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      Cost Effectiveness of Vericiguat for the Treatment of Chronic Heart Failure with Reduced Ejection Fraction Following a Worsening Heart Failure Event from a US Medicare Perspective

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          Abstract

          Objective

          Given the high economic burden of disease among adult patients with chronic heart failure with reduced ejection fraction (HFrEF) following a worsening heart failure event in the US, this study aimed to estimate the cost effectiveness of vericiguat plus prior standard-of-care therapies (PSoCT) versus PSoCT alone from a US Medicare perspective.

          Methods

          A four-state Markov model (alive prior to heart failure hospitalization, alive during heart failure hospitalization, alive post-heart failure hospitalization, and death) was developed to predict clinical and economic outcomes, based on the results of the VICTORIA trial, in which patients with chronic HFrEF following a worsening heart failure were randomized to placebo or vericiguat, in addition to PSoCT, which consisted of β-blockers, renin-angiotensin-aldosterone inhibitors, mineralocorticoid receptor antagonists, and the angiotensin receptor–neprilysin inhibitor sacubitril/valsartan. Risks of heart failure hospitalization and cardiovascular mortality were based on multivariable regression models derived from VICTORIA data. Utilities were derived from VICTORIA EQ-5D data and the literature. Costs included drug acquisition, heart failure hospitalization, routine care, and terminal care. Primary outcomes included heart failure hospitalization, cardiovascular mortality, life-years, quality-adjusted life-years (QALYs), and incremental costs per QALY gained over a 30-year lifetime horizon, discounted at 3.0% annually.

          Results

          For the VICTORIA overall intent-to-treat population, compared with PSoCT, vericiguat plus PSoCT resulted in 19 fewer heart failure hospitalizations and 13 fewer cardiovascular deaths per 1000 patients, as well as 0.28 QALY gained per patient at an incremental cost of $23,322, leading to $82,448 per QALY gained.

          Conclusions

          Based on the results of VICTORIA, patients treated with vericiguat had lower rates of heart failure hospitalization and cardiovascular death. The addition of vericiguat to PSoCT was estimated to increase QALYs and to be cost effective at a willingness-to-pay threshold of $100,000 per QALY gained.

          Supplementary Information

          The online version contains supplementary material available at 10.1007/s40273-021-01091-w.

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          Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction

          John J.V. McMurray, Scott D. Solomon, Silvio E Inzucchi … (2020)
          In patients with type 2 diabetes, inhibitors of sodium-glucose cotransporter 2 (SGLT2) reduce the risk of a first hospitalization for heart failure, possibly through glucose-independent mechanisms. More data are needed regarding the effects of SGLT2 inhibitors in patients with established heart failure and a reduced ejection fraction, regardless of the presence or absence of type 2 diabetes.
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            Angiotensin–Neprilysin Inhibition versus Enalapril in Heart Failure

            John J.V. McMurray, Milton Packer, Akshay S Desai … (2014)
            We compared the angiotensin receptor-neprilysin inhibitor LCZ696 with enalapril in patients who had heart failure with a reduced ejection fraction. In previous studies, enalapril improved survival in such patients. In this double-blind trial, we randomly assigned 8442 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive either LCZ696 (at a dose of 200 mg twice daily) or enalapril (at a dose of 10 mg twice daily), in addition to recommended therapy. The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure, but the trial was designed to detect a difference in the rates of death from cardiovascular causes. The trial was stopped early, according to prespecified rules, after a median follow-up of 27 months, because the boundary for an overwhelming benefit with LCZ696 had been crossed. At the time of study closure, the primary outcome had occurred in 914 patients (21.8%) in the LCZ696 group and 1117 patients (26.5%) in the enalapril group (hazard ratio in the LCZ696 group, 0.80; 95% confidence interval [CI], 0.73 to 0.87; P<0.001). A total of 711 patients (17.0%) receiving LCZ696 and 835 patients (19.8%) receiving enalapril died (hazard ratio for death from any cause, 0.84; 95% CI, 0.76 to 0.93; P<0.001); of these patients, 558 (13.3%) and 693 (16.5%), respectively, died from cardiovascular causes (hazard ratio, 0.80; 95% CI, 0.71 to 0.89; P<0.001). As compared with enalapril, LCZ696 also reduced the risk of hospitalization for heart failure by 21% (P<0.001) and decreased the symptoms and physical limitations of heart failure (P=0.001). The LCZ696 group had higher proportions of patients with hypotension and nonserious angioedema but lower proportions with renal impairment, hyperkalemia, and cough than the enalapril group. LCZ696 was superior to enalapril in reducing the risks of death and of hospitalization for heart failure. (Funded by Novartis; PARADIGM-HF ClinicalTrials.gov number, NCT01035255.).
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              Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association.

              Paul A Heidenreich, Nancy M Albert, Larry A Allen … (2013)
              Heart failure (HF) is an important contributor to both the burden and cost of national healthcare expenditures, with more older Americans hospitalized for HF than for any other medical condition. With the aging of the population, the impact of HF is expected to increase substantially. We estimated future costs of HF by adapting a methodology developed by the American Heart Association to project the epidemiology and future costs of HF from 2012 to 2030 without double counting the costs attributed to comorbid conditions. The model assumes that HF prevalence will remain constant by age, sex, and race/ethnicity and that rising costs and technological innovation will continue at the same rate. By 2030, >8 million people in the United States (1 in every 33) will have HF. Between 2012 and 2030, real (2010$) total direct medical costs of HF are projected to increase from $21 billion to $53 billion. Total costs, including indirect costs for HF, are estimated to increase from $31 billion in 2012 to $70 billion in 2030. If one assumes all costs of cardiac care for HF patients are attributable to HF (no cost attribution to comorbid conditions), the 2030 projected cost estimates of treating patients with HF will be 3-fold higher ($160 billion in direct costs). The estimated prevalence and cost of care for HF will increase markedly because of aging of the population. Strategies to prevent HF and improve the efficiency of care are needed.
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                Author and article information

                Contributors
                Adnan Alsumali:
                ORCID: http://orcid.org/0000-0002-5139-3583
                adnan.alsumali@merck.com
                Journal
                Journal ID (nlm-ta): Pharmacoeconomics
                Journal ID (iso-abbrev): Pharmacoeconomics
                Title: Pharmacoeconomics
                Publisher: Springer International Publishing (Cham )
                ISSN (Print): 1170-7690
                ISSN (Electronic): 1179-2027
                Publication date (Electronic): 8 October 2021
                Publication date PMC-release: 8 October 2021
                Publication date (Print): 2021
                Volume: 39
                Issue: 11
                Pages: 1343-1354
                Affiliations
                [1 ]GRID grid.417993.1, ISNI 0000 0001 2260 0793, BARDS-Health Economics and Decision Science, , Merck & Co, Inc., ; 2000 Galloping Hill Road, Kenilworth, NJ 07033 USA
                [2 ]GRID grid.417993.1, ISNI 0000 0001 2260 0793, Center for Observational and Real-world Evidence, , Merck & Co, Inc., ; Kenilworth, NJ USA
                [3 ]GRID grid.8991.9, ISNI 0000 0004 0425 469X, London School of Hygiene and Tropical Medicine, ; London, UK
                [4 ]OPEN Health, Bethesda, MD USA
                [5 ]GRID grid.419737.f, ISNI 0000 0004 6047 9949, BARDS-HTA, , MSD Ltd, ; Hoddesdon, Hertfordshire UK
                Author information
                http://orcid.org/0000-0002-5139-3583
                http://orcid.org/0000-0002-0777-1997
                http://orcid.org/0000-0001-8316-6089
                http://orcid.org/0000-0001-7151-4330
                http://orcid.org/0000-0002-9793-7611
                http://orcid.org/0000-0003-3803-1817
                Article
                Publisher ID: 1091
                DOI: 10.1007/s40273-021-01091-w
                PMC ID: 8516766
                PubMed ID: 34623625
                SO-VID: 1dba15f9-3fdc-42ea-a050-9681c4062fc9
                Copyright © © Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A., Andrew Briggs, Rongzhe Liu, Ibrahim Diakite, Dipen Patel 2021
                License:

                Open AccessThis article is licensed under a Creative Commons Attribution- Non-commercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

                History
                Date accepted : 16 September 2021
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100004334, merck;
                Categories
                Subject: Original Research Article
                Custom metadata
                issue-copyright-statement © Springer Nature Switzerland AG 2021

                ScienceOpen disciplines: Economics of health & social care
                Data availability:
                ScienceOpen disciplines: Economics of health & social care

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