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Fondaparinux), Lovenox® (Enoxaparin), Fragmin® (Dalteparin

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Fondaparinux), Lovenox® (Enoxaparin), Fragmin® (Dalteparin UnitedHealthcare® Value & Balance Exchange Medical Benefit Drug Policy Injectable Anticoagulants Arixtra® (Fondaparinux), ® ® Lovenox (Enoxaparin), Fragmin (Dalteparin) Policy Number: IEXD0210.01 Effective Date: January 1, 2021 Instructions for Use Table of Contents Page Related Policies Applicable States ........................................................................... 1 None Coverage Rationale ....................................................................... 1 Applicable Codes .......................................................................... 2 Background ................................................................................... 3 Clinical Evidence ........................................................................... 4 U.S. Food and Drug Administration ............................................. 4 Centers for Medicare and Medicaid Services ............................. 4 References ..................................................................................... 5 Policy History/Revision Information ............................................. 5 Instructions for Use ....................................................................... 5 Applicable States This Medical Benefit Drug Policy only applies to the states of Arizona, Maryland, North Carolina, Oklahoma, Tennessee, Virginia, and Washington. Coverage Rationale This policy refers to the following Injectable Anticoagulants: Arixtra® (fondaparinux) Lovenox® (enoxaparin) Fragmin® (dalteparin) Fondaparinux is proven and medically necessary when all of the following criteria are met: Used for at least one of the following: o Treatment of deep venous thrombosis (DVT) o Prophylaxis of deep venous thrombosis (DVT) o Treatment of acute pulmonary embolism (PE) o Prophylaxis of pulmonary embolism (PE) and Patient does not have any of the following: o Severe renal impairment (CrCl <30ml/min) o Active major bleeding o Bacterial endocarditis o Thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of fondaparinux sodium Injectable Anticoagulants Arixtra® (Fondaparinux), Lovenox® (Enoxaparin), Fragmin® (Dalteparin) Page 1 of 5 UnitedHealthcare Value & Balance Exchange Medical Benefit Drug Policy Effective 01/01/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc. o Body weight <50 kg (venous thromboembolism prophylaxis only) o Planned or recent neuraxial anesthesia or spinal puncture and Medication is dosed in accordance with the United States Food and Drug Administration (FDA) approved labeling: dose does not exceed 10mg subcutaneously daily and Authorization is for no more than 12 months Enoxaparin is proven and medically necessary when all of the following criteria are met: Used for at least one of the following: o Treatment of deep venous thrombosis (DVT) o Prophylaxis of deep venous thrombosis (DVT) o Treatment of acute pulmonary embolism (PE) o Prophylaxis of pulmonary embolism (PE) o Prophylaxis of ischemic complications of unstable angina and non–Q-wave myocardial infarction (MI) o Treatment of acute ST-segment elevation myocardial infarction (STEMI) and Patient does not have any of the following: o Active major bleeding o History of heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies o Planned or recent neuraxial anesthesia or spinal puncture o Prior hypersensitivity to heparin or pork products and Medication is dosed in accordance with the United States Food and Drug Administration (FDA) approved labeling and is adjusted based on the indication for use, patient’s weight, and renal function and Authorization is for no more than 12 months Fragmin is proven and medically necessary when all of the following criteria are met: Used for at least one of the following: o Prophylaxis of deep venous thrombosis (DVT) o Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer o Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients 1 month of age and older o Prophylaxis of ischemic complications of unstable angina and non–Q-wave myocardial infarction (MI) and Patient does not have any of the following: o Active major bleeding o History of heparin induced thrombocytopenia or heparin induced thrombocytopenia with thrombosis o Planned or recent neuraxial anesthesia or spinal puncture o Prior hypersensitivity to heparin or pork products and Medication is dosed in accordance with the United States Food and Drug Administration (FDA) approved labeling and is adjusted based on the indication for use, patient’s weight, and renal function and Authorization is for no more than 12 months Applicable Codes The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may Injectable Anticoagulants Arixtra® (Fondaparinux), Lovenox® (Enoxaparin), Fragmin® (Dalteparin) Page 2 of 5 UnitedHealthcare Value & Balance Exchange Medical Benefit Drug Policy Effective 01/01/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc. require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply. HCPCS Code Description J1650 Injection, enoxaparin sodium, 10 mg J1652 Injection, fondaparinux sodium, 0.5 mg J1645 Injection, dalteparin sodium, per 2500 iU Diagnosis Code Description I21.0 ST elevation (STEMI) myocardial infarction of anterior wall I21.1 ST elevation (STEMI) myocardial infarction of inferior wall I21.2 ST elevation (STEMI) myocardial infarction of other sites I21.3 ST elevation (STEMI) myocardial infarction of unspecified site I22.0 Subsequent ST elevation (STEMI) myocardial infarction of anterior wall I22.1 Subsequent ST elevation (STEMI) myocardial infarction of inferior wall I22.8 Subsequent ST elevation (STEMI) myocardial infarction of other sites I22.9 Subsequent ST elevation (STEMI) myocardial infarction of unspecified site I24.0 Acute coronary thrombosis not resulting in myocardial infarction I24.9 Acute ischemic heart disease, unspecified I26.0 Pulmonary embolism with acute cor pulmonale I26.9 Pulmonary embolism without acute cor pulmonale I82.0 Budd-Chiari syndrome I82.1 Thrombophlebitis migrans I82.2 Embolism and thrombosis of vena cava and other thoracic veins I82.3 Embolism and thrombosis of renal vein I82.4 Acute embolism and thrombosis of deep veins of lower extremity I82.5 Chronic embolism and thrombosis of deep veins of lower extremity I82.6 Acute embolism and thrombosis of veins of upper extremity I82.7 Chronic embolism and thrombosis of veins of upper extremity I82.8 Embolism and thrombosis of other specified veins I82.9 Embolism and thrombosis of unspecified vein I82.A Embolism and thrombosis of axillary vein I82.B Embolism and thrombosis of subclavian vein I82.C Embolism and thrombosis of internal jugular vein O88.21 Thromboembolism in pregnancy O88.81 Other embolism in pregnancy O88.82 Other embolism in childbirth T82.86 Thrombosis of cardiac and vascular prosthetic devices, implants and grafts Background Low Molecular Weight Heparins (LMWH) Summary5 Compared to unfractionated heparin, low molecular weight heparins (LMWHs) produce a more predictable anticoagulant response, reflecting their better bioavailability, longer half-life, and dose-independent clearance. Injectable Anticoagulants Arixtra® (Fondaparinux), Lovenox® (Enoxaparin), Fragmin® (Dalteparin) Page 3 of 5 UnitedHealthcare Value & Balance Exchange Medical Benefit Drug Policy Effective 01/01/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc. LMWHs can be administered by subcutaneous (SC) injection and usually do not require laboratory monitoring, making them more convenient for outpatient treatment compared to unfractionated heparin. LMWHs have different approved indications. Enoxaparin is the only LMWH that is approved for both venous thromboembolism (VTE) prophylaxis and treatment. Enoxaparin and dalteparin are the only LMWHs approved for the prevention of ischemic complications in patients with unstable angina and non-q-wave myocardial infarction; however, enoxaparin is the only LMWH approved for acute ST- segment elevation myocardial infarction (STEMI). Pharmacology5 LMWHs exert their antithrombotic activity by binding to and accelerating the activity of antithrombin III. By activating antithrombin III, coagulation factor Xa and factor IIa (thrombin) are inhibited. The resultant thrombin inhibition prevents the formation of fibrin clots. At recommended doses, LMWHs have a weaker effect on platelet activation and are associated with a lower incidence of heparin-induced thrombocytopenia compared to unfractionated heparin. Enoxaparin and dalteparin have no effect on prothrombin time or activated partial thromboplastin time (aPTT). Neither aPTT nor prothrombin time can be used for therapeutic monitoring of any of the LMWHs. Anti-Xa activity is used as a biomarker for treatment; however, routine monitoring is generally not recommended. Clearance of LMWH is primarily renal. For this reason, the biologic half-life
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