Cost-effectiveness analysis of sodium zirconium cyclosilicate for hyperkalemia among patients with chronic kidney disease or heart failure in Kuwait

References

• Simon LV, Hashmi MF, Farrell MW. Hyperkalemia. In: StatPearls. Treasure Island: StatPearls Publishing; 2022.
   Google Scholar
• Lehnhardt A, Kemper MJ. Pathogenesis, diagnosis and management of hyperkalemia. Pediatr Nephrol. 2011;26(3):377–384. doi: 10.1007/s00467-010-1699-3.
   PubMed Web of Science ®Google Scholar
• Sidhu K, Sanjanwala R, Zieroth S. Hyperkalemia in heart failure. Curr Opin Cardiol. 2020;35(2):150–155. doi: 10.1097/HCO.0000000000000709.
   PubMed Web of Science ®Google Scholar
• Murat S, Kaya H, Çavuşoğlu Y, et al. Hyperkalemia in chronic heart failure with renal dysfunction or diabetes mellitus: results from the TREAT HF study. Turk Kardiyol Dern Ars. 2021;49(3):198–205. doi: 10.5543/tkda.2021.58675.
   Web of Science ®Google Scholar
• Hundemer GL, Sood MM. Hyperkalemia with RAAS inhibition: mechanism, clinical significance, and management. Pharmacol Res. 2021;172:105835. doi: 10.1016/j.phrs.2021.105835.
   PubMed Web of Science ®Google Scholar
• AlSahow A, AbdulShafy M, Al-Ghamdi S, et al. Prevalence and management of hyperkalemia in chronic kidney disease and heart failure patients in the Gulf cooperation council (GCC). J Clin Hypertens (Greenwich). 2023;25(3):251–258. doi: 10.1111/jch.14633.
   Web of Science ®Google Scholar
• Humphrey T, Davids MR, Chothia MY, et al. How common is hyperkalaemia? A systematic review and meta-analysis of the prevalence and incidence of hyperkalaemia reported in observational studies. Clin Kidney J. 2021;15(4):727–737. doi: 10.1093/ckj/sfab243.
   Web of Science ®Google Scholar
• Kanda E, Kashihara N, Kohsaka S, et al. Clinical and economic burden of hyperkalemia: a nationwide hospital-based cohort study in Japan. Kidney Med. 2020;2(6):742–752.e1. doi: 10.1016/j.xkme.2020.09.003.
   Google Scholar
• Kjeldsen KP, Schmidt TA. Potassium homoeostasis and pathophysiology of hyperkalaemia. Eur Heart J Suppl. 2019;21(Suppl A):A2–A5. doi: 10.1093/eurheartj/suy033.
   Web of Science ®Google Scholar
• Dunn JD, Benton WW, Orozco-Torrentera E, et al. The burden of hyperkalemia in patients with cardiovascular and renal disease. Am J Manag Care. 2015;21(15 Suppl):s307–s315.
   PubMed Web of Science ®Google Scholar
• An JN, Lee JP, Jeon HJ, et al. Severe hyperkalemia requiring hospitalization: predictors of mortality. Crit Care. 2012;16(6):R225. doi: 10.1186/cc11872.
   PubMed Web of Science ®Google Scholar
• Horne L, Ashfaq A, MacLachlan S, et al. Epidemiology and health outcomes associated with hyperkalemia in a primary care setting in England. BMC Nephrol. 2019;20(1):85. doi: 10.1186/s12882-019-1250-0.
   PubMed Web of Science ®Google Scholar
• Betts KA, Woolley JM, Mu F, et al. The cost of hyperkalemia in the United States. Kidney Int Rep. 2017;3(2):385–393. doi: 10.1016/j.ekir.2017.11.003.
   PubMed Web of Science ®Google Scholar
• Hougen I, Leon SJ, Whitlock R, et al. Hyperkalemia and its association with mortality, cardiovascular events, hospitalizations, and intensive care unit admissions in a population-based retrospective cohort. Kidney Int Rep. 2021;6(5):1309–1316. doi: 10.1016/j.ekir.2021.02.038.
   Web of Science ®Google Scholar
• Luo J, Brunelli SM, Jensen DE, et al. Association between serum potassium and outcomes in patients with reduced kidney function. Clin J Am Soc Nephrol. 2016;11(1):90–100. doi: 10.2215/CJN.01730215.
   PubMed Web of Science ®Google Scholar
• Palaka E, Grandy S, Darlington O, et al. Associations between serum potassium and adverse clinical outcomes: a systematic literature review. Int J Clin Pract. 2020;74(1):e13421. doi: 10.1111/ijcp.13421.
   PubMed Web of Science ®Google Scholar
• Roger SD, Spinowitz BS, Lerma EV, et al. Efficacy and safety of sodium zirconium cyclosilicate for treatment of hyperkalemia: an 11-month open-label extension of HARMONIZE. Am J Nephrol. 2019;50(6):473–480. doi: 10.1159/000504078.
   PubMed Web of Science ®Google Scholar
• Kosiborod M, Rasmussen HS, Lavin P, et al. Effect of sodium zirconium cyclosilicate on potassium lowering for 28 days among outpatients with hyperkalemia: the HARMONIZE randomized clinical trial. JAMA. 2014;312(21):2223–2233. doi: 10.1001/jama.2014.15688.
   PubMed Web of Science ®Google Scholar
• Spinowitz BS, Fishbane S, Pergola PE, et al. Sodium zirconium cyclosilicate among individuals with hyperkalemia: a 12-Month phase 3 study. Clin J Am Soc Nephrol. 2019;14(6):798–809. doi: 10.2215/CJN.12651018.
   PubMed Web of Science ®Google Scholar
• Husereau D, Drummond M, Petrou S, et al. Consolidated health economic evaluation reporting standards (CHEERS)–explanation and elaboration: a report of the ISPOR health economic evaluation publication guidelines good reporting practices task force. Value Health. 2013;16(2):231–250. doi: 10.1016/j.jval.2013.02.002.
   PubMed Web of Science ®Google Scholar
• Caro JJ, Briggs AH, Siebert U, et al. Modeling good research practices–overview: a report of the ISPOR-SMDM modeling good research practices task force-1. Med Decis Making. 2012;32(5):667–677. doi: 10.1177/0272989X12454577.
   PubMed Web of Science ®Google Scholar
• National Institute for Health and Care Excellence. Discounting. 2023. https://view.officeapps.live.com/op/view.aspx?src=https%3A//www.nice.org.uk/Media/Default/About/what-we-do/our-programmes/nice-guidance/chte-methods-consultation/Discounting-task-and-finish-group-report.docx&wdOrigin=BROWSELINK.
   Google Scholar
• Weir MR, Bakris GL, Bushinsky DA, et al. Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors. N Engl J Med. 2015;372(3):211–221. doi: 10.1056/NEJMoa1410853.
   PubMed Web of Science ®Google Scholar
• Pitt B, Anker SD, Bushinsky DA, et al. Evaluation of the efficacy and safety of RLY5016, a polymeric potassium binder, in a double-blind, placebo-controlled study in patients with chronic heart failure (the PEARL-HF) trial. Eur Heart J. 2011;32(7):820–828. doi: 10.1093/eurheartj/ehq502.
   PubMed Web of Science ®Google Scholar
• Epstein M, Reaven NL, Funk SE, et al. Evaluation of the treatment gap between clinical guidelines and the utilization of renin-angiotensin-aldosterone system inhibitors. Am J Manag Care. 2015;21(11 Suppl):S212–S220.
   PubMed Web of Science ®Google Scholar
• Yao G, Freemantle N, Calvert MJ, et al. The long-term cost-effectiveness of cardiac resynchronization therapy with or without an implantable cardioverter-defibrillator. Eur Heart J. 2007;28(1):42–51. doi: 10.1093/eurheartj/ehl382.
   Web of Science ®Google Scholar
• Krogager ML, Eggers-Kaas L, Aasbjerg K, et al. Short-term mortality risk of serum potassium levels in acute heart failure following myocardial infarction. Eur Heart J Cardiovasc Pharmacother. 2015;1(4):245–251. doi: 10.1093/ehjcvp/pvv026.
   Google Scholar
• Humphrey TJL, James G, Wittbrodt ET, et al. Adverse clinical outcomes associated with RAAS inhibitor discontinuation: analysis of over 400 000 patients from the UK clinical practice research datalink (CPRD). Clin Kidney J. 2021;14(10):2203–2212. doi: 10.1093/ckj/sfab029.
   Web of Science ®Google Scholar
• Evans M, Bain SC, Hogan S, et al. Irbesartan delays progression of nephropathy as measured by estimated glomerular filtration rate: post hoc analysis of the irbesartan diabetic nephropathy trial. Nephrol Dial Transplant. 2012;27(6):2255–2263. doi: 10.1093/ndt/gfr696.
   Web of Science ®Google Scholar
• Go AS, Chertow GM, Fan D, et al. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004;351(13):1296–1305. doi: 10.1056/NEJMoa041031.
   PubMed Web of Science ®Google Scholar
• Xie X, Liu Y, Perkovic V, et al. Renin-Angiotensin system inhibitors and kidney and cardiovascular outcomes in patients with CKD: a bayesian network meta-analysis of randomized clinical trials. Am J Kidney Dis. 2016;67(5):728–741. doi: 10.1053/j.ajkd.2015.10.011.
   PubMed Web of Science ®Google Scholar
• Gorodetskaya I, Zenios S, McCulloch CE, et al. Health-related quality of life and estimates of utility in chronic kidney disease. Kidney Int. 2005;68(6):2801–2808. doi: 10.1111/j.1523-1755.2005.00752.x.
   PubMed Web of Science ®Google Scholar
• Lee AJ, Morgan CL, Conway P, et al. Characterisation and comparison of health-related quality of life for patients with renal failure. Curr Med Res Opin. 2005;21(11):1777–1783. doi: 10.1185/030079905X65277.
   PubMed Web of Science ®Google Scholar
• Göhler A, Geisler BP, Manne JM, 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(1):185–187. doi: 10.1111/j.1524-4733.2008.00425.x.
   PubMed Web of Science ®Google Scholar
• Sennfält K, Magnusson M, Carlsson P. Comparison of hemodialysis and peritoneal dialysis–a cost-utility analysis. Perit Dial Int. 2002;22(1):39–47. doi: 10.1177/089686080202200107.
   PubMed Web of Science ®Google Scholar
• Kent S, Briggs A, Eckermann S, et al. Are value of information methods ready for prime time? An application to alternative treatment strategies for NSTEMI patients. Int J Technol Assess Health Care. 2013;29(4):435–442. doi: 10.1017/S0266462313000433.
   PubMed Web of Science ®Google Scholar
• Sullivan PW, Slejko JF, Sculpher MJ, et al. Catalogue of EQ-5D scores for the United Kingdom. Med Decis Making. 2011;31(6):800–804. doi: 10.1177/0272989X11401031.
   PubMed Web of Science ®Google Scholar
• Kristiansen IS, Kvien TK, Nord E. Cost effectiveness of replacing diclofenac with a fixed combination of misoprostol and diclofenac in patients with rheumatoid arthritis. Arthritis and Rheumatism. 1999;42(11):2293–2302. doi: 10.1002/1529-0131(199911)42:11<2293::AID-ANR6>3.0.CO;2-1.
   PubMedGoogle Scholar
• Nafees B, Stafford M, Gavriel S, et al. Health state utilities for non small cell lung cancer. Health Qual Life Outcomes. 2008;6(1):84. doi: 10.1186/1477-7525-6-84.
   PubMed Web of Science ®Google Scholar
• Bakris GL, Pitt B, Weir MR, et al. Effect of patiromer on serum potassium level in patients with hyperkalemia and diabetic kidney disease: the AMETHYST-DN randomized clinical trial. JAMA. 2015;314(2):151–161. doi: 10.1001/jama.2015.7446.
   PubMed Web of Science ®Google Scholar
• Nasir K, Ahmad A. Treatment of hyperkalemia in patients with chronic kidney disease: a comparison of calcium polystyrene sulphonate and sodium polystyrene sulphonate. JAMC. 2014;26(4):455–458.
   Google Scholar
• Kamel SK, Schreiber M. Asking the question again: are cation exchange resins effective for the treatment of hyperkalemia? Nephrol Dial Transplant. 2012;27(12):4294–4297. doi: 10.1093/ndt/gfs293.
   Web of Science ®Google Scholar
• Catherine M C, Carrero J-J, Ellison DH, et al. Potassium homeostasis and management of dyskalemia in kidney diseases: conclusions from a kidney disease: improving global outcomes (KDIGO) controversies conference. Kidney Int. 2020;97(1):42–61. doi: 10.1016/j.kint.2019.09.018.
   Web of Science ®Google Scholar
• Zann V, McDermott J, Jacobs JW, et al. Palatability and physical properties of potassium-binding resin RDX7675: comparison with sodium polystyrene sulfonate. Drug Des Devel Ther. 2017;11:2663–2673. doi: 10.2147/DDDT.S143461.
   Web of Science ®Google Scholar
• Noel JA, Bota SE, Petrcich W, et al. Risk of hospitalization for serious adverse gastrointestinal events associated with sodium polystyrene sulfonate use in patients of advanced age. JAMA Intern Med. 2019;179(8):1025–1033. doi: 10.1001/jamainternmed.2019.0631.
   PubMed Web of Science ®Google Scholar
• Shrestha DB, Budhathoki P, Sedhai YR, et al. Patiromer and sodium zirconium cyclosilicate in treatment of hyperkalemia: a systematic review and meta-analysis. Curr Ther Res Clin Exp. 2021;95:100635. doi: 10.1016/j.curtheres.2021.100635.
   PubMed Web of Science ®Google Scholar
• Meaney CJ, Beccari MV, Yang Y, et al. Systematic review and meta-analysis of patiromer and sodium zirconium cyclosilicate: a new armamentarium for the treatment of hyperkalemia. Pharmacotherapy. 2017;37(4):401–411. doi: 10.1002/phar.1906.
   PubMed Web of Science ®Google Scholar
• Zhang Y, Xu R, Wang F, et al. Effects and safety of a novel oral Potassium-Lowering drug-sodium zirconium cyclosilicate for the treatment of hyperkalemia: a systematic review and meta-analysis. Cardiovasc Drugs Ther. 2021;35(5):1057–1066. doi: 10.1007/s10557-020-07134-2.
   Web of Science ®Google Scholar
• Wong M, Tavazzi L. Effect of drug therapy for heart failure on quality of life. J Clin Hypertens (Greenwich). 2004;6(5):256–261. doi: 10.1111/j.1524-6175.2004.03447.x.
   Google Scholar
• Veltassa. Summary of product characteristics. https://www.ema.europa.eu/en/documents/product-information/veltassa-epar-product-information_en.pdf.
   Google Scholar
• Lokelma. Summary of product characteristics. https://www.ema.europa.eu/en/documents/product-information/lokelma-epar-product-information_en.pdf.
   Google Scholar
• Lesko LJ, Offman E, Brew CT, et al. Evaluation of the potential for drug interactions with patiromer in healthy volunteers. J Cardiovasc Pharmacol Ther. 2017;22(5):434–446. doi: 10.1177/1074248417691135.
   PubMed Web of Science ®Google Scholar
• Pollack CV, Agiro A, Mu F, et al. Impact on hospitalizations of long-term versus short-term therapy with sodium zirconium cyclosilicate during routine outpatient care of patients with hyperkalemia: the recognize I study. Expert Rev Pharmacoecon Outcomes Res. 2023;23(2):241–250. doi: 10.1080/14737167.2023.2161514.
   PubMed Web of Science ®Google Scholar
• Kim K, Fagerström J, Chen G, et al. Cost effectiveness of sodium zirconium cyclosilicate for the treatment of hyperkalaemia in patients with CKD in Norway and Sweden. BMC Nephrol. 2022;23(1):281. doi: 10.1186/s12882-022-02903-7.
   PubMed Web of Science ®Google Scholar