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      Cost-Effectiveness Analysis of Patiromer and Spironolactone Therapy in Heart Failure Patients with Hyperkalemia

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          Abstract

          Background and Objective

          Certain patients with heart failure (HF) are unable to tolerate spironolactone therapy due to hyperkalemia. Patiromer is a novel agent used to treat hyperkalemia and has been shown to be efficacious, safe, and well-tolerated. The potential clinical outcomes and economic value of using patiromer and spironolactone in patients with HF unable to otherwise tolerate spironolactone due to hyperkalemia are unclear. The objective of this analysis was to model the potential pharmacoeconomic value of using patiromer and spironolactone in patients with a history of hyperkalemia that prevents them from utilizing spironolactone.

          Methods

          We performed a cost-effectiveness analysis of treatment with patiromer, spironolactone, and an angiotensin-converting enzyme inhibitor (ACEI) in patients with New York Heart Association (NYHA) class III–IV HF compared with ACEI alone. A Markov model was constructed to simulate a cohort of 65-year-old patients diagnosed with HF from the payer perspective across the lifetime horizon. Clinical inputs were derived from the RALES and OPAL-HK randomized trials of spironolactone and patiromer, respectively. Utility estimates and costs were derived from the literature and list prices. Outcomes assessed included hospitalization, life expectancy, and quality-adjusted life-years (QALYs), costs, and the incremental cost-effectiveness ratio (ICER). One-way and probability sensitivity analyses were performed to test the robustness of the model findings.

          Results

          Treatment with patiromer–spironolactone–ACEI was projected to increase longevity compared with ACEI alone (5.29 vs. 4.62 life-years gained, respectively), greater QALYs (2.79 vs. 2.60), and costs (US$28,200 vs. US$18,200), giving an ICER of US$52,700 per QALY gained. The ICERs ranged from US$40,000 to US$85,800 per QALY gained in 1-way sensitivity analyses.

          Conclusion

          Our results suggest that the use of spironolactone–patiromer–ACEI may provide clinical benefit and good economic value in patients with NYHA class III–IV HF unable to tolerate spironolactone due to hyperkalemia.

          Electronic supplementary material

          The online version of this article (10.1007/s40273-018-0709-3) contains supplementary material, which is available to authorized users.

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          Most cited references25

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          Rates of hyperkalemia after publication of the Randomized Aldactone Evaluation Study.

          David Juurlink, Muhammad Mamdani, Douglas S Lee … (2004)
          The Randomized Aldactone Evaluation Study (RALES) demonstrated that spironolactone significantly improves outcomes in patients with severe heart failure. Use of angiotensin-converting-enzyme (ACE) inhibitors is also indicated in these patients. However, life-threatening hyperkalemia can occur when these drugs are used together. We conducted a population-based time-series analysis to examine trends in the rate of spironolactone prescriptions and the rate of hospitalization for hyperkalemia in ambulatory patients before and after the publication of RALES. We linked prescription-claims data and hospital-admission records for more than 1.3 million adults 66 years of age or older in Ontario, Canada, for the period from 1994 through 2001. Among patients treated with ACE inhibitors who had recently been hospitalized for heart failure, the spironolactone-prescription rate was 34 per 1000 patients in 1994, and it increased immediately after the publication of RALES, to 149 per 1000 patients by late 2001 (P<0.001). The rate of hospitalization for hyperkalemia rose from 2.4 per 1000 patients in 1994 to 11.0 per 1000 patients in 2001 (P<0.001), and the associated mortality rose from 0.3 per 1000 to 2.0 per 1000 patients (P<0.001). As compared with expected numbers of events, there were 560 (95 percent confidence interval, 285 to 754) additional hyperkalemia-related hospitalizations and 73 (95 percent confidence interval, 27 to 120) additional hospital deaths during 2001 among older patients with heart failure who were treated with ACE inhibitors in Ontario. Publication of RALES was not associated with significant decreases in the rates of readmission for heart failure or death from all causes. The publication of RALES was associated with abrupt increases in the rate of prescriptions for spironolactone and in hyperkalemia-associated morbidity and mortality. Closer laboratory monitoring and more judicious use of spironolactone may reduce the occurrence of this complication. Copyright 2004 Massachusetts Medical Society
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            Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors.

            Matthew Weir, George L. Bakris, David A Bushinsky … (2015)
            Hyperkalemia increases the risk of death and limits the use of inhibitors of the renin-angiotensin-aldosterone system (RAAS) in high-risk patients. We assessed the safety and efficacy of patiromer, a nonabsorbed potassium binder, in a multicenter, prospective trial.
            Article 0 comments Cited 199 times – based on 0 reviews     Review now
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              Effect of spironolactone on diastolic function and exercise capacity in patients with heart failure with preserved ejection fraction: the Aldo-DHF randomized controlled trial.

              Frank Edelmann, Rolf Wachter, Albrecht G Schmidt … (2013)
              Diastolic heart failure (ie, heart failure with preserved ejection fraction) is a common condition without established therapy, and aldosterone stimulation may contribute to its progression. To assess the efficacy and safety of long-term aldosterone receptor blockade in heart failure with preserved ejection fraction. The primary objective was to determine whether spironolactone is superior to placebo in improving diastolic function and maximal exercise capacity in patients with heart failure with preserved ejection fraction. The Aldo-DHF trial, a multicenter, prospective, randomized, double-blind, placebo-controlled trial conducted between March 2007 and April 2012 at 10 sites in Germany and Austria that included 422 ambulatory patients (mean age, 67 [SD, 8] years; 52% female) with chronic New York Heart Association class II or III heart failure, preserved left ventricular ejection fraction of 50% or greater, and evidence of diastolic dysfunction. Patients were randomly assigned to receive 25 mg of spironolactone once daily (n=213) or matching placebo (n=209) with 12 months of follow-up. The equally ranked co-primary end points were changes in diastolic function (E/e') on echocardiography and maximal exercise capacity (peak VO2) on cardiopulmonary exercise testing, both measured at 12 months. Diastolic function (E/e') decreased from 12.7 (SD, 3.6) to 12.1 (SD, 3.7) with spironolactone and increased from 12.8 (SD, 4.4) to 13.6 (SD, 4.3) with placebo (adjusted mean difference, -1.5; 95% CI, -2.0 to -0.9; P < .001). Peak VO2 did not significantly change with spironolactone vs placebo (from 16.3 [SD, 3.6] mL/min/kg to 16.8 [SD, 4.6] mL/min/kg and from 16.4 [SD, 3.5] mL/min/kg to 16.9 [SD, 4.4] mL/min/kg, respectively; adjusted mean difference, +0.1 mL/min/kg; 95% CI, -0.6 to +0.8 mL/min/kg; P = .81). Spironolactone induced reverse remodeling (left ventricular mass index declined; difference, -6 g/m2; 95% CI, -10 to-1 g/m2; P = .009) and improved neuroendocrine activation (N-terminal pro-brain-type natriuretic peptide geometric mean ratio, 0.86; 95% CI, 0.75-0.99; P = .03) but did not improve heart failure symptoms or quality of life and slightly reduced 6-minute walking distance (-15 m; 95% CI, -27 to -2 m; P = .03). Spironolactone also modestly increased serum potassium levels (+0.2 mmol/L; 95% CI, +0.1 to +0.3; P < .001) and decreased estimated glomerular filtration rate (-5 mL/min/1.73 m2; 95% CI, -8 to -3 mL/min/1.73 m2; P < .001) without affecting hospitalizations. In this randomized controlled trial, long-term aldosterone receptor blockade improved left ventricular diastolic function but did not affect maximal exercise capacity, patient symptoms, or quality of life in patients with heart failure with preserved ejection fraction. Whether the improved left ventricular function observed in the Aldo-DHF trial is of clinical significance requires further investigation in larger populations. clinicaltrials.gov Identifier: ISRCTN94726526; Eudra-CT No: 2006-002605-31.
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                Author and article information

                Contributors
                David L. Veenstra: 001-206.221.6936 , veenstra@uw.edu
                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 September 2018
                Publication date PMC-release: 8 September 2018
                Publication date (Print): 2018
                Volume: 36
                Issue: 12
                Pages: 1463-1473
                Affiliations
                [1 ]ISNI 0000000122986657, GRID grid.34477.33, Department of Pharmacy, , University of Washington, ; 1959 NE Pacific St, HSB H375-P, Box 357630, Seattle, WA 98195-7630 USA
                [2 ]ISNI 0000 0001 2216 9681, GRID grid.36425.36, Division of Cardiology, , Stony Brook University, ; Stony Brook, NY USA
                [3 ]CMD Consulting, Sandy, UT USA
                [4 ]Magellan Rx, Salt Lake City, UT USA
                [5 ]Epidemiology, HEOR and Observational Research, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, CA USA
                [6 ]ISNI 0000 0001 2297 6811, GRID grid.266102.1, Department of Clinical Pharmacy, , University of California, ; San Francisco, CA USA
                [7 ]ISNI 0000000086837370, GRID grid.214458.e, University of Michigan School of Medicine, ; Ann Arbor, MI USA
                [8 ]ISNI 0000 0004 1936 9342, GRID grid.262962.b, Division of Cardiology, Department of Medicine, , Saint Louis University School of Medicine, ; Saint Louis, MI USA
                Article
                Publisher ID: 709
                DOI: 10.1007/s40273-018-0709-3
                PMC ID: 6244629
                PubMed ID: 30194623
                SO-VID: c8073b3f-cd2c-457d-96bc-43d98e1d0990
                Copyright © © The Author(s) 2018
                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

                History
                Funding
                Funded by: Relypsa, Inc., a Vifor Pharma Group Company
                Categories
                Subject: Original Research Article
                Custom metadata
                issue-copyright-statement © Springer Nature Switzerland AG 2018

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

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