Literature DB >> 35358286

Correction: Cost-effectiveness of apixaban compared to other anticoagulants in patients with atrial fibrillation in the real-world and trial settings.

Lisa A de Jong, Jessie Groeneveld, Jelena Stevanovic, Harrie Rila, Robert G Tieleman, Menno V Huisman, Maarten J Postma, Marinus van Hulst.   

Abstract

[This corrects the article DOI: 10.1371/journal.pone.0222658.].

Entities:  

Year:  2022        PMID: 35358286      PMCID: PMC8970364          DOI: 10.1371/journal.pone.0266625

Source DB:  PubMed          Journal:  PLoS One        ISSN: 1932-6203            Impact factor:   3.240


Following the publication of this article [1] the authors received additional information that a correction [2] was published on an article [3] which the authors used for the real-world data (RWD) analysis. The authors were notified that a proportion of Medicare patients from the CMS database were unintentionally omitted from the original analysis [3]. The published corrected study [2] now incorporates the complete dataset. As a result, the authors have re-analyzed the RWD-based analysis based on the corrected dataset reported in [2]. This has resulted in numerical changes to the outcomes of RWD analyses, which are reflected in the updated versions of Fig 3, Tables 3, 4 and 5, and Supporting Information files provided with this notice.
Fig 3

Probability of being the most cost-effective treatment choice per willingness-to-pay threshold for the RWD-based analysis.

Abbreviations: QALY, quality adjusted life-years; RWD, real-world data; VKA, vitamin K antagonist. threshold for the RWD-based analysis.

Table 3

Base-case costs outcomes of the NMA-based and RWD-based analyses presented as costs per patient over a lifetime horizon.

NMA-based analysis
Apixaban VKA Dabigatran 110 mg Dabigatran 150 mg Rivaroxaban Edoxaban
Drug costs€ 3,925 (10%)€ 95 (<1%)€ 3,426 (8%)€ 3,323 (8%)€ 3,683 (9%)€ 4,020 (10%)
Monitoring/ management costs€ 1,181 (3%)€ 2,192 (5%)€ 1,148 (3%)€ 1,179 (3%)€ 1,174 (3%)€ 1,176 (3%)
Event costs€ 18,573 (45%)€ 19,872 (49%)€ 20,227 (46%)€ 19,320 (46%)€ 19,100 (46%)€ 18,470 (45%)
Indirect costs€ 17,289 (42%)€ 18,005 (45%)€ 18,811 (43%)€ 17,905 (43%)€ 18,010 (43%)€ 17,463 (42%)
Total costs € 40,968€ 40,163€ 43,612€ 41,726€ 41,967€ 41,129
RWD-based analysis
  Apixaban VKA Dabigatran Rivaroxaban
Drug costs€ 3,661 (12%)€ 89 (<1%)€ 3,171 (9%)€ 3,471 (10%)
Monitoring/ management costs€ 1,000 (3%)€ 1,940 (6%)€ 984 (3%)€ 990 (3%)
Event costs€ 15,208 (48%)€ 17,339 (53%)€ 16,383 (48%)€ 16,118 (48%)
Indirect costs€ 11,878 (37%)€ 13,051 (40%)€ 13,307 (39%)€ 12,740 (38%)
Total costs € 31,747€ 32,419€ 33,845€ 33,714

Abbreviations: NMA, network meta-analysis; RWD, real-world data; VKA, vitamin K antagonist.

Table 4

Base-case results of the NMA-based and RWD-based analyses comparing apixaban to VKA and other NOACs.

ComparatorIncremental costIncremental QALYCost per QALY gainedIncremental LYCost per LY gained
NMA-based analysis
VKA€9200.262€3,5060.269€3,415
Dabigatran (110mg)- €2,6920.177Dominant0.207Dominant
Dabigatran (150 mg)- €8190.131Dominant0.157Dominant
Rivaroxaban- €1,0270.101Dominant0.126Dominant
Edoxaban- €1970.065Dominant0.085Dominant
RWD-based analysis
VKA- €6720.285Dominant0.299Dominant
Dabigatran- €2,0980.216Dominant0.266Dominant
Rivaroxaban- €1,5710.113Dominant0.140Dominant

Abbreviations: LY, life-years; NMA, network meta-analysis; QALY, quality adjusted life-years, RWD, real-world data; VKA, vitamin K antagonist.

Table 5

Results of the scenario analyses: NMA-based and RWD-based analyses calculated from healthcare payer’s perspective (scenario 1), equal drugs costs for NOACs (scenario 2) and equal event unrelated AC discontinuation rates for NOACs and VKAs (scenario 3).

Scenario 1: healthcare payer’s perspective
Comparator Incremental cost Incremental QALY Cost per QALY gained Incremental LY Cost per LY gained
NMA-based analysis
VKA€1,5180.262€5,7870.269€5,636
Dabigatran (110mg)- €1,1220.177Dominant0.207Dominant
Dabigatran (150 mg)- €1420.131Dominant0.157Dominant
Rivaroxaban- €2770.101Dominant0.126Dominant
Edoxaban€130.065€2060.085€157
RWD-based analysis
VKA€4980.285€1,7500.299€1,668
Dabigatran- €6690.216Dominant0.266Dominant
Rivaroxaban- €9430.137Dominant0.170Dominant
Scenario 2: equal drug costs for NOACs
Comparator Incremental cost Incremental QALY Cost per QALY gained Incremental LY Cost per LY gained
NMA-based analysis
Dabigatran (110mg)- €2,2870.177Dominant0.207Dominant
Dabigatran (150 mg)- €4110.131Dominant0.157Dominant
Rivaroxaban- €8280.101Dominant0.126Dominant
Edoxaban€1860.065€2,8840.085€2,193
RWD-based analysis
Dabigatran- €1,7670.216Dominant0.266Dominant
Rivaroxaban- €1600.137Dominant0.170Dominant
Scenario 3: equal event unrelated AC discontinuation rate for NOACs and VKAs
Comparator Incremental cost Incremental QALY Cost per QALY gained Incremental LY Cost per LY gained
NMA-based analysis
VKA€1,3900.246€5,6480.249€5,580
Dabigatran (110mg)- €6750.082Dominant0.103Dominant
Dabigatran (150 mg)€1,9590.008€244,0790.022€90,398
Rivaroxaban- €1000.056Dominant0.077Dominant
Edoxaban€3850.038€10,2430.055€6,951
RWD-based analysis
VKA- €4450.279Dominant0.291Dominant
Dabigatran- €1,1600.173Dominant0.224Dominant
Rivaroxaban- €1,6660.115Dominant0.147Dominant

Abbreviations: AC, anticoagulant; LY, life-years; NMA, network meta-analysis; QALY, quality adjusted life-year; RWD, real-world data; VKA, vitamin K antagonist.

Probability of being the most cost-effective treatment choice per willingness-to-pay threshold for the RWD-based analysis.

Abbreviations: QALY, quality adjusted life-years; RWD, real-world data; VKA, vitamin K antagonist. threshold for the RWD-based analysis. Abbreviations: NMA, network meta-analysis; RWD, real-world data; VKA, vitamin K antagonist. Abbreviations: LY, life-years; NMA, network meta-analysis; QALY, quality adjusted life-years, RWD, real-world data; VKA, vitamin K antagonist. Abbreviations: AC, anticoagulant; LY, life-years; NMA, network meta-analysis; QALY, quality adjusted life-year; RWD, real-world data; VKA, vitamin K antagonist. Statements in [1] that were affected by the re-analysis are listed and corrected in the table below titled, “Table 6. Text Corrections”. In this table, reference 12a is used to designate Lip et al. (2020) (listed as reference [2] in this Correction).
Table 6

Text Corrections.

LocationOriginal textCorrected text
Methods, second paragraph, fifth sentenceFollowing the pre-defined eligibility criteria, the real-world study of Lip et al. [12] was considered the most appropriate for use in the RWD-based analysis.Following the pre-defined eligibility criteria, the real-world study of Lip et al. [12,12a] was considered the most appropriate for use in the RWD-based analysis.
Methods, Patient characteristics section, fifth sentenceThe patients were on average 74.3 years old, 54.1% were male and the average CHA2DS2-VASc score was 3.7.The patients were on average 76.1 years old, 51.4% were male and the average CHA2DS2-VASc score was 3.9.
Methods, Transition probabilities section, Event rates subsection, second paragraph, second sentenceBased on the real-world study by Lip et al. [12] we included RWD-based event rates of apixaban and VKA and hazard ratios of dabigatran and rivaroxaban for ischaemic stroke, ICH, other MB and SE, and distributions of haemorrhagic stroke among ICH and GI bleeding among other MB.Based on the real-world study by Lip et al. [12,12a]] we included RWD-based event rates of apixaban and VKA and hazard ratios of dabigatran and rivaroxaban for ischaemic stroke, ICH, other MB and SE, and distributions of haemorrhagic stroke among ICH and GI bleeding among other MB.
Results, Deterministic results section, first paragraph, first sentenceTable 3 summarizes the costs outcomes per category. Event costs are the largest contributor to the total costs (45–49% and 47–53% in the NMA-based and RWD-based analyses, respectively).Table 3 summarizes the costs outcomes per category. Event costs are the largest contributor to the total costs (45–49% and 48–53% in the NMA-based and RWD-based analyses, respectively).
Results, Deterministic results section, first paragraph, second sentenceIndirect costs also have high impact on the total costs: in both analyses 39–45% of the total costs are related to indirect costs.Indirect costs also have high impact on the total costs: in both analyses 37–45% of the total costs are related to indirect costs.
Results, Deterministic results section, first paragraph, third sentenceIn VKA treated patients, the impact of drug costs is negligible compared to NOACs (<1%% vs. 8–10% of total costs).In VKA treated patients, the impact of drug costs is negligible compared to NOACs (<1% vs. 8–12% of total costs).
Results, Sensitivity analyses section, first paragraph, sentences 5 and 6In RWD-based analysis, similar results were found: apixaban is the most cost-effective treatment with 90%, and apixaban was–compared to VKA, dabigatran and rivaroxaban respectively—cost-effective in 0%, 0% and 9% of the iterations. Nevertheless, apixaban was only significantly dominant compared to VKA in the RWD-based analysis, as in more than 95% of the PSA simulations apixaban was cost-saving and more effective compared to VKA.In RWD-based analysis, similar results were found: apixaban is the most cost-effective treatment with 94%, and apixaban was–compared to VKA, dabigatran and rivaroxaban respectively—cost-effective in 0%, 0% and 5% of the iterations. Nevertheless, apixaban was only significantly dominant compared to VKA in the RWD-based analysis, as in more than 89% of the PSA simulations apixaban was cost-saving and more effective compared to VKA.
Results, Scenario analyses section, second paragraph, first sentenceIn RWD-based analysis, apixaban is cost-effective compared to VKA (€292/QALY), and cost-saving (dominant) compared to dabigatran and rivaroxaban.In RWD-based analysis, apixaban is cost-effective compared to VKA (€1,750/QALY), and cost-saving (dominant) compared to dabigatran and rivaroxaban.
Discussion, first paragraph, fifth sentenceApixaban was shown, in both analyses, to be the most cost-effective treatment option at a WTP threshold of €20,000/QALY (50% and 90%, respectively).Apixaban was shown, in both analyses, to be the most cost-effective treatment option at a WTP threshold of €20,000/QALY (50% and 94%, respectively).
Discussion, seventh paragraph, first sentenceThe major advantage of this study is that both an NMA and RWD were used for cost-effectiveness. For the RWD-based analysis we used the publication of Lip et al. that best met the inclusion criteria for the systematic literature search underlying the NMA [12].The major advantage of this study is that both an NMA and RWD were used for cost-effectiveness. For the RWD-based analysis we used the publication of Lip et al. that best met the inclusion criteria for the systematic literature search underlying the NMA [12,12a].
The S3 Table legend in [1] cited reference 3 for Lip et al. (2018), which aligns with the reference number in S1 Appendix rather than the reference number in the article’s main reference list. The legend has been updated, below, to cite publication years for the Lip et al. article (2018) and correction (2020) [2]. An Editorial Board member has reviewed the updates to the RWD-based analysis and determined that the conclusions of article [1] are upheld.

Supporting information

The following are corrected versions of the Supporting Information files reported in [1].

Patient baseline characteristics model inputs used in the NMA-based and RWD-based analyses.

(DOCX) Click here for additional data file.

Event rates for apixaban and VKA and dabigatran 110 mg, dabigatran 150 mg, rivaroxaban, and edoxaban and distributions of patients across different levels of ischaemic and haemorrhagic stroke severity.

(DOCX) Click here for additional data file.

Input parameters for the RWD-based analysis obtained from real-world study comparing apixaban with VKA and other NOACs by Lip et al. (2018, 2020).

(DOCX) Click here for additional data file.

Background mortality, case fatality and mortality risk adjustment factors per event.

(DOCX) Click here for additional data file.

Event rates per 100 patient-years for no treatment after event unrelated treatment discontinuation.

(DOCX) Click here for additional data file.

Probabilistic sensitivity analysis results.

(DOCX) Click here for additional data file.
  3 in total

1.  Correction to: Effectiveness and Safety of Oral Anticoagulants Among Nonvalvular Atrial Fibrillation Patients: The ARISTOPHANES Study.

Authors: 
Journal:  Stroke       Date:  2020-03-23       Impact factor: 7.914

2.  Effectiveness and Safety of Oral Anticoagulants Among Nonvalvular Atrial Fibrillation Patients.

Authors:  Gregory Y H Lip; Allison Keshishian; Xiaoyan Li; Melissa Hamilton; Cristina Masseria; Kiran Gupta; Xuemei Luo; Jack Mardekian; Keith Friend; Anagha Nadkarni; Xianying Pan; Onur Baser; Steven Deitelzweig
Journal:  Stroke       Date:  2018-12       Impact factor: 7.914

3.  Cost-effectiveness of apixaban compared to other anticoagulants in patients with atrial fibrillation in the real-world and trial settings.

Authors:  Lisa A de Jong; Jessie Groeneveld; Jelena Stevanovic; Harrie Rila; Robert G Tieleman; Menno V Huisman; Maarten J Postma; Marinus van Hulst
Journal:  PLoS One       Date:  2019-09-17       Impact factor: 3.240

  3 in total

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