Cost-Effectiveness of Empagliflozin in Combination with Standard Care versus Standard Care Only in the Treatment of Heart Failure Patients in Finland

References

• McDonagh TA, Metra M, Adamo M, et al. 2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021;42(36):3599–3726. doi:10.1093/eurheartj/ehab368
   PubMed Web of Science ®Google Scholar
• Heart Failure. Current Care Guidelines. Working group set up by the Finnish Medical Society Duodecim and the Finnish Cardiac Society. Helsinki: The Finnish Medical Society Duodecim; 2017. Available from: https://www.kaypahoito.fi/hoi50113. Accessed April 14, 2021.
   Google Scholar
• Huusko J, Kurki S, Toppila I, et al. Heart failure in Finland: clinical characteristics, mortality, and healthcare resource use. ESC Heart Fail. 2019;6(4):603–612. doi:10.1002/ehf2.12443
   PubMed Web of Science ®Google Scholar
• Koskinen J, Ukkonen H. Sydämen kroonisen vajaatoiminnan nykyhoito. Duodecim. 2019;135:37–44.
   Google Scholar
• Malik A, Brito D, Vaqar S, Chhabra L. Congestive Heart Failure. Treasure Island (FL): StatPearls; 2021.
   Google Scholar
• Packer M, Anker SD, Butler J, et al. Cardiovascular and renal outcomes with empagliflozin in heart failure. N Engl J Med. 2020;383(15):1413–1424. doi:10.1056/NEJMoa2022190
   PubMed Web of Science ®Google Scholar
• McMurray JJV, Solomon SD, Inzucchi SE, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med. 2019;381(21):1995–2008. doi:10.1056/NEJMoa1911303
   PubMed Web of Science ®Google Scholar
• Anker SD, Butler J, Filippatos G, et al. EMPEROR-preserved trial investigators. empagliflozin in heart failure with a preserved ejection fraction. N Engl J Med. 2021;385(16):1451–1461. doi:10.1056/NEJMoa2107038
   PubMed Web of Science ®Google Scholar
• Application instructions - health economic evaluation [https://www.hila.fi/]. Preparing a health economic evaluation to be attached to the application for reimbursement status and wholesale price for a medicinal product. Helsinki: Lääkkeiden hintalautakunta; 2019. Available from: https://www.hila.fi/content/uploads/2020/01/Instructions_TTS_2019.pdf. Accessed April 19, 2022.
   Google Scholar
• Huusko J, Purmonen T, Toppila I, Lassenius M, Ukkonen H. Real-world clinical diagnostics of heart failure patients with reduced or preserved ejection fraction. ESC Heart Fail. 2020;7:1039–1048. doi:10.1002/ehf2.12665
   PubMed Web of Science ®Google Scholar
• Joensuu JT, Huoponen S, Aaltonen KJ, Konttinen YT, Nordström D, Blom M. The cost-effectiveness of biologics for the treatment of rheumatoid arthritis: a systematic review. PLoS One. 2015;10(3):e0119683. doi:10.1371/journal.pone.0119683
   PubMed Web of Science ®Google Scholar
• Hallinen T, Soini E, Asseburg C, et al. Cost-effectiveness of apixaban versus other direct oral anticoagulants and warfarin in the prevention of thromboembolic complications among Finnish patients with non-valvular atrial fibrillation. Clinicoecon Outcomes Res. 2021;13:745–755. doi:10.2147/CEOR.S317078
   PubMed Web of Science ®Google Scholar
• Napier R, McNulty SE, Eton DT, Redfield MM, AbouEzzeddine O, Dunlay SM. Comparing measures to assess health-related quality of life in heart failure with preserved ejection fraction. JACC Heart Fail. 2018;6(7):552–560. doi:10.1016/j.jchf.2018.02.006
   PubMed Web of Science ®Google Scholar
• Pokharel Y, Khariton Y, Tang Y, et al. Association of serial kansas city cardiomyopathy questionnaire assessments with death and hospitalization in patients with heart failure with preserved and reduced ejection fraction: a secondary analysis of 2 randomized clinical trials. JAMA Cardiol. 2017;2(12):1315–1321. doi:10.1001/jamacardio.2017.3983
   PubMed Web of Science ®Google Scholar
• Joseph SM, Novak E, Arnold SV, et al. Comparable performance of the Kansas City Cardiomyopathy Questionnaire in patients with heart failure with preserved and reduced ejection fraction. Circ Heart Fail. 2013;6(6):1139–1146. doi:10.1161/CIRCHEARTFAILURE.113.000359
   PubMed Web of Science ®Google Scholar
• Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000;35(5):1245–1255. doi:10.1016/S0735-1097(00)00531-3
   PubMed Web of Science ®Google Scholar
• Myers J, Zaheer N, Quaglietti S, Madhavan R, Froelicher V, Heidenreich P. Association of functional and health status measures in heart failure. J Card Fail. 2006;12(6):439–445. doi:10.1016/j.cardfail.2006.04.004
   PubMed Web of Science ®Google Scholar
• Parissis JT, Nikolaou M, Farmakis D, et al. Self-assessment of health status is associated with inflammatory activation and predicts long-term outcomes in chronic heart failure. Eur J Heart Fail. 2009;11(2):163–169. doi:10.1093/eurjhf/hfn032
   PubMed Web of Science ®Google Scholar
• Sullivan MD, Levy WC, Russo JE, Crane B, Spertus JA. Summary health status measures in advanced heart failure: relationship to clinical variables and outcome. J Card Fail. 2007;13(7):560–568. doi:10.1016/j.cardfail.2007.04.001
   PubMed Web of Science ®Google Scholar
• Medical device development tool (MDDT) qualification decision summary for Kansas City cardiomyopathy questionnaire (KCCQ). FDA’s medical device development tools (MDDT) program; 2016. Available from: https://www.fda.gov/medical-devices/science-and-research-medical-devices/medical-device-development-tools-mddt#Qualified_Tools. Accessed December 19, 2022.
   Google Scholar
• Statistics Finland. Deaths by underlying cause of death (ICD-10, 3-character level), age and sex, 1998-2021. Helsinki: 2022. Available from: https://stat.fi/en/statistics/ksyyt. Accessed March 1, 2022.
   Google Scholar
• Statistics Finland. Life table by age and sex, 1986-2021. Helsinki: 2022. Available from: https://stat.fi/en/statistics/kuol. Accessed March 18, 2022.
   Google Scholar
• Latimer N; Undertaking survival analysis for economic evaluations alongside clinical trials - extrapolation with patient-level data [https://nicedsu.sites.sheffield.ac.uk]. Technical support document 14. Sheffield: NICE Decision Support Unit; 2011. Available from: https://www.sheffield.ac.uk/sites/default/files/2022-02/TSD14-Survival-analysis.updated-March-2013.v2.pdf. Accessed June 1, 2022.
   Google Scholar
• Saarni SI, Härkänen T, Sintonen H, et al. The impact of 29 chronic conditions on health-related quality of life: a general population survey in Finland using 15D and EQ-5D. Qual Life Res. 2006;15(8):1403–1414. doi:10.1007/s11136-006-0020-1
   PubMed Web of Science ®Google Scholar
• Kelasto statistical database [https://www.kela.fi/web/en]. Reimbursements of medicine expenses: number of recipients and prescription data. Helsinki: The Social Insurance Institution of Finland; 2022. Available from: https://www.kela.fi/web/en/statistics-by-topic-dispensed-medicines-reimbursable-under-the-nhi-scheme. Accessed March 8, 2022.
   Google Scholar
• Biermann J, Neumann T, Angermann CE, et al. Resource use and costs in systolic heart failure according to disease severity: a pooled analysis from the German Competence Network Heart Failure. J Public Health. 2012;20:23–30. doi:10.1007/s10389-011-0452-0
   Google Scholar
• Mäklin S, Kokko P. Terveyden- ja sosiaalihuollon yksikkökustannukset Suomessa vuonna 2017 [Health and social care unit costs in Finland in 2017]. Työpaperi: 21/2020. Helsinki: Terveyden ja hyvinvoinnin laitos; 2021. Finnish. Available from: https://www.julkari.fi/bitstream/handle/10024/142882/URN_ISBN_978-952-343-493-6.pdf. Accessed December 19, 2022.
   Google Scholar
• Reifsnider OS, Kansal AR, Franke J, et al. Cost-effectiveness of empagliflozin in the UK in an EMPA-REG OUTCOME subgroup with type 2 diabetes and heart failure. ESC Heart Fail. 2020;7(6):3910–3918. doi:10.1002/ehf2.12985
   PubMed Web of Science ®Google Scholar
• Zhou J, Liew D, Kaye DM, Zoungas S, Stub D. Cost-effectiveness of empagliflozin in patients with heart failure and preserved ejection fraction. Circ Cardiovasc Qual Outcomes. 2022;15(10):e008638. doi:10.1161/CIRCOUTCOMES.121.008638
   PubMed Web of Science ®Google Scholar
• Wu M, Qin S, Wang L, et al. Economic evaluation of dapagliflozin in the treatment of patients with heart failure: a systematic review. Front Pharmacol. 2022;13:860109. doi:10.3389/fphar.2022.860109
   PubMedGoogle Scholar
• McEwan P, Darlington O, McMurray JJV, et al. Cost-effectiveness of dapagliflozin as a treatment for heart failure with reduced ejection fraction: a multinational health-economic analysis of DAPA-HF. Eur J Heart Fail. 2020;22(11):2147–2156. doi:10.1002/ejhf.1978
   PubMed Web of Science ®Google Scholar
• Michaeli DT, Michaeli T. Overall survival, progression-free survival, and tumor response benefit supporting initial US food and drug administration approval and indication extension of new cancer drugs, 2003–2021. J Clin Oncol. 2022;40(35):4095–4106. doi:10.1200/JCO.22.00535
   PubMed Web of Science ®Google Scholar
• Michaeli DT, Mills M, Kanavos P. Value and price of multi-indication cancer drugs in the USA, Germany, France, England, Canada, Australia, and Scotland. Appl Health Econ Health Policy. 2022;20(5):757–768. doi:10.1007/s40258-022-00737-w
   PubMed Web of Science ®Google Scholar
• Michaeli DT, Mills M, Michaeli T, Miracolo A, Kanavos P. Initial and supplementary indication approval of new targeted cancer drugs by the FDA, EMA, Health Canada, and TGA. Invest New Drugs. 2022;40(4):798–809. doi:10.1007/s10637-022-01227-5
   PubMed Web of Science ®Google Scholar
• Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022;145(18):e895–e1032. doi:10.1161/CIR.0000000000001063
   PubMed Web of Science ®Google Scholar
• Statistics Finland. Price index of public expenditure, Local government finances by function area. Helsinki: 2022. Available from: https://stat.fi/en/statistics/jmhi. Accessed March 1, 2022.
   Google Scholar
• Sullivan PW, Ghushchyan VH. EQ-5D scores for diabetes-related comorbidities. Value Health. 2016;19(8):1002–1008. doi:10.1016/j.jval.2016.05.018
   PubMed Web of Science ®Google Scholar
• Sullivan PW, Ghushchyan V. Preference-Based EQ-5D index scores for chronic conditions in the United States. Med Decis Making. 2006;26(4):410–420. doi:10.1177/0272989X06290495
   PubMed Web of Science ®Google Scholar
• Currie CJ, Morgan CL, Poole CD, Sharplin P, Lammert M, McEwan P. Multivariate models of health-related utility and the fear of hypoglycaemia in people with diabetes. Curr Med Res Opin. 2006;22(8):1523–1534. doi:10.1185/030079906X115757
   PubMed Web of Science ®Google Scholar