Prior Authorization Guideline

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1 Guideline Guideline Name Formulary Xarelto (rivaroxaban) UnitedHealthcare Community & State Approval Date 0/0/203 Revision Date 8//204 Technician Note: CPS Approval Date: /5/20; CPS Revision Date: 8/20/204 Indications Xarelto (rivaroxaban) Prophylaxis of deep vein thrombosis (DVT) Reduction of risk of stroke and systemic embolism in nonvalvular atrial fibrillation (AF) Indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing knee or hip replacement surgery. Indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. [, 2, 3, 4] There are limited data on the relative effectiveness of Xarelto and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled. Treatment of deep vein thrombosis (DVT) Indicated for the treatment of DVT. Treatment of pulmonary embolism (PE) Indicated for the treatment of PE. Reduction in the Risk of Recurrence of deep vein thrombosis (DVT) and of pulmonary embolism (PE) Indicated for the reduction in the risk of recurrence of DVT and of PE following an initial 6 months treatment for DVT and/or PE.

2 Criteria 35 days [5, B] Continuation of therapy upon hospital discharge Will be approved as continuation of therapy upon hospital discharge 35 days [5, B] Prophylaxis of deep vein thrombosis (DVT) following hip or knee replacement surgery One of the following: Completion of total knee replacement surgery [] Completion of total hip replacement surgery []

3 Reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation (AF) 2 Month of atrial fibrillation (AF) AND 2 Patient does not have any of the following conditions: [, 2, 3, C] A mechanical prosthetic heart valve A bioprosthetic heart valve Treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) 2 months [D]

4 of one of the following: Deep vein thrombosis (DVT) [, 2-3] Pulmonary embolism (PE) [, 2-3] Reduction in the risk of recurrence of deep vein thrombosis (DVT) and of pulmonary embolism (PE) 2 months [E] Previous diagnosis of one of the following: [] Deep vein thrombosis (DVT) Pulmonary embolism (PE) AND 2 Patient must have been treated with an anticoagulant [eg, warfarin, Pradaxa (dabigatran), Eliquis (apixiban), Xarelto (rivaroxaban)] for at least 6 months prior to request [, 3]

5 Endnotes A. Clinical trials of Xarelto for prevention of VTE following total hip replacement or total knee replacement surgery included only patients aged 8 years or older. [6-9] Safety and effectiveness in pediatric patients have not been established. [] B. The ACCP guidelines recommend a duration of thromboprophylaxis for at least 0 days following orthopedic surgeries. For patients undergoing total hip replacement or total knee replacement, the ACCP guidelines recommend that thromboprophylaxis be extended beyond 0 days and up to 35 days after surgery. [5] C. Non-valvular atrial fibrillation is defined as occurring in the absence of hemodynamically significant valvular disease, or a prosthetic heart valve. [0] D. The duration of therapy in the EINSTEIN-DVT and EINSTEIN-PE studies was either 3, 6, or 2 months based on investigator s assessment prior to randomization. [2, 3] E. The duration of therapy in the EINSTEIN- EXTENSION study was 6 or 2 months based on investigator s assessment prior to randomization. [3] References. Xarelto Prescribing Information. Janssen Pharmaceuticals, Inc., March Patel MR, Mahaffey KW, Garg J, et.al. Rivaroxaban versus warfarin in nonvalvular atrial fibriallation. N Engl J Med. 20; 365: Patel MR, Mahaffey KW, Garg J, et al. Supplementary Appendix to: [Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 20; 365:883-9]. Available at 4. DRUGEX System [Internet Database]. Greenwood Village, CO: Thomson Micromedex. Updated periodically. Accessed October 0, Kearon C, Akl EA, Comerota AJ, et al. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence- Based Clinical Practice Guidelines. Chest. 202;4(2 Suppl):e49S-94S. 6. Eriksson BI, Borris LC, Friedman RJ, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. New Engl J Med. 2008;358(26): Kakkar AK, Brenner B, Dahl OE, et al. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a doubleblind, randomized controlled trial. Lancet. 2008;372: Lassen MR, Ageno W, Borris LC, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. New Engl J Med. 2008;358(26): Turpie AG, Lassen MR, Davidson BL, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009;373: Fuster V, Ryden L, Cannom D et al. ACC/AHA/ESC 2006 Guidelines for the Management of patients with atrial fibrillation. Circulation. 2006;4:e257-e354.. You JJ, Singer DE, Howard PA, et al. Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 202 Feb;4(2 Suppl):e53S- 75S. 2. Büller HR, Prins MH, Lensin AW, et al. for EINSTEIN PE Study Group. Oral Rivaroxaban for the Treatment of Symptomatic Pulmonary Embolism. N Engl J Med. 202;366(4): Bauersachs R, Berkowitz SD, Brenner B, et al. for EINSTEIN Study Group. Oral Rivaroxaban for the Treatment of Venous Thromboembolism. N Engl J Med. 200; 363(26):

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