PMID- 30194623 OWN - NLM STAT- MEDLINE DCOM- 20190920 LR - 20190920 IS - 1179-2027 (Electronic) IS - 1170-7690 (Print) IS - 1170-7690 (Linking) VI - 36 IP - 12 DP - 2018 Dec TI - Cost-Effectiveness Analysis of Patiromer and Spironolactone Therapy in Heart Failure Patients with Hyperkalemia. PG - 1463-1473 LID - 10.1007/s40273-018-0709-3 [doi] AB - 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. FAU - Bounthavong, Mark AU - Bounthavong M AD - Department of Pharmacy, University of Washington, 1959 NE Pacific St, HSB H375-P, Box 357630, Seattle, WA, 98195-7630, USA. FAU - Butler, Javed AU - Butler J AD - Division of Cardiology, Stony Brook University, Stony Brook, NY, USA. FAU - Dolan, Chantal M AU - Dolan CM AD - CMD Consulting, Sandy, UT, USA. FAU - Dunn, Jeffrey D AU - Dunn JD AD - Magellan Rx, Salt Lake City, UT, USA. FAU - Fisher, Kathryn A AU - Fisher KA AD - CMD Consulting, Sandy, UT, USA. FAU - Oestreicher, Nina AU - Oestreicher N AD - Epidemiology, HEOR and Observational Research, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, CA, USA. AD - Department of Clinical Pharmacy, University of California, San Francisco, CA, USA. FAU - Pitt, Bertram AU - Pitt B AD - University of Michigan School of Medicine, Ann Arbor, MI, USA. FAU - Hauptman, Paul J AU - Hauptman PJ AD - Division of Cardiology, Department of Medicine, Saint Louis University School of Medicine, Saint Louis, MI, USA. FAU - Veenstra, David L AU - Veenstra DL AD - Department of Pharmacy, University of Washington, 1959 NE Pacific St, HSB H375-P, Box 357630, Seattle, WA, 98195-7630, USA. veenstra@uw.edu. LA - eng GR - U54 GM115428/GM/NIGMS NIH HHS/United States PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - New Zealand TA - Pharmacoeconomics JT - PharmacoEconomics JID - 9212404 RN - 0 (Diuretics) RN - 0 (Polymers) RN - 1FQ2RY5YHH (patiromer) RN - 27O7W4T232 (Spironolactone) EIN - Pharmacoeconomics. 2019 May 14;:. PMID: 31089966 MH - Aged MH - Cost-Benefit Analysis MH - Diuretics/administration & dosage/economics MH - Economics, Pharmaceutical MH - Heart Failure/complications/*drug therapy/economics MH - Hospitalization/economics MH - Humans MH - Hyperkalemia/*drug therapy/economics/etiology MH - Markov Chains MH - Polymers/*administration & dosage/economics MH - Quality-Adjusted Life Years MH - Randomized Controlled Trials as Topic MH - Spironolactone/*administration & dosage/economics MH - Treatment Outcome PMC - PMC6244629 COIS- Mark Bounthavong and David L. Veenstra report consulting relationships with Relypsa, Inc., a Vifor Pharma Group Company. Javed Butler reports consultancy/advisory board fees from Amgen, Array, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CVRx, G3 Pharmaceutical, Innolife, Janssen, Luitpold, Medtronic, Merck, Novartis, Relypsa, Inc., a Vifor Pharma Group Company, Stealth Peptide, SC Pharma, Vifor, and ZS Pharma; other research support and research grants from European Union and the National Institutes of Health; and speaker/honoraria from Novartis and Janssen. Chantal M. Dolan and Kathryn A. Fisher are employees of CMD Consulting, and report consulting relationships with Genentech Inc., Gilead Sciences, Halozyme Therapeutics, Iconic Therapeutics, Semnur Pharmaceuticals and Relypsa, Inc., a Vifor Pharma Group Company. Jeffrey A. Dunn reports consultancy/advisory board fees from Relypsa, Inc., a Vifor Pharma Group Company. Nina Oestreicher reports previous employment by Relypsa, Inc., a Vifor Pharma Group Company at the time of the study. Bertram Pitt reports serving as a consultant to Sanofi, Relypsa, Merck, Bayer, AstraZeneca, scPharmaceuticals, Tricida, KBP Biosciences, Stealth Peptides, Sarfez, and AuraSense; stock options in scPharmaceuticals, Tricida, KBP Biosciences, Sarfez, and AuraSense; serving on data safety monitoring committees for and receiving personal fees from Johnson & Johnson; and, in addition, he has a pending patent EFS ID 14916043, application number licensed to the University of Michigan School of Medicine. Paul J. Hauptman reports consultant/advisory board fees, research grants, and speaker/honoraria from Relypsa, Inc., a Vifor Pharma Group Company. EDAT- 2018/09/09 06:00 MHDA- 2019/09/21 06:00 PMCR- 2018/09/08 CRDT- 2018/09/09 06:00 PHST- 2018/09/09 06:00 [pubmed] PHST- 2019/09/21 06:00 [medline] PHST- 2018/09/09 06:00 [entrez] PHST- 2018/09/08 00:00 [pmc-release] AID - 10.1007/s40273-018-0709-3 [pii] AID - 709 [pii] AID - 10.1007/s40273-018-0709-3 [doi] PST - ppublish SO - Pharmacoeconomics. 2018 Dec;36(12):1463-1473. doi: 10.1007/s40273-018-0709-3.