This document analyzes the cost-effectiveness of replacing warfarin with novel oral anticoagulants (NOACs) like apixaban, edoxaban, rivaroxaban, and dabigatran for treating venous thromboembolism (VTE) and stroke prevention in atrial fibrillation patients. Decision trees were constructed comparing the five therapies. Results found that for VTE treatment, apixaban was the most cost-effective due to superior efficacy and price. For stroke prevention, apixaban was most efficacious but warfarin was least expensive, so warfarin still provides good value.
Dual antiplatelet therapy has long been the standard of care in preventing coronary and cerebrovascular thrombotic events in patients
with chronic coronary syndrome and acute coronary syndrome undergoing percutaneous coronary intervention, but choosing the optimal
treatment duration and composition has become a major challenge. Numerous studies have shown that certain patients benefit from ei ther shortened or extended treatment duration. Furthermore, trials evaluating novel antithrombotic strategies, such as P2Y12 inhibitor
monotherapy, low-dose factor Xa inhibitors on top of antiplatelet therapy, and platelet function- or genotype-guided (de-)escalation of
treatment, have shown promising results. Current guidelines recommend risk stratification for tailoring treatment duration and composition. Although several risk stratification methods evaluating ischaemic and bleeding risk are available to clinicians, such as the use of risk
scores, platelet function testing , and genotyping, risk stratification has not been broadly adopted in clinical practice. Multiple risk scores
have been developed to determine the optimal treatment duration, but external validation studies have yielded conflicting results in terms
of calibration and discrimination and there is limited evidence that their adoption improves clinical outcomes. Likewise, platelet function
testing and genotyping can provide useful prognostic insights, but trials evaluating treatment strategies guided by these stratification methods have produced mixed results. This review critically appraises the currently available antithrombotic strategies and provides a viewpoint
on the use of different risk stratification methods alongside clinical judgement in current clinical practice.
Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic DrugsRashiab Rashid
In patients with ischemic cardiomyopathy and an ICD who had ventricular tachycardia despite antiarrhythmic drug therapy, there was a significantly lower rate of the composite primary outcome of death, ventricular tachycardia storm, or appropriate
ICD shock among patients undergoing catheter ablation than among those receiving an escalation in antiarrhythmic drug therapy.
Dual antiplatelet therapy (DAPT) with aspirin (ASA) and a P2Y12 inhibitor (clopidogrel, ticagrelor, or prasugrel) is a standard therapeutic regimen to prevent stent thrombosis after percutaneous coronary intervention (PCI) with drug-eluting stents (DESs). The duration of DAPT has significant risk/benefit consequences and implications on quality improvement and patient safety. Since the last American College of Cardiology (ACC) and American Heart Association (AHA) PCI DAPT Guidelines were published in 2016,1 there has been an explosion of data regarding strategies to shorten the duration of DAPT. This Tip of the Month (TOTM) will place perspective on the most recent studies in comparison with the older guidelines—but with advice to address the current demands of contemporary decision processes.
AHA 2010 research highlights: A slideshow presentation theheart.org
http://www.theheart.org/editorial-program/1156073.do
The American Heart Association (AHA) 2010 Scientific Sessions took place in Chicago. Key trials presented at the sessions include: ADVANCE,RAFT,QRS EMPHASIS-HF,ASCEND HF,ROCKET AF,CLOSURE I,GRAVITAS,P-OM3,BASKET-PROVE,DEFINE,SYMPLICITY HTN,ASCOT CRP and ACT.
Dual antiplatelet therapy has long been the standard of care in preventing coronary and cerebrovascular thrombotic events in patients
with chronic coronary syndrome and acute coronary syndrome undergoing percutaneous coronary intervention, but choosing the optimal
treatment duration and composition has become a major challenge. Numerous studies have shown that certain patients benefit from ei ther shortened or extended treatment duration. Furthermore, trials evaluating novel antithrombotic strategies, such as P2Y12 inhibitor
monotherapy, low-dose factor Xa inhibitors on top of antiplatelet therapy, and platelet function- or genotype-guided (de-)escalation of
treatment, have shown promising results. Current guidelines recommend risk stratification for tailoring treatment duration and composition. Although several risk stratification methods evaluating ischaemic and bleeding risk are available to clinicians, such as the use of risk
scores, platelet function testing , and genotyping, risk stratification has not been broadly adopted in clinical practice. Multiple risk scores
have been developed to determine the optimal treatment duration, but external validation studies have yielded conflicting results in terms
of calibration and discrimination and there is limited evidence that their adoption improves clinical outcomes. Likewise, platelet function
testing and genotyping can provide useful prognostic insights, but trials evaluating treatment strategies guided by these stratification methods have produced mixed results. This review critically appraises the currently available antithrombotic strategies and provides a viewpoint
on the use of different risk stratification methods alongside clinical judgement in current clinical practice.
Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic DrugsRashiab Rashid
In patients with ischemic cardiomyopathy and an ICD who had ventricular tachycardia despite antiarrhythmic drug therapy, there was a significantly lower rate of the composite primary outcome of death, ventricular tachycardia storm, or appropriate
ICD shock among patients undergoing catheter ablation than among those receiving an escalation in antiarrhythmic drug therapy.
Dual antiplatelet therapy (DAPT) with aspirin (ASA) and a P2Y12 inhibitor (clopidogrel, ticagrelor, or prasugrel) is a standard therapeutic regimen to prevent stent thrombosis after percutaneous coronary intervention (PCI) with drug-eluting stents (DESs). The duration of DAPT has significant risk/benefit consequences and implications on quality improvement and patient safety. Since the last American College of Cardiology (ACC) and American Heart Association (AHA) PCI DAPT Guidelines were published in 2016,1 there has been an explosion of data regarding strategies to shorten the duration of DAPT. This Tip of the Month (TOTM) will place perspective on the most recent studies in comparison with the older guidelines—but with advice to address the current demands of contemporary decision processes.
AHA 2010 research highlights: A slideshow presentation theheart.org
http://www.theheart.org/editorial-program/1156073.do
The American Heart Association (AHA) 2010 Scientific Sessions took place in Chicago. Key trials presented at the sessions include: ADVANCE,RAFT,QRS EMPHASIS-HF,ASCEND HF,ROCKET AF,CLOSURE I,GRAVITAS,P-OM3,BASKET-PROVE,DEFINE,SYMPLICITY HTN,ASCOT CRP and ACT.
there are several limitation in VKA,to over come these problem NOACs came in picture but still limited indication for NOACs currently,required further study inter and intra comparison between anticoagulants.
Stroke prevention for nonvalvular AF, summary of evidence-based guidelinesErsifa Fatimah
Ternyata... guideline yang ngebahas prevensi stroke pada nonvalvular AF tu banyak banget! Yang dirilis komunitas Neuro maupun Cardio, yang internasional maupun yang lokal. Dan pertanyaan besarnya tetep: What's the best strategy?
*Bonus special issue: manajemen prevensi stroke infark dengan antikoagulan pasca brain hemorrhage.
La gestion du traitement par NOAC chez le patient avec une cardiopathie isché...
AMCP Nexus Poster Charles Ng
1. Is it time to replace warfarin with novel oral
anticoagulants (NOACs) for treating thrombotic disorders?
Charles Ng, C. Daniel Mullins, PhD
References
Background
• Warfarin has been the gold standard for venous thromboembolism (VTE)
treatment and stroke/systemic embolism prophylaxis in patients with
nonvalvular atrial fibrillation (NVAF) for the past 50 years.1,2
• Within the past few years, NOACs such as edoxaban, apixaban,
rivaroxaban, and dabigatran have emerged as the preferred treatment
due to their favorable pharmacokinetics, pharmacodynamics, and
minimal adverse events.1,2
Objective
• A decision tree was constructed for each of the indications: VTE
treatment and stroke/systemic embolism prophylaxis in NVAF patients.
• Each tree compared five therapies: edoxaban, apixaban, rivaroxaban,
dabigatran, and warfarin.
• The transition probabilities were derived from their respective phase 3
clinical trials.
• Costs were derived from various literature sources with a one-year time
frame.
Methods
Model Inputs
Clinical Trial Summary
To determine the cost-effectiveness of the NOACs versus warfarin from a
managed care organization (MCO) perspective.
Decision Tree
Table 1. VTE clinical efficacy and safety summaries derived from NOAC’s respective phase 3 trials
Table 2. NVAF clinical efficacy and safety summaries derived from NOAC’s respective phase 3 clinical trials
Table 4. Data derived from NOAC’s respective phase 3 clinical trials and various literature sources
Table 3. Data derived from NOAC’s respective phase 3 clinical trials and various literature sources
CRNMB: Clinically relevant non-major bleeding
Results: NVAF Treatment
Conclusions
Contact
• Apixaban had the lowest average yearly cost of $7,755.91, followed
by warfarin ($7,864.46), dabigatran ($8,903.02), edoxaban
($9,557.37), and rivaroxaban ($10,630.41).
• Effectiveness was measured by treatment response without a major
bleeding or CRNMB event. Warfarin had the lowest efficacy of 0.87,
followed by rivaroxaban (0.88), edoxaban (0.89), dabigatran (0.91),
and apixaban (0.94).
• For VTE treatment, apixaban is the most cost-effective option due
to its superior price and efficacy profile, therefore it should be
added to the MCO formulary for this indication.
• For stroke/systemic embolism prophylaxis in NVAF patients,
apixaban is the most efficacious option, but warfarin is the least
expensive option.
• From a cost effectiveness viewpoint, warfarin should not be
replaced by the NOACs because it demonstrates good value, but for
those seeking the most efficacious treatment, apixaban should be
the drug of choice.
1. Venous Thromboembolism (Blood Clots) [Internet]. [cited 2016 May 4]. Available from: http://www.cdc.gov/ncbddd/dvt/data.html
2. Atrial Fibrillation Fact Sheet [Internet]. [cited 2016 May 4]. Available from: http://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm
3. Hokusai-VTE Investigators, Büller HR, Décousus H, et al. Edoxaban versus Warfarin for the Treatment of Symptomatic Venous Thromboembolism. N Engl J Med. 2013, Oct 10:
369:1406-1415. Available at: http://www.nejm.org/doi/pdf/10.1056/NEJMoa1306638
4. Agnelli G, Buller HR, Cohen A, et al. Oral Apixaban for the Treatment ofAcute Venous Thromboembolism. N Engl J Med. 2013, Aug 29: 369:799-808. Available at:
http://www.nejm.org/doi/pdf/10.1056/NEJMoa1302507
5. Prins et al.: Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized
studies. Thrombosis Journal 2013 11:21
6. Schulman S, Kearon C, Kakkar AK, et al. Dabigatran versus Warfarin in the Treatment ofAcute Venous Thromboembolism. N Engl J Med. 2009, Dec 10: 2342-52. Available at:
http://www.nejm.org/doi/pdf/10.1056/NEJMoa0906598
7. Giugliano RP, Ruff CT, Braunwald E, et al. Edoxaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2013, Nov 28: 369:2093-2104. Available at:
http://www.nejm.org/doi/full/10.1056/NEJMoa1310907
8. Granger CB,Alexander JH, McMurray JJ, et al.Apixaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2011, Sep 15: 365:981-992. Available at:
http://www.nejm.org/doi/full/10.1056/NEJMoa1107039
9. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. N Engl J Med. 2011, Sep 8: 365:883-891. Available at:
http://www.nejm.org/doi/full/10.1056/NEJMoa1009638
10.Connolly SJ, Ezekowitz MD, Phil D, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2009, Sep 7: 361:1139-1151. Available at:
http://www.nejm.org/doi/full/10.1056/NEJMoa0905561
11.Amin A, Lingohr-Smith M, BrunoA, Trocio J, Lin J (2015) Economic Evaluations of Medical Cost Differences: Use of Targeted-Specific Oral Anticoagulants vs. Warfarin among
Patients with Nonvalvular Atrial Fibrillation and Venous Thromboembolism in the U.S. J Hematol Thrombo Dis 3: 209. doi:10.4172/2329-8790.1000209
12.Biskupiak J, Ghate SR, Jiao T, et al. Cost implications of formulary decisions on oral anticoagulants in nonvalvular atrial fibrillation. J Manag Care Pharm. 2013 Nov-
Dec;19(9):789-98. Available at: http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=17308
13.Magnuson EA, Vilain K, Wang K, et al. Cost-effectiveness of edoxaban vs warfarin in patients with atrial fibrillation based on results of the ENGAGE AF-TIMI 48 trial. Am Heart J.
2015 Dec;170(6):1140-50. Available at: https://www.ncbi.nlm.nih.gov/pubmed/26678636
14.Amin A, Lingohr-Smith M, BrunoA, Trocio J, Lin J (2015) Economic Evaluations of Medical Cost Differences: Use of Targeted-Specific Oral Anticoagulants vs. Warfarin among
Patients with Nonvalvular Atrial Fibrillation and Venous Thromboembolism in the U.S.. J Hematol Thrombo Dis 3: 209. doi:10.4172/2329-8790.1000209
15.REDBOOK [Internet]. Greenwood Village, Colorado: Thomson Reuters (Healthcare) Inc. 1974 – [cited 2016 Apr 26]. Available from http://www.micromedexsolutions.com/proxy-
hs.researchport.umd.edu/micromedex2/librarian/CS/8840FB/ND_PR/evidencexpert/ND_P/evidencexpert/DUPLICATIONSHIELDSYNC/D7A020/ND_PG/evidencexpert/ND_B/evid
encexpert/ND_AppProduct/evidencexpert/ND_T/evidencexpert/PFActionId/redbook.FindRedBook?navitem=topRedBook&isToolPage=true
Charles Ng: CharlesNg58@gmail.com; 443-939-8431; www.linkedin.com/in/CharlesNg58
Results: VTE Treatment
• Warfarin had the lowest average yearly cost of $1,119.71, followed
by edoxaban ($3,596.70), dabigatran ($4,110.33), apixaban
($4,385.71), and rivaroxaban ($4,438.61).
• The effectiveness was treatment response without a major
bleeding event. Warfarin and edoxaban had the lowest efficacy of
0.90, followed by rivaroxaban (0.91), dabigatran (0.92), and
apixaban (0.94).
• The incremental cost-effectiveness ratio of dabigatran versus
warfarin and apixaban versus dabigatran was $175,918.82 and
$12,517.27 per additional treatment response without a major
bleeding event, respectively.
Presented at Academy of Managed Care Pharmacy (AMCP) Nexus 2016 at the Gaylord National Resort & Convention Center in Washington, DC, October 4-5, 2016