Budget impact analysis of dabigatran compared with rivaroxaban in the prevention of the thromboembolic risk in patients with non-valvular atrial fibrillation
DOI:
https://doi.org/10.7175/fe.v18i1.1327Keywords:
Dabigatran, Rivaroxaban, Non-Valvular Atrial Fibrillation, Budget impact analysisAbstract
BACKGROUND: Dabigatran 150 mg BID (D150) and rivaroxaban 20 mg (R20) are indicated for the prevention of thromboembolic events in patients with Non-Valvular Atrial Fibrillation (NVAF). Outcomes from observational study demonstrated that D150 and R20 reduced the rate of thromboembolic events.
OBJECTIVE: This analysis estimated the budget impact of the use of D150 and R20 for the treatment of NAFV patients in Italy.
METHODS: A budget-impact model (BIM) was developed to estimate the direct costs up to 12 months from an Italian NHS perspective. The resource utilization (drugs and intracranial hemorrhage or major extracranial bleeding event) was derived from an observational study. Only direct medical costs were considered. Ex-factory prices and National Tariffs were considered to estimate the costs of drugs and medical resource used, respectively. The BIM showed the difference of expenditure and clinical events (intracranial hemorrhage or major extracranial bleeding) generated by the base case calculated for current prescription volumes (D150 30%, R20 100%), and for different prescription volume scenarios (D150 at 70% and 100%). Key variables were tested in the sensitivity analysis.
RESULTS: D150 was associated with a medical cost offset driven by fewer intracranial hemorrhage and major extracranial bleeding event, these offset the incremental drug cost and results in an annual saving per patient treated (D150: € 1,052.78; R20: € 1,161.23). The present scenario determines an annual cost of € 262,543,583. The impact of total annual costs for the Italian NHS would be lower if D150 prescription volumes would be higher. The total cost is predicted to decrease by 3.8% if the D150 prescription increase to 70% and it is predicted to decrease by 6.7% if the D150 prescription increase to 100%.
CONCLUSION: The use of D150, as an alternative to R20 to prevent events in patients with NVAF, could represent a cost-saving option for the Italian NHS.
References
Pradaxa – Prescribing Information. Ridgefield, CT: Boehringer Ingelheim; 2012. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s011lbl.pdf (last accessed April 2017)
Xarelto – Prescribing Information. Leverkusen, Germany: Janssen; 2011. Available at: http://www.xareltohcp.com/shared/product/xarelto/prescribing-information.pdf (last accessed April 2017)
Connolly SJ, Ezekowitz MD, Yusuf S, et al. RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361: 1139-51; https://doi.org/10.1056/NEJMoa0905561
Patel MR, Mahaffey KW, Garg J, et al; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365: 883-91; https://doi.org/10.1056/NEJMoa1009638
Rognoni C, Marchetti M, Quaglini S, et al. Apixaban, dabigatran, and rivaroxaban versus warfarin for stroke prevention in non-valvular atrial fibrillation: a cost-effectiveness analysis. Clin Drug Investig 2014; 34: 9-17; https://doi.org/10.1007/s40261-013-0144-3
Pollack CV Jr, Reilly PA, Eikelboom J, et al. Idarucizumab for Dabigatran Reversal. N Engl J Med 2015; 373: 511-20; https://doi.org/10.1056/NEJMoa1502000
Mauskopf JA, Sullivan SD, Annemans L, et al. Principles of good practice for budget impact analysis: report of the ISPOR Task Force on Good Research Practices—budget impact analysis. Value Health 2007; 10: 336-47; https://doi.org/10.1111/j.1524-4733.2007.00187.x
Sullivan SD, Mauskopf JA, Augustovski F, et al. Budget impact analysis principles of good practice: report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. Value Health 2014; 17: 5-14; https://doi.org/10.1016/j.jval.2013.08.2291
Graham DJ, Reichman ME, Wernecke M, et al. Stroke, Bleeding, and Mortality Risks in Elderly Medicare Beneficiaries Treated With Dabigatran or Rivaroxaban for Nonvalvular Atrial Fibrillation. JAMA Intern Med 2016; 176: 1662-71; https://doi.org/10.1001/jamainternmed.2016.5954
ISTAT Popolazione residente 1 gennaio 2016. Available at: http://dati.istat.it/Index.aspx?DataSetCode=DCIS_POPRES1 (last accessed August 2016)
Davis RC, Hobbs FD, Kenkre JE, et al. Prevalence of atrial fibrillation in the general population and in high-risk groups: the ECHOES study. Europace 2012; 14: 1553-9; https://doi.org/10.1093/europace/eus087
IMS Health S.p.A. Estimation from Market Dynamics (IMS) in line with actual trend
IMS Health S.p.A. IMS analysis on sold packages in AF market
Data on file. IHS Markit
Data on file. Boehringer Ingelheim
Ravasio R, Pedone MP, Ratti M. Cost efficacy analysis of new oral anticoagulant for stroke prevention in non-valvular atrial fibrillation in Italy. PharmacoEcon Ital Res Artic 2014; 16: 22; https://doi.org/10.1007/s40276-014-0022-x
Belisari A, Iannazzo S, Di Pasquale G, et al. Budget impact analysis of idarucizumab for the management of patients treated with dabigatran in emergency / urgent situations in Italy. Farmeconomia. Health economics and therapeutic pathways 2016; 17: 47-58; https://doi.org/10.7175/fe.v17i2.1243
Pollack CV Jr, Reilly PA, van Ryn J, et al. Idarucizumab for Dabigatran Reversal - Full Cohort Analysis. N Engl J Med 2017; 377: 431-41; https://doi.org/10.1056/NEJMoa1707278
Database CORE (Collaborative Outcome Research) CINECA
Lip GYH, Larsen TB, Skjøth F, et al. Indirect comparisons of new oral anticoagulant drugs for efficacy and safety when used for stroke prevention in atrial fibrillation. J Am Coll Cardiol 2012; 60: 738-46; https://doi.org/10.1016/j.jacc.2012.03.019
Schneeweiss S, Gagne JJ, Patrick AR, et al. Comparative efficacy and safety of new oral anticoagulants in patients with atrial fibrillation. Circ Cardiovasc Qual Outcomes 2012; 5: 480-6; https://doi.org/10.1161/CIRCOUTCOMES.112.965988
Larsen TB, Skjøth F, Nielsen PB, et al. Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study. BMJ 2016; 353: i3189; https://doi.org/10.1136/bmj.i3189
Gorst-Rasmussen A, Lip GY, Bjerregaard Larsen T. Rivaroxaban versus warfarin and dabigatran in atrial fibrillation: comparative effectiveness and safety in Danish routine care. Pharmacoepidemiol Drug Saf 2016; 25: 1236-44; https://doi.org/10.1002/pds.4034
Nielsen PB, Skjøth F, Søgaard M, et al. Effectiveness and safety of reduced dose non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study. BMJ 2017; 356: j510; https://doi.org/10.1136/bmj.j510
Peng S, Deger KA, Ustyugova A, et al. Cost-effectiveness analysis of dabigatran versus rivaroxaban for stroke prevention in patients with non-valvular atrial fibrillation using real-world evidence in elderly US Medicare beneficiaries. Curr Med Res Opin 2017; 26: 1-9; https://doi.org/10.1080/03007995.2017.1375470
Published
How to Cite
Issue
Section
License
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal. The Publication Agreement can be downloaded here, and should be signed by the Authors and sent to the Publisher when the article has been accepted for publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (see The Effect of Open Access).
- Authors are permitted to post their work online after publication (the article must link to publisher version, in html format)
