The Cost-Effectiveness of Rivaroxaban Plus Aspirin Compared with Aspirin Alone in the COMPASS Trial: A US Perspective.
Journal
American journal of cardiovascular drugs : drugs, devices, and other interventions
ISSN: 1179-187X
Titre abrégé: Am J Cardiovasc Drugs
Pays: New Zealand
ID NLM: 100967755
Informations de publication
Date de publication:
28 Dec 2023
28 Dec 2023
Historique:
accepted:
20
11
2023
medline:
28
12
2023
pubmed:
28
12
2023
entrez:
28
12
2023
Statut:
aheadofprint
Résumé
Rivaroxaban 2.5 mg twice daily with aspirin 100 mg daily was shown to be better than aspirin 100 mg daily for preventing cardiovascular (CV) death, stroke or myocardial infarction in patients with either stable coronary artery disease (CAD) or peripheral artery disease (PAD). The cost-effectiveness of this regimen in this population is essential for decision-makers to know. US direct healthcare system costs (in USD) were applied to hospitalized events, procedures and study drugs utilized by all patients. We determined the mean cost per participant for the full duration of the trial (mean follow-up of 23 months) plus quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio (ICER) over a lifetime using a two-state Markov model with 1-year cycle length. Sensitivity analyses were performed on the price of rivaroxaban and the annual discontinuation rate. The costs of events and procedures were reduced for Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) patients who received rivaroxaban 2.5 mg orally (BID) plus acetylsalicylic acid (ASA) compared with ASA alone. Total costs were higher for the combination group ($7426 versus $4173) after considering acquisition costs of the study drug. Over a lifetime, patients receiving rivaroxaban plus ASA incurred $27,255 more and gained 1.17 QALYs compared with those receiving ASA alone resulting in an ICER of $23,295/QALY. ICERs for PAD only and polyvascular disease subgroups were lower. Rivaroxaban 2.5 mg BID plus ASA compared with ASA alone was cost-effective (high value) in the USA. COMPASS ClinicalTrials.gov identifier: NCT01776424.
Sections du résumé
BACKGROUND
BACKGROUND
Rivaroxaban 2.5 mg twice daily with aspirin 100 mg daily was shown to be better than aspirin 100 mg daily for preventing cardiovascular (CV) death, stroke or myocardial infarction in patients with either stable coronary artery disease (CAD) or peripheral artery disease (PAD). The cost-effectiveness of this regimen in this population is essential for decision-makers to know.
METHODS
METHODS
US direct healthcare system costs (in USD) were applied to hospitalized events, procedures and study drugs utilized by all patients. We determined the mean cost per participant for the full duration of the trial (mean follow-up of 23 months) plus quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio (ICER) over a lifetime using a two-state Markov model with 1-year cycle length. Sensitivity analyses were performed on the price of rivaroxaban and the annual discontinuation rate.
RESULTS
RESULTS
The costs of events and procedures were reduced for Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) patients who received rivaroxaban 2.5 mg orally (BID) plus acetylsalicylic acid (ASA) compared with ASA alone. Total costs were higher for the combination group ($7426 versus $4173) after considering acquisition costs of the study drug. Over a lifetime, patients receiving rivaroxaban plus ASA incurred $27,255 more and gained 1.17 QALYs compared with those receiving ASA alone resulting in an ICER of $23,295/QALY. ICERs for PAD only and polyvascular disease subgroups were lower.
CONCLUSION
CONCLUSIONS
Rivaroxaban 2.5 mg BID plus ASA compared with ASA alone was cost-effective (high value) in the USA. COMPASS ClinicalTrials.gov identifier: NCT01776424.
Identifiants
pubmed: 38153624
doi: 10.1007/s40256-023-00620-6
pii: 10.1007/s40256-023-00620-6
doi:
Banques de données
ClinicalTrials.gov
['NCT01776424']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2023. The Author(s).
Références
Roth GA, Mensah GA, Johnson CO, et al. Global burden of cardiovascular diseases and risk factors, 1990–2019. J Am Coll Cardiol. 2020;76:2982–3021.
American Heart Association. Cardiovascular disease: A costly burden for America projections through 2035. 2017. Available online from https://www.heart.org/-/media/Files/About-Us/Policy-Research/Fact-Sheets/Public-Health-Advocacy-and-Research/CVD-A-Costly-Burden-for-America-Projections-Through-2035.pdf . Accessed December 23, 2023.
Eikelboom JW, Connolly SJ, Bosch J, et al., on behalf of the COMPASS Investigators. Rivaroxaban with or without aspirin in stable cardiovascular disease. N Engl J Med. 2017;377:1319–30.
Lamy A, Eikelboom J, Tong W, Yuan F, Bangdiwala SI, Bosch J, Connolly S, Lonn E, Dagenais GR, Branch KRH, Wang W-J, Bhatt DL, Probstfield J, Ertl G, Störk S, Steg PG, Aboyans V, Durand-Zaleski I, Ryden L, Yusuf S. The cost-effectiveness of rivaroxaban with or without aspirin in the COMPASS trial. Eur Heart J Qual Care Clin Outcomes. 2023;9:502–10.
doi: 10.1093/ehjqcco/qcac054
pubmed: 36001989
Bosch J, Eikelboom JW, Connolly SJ, et al. Rationale, design and baseline characteristics of participants in the cardiovascular outcomes for people using anticoagulation strategies (COMPASS) trial. Can J Cardiol. 2017;33:1027–35.
Drummond M, Schulpher M, Torrance G, O’Brien B, Stoddart G. Methods for the economic evaluation of health care programmes. 3rd ed. UK: Oxford Medical Publication; 2005.
doi: 10.1093/oso/9780198529446.001.0001
Lamy A, Tong W, Gao P, Chrolavicius S, Gafni A, Yusuf S, Connolly SJ. The cost of clopidogrel use in atrial fibrillation in the ACTIVE-A trial. Can J Cardiol. 2012;28:95–101.
doi: 10.1016/j.cjca.2011.08.112
pubmed: 21983111
Lamy A, Tong W, Jung H, Gafni A, Singh K, Tyrwhitt J, Yusuf S, Gerstein HC, ORIGIN Investigators. Cost implications of the use of basal insulin glargine in people with early dysglycemia: the ORIGIN trial. J Diabetes Complications. 2014;28:553–8.
doi: 10.1016/j.jdiacomp.2014.02.012
pubmed: 24684774
Lamy A, Tong W, Devereaux PJ, Gao P, Gafni A, Singh K, Taggart D, Straka Z, Akar AR, Piegas L, Ou Y, Yusuf S. The cost implications of off-pump versus on-pump coronary artery bypass graft surgery at one year. Ann Thorac Surg. 2014;98:1620–5.
doi: 10.1016/j.athoracsur.2014.06.046
pubmed: 25261272
Anderson JL, Heidenreich PA, Barnett PG, et al. ACC/AHA statement on cost/value methodology in clinical practice guidelines and performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures and Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63:2304–22.
Institute for Clinical and Economic Review. Additive therapies for cardiovascular disease: effectiveness and value. Institute for Clinical and Economic Review; 2019. Available at https://icer-review.org/wp-content/uploads/2019/02/ICER_CVD_Draft_Evidence_Report_072419.pdf . Accessed April 22, 2020.
MEDPAR—Centers for Medicare & Medicaid Services. Available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareFeeforSvcPartsAB/MEDPAR.html . Accessed October 30, 2018.
Lamy A, Wang X, Gao P, Tong W, Gafni A, Dans A, Avezum A, Ferreira R, Young J, Yusuf S, Teo K, ONTARGET Investigators. The cost implications of the use of telmisartan or ramipril in patients at high risk for vascular events: the ONTARGET study. J Med Econ. 2011;14:792–7.
doi: 10.3111/13696998.2011.627405
pubmed: 21981559
Yuan F, Bangdiwala S, Tong W, Lamy A. Projecting effectiveness after ending a randomized controlled trial: A two-state Markov microsimulation model. Int J Technol Assess Health Care. 2020:1–8.
Yuan F, Bangdiwala SI, Tong W, Lamy A. The impact of statistical properties of incremental monetary net benefit and incremental cost-effectiveness ratio on health economic modeling choices. Expert Rev Pharmacoecon Outcomes Res. 2022;23(1):69–78.
doi: 10.1080/14737167.2023.2144838
pubmed: 36334614
Arias E, Heron M, Xu J. United States Life Tables, 2013. Natl Vital Stat Rep. 2017 Apr;66(3):1-64. PMID: 28437241.
Sonnenberg FA, Beck JR. Markov models in medical decision making: a practical guide. Med Decis Making. 1993;13:322–38.
doi: 10.1177/0272989X9301300409
pubmed: 8246705
Royston P, Parmar MKB. The use of restricted mean survival time to estimate the treatment effect in randomized clinical trials when the proportional hazards assumption is in doubt. Stat Med. 2011;30:2409–21.
doi: 10.1002/sim.4274
pubmed: 21611958
Royston P, Parmar MKB. Restricted mean survival time: an alternative to the hazard ratio for the design and analysis of randomized trials with a time-to-event outcome. BMC Med Res Methodol. 2013;13:152.
doi: 10.1186/1471-2288-13-152
pubmed: 24314264
pmcid: 3922847
Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, Kuntz KM, Meltzer DO, Owens DK, Prosser LA, Salomon JA, Sculpher MJ, Trikalinos TA, Russell LB, Siegel JE, Ganiats TG. Recommendations for conduct, methodological practices, and reporting of cost-effectiveness analyses: second panel on cost-effectiveness in health and medicine. JAMA. 2016;316:1093–103.
doi: 10.1001/jama.2016.12195
pubmed: 27623463
Shaw JW, Johnson JA, Coons SJ. US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care. 2005;43:203–20.
doi: 10.1097/00005650-200503000-00003
pubmed: 15725977
NICE. Developing NICE guidelines: the manual | Guidance and guidelines|NICE. Available at https://www.nice.org.uk/process/pmg20/chapter/incorporating-economic-evaluation . Accessed November 5, 2018.
Bioethics and Disability Report Series. Available at https://ncd.gov/ . Accessed September 27, 2023.
Cost-Effectiveness, the QALY, and the evLYG. ICER. Available at https://icer.org/our-approach/methods-process/cost-effectiveness-the-qaly-and-the-evlyg/ . Accessed September 27, 2023.
Demystifying ICER’s equal value of life years gained metric. ISPOR | International Society For Pharmacoeconomics and Outcomes Research. Available at https://www.ispor.org/publications/journals/value-outcomes-spotlight/vos-archives/issue/view/overcoming-vaccine-hesitancy-injecting-trust-in-the-community/demystifying-icer-s-equal-value-of-life-years-gained-metric . Accessed September 27, 2023.
Paulden M, Claxton K. Budget allocation and the revealed social rate of time preference for health. Health Econ. 2012;21:612–8.
doi: 10.1002/hec.1730
pubmed: 21438069
Wilson PWF, D’Agostino R, Bhatt DL, Eagle K, Pencina MJ, Smith SC, Alberts MJ, Dallongeville J, Goto S, Hirsch AT, Liau C-S, Ohman EM, Röther J, Reid C, Mas J-L, Steg PG, REACH Registry. An international model to predict recurrent cardiovascular disease. Am J Med. 2012;125:695-703.e1.
doi: 10.1016/j.amjmed.2012.01.014
pubmed: 22727237
Ademi Z, Zomer E, Tonkin A, Liew D. Cost-effectiveness of rivaroxaban and aspirin compared to aspirin alone in patients with stable cardiovascular disease: an Australian perspective. Int J Cardiol. 2018;270:54–9.
doi: 10.1016/j.ijcard.2018.06.091
pubmed: 30220379
Zomer E, Si S, Hird TR, Liew D, Owen AJ, Tonkin A, Reid CM, Ademi Z. Cost-effectiveness of low-dose rivaroxaban and aspirin versus aspirin alone in people with peripheral or carotid artery disease: an Australian healthcare perspective. Eur J Prev Cardiol. 2019;26:858–68.
doi: 10.1177/2047487318817910
pubmed: 30526023
Cowie MR, Lamy A, Levy P, Mealing S, Millier A, Mernagh P, Cristeau O, Bowrin K, Briere J-B. Health economic evaluation of rivaroxaban in the treatment of patients with chronic coronary artery disease or peripheral artery disease. Cardiovasc Res. 2019. https://doi.org/10.1093/cvr/cvz278 .
doi: 10.1093/cvr/cvz278
pubmed: 31166587
pmcid: 7449563
Spoorendonk JA, Briere J-B, Bowrin K, Millier A, Coppens M, Tempelaar S, Verheggen B. Clinical implications and cost-effectiveness analysis of rivaroxaban in patients with coronary artery disease or peripheral arterial disease in the Netherlands. J Med Econ. 2021;24:1231–9.
doi: 10.1080/13696998.2021.1997024
pubmed: 34749569
Ferrara P, Cortesi PA, Di Laura D, Maggioni AP, Mantovani LG. Cost-effectiveness analysis of rivaroxaban plus aspirin compared with aspirin alone in patients with coronary and peripheral artery diseases in Italy. Clin Drug Investig. 2021;41:459–68.
doi: 10.1007/s40261-021-01023-8
pubmed: 33725323
pmcid: 8149345
Feng T, Zheng Z, Gao S, Xu J, Cao P, Jia H, Yu X. Cost-effectiveness analysis of rivaroxaban in Chinese patients with stable cardiovascular disease. Front Pharmacol. 2022;13: 921387.
doi: 10.3389/fphar.2022.921387
pubmed: 35795549
pmcid: 9251332
Lee M-C, Liao C-T, Toh HS, Chou C-C, Chang W-T, Chen Z-C, Wu W-S, Yu T, Strong C. Cost-effectiveness analysis of rivaroxaban plus aspirin versus aspirin alone in secondary prevention among patients with chronic cardiovascular diseases. Cardiovasc Drugs Ther. 2021;35:539–47.
doi: 10.1007/s10557-020-07059-w
pubmed: 32910340
Gaziano TA, Fonarow GC, Claggett B, Chan WW, Deschaseaux-Voinet C, Turner SJ, Rouleau JL, Zile MR, McMurray JJV, Solomon SD. Cost-effectiveness analysis of sacubitril/valsartan vs enalapril in patients with heart failure and reduced ejection fraction. JAMA Cardiol. 2016;1:666–72.
doi: 10.1001/jamacardio.2016.1747
pubmed: 27438344
House TW. FACT SHEET: Biden-Harris Administration Announces First Ten Drugs Selected for Medicare Price Negotiation. The White House. Available at https://www.whitehouse.gov/briefing-room/statements-releases/2023/08/29/fact-sheet-biden-harris-administration-announces-first-ten-drugs-selected-for-medicare-price-negotiation/ . Accessed September 19, 2023.