram E, Chen CH, Negrusz-Kawecka M, Rosenthal A, et al; PARADIGM-HF Investigators and Committees. Efficacy and safety of LCZ696 (sacubitril-valsartan) according to age: insights from PARADIGM-HF. Eur Heart J. 2015;36:2576-84. [PMID: 26231885] doi:10.1093/eurheartj/ehv330
50. U.S. Department of Labor. Consumer Price Index. Washington, DC: U.S. Department of Labor; 2016. Accessed at www.bls.gov/bls/inflation.htm on 1 March 2015.
51. Agency for Healthcare Research and Quality. National Inpatient Sample: National Statistics on All Stays. Rockville, MD: Agency for Healthcare Research and Quality; 2016. Accessed at http://hcupnet .ahrq.gov/HCUPnet.jsp on 8 August 2015.
52. Centers for Medicare & Medicaid Services. Hospital Outpatient Prospective Payment-Proposed Rule. Baltimore: Centers for Medicare & Medicaid Services; 2013. Accessed at www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatient PPS/Hospital-Outpatient-Regulations-And-Notices.html on 16 February 2015.
53. Liao L, Anstrom KJ, Gottdiener JS, Pappas PA, Whellan DJ, Kitzman DW, et al. Long-term costs and resource use in elderly participants with congestive heart failure in the Cardiovascular Health Study. Am Heart J. 2007;153:245-52. [PMID: 17239685]
54. Reed SD, Li Y, Dunlap ME, Kraus WE, Samsa GP, Schulman KA, et al. In-hospital resource use and medical costs in the last year of life by mode of death (from the HF-ACTION randomized controlled trial).AmJCardiol.2012;110:1150-5.[PMID:22762718]doi:10.1016/j .amjcard.2012.05.059