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1 Xarelto (rivarox xaban) Policy Number: Origination: 06/2014 Last Review: 07/2015 Next Review: 07/2016 Policy BCBSKC will provide coverage for Xarelto when it is determined to be medically necessary because the following criteria are met. When Policy Topic is covered: Coverage of Xarelto (in 15 mg and 20 mg tablet strengths) is recommended in following criteria: Food and Drug Administration (FDA)-Approved Indications 1. Nonvalvular Atrial Fibrillation (or Atrial Flutter). Approve. those who meet the indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In the ROCKET AF trial, Xarelto doses of 15 mg or 20 mg QD were shown to be non-inferior to warfarin when the primary composite endpoint, the time to first occurrence of stroke or non-cns systemic embolism, was examined in patients with nonvalvular atrial fibrillation. The 2014 guidelines for nonvalvular atrial fibrillation recommend patients with atrial flutter follow the antithrombotic therapy decisionss that are in place for atrial fibrillation. 1,10 The decision to adopt the criteria regarding atrial flutter was based on the professional opinionn of specialist physicians. 2. Prophylaxis of Deep Vein Thrombosis (DVT) in Patients Undergoing Knee Replacement Surgery. Approve. or Hip indicated for this condition. 1 The Xarelto dose is 10 mg QD, taken at least 6 to 10 hours after surgery once hemostasis has been achieved. For patients undergoing hip replacement surgery, a 35-day treatment period is recommended. For those undergoingg knee replacement surgery, a 12-day treatment duration is recommended.. Note: The 10-mg Xarelto strength is not impacted by this policy. 3. Treatment of Deep Vein Thrombosis (DVT). Approve. indicated for the treatment of DVT. 1 The recommended dose is 15 mg BID with food for the first 21 days, followed by 20 mg QD with food for thee remaining treatment. 4. Treatment of Pulmonary Embolism (PE). Approve. indicated for the treatment of PE. 1 The recommended dose is 15 mg BID with food for the first 21 days, followed by 20 mg QD with food for thee remaining treatment.

2 5. Reduction in the Risk of Recurrence of Deep Vein Thrombosis (DVT) and of Pulmonary Embolism (PE). Approve. indicated for the reduction in the risk of recurrence of DVT and or PE following initial 6 months treatment for DVT and/or PE. 1 The recommended dose is 20 mg QD with food. Other Uses with Supportive Evidence 6. Treatment or Prevention of Other Thromboembolic-Related Indications not Addressed in the Exclusions Section Below (e.g., long-term use for thromboprophylaxis in medically-ill patients). Approve if the patient meets ONE of the following criteria (a, b or c). a) The patient has tried one of the following therapies for the condition: warfarin, Pradaxa (dabigatran capsules), Eliquis (apixaban tablets), Savaysa (edoxaban tablets), fondaparinux or a low molecular weight heparin (LMWH) product (e.g., enoxaparin, Fragmin [dalteparin injection]); OR b) The patient is unable to take one of the medications listed above (i.e., warfarin, Pradaxa, Eliquis, Savaysa, fondaparinux, or a LMWH product) for the condition due to ONE of the following reasons: i. allergic, immunologic or inherited disorders; OR ii. adverse effects (e.g., major organ toxicities, major bleeding); OR iii. the patient has experienced ineffectiveness of anticoagulation therapy in a prior setting, OR iv. the patient has drug-drug interactions that cannot be managed (warfarin); OR v. the patient lacks access to proper monitoring (warfarin); OR vi. the patient has experienced prior heparin-induced thrombocytopenia (HIT) or heparininduced thrombocytopenia and thrombosis (HITT) (fondaparinux and LMWH); OR vii. the patient is unable to perform injections or have injections administered to them (fondaparinux and LMWH); OR c) The patient has been started on Xarelto for the treatment of an acute thromboembolic condition. Note: If the patient has a history of an ACS or coronary artery disease (CAD) (excluded indications), but is requesting Xarelto for a non-acs or a non-cad condition, approval can be considered if criteria are met. Many other medications have been determined to be effective in the treatment of various thromboembolic conditions, as noted in the 2012 ACCP evidence-based clinical practice guidelines for antithrombotic therapy and the prevention of thrombosis. 12 The criteria will allow for continuation of therapy for patients who have been started on Xarelto for an acute thromboembolic condition. In the professional opinion of specialist physicians reviewing the data, we have adopted these criteria. 7. Patients Currently Receiving Xarelto Therapy. For patients started on Xarelto, if there is insufficient information available to make a determination regarding approval OR if the prescribing physician or a representative of the physician cannot be contacted OR if the patient requires time to initiate another therapy (e.g., warfarin, LMWH), a short-term supply of Xarelto for up to 14 days can be approved. In the professional opinion of specialist physicians reviewing the data, we have adopted these criteria. When Policy Topic is not covered: Coverage of Xarelto in 15 mg and 20 mg tablets strengths is recommended in circumstances that are listed in the Recommended Authorization Criteria (FDA-Approved Indications and Other Uses with Supportive Evidence). The following provides rationale for specific Exclusions. This is not an exhaustive list of Exclusions.

3 1. Use After an Acute Coronary Syndrome (ACS) [e.g., unstable angina, non-st elevation myocardial infarction {MI}, or ST elevation MI] to Reduce the Potential for Thrombotic Events (e.g., cardiovascular [CV] death, MI, or stroke). Xarelto has been studied in ACS. 6-7 Doses of Xarelto used in the most robust trial to date were 2.5 mg or 5 mg BID. 7 Other alternative, proven, effective, established therapies that are detailed in nationally-recognized guidelines are available for those who have experienced an ACS (e.g., warfarin, heparin, aspirin, clopidogrel, Effient [prasugrel tablets], Brilinta [ticagrelor tablets], and LMWHs). 8-9 In the professional opinion of specialist physicians reviewing the data, we have adopted these criteria. 2. Primary or Secondary Prevention of Coronary Artery Disease (CAD). not indicated for this condition and data are limited. Many other proven, established medications are used for patients with CAD. In the professional opinion of specialist physicians reviewing the data, we have adopted these criteria. 3. Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. Criteria will be updated as new published data are available. Considerations Xarelto requires prior authorization through the pharmacy services department. This Blue Cross and Blue Shield of Kansas City policy Statement was developed using available resources such as, but not limited to: Hayes Medical Technology Directory, Food and Drug Administration (FDA) approvals, Facts and Comparisons, National specialty guidelines, Local medical policies of other health plans, Medicare (CMS), Local providers. Description of Procedure or Service Xarelto, an oral factor Xa inhibitor, is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. 1 For this indication, there are limited data on the relative effectiveness of Xarelto and warfarin in reducing the risk of stroke and systemic embolism when patients receiving warfarin therapy are well controlled. also indicated for the treatment of deep vein thrombosis (DVT) and for the treatment of pulmonary embolism (PE). indicated for the reduction in the risk of recurrence of DVT and/or PE following an initial 6 months treatment for DVT and PE. also indicated for the prophylaxis of DVT, which may lead to PE, in those undergoing knee or hip replacement surgery. The Xarelto dose for nonvalvular atrial fibrillation for patients with an estimated creatinine clearance (CrCL) > 50 ml/min is 20 mg once daily (QD) with the evening meal. In patients with nonvalvular atrial fibrillation with an estimated CrCL of 15 to 50 ml/min, the recommended dose is 15 mg QD with the evening meal. For patients receiving treatment for the prophylaxis of DVT, the recommended Xarelto dose is 10 mg QD with or without food; initiate therapy at least 6 to 10 hours after surgery once hemostasis has been established. Use is short-term (12 days for knee replacement surgery and 35 days for hip replacement surgery). For the treatment of DVT, PE, and the reduction of the risk of recurrence of DVT and of PE the recommended dose is 15 mg twice daily (BID) with food for the first 21 days for the initial treatment of acute DVT or PE. After the initial treatment period, 20 mg orally QD with food for the remaining treatment and the long-term reduction in the risk of recurrence of DVT and/or PE is recommended. available in the following tablet strengths: 10 mg, 15 mg and 20 mg. The 10 mg strength is not targeted in this policy because this dosage strength is generally used for the prophylaxis of DVT in patients undergoing knee or hip replacement surgery. In the pivotal trials that led to the approval for this indication, Xarelto was generally more efficacious than comparator agents (e.g., enoxaparin) and use was short-term (the mean duration of therapy was less than 33 days). 1 Rationale CLINICAL EFFICACY The efficacy and safety of Xarelto were assessed in the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and

4 Embolism Trial in Atrial Fibrillation) trial (n = 14,264). 1-2 ROCKET AF was a multinational, randomized, double-blind, double-dummy, event-driven trial that compared Xarelto (20 mg QD with the evening meal in those with an estimated CrCL > 50 ml/min and 15 mg QD with the evening meal in those with an estimated CrCL 30 to < 50 ml/min) to warfarin (titrated to achieve an International Normalized Ratio [INR] of 2.0 to 3.0) to reduce the risk of stroke and non-central nervous system (CNS) systemic embolism in patients with nonvalvular atrial fibrillation. Patients in the trial had to have additional risk factors for stroke (e.g., prior stroke). The trial was designed to determine if Xarelto was noninferior to warfarin regarding the primary endpoint of stroke or non-cns systemic embolism. Regarding the primary composite endpoint involving the intent-to-treat (ITT) population, the time to the first occurrence of stroke or non-cns systemic embolism demonstrated that Xarelto was non-inferior to warfarin (hazard ratio [HR] 0.88; 95% confidence interval [CI]: 0.74, 1.03; P < for noninferiority). In the ITT analysis, the primary endpoint occurred in 269 patients given Xarelto (3.8%; 2.1 event rate [per 100 patient-years]) and in 306 patients given warfarin (4.3%; 2.4 event rate [per 100 patients-years]). Xarelto was not noted to be superior to warfarin. 1-2 In ROCKET AF, a total of 14,264 patients were randomized and the median follow-up on therapy was 590 days. 1-2 The mean patient age was 71 years and 3.5 was the mean CHADS 2 score (C = congestive heart failure, H = hypertension, A = age 75 years, D = diabetes mellitus, S = previous stroke or transient ischemic attack [doubled]). 1-2 Approximately 60% of patients were male and 83% were Caucasian. 1 Many patients had coexisting conditions such as hypertension (90%), congestive heart failure (62%), a history of stroke (55%), and diabetes mellitus (40%). 1-2 Approximately 62% of patients had previously used vitamin K antagonists and approximately 35% of patients received aspirin concurrently with their assigned study medication. 2 Patients in the warfarin group attained INR values within the defined therapeutic range (2.0 to 3.0) 55% of the time, which was lower during the first few months of the study. 1-2 No differences were observed between groups regarding major bleeding, but those in the Xarelto group had lower rates of intracranial hemorrhage (0.5% vs. 0.7%; P = 0.02) and fatal bleeding (0.2% vs. 0.5%; P = 0.003). 1-2 The protocol for ROCKET AF did not require specific anticoagulation after study drug discontinuation. However, patients in the warfarin group who completed the trial generally continued to receive warfarin. 2 Patients receiving Xarelto were usually transitioned to warfarin without a period of coadministration of warfarin and Xarelto. Therefore, some patients may not have been adequately anticoagulated after Xarelto cessation. During the 28 days after the end of the study, there were twenty-two strokes in the 4,637 patients receiving Xarelto vs. six strokes in the 4,691 patients given warfarin. 1 Xarelto for the treatment of DVT and/or PE, and for the reduction in the risk of recurrence of DVT and of PE was evaluated in EINSTEIN DVT and EINSTEIN PE. 1,3-4 These trials were multinational, openlabel, non-inferiority studies that compared Xarelto (15 mg BID for 3 weeks, followed by 20 mg QD with food) to enoxaparin by subcutaneous (SC) injection (1.0 mg/kg of body weight BID for at least 5 days), followed by a vitamin K antagonist (either warfarin or acenocoumarol dose adjusted to maintain an INR of 2.0 to 3.0). 1,3 for 3, 6, or 12 months. In total, 8,281 patients (3,449 in EINSTEIN DVT and 4,832 in EINSTEIN PE) were randomized and followed on therapy for a mean of 208 days for patients given Xarelto and 204 days in patients given enoxaparin followed by a vitamin K antagonist. In the EINSTEIN DVT and EINSTEIN PE studies, Xarelto was found to be non-inferior to enoxaparin followed by a vitamin K antagonist for the primary composite endpoint of time to first occurrence of recurrent DVT or non-fatal or fatal PE. In the EINSTEIN DVT study 36 events occurred with Xarelto (2.1%) vs. 51 events with enoxaparin followed by a vitamin K antagonist (3.0%) [HR 0.68, 95% CI: 0.44, 1.04]. In the EINSTEIN PE study events occurred in 50 patients (2.1%) given Xarelto vs. 44 patients (1.8%) in the enoxaparin followed by a vitamin K antagonist group (HR 1.12, 95% CI: 0.75, 1.68). The EINSTEIN Extension was a multinational, double-blind, superiority study that assessed 602 patients in the group given Xarelto 20 mg QD with food and 594 in the placebo group for the reduction in the risk of recurrence of DVT and PE in those who had completed 6 to 14 months of treatment after an acute event. Patient follow-up was 190 days. Xarelto had superior efficacy compared with placebo (8 events with Xarelto [1.3%] vs. 42 events with placebo [7.1%]; P < ).

5 Xarelto has been used off-label for other conditions requiring antithrombotic therapy. Xarelto has been used for extended prophylaxis in acutely ill medical patients. 5 Xarelto has also been studied in patients who have experienced an acute coronary syndrome (ACS). 6-7 A double-blind, placebo-controlled trial randomized patients with a recent ACS (e.g., myocardial infarction [MI], unstable angina) (n = 15,526) to Xarelto 2.5 mg BID, Xarelto 5 mg BID, or placebo; patients also received standard medical therapy according to guidelines. 7 The mean duration of therapy was approximately 13 months; however, some patients received medications for up to 31 months. 7 The primary efficacy endpoint, a composite of death from cardiovascular (CV) causes, MI, or stroke, was reduced by a statistically significant extent with Xarelto (9.1% for those given Xarelto 2.5 mg BID and 8.8% for those given Xarelto 5 mg BID) compared with placebo (10.7%). Of note, Xarelto therapy reduced the risk of stent thrombosis compared with placebo (2.3% vs. 2.9%; P = 0.02). However, patients given Xarelto had an increased risk of intracranial hemorrhage and major bleeding not related to coronary-artery bypass grafting. 7 Many other medications are utilized for patients with an ACS and nationally-recognized guidelines provide recommendations. 8-9 References: 1. Xarelto [prescribing information]. Titusville, NJ: Janssen; Eli Lilly and Company; September Patel MR, Mahaffey KW, Garg J, et al, and the ROCKET AF Steering Committee, for the ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10): The EINSTEIN Investigators, Bauersachs R, Berkowitz SD, et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363: The EINSTEIN-PE Investigator, Buller HR, Prins MH, Lensing AWA, et al. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366: Cohen AT, Spiro TE, Buller HR, et al. Rivaroxaban for thromboprophylaxis in acute ill medical patients. N Engl J Med. 2013;368: Mega JL, Braunwald E, Mohanavelu S, et al, on behalf of the ATLAS ACS-TIMI 46 Study Group. Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): a randomized, double-blind, phase II trial. Lancet. 2009;374: Mega JL, Braunwald E, Wiviott SD, et al, for the ATLAS ACS 2-TIMI 51 Investigators. Rivaroxaban in patients with recent acute coronary syndrome. N Engl J Med. 2012;366(1): O Gara PT, Kushner FG, Ascheim DD, et al, American College of Cardiology Foundation/American Heart Association Task Force on Practice guidelines ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;127(4):e Available at Accessed on September 25, Jneid H, Anderson JL, Wright S, et al ACCF/AHA focused update of the guideline for the management of patients with unstable angina/non-st elevation myocardial infarction (updating the 2007 guideline and replacing the 2011 focused update): A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2012;126: Available at Access on September 25, January CT, Wann LS, Alpert JS, et al AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the heart rhythm society. Circulation April 10 [Epub ahead of print]. Available at Accessed on September 19, Guyatt GH, Akl EA, Crowther M, et al., for the American College of Chest Physicians Antithrombotic Therapy and Prevention of Thrombosis Panel. Executive summary: antithrombotic therapy and prevention of thrombosis, 9 th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141:7S-47S. Available at Accessed on September 25, Billing Coding/Physician Documentation Information NA Additional Policy Key Words Policy Number: Related Topics N/A

6 Policy Implementation/Update Information 06/2014 New Policy titled Xarelto (rivaroxaban) 07/2015 Annual Review- For the treatment or prevention of other thromboembolic-related indications, Savaysa was added to the list of multiple other agents (e.g., oral anticoagulants and heparin-type products) for which the patient is recommended to have tried one of prior to approval This Medical Policy is designed for informational purposes only and is not an authorization, an explanation of benefits, or a contract. Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there is any exclusion or other benefit limitations applicable to this service or supply. Medical technology is constantly changing and Blue Cross and Blue Shield of Kansas City reserves the right to review and revise medical policy. This information is proprietary and confidential and cannot be shared without the written permission of Blue Cross and Blue Shield of Kansas City.

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