Unintended Consequences of Increased Out-of-Pocket Costs During Medicare Coverage Gap on Anticoagulant Discontinuation and Stroke.
Atrial fibrillation
Direct oral anticoagulants
Discontinuation rates
Medicare coverage gap
Out-of-pocket costs
Stroke
Systemic embolism
Journal
Advances in therapy
ISSN: 1865-8652
Titre abrégé: Adv Ther
Pays: United States
ID NLM: 8611864
Informations de publication
Date de publication:
10 2023
10 2023
Historique:
received:
12
05
2023
accepted:
17
07
2023
medline:
14
9
2023
pubmed:
12
8
2023
entrez:
11
8
2023
Statut:
ppublish
Résumé
This study aims to assess the risk of direct oral anticoagulant (DOAC) discontinuation among Medicare beneficiaries with non-valvular atrial fibrillation (NVAF) who reach the Medicare coverage gap stratified by low-income subsidy (LIS) status and the impact of DOAC discontinuation on rates of stroke and systemic embolism (SE) among beneficiaries with increased out-of-pocket (OOP) costs due to not receiving LIS. In this retrospective cohort study, Medicare claims data (2015-2020) were used to identify beneficiaries with NVAF who initiated rivaroxaban or apixaban and entered the coverage gap during ≥ 1 year. DOAC discontinuation rates during the coverage gap were stratified by receipt of Medicare Part D Low-Income Subsidy (LIS), a proxy for not experiencing increased OOP costs. Among non-LIS beneficiaries, incidence rates of stroke and SE during the subsequent 12 months were compared between beneficiaries who did and did not discontinue DOAC in the coverage gap. Among 303,695 beneficiaries, mean age was 77.3 years, and 28% received LIS. After adjusting for baseline differences, non-LIS beneficiaries (N = 218,838) had 78% higher risk of discontinuing DOAC during the coverage gap vs. LIS recipients (adjusted hazard ratio [aHR], 1.78; 95% CI [1.73, 1.82]). Among non-LIS beneficiaries, DOAC discontinuation during coverage gap (N = 91,397; 34%) was associated with 14% higher risk of experiencing stroke and SE during the subsequent 12 months (aHR, 1.14; 95% CI [1.08, 1.20]). Increased OOP costs during Medicare coverage gap were associated with higher risk of DOAC discontinuation, which in turn was associated with higher risk of stroke and SE among beneficiaries with NVAF.
Identifiants
pubmed: 37568060
doi: 10.1007/s12325-023-02620-z
pii: 10.1007/s12325-023-02620-z
pmc: PMC10499728
doi:
Substances chimiques
Anticoagulants
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Pagination
4523-4544Informations de copyright
© 2023. The Author(s).
Références
Ballestri S, Romagnoli E, Arioli D, et al. Risk and management of bleeding complications with direct oral anticoagulants in patients with atrial fibrillation and venous thromboembolism: a narrative review. Adv Ther. 2023;40(1):41–66.
doi: 10.1007/s12325-022-02333-9
pubmed: 36244055
Yamashiro K, Kurita N, Tanaka R, et al. Adequate adherence to direct oral anticoagulant is associated with reduced ischemic stroke severity in patients with atrial fibrillation. J Stroke Cerebrovasc Dis. 2019;28(6):1773–80.
doi: 10.1016/j.jstrokecerebrovasdis.2018.09.019
pubmed: 30318259
Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383(9921):955–62.
doi: 10.1016/S0140-6736(13)62343-0
pubmed: 24315724
Ozaki AF, Choi AS, Le QT, et al. Real-world adherence and persistence to direct oral anticoagulants in patients with atrial fibrillation: a systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes. 2020;13(3): e005969.
doi: 10.1161/CIRCOUTCOMES.119.005969
pubmed: 32148102
Chen N, Brooks MM, Hernandez I. Latent classes of adherence to oral anticoagulation therapy among patients with a new diagnosis of atrial fibrillation. JAMA Netw Open. 2020;3(2): e1921357.
doi: 10.1001/jamanetworkopen.2019.21357
pubmed: 32074287
pmcid: 7081375
Hernandez I, He M, Brooks MM, Saba S, Gellad WF. Adherence to anticoagulation and risk of stroke among Medicare beneficiaries newly diagnosed with atrial fibrillation. Am J Cardiovasc Drugs. 2020;20(2):199–207.
doi: 10.1007/s40256-019-00371-3
pubmed: 31523759
pmcid: 7073283
Hernandez I, He M, Chen N, Brooks MM, Saba S, Gellad WF. Trajectories of oral anticoagulation adherence among Medicare beneficiaries newly diagnosed with atrial fibrillation. J Am Heart Assoc. 2019;8(12): e011427.
doi: 10.1161/JAHA.118.011427
pubmed: 31189392
pmcid: 6645643
Services CfMM. Costs in the Coverage Gap; 2021. https://www.medicare.gov/drug-coverage-part-d/costs-for-medicare-drug-coverage/costs-in-the-coverage-gap . Accessed March 10, 2021.
Cubanski J, Damico A, Neuman T. Medicare Part D in 2018: the latest on enrollment, premiums, and cost sharing. May 17, 2018. https://www.kff.org/medicare/issue-brief/medicare-part-d-in-2018-the-latest-on-enrollment-premiums-and-cost-sharing/ . Accessed March 10, 2021.
Park YJ, Martin EG. Medicare part D’s effects on drug utilization and out-of-pocket costs: a systematic review. Health Serv Res. 2017;52(5):1685–728.
doi: 10.1111/1475-6773.12534
pubmed: 27480577
Polinski JM, Kilabuk E, Schneeweiss S, Brennan T, Shrank WH. Changes in drug use and out-of-pocket costs associated with Medicare Part D implementation: a systematic review. J Am Geriatr Soc. 2010;58(9):1764–79.
doi: 10.1111/j.1532-5415.2010.03025.x
pubmed: 20863336
pmcid: 2946375
CMS Eligibility for Low-Income Subsidy, Low Income Subsidy Guidance for States; 2009. https://www.cms.gov/Medicare/Eligibility-and-Enrollment/LowIncSubMedicarePresCov/EligibilityforLowIncomeSubsidy .
Ganapathy V, Xie L, Wang Y, Zhang Q, Baser O. Prescription fill patterns after reaching the Medicare Part D coverage gap among patients with COPD on maintenance bronchodilators. Academy of Managed Care Pharmacy Annual Meeting; 2017.
Polinski JM, Shrank WH, Huskamp HA, Glynn RJ, Liberman JN, Schneeweiss S. Changes in drug utilization during a gap in insurance coverage: an examination of the Medicare Part D coverage gap. PLoS Med. 2011;8(8): e1001075.
doi: 10.1371/journal.pmed.1001075
pubmed: 21857811
pmcid: 3156689
Research Data Assistance Center: Find, Request and Use CMS Data; 2022. https://resdac.org/ . Accessed Oct 7, 2022.
Melgaard L, Gorst-Rasmussen A, Lane DA, Rasmussen LH, Larsen TB, Lip GY. Assessment of the CHA2DS2-VASc score in predicting ischemic stroke, thromboembolism, and death in patients with heart failure with and without atrial fibrillation. JAMA. 2015;314(10):1030–8.
doi: 10.1001/jama.2015.10725
pubmed: 26318604
Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010;138(5):1093–100.
doi: 10.1378/chest.10-0134
pubmed: 20299623
Quan H, Li B, Couris CM, et al. Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol. 2011;173(6):676–82.
doi: 10.1093/aje/kwq433
pubmed: 21330339
Imbens GW. The role of the propensity score in estimating dose-response functions. Biometrika. 2000;87(3):706–10.
doi: 10.1093/biomet/87.3.706
Brookhart MA, Wyss R, Layton JB, Sturmer T. Propensity score methods for confounding control in nonexperimental research. Circ Cardiovasc Qual Outcomes. 2013;6(5):604–11.
doi: 10.1161/CIRCOUTCOMES.113.000359
pubmed: 24021692
pmcid: 4032088
Zissimopoulos J, Joyce GF, Scarpati LM, Goldman DP. Did Medicare Part D reduce disparities? Am J Manag Care. 2015;21(2):119–28.
pubmed: 25880361
pmcid: 4405127
Chandra A, Flack E, Obermeyer Z. The health costs of cost-sharing. HKS Faculty Research Working Paper Series RWP21-005, March 2021; 2021.
Zhou B, Seabury S, Goldman D, Joyce G. Formulary restrictions and stroke risk in patients with atrial fibrillation. Am J Manag Care. 2022;28(10):521–8.
doi: 10.37765/ajmc.2022.89195
pubmed: 36252171
Deitelzweig S, Luo X, Gupta K, et al. All-cause, stroke/systemic embolism-, and major bleeding-related health-care costs among elderly patients with nonvalvular atrial fibrillation treated with oral anticoagulants. Clin Appl Thromb Hemost. 2018;24(4):602–11.
doi: 10.1177/1076029617750269
pubmed: 29363999
pmcid: 6714709
Amin A, Keshishian A, Trocio J, et al. A real-world observational study of hospitalization and health care costs among nonvalvular atrial fibrillation patients prescribed oral anticoagulants in the U.S. Medicare population. J Manag Care Spec Pharm. 2020;26(5):639–51.
pubmed: 32347184
Newman TV, Gabriel N, Liang Q, et al. Comparison of oral anticoagulation use and adherence among Medicare beneficiaries enrolled in stand-alone prescription drug plans vs Medicare Advantage prescription drug plans. J Manag Care Spec Pharm. 2022;28(2):266–74.
pubmed: 35098746
Wong ES, Done N, Zhao M, Woolley AB, Prentice JC, Mull HJ. Comparing total medical expenditure between patients receiving direct oral anticoagulants vs warfarin for the treatment of atrial fibrillation: evidence from VA-Medicare dual enrollees. J Manag Care Spec Pharm. 2021;27(8):1056–66.
pubmed: 34337995
Cubanski J, Neuman T, Damico A. Closing the Medicare Part D coverage gap: trends, recent changes, and what’s ahead; 2018. https://www.kff.org/medicare/issue-brief/closing-the-medicare-part-d-coverage-gap-trends-recent-changes-and-whats-ahead/ . Accessed Oct 28, 2022.
Cubanski J, Neuman T, Freed M. Explaining the prescription drug provisions in the Inflation Reduction Act; 2022. https://www.kff.org/medicare/issue-brief/explaining-the-prescription-drug-provisions-in-the-inflation-reduction-act/ . Accessed Oct 24, 2022.