Medication Policy Manual. Topic: Eliquis, apixaban Date of Origin: July 12, Committee Approval Date: July 11, 2014 Next Review Date: July 2015

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1 Medication Policy Manual Policy No: dru313 Topic: Eliquis, apixaban Date of Origin: July 12, 2013 Committee Approval Date: July 11, 2014 Next Review Date: July 2015 Effective Date: August 1, 2014 IMPORTANT REMINDER This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status. Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care. Description Apixaban (Eliquis) is an anticoagulant that helps prevent blood clots in some patients. Blood clots may lead to a variety of complications such as heart attack or stroke dru313.1 Page 1 of 5

2 Policy/Criteria I. Most contracts require prior authorization approval of apixaban (Eliquis) prior to coverage. Apixaban (Eliquis) may be considered medically necessary in patients requiring anticoagulation when criteria A and B below are met: A. Dabigatran (Pradaxa) has been ineffective, not tolerated, or is contraindicated AND B. Rivaroxaban (Xarelto) has been ineffective, not tolerated, or is contraindicated II. Administration, Quantity Limitations, and Authorization Period A. OmedaRx considers apixaban (Eliquis) to be a self-administered medication. B. When prior authorization is approved, apixaban (Eliquis) may be authorized in quantities of 60 tablets per month. C. Authorization may be reviewed at least yearly to confirm that current medical necessity criteria are met and that the medication is effective. Position Statement Dabigatran (Pradaxa) and rivaroxaban (Xarelto) have the most clinical experience and are the best value branded oral anticoagulants for OmedaRx members. Clinical Efficacy Atrial Fibrillation - There is moderate certainty in the evidence for the efficacy of apixaban (Eliquis) versus warfarin and aspirin for anticoagulation in atrial fibrillation. This is based on two trials which evaluated the endpoint of reduction of stroke or systemic embolism. In one low confidence trial versus warfarin, the event rate of stroke or systemic embolism per year was 1.27% and 1.60% in the apixaban (Eliquis) and warfarin groups, respectively (hazard ratio 0.79; 95% confidence interval: 0.66, 0.95; P = 0.01). This trial was appraised as low confidence due to major concerns including high rate of treatment discontinuation and treatment crossover, which may have confounded efficacy results. [1] One fair confidence trial versus aspirin was stopped early due to the significant decrease in event rate of stroke or systemic embolism reported with apixaban (Eliquis). The event rate per year was 1.6% and 3.7% in the apixaban (Eliquis) and aspirin groups, respectively (hazard ratio 0.45; 95% confidence interval: 0.32, 0.62; p < 0.001). [2] dru313.1 Page 2 of 5

3 - There is low certainty in the evidence for the comparative efficacy of all branded oral anticoagulants for prevention of stroke or systemic embolism in atrial fibrillation. [3,4] This is based on two low quality systematic reviews with meta-analyses which included studies evaluating new oral anticoagulants [apixaban (Eliquis), dabigatran (Pradaxa), and rivaroxaban (Xarelto)] versus vitamin K antagonists (e.g. warfarin) for reduction of stroke or systemic embolism in atrial fibrillation. In both reviews, the authors concluded that the new oral anticoagulants were associated with a similar increase in efficacy versus vitamin K antagonists like warfarin; however, data from direct comparative clinical trials are needed to confirm these results. These reviews were appraised as low quality because relative conclusions were made based on low quality data. Other Conditions Requiring Anticoagulation - The branded oral anticoagulants including apixaban (Eliquis), dabigatran (Pradaxa), and rivaroxaban (Xarelto), have been studied in a variety of other conditions requiring anticoagulation such as deep vein thrombosis prophylaxis following hip or knee replacement. - The data is suggestive that all three branded anticoagulants are effective in these conditions and because comparative evidence is limited to indirect comparison, a conclusion that one is more effective than another cannot be made. Safety - The safety of apixaban (Eliquis) relative to other anticoagulants used in atrial fibrillation is uncertain due to its short track record of clinical experience. In addition, comparative evidence for the branded oral anticoagulants is based on indirect comparison. [4-7] - As with other anticoagulants used in atrial fibrillation, the most common adverse events (> 1%) reported in clinical trials with apixaban (Eliquis) were related to bleeding. [8] - All branded oral anticoagulants, including apixaban (Eliquis) have a boxed warning that discontinuation puts patients at an increased risk of blood clots. [8-10] dru313.1 Page 3 of 5

4 Cross References N/A Codes Number Description N/A Appendix 1: Summary of Branded Oral Anticoagulant Approvals and Published Data apixaban (Eliquis) dabigatran (Pradaxa) rivaroxaban (Xarelto) Mechanism of action Factor Xa inhibitor Direct thrombin inhibitor Factor Xa inhibitor Indication Approval Status Atrial fibrillation U.S. (12/2012) Europe (9/2012) U.S. (10/2010) Europe (4/2011) U.S. (11/2011) Europe (9/2011) Post hip/knee surgery U.S. (3/2014) Europe (5/2011) U.S. Europe (3/2008) U.S. (7/2011) Europe (7/2008) Medically ill No published data Acute coronary syndrome No published data U.S. Europe (6/2013) Treatment of VTE VTE = venous thromboembolism U.S. (4/2014) Europe U.S. (11/2012) Europe (1/2012) dru313.1 Page 4 of 5

5 References 1. Granger, CB, Alexander, JH, McMurray, JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. The New England journal of medicine Sep 15;365(11): PMID: Connolly, SJ, Eikelboom, J, Joyner, C, et al. Apixaban in patients with atrial fibrillation. The New England journal of medicine Mar 3;364(9): PMID: Dentali, F, Riva, N, Crowther, M, Turpie, AG, Lip, GY, Ageno, W. Efficacy and safety of the novel oral anticoagulants in atrial fibrillation: a systematic review and metaanalysis of the literature. United States, p Baker, WL, Phung, OJ. Systematic review and adjusted indirect comparison metaanalysis of oral anticoagulants in atrial fibrillation. United States, p Gomez-Outes, A, Terleira-Fernandez, AI, Suarez-Gea, ML, Vargas-Castrillon, E. Dabigatran, rivaroxaban, or apixaban versus enoxaparin for thromboprophylaxis after total hip or knee replacement: systematic review, meta-analysis, and indirect treatment comparisons. BMJ. 2012;344:e3675. PMID: Albertsen, IE, Larsen, TB, Rasmussen, LH, Overvad, TF, Lip, GY. Prevention of venous thromboembolism with new oral anticoagulants versus standard pharmacological treatment in acute medically ill patients: a systematic review and meta-analysis. Drugs Sep 10;72(13): PMID: Fox, BD, Kahn, SR, Langleben, D, Eisenberg, MJ, Shimony, A. Efficacy and safety of novel oral anticoagulants for treatment of acute venous thromboembolism: direct and adjusted indirect meta-analysis of randomised controlled trials. BMJ. 2012;345:e7498. PMID: Eliquis [package insert]. Princeton, New Jersey: Bristol-Myers Squibb Company; 12/ Pradaxa [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; 12/ Xarelto [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 11/2012. dru313.1 Page 5 of 5

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