PMID- 32207659 OWN - NLM STAT- MEDLINE DCOM- 20210511 LR - 20210511 IS - 1941-837X (Electronic) IS - 1369-6998 (Linking) VI - 23 IP - 7 DP - 2020 Jul TI - Cost-effectiveness analysis of implantable cardiac devices in patients with systolic heart failure: a US perspective using real world data. PG - 690-697 LID - 10.1080/13696998.2020.1746316 [doi] AB - Aims: Heart failure with reduced ejection fraction (HFrEF) has a substantial impact on costs and patients' quality-of-life. This study aimed to estimate the cost-effectiveness of implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy pacemakers (CRT-P), cardiac resynchronization therapy defibrillators (CRT-D), and optimal pharmacologic therapy (OPT) in patients with HFrEF, from a US payer perspective.Materials and methods: The analyses were conducted by adapting the UK-based cost-effectiveness analyses (CEA) to the US payer perspective by incorporating real world evidence (RWE) on baseline hospitalization risk and Medicare-specific costs. The CEA was based on regression equations estimated from data from 13 randomized clinical trials (n = 12,638). Risk equations were used to predict all-cause mortality, hospitalization rates, health-related quality-of-life, and device-specific treatment effects (vs. OPT). These equations included the following prognostic characteristics: age, QRS duration, New York Heart Association (NYHA) class, ischemic etiology, and left bundle branch block (LBBB). Baseline hospitalization rates were calibrated based on RWE from Truven Health Analytics MarketScan data (2009-2014). A US payer perspective, lifetime time horizon, and 3% discount rates for costs and outcomes were used. Benefits were expressed as quality-adjusted life-years (QALYs). Incremental cost-effectiveness analysis was conducted for 24 sub-groups based on LBBB status, QRS duration, and NYHA class.Results: Results of the analyses show that CRT-D was the most cost-effective treatment at a $100,000/QALY threshold in 14 of the 16 sub-groups for which it is indicated. Results were most sensitive to changes in estimates of hospitalization costs.Limitations: Study limitations include small sample sizes for NYHA I and IV sub-groups and lack of data availability for duration of treatment effect.Conclusions: CRT-D has higher greater cost-effectiveness across more sub-groups in the indicated patient populations against as compared to OPT, ICD, and CRT-P, from a US payer perspective. FAU - Shah, Dhvani AU - Shah D AUID- ORCID: 0000-0002-0287-337X AD - Value, Access and Outcomes, ICON plc, New York, NY, USA. FAU - Lu, Xiaoxiao AU - Lu X AD - Economics, Reimbursement & Evidence, Medtronic plc, Mounds View, MN, USA. FAU - Paly, Victoria F AU - Paly VF AD - Value, Access and Outcomes, ICON plc, New York, NY, USA. FAU - Tsintzos, Stelios I AU - Tsintzos SI AD - Market Development, Medtronic plc, Tolochenaz, Switzerland. FAU - May, Damian M AU - May DM AD - Economics, Reimbursement & Evidence, Medtronic plc, Mounds View, MN, USA. LA - eng PT - Journal Article DEP - 20200414 PL - England TA - J Med Econ JT - Journal of medical economics JID - 9892255 SB - IM MH - Aged MH - Cardiac Resynchronization Therapy Devices/*economics MH - *Cost-Benefit Analysis MH - Databases, Factual MH - Defibrillators, Implantable/*economics MH - Female MH - Health Care Costs MH - Heart Failure, Systolic/*drug therapy/*surgery MH - Humans MH - Male MH - Medicare MH - Middle Aged MH - Quality-Adjusted Life Years MH - Retrospective Studies MH - United States OTO - NOTNLM OT - C10 OT - C50 OT - Heart failure OT - Medicare OT - US OT - cost-effectiveness OT - implantable cardiac devices EDAT- 2020/03/25 06:00 MHDA- 2021/05/12 06:00 CRDT- 2020/03/25 06:00 PHST- 2020/03/25 06:00 [pubmed] PHST- 2021/05/12 06:00 [medline] PHST- 2020/03/25 06:00 [entrez] AID - 10.1080/13696998.2020.1746316 [doi] PST - ppublish SO - J Med Econ. 2020 Jul;23(7):690-697. doi: 10.1080/13696998.2020.1746316. Epub 2020 Apr 14.