Prophylaxis of deep vein thrombosis (DVT)
Indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing knee or hip replacement surgery.
Reduction of risk of stroke and systemic embolism in non- valvular atrial fibrillation (AF)
Indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. [1, 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.
Prior Authorization Guideline
Guideline Name Xarelto (rivaroxaban) Formulary
• UnitedHealthcare Community & State
Approval Date 10/10/2013
Revision Date 8/11/2014
Technician Note:
CPS Approval Date: 11/15/2011; CPS Revision Date: 8/20/2014
Indications Xarelto (rivaroxaban)
Criteria
Product Name: Xarelto*
Diagnosis Continuation of therapy upon hospital discharge
Approval Length 35 days [5, B]
Guideline Type Prior Authorization
Approval Criteria
1
Will be approved as continuation of therapy upon hospital discharge
Notes *Prior authorization may not apply depending on the plan
Product Name: Xarelto*
Diagnosis Prophylaxis of deep vein thrombosis (DVT) following hip or knee replacement
surgery
Approval Length 35 days [5, B]
Guideline Type Prior Authorization
Approval Criteria
1
One of the following:
• Completion of total knee replacement surgery [1]
• Completion of total hip replacement surgery [1]
Product Name: Xarelto*
Diagnosis Reduction of risk of stroke and systemic embolism in non-valvular atrial
fibrillation (AF)
Approval Length 12 Month
Guideline Type Prior Authorization
Approval Criteria
1
Diagnosis of atrial fibrillation (AF)
AND
2
Patient does not have any of the following conditions: [1, 2, 3, C]
• A mechanical prosthetic heart valve
• A bioprosthetic heart valve
Notes *Prior authorization may not apply depending on the plan
Product Name: Xarelto*
Diagnosis Treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE)
Approval Length 12 months [D]
Guideline Type Prior Authorization
Approval Criteria
Diagnosis of one of the following:
• Deep vein thrombosis (DVT) [1, 12-13]
• Pulmonary embolism (PE) [1, 12-13]
Notes *Prior authorization may not apply depending on the plan
Product Name: Xarelto*
Diagnosis Reduction in the risk of recurrence of deep vein thrombosis (DVT) and of
pulmonary embolism (PE)
Approval Length 12 months [E]
Guideline Type Prior Authorization
Approval Criteria
1
Previous diagnosis of one of the following: [1]
• 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 [1, 13]
Endnotes
A. Clinical trials of Xarelto for prevention of VTE following total hip replacement or total knee replacement surgery included only patients aged 18 years or older. [6-9] Safety and effectiveness in pediatric patients have not been established. [1]
B. The ACCP guidelines recommend a duration of thromboprophylaxis for at least 10 days following orthopedic surgeries. For patients undergoing total hip replacement or total knee replacement, the ACCP guidelines recommend that thromboprophylaxis be extended beyond 10 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. [10]
D. The duration of therapy in the EINSTEIN-DVT and EINSTEIN-PE studies was either 3, 6, or 12 months based on investigator’s assessment prior to randomization. [12, 13]
E. The duration of therapy in the EINSTEIN- EXTENSION study was 6 or 12 months based on investigator’s assessment prior to randomization. [13]
References
1. Xarelto Prescribing Information. Janssen Pharmaceuticals, Inc., March 2014.
2. Patel MR, Mahaffey KW, Garg J, et.al. Rivaroxaban versus warfarin in nonvalvular atrial fibriallation. N Engl J Med. 2011; 365:883-91.
3. Patel MR, Mahaffey KW, Garg J, et al. Supplementary Appendix to: [Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011; 365:883-91]. Available at www.nejm.org.
4. DRUGEX® System [Internet Database]. Greenwood Village, CO: Thomson Micromedex. Updated periodically. Accessed October 10, 2011.
5. 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. 2012;141(2 Suppl):e419S-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):2765-75. 7. 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 double- blind, randomized controlled trial. Lancet. 2008;372:31-39.
8. Lassen MR, Ageno W, Borris LC, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis
after total knee arthroplasty. New Engl J Med. 2008;358(26):2776-86.
9. Turpie AG, Lassen MR, Davidson BL, et al. Rivaroxaban versus enoxaparin for
thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009;373:1673-80.
10. Fuster V, Ryden L, Cannom D et al. ACC/AHA/ESC 2006 Guidelines for the Management of patients with atrial fibrillation. Circulation. 2006;114:e257-e354.
11. 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. 2012 Feb;141(2 Suppl):e531S-75S.
12. 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. 2012;366(14):1287-97. 13. Bauersachs R, Berkowitz SD, Brenner B, et al. for EINSTEIN Study Group. Oral Rivaroxaban
