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Home , Dalteparin sodium, Fondaparinux

UnitedHealthcare® Value & Balance Exchange Medical Benefit Drug Policy Injectable Arixtra® (), 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 (DVT) o Prophylaxis of deep venous thrombosis (DVT) o Treatment of acute (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 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 -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, , 10 mg J1652 Injection, fondaparinux sodium, 0.5 mg J1645 Injection, , 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 (LMWH) Summary5 Compared to unfractionated heparin, low molecular weight heparins (LMWHs) produce a more predictable response, reflecting their better , 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 activity by binding to and accelerating the activity of III. By activating antithrombin III, coagulation factor Xa and factor IIa () 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 of LMWHs may be prolonged in patients with renal failure resulting in drug accumulation.

Clinical Evidence

Reference the Clinical Studies information provided in the product labeling. 1,2,3

U.S. Food and Drug Administration (FDA)

This section is to be used for informational purposes only. FDA approval alone is not a basis for coverage.

Arixtra (fondaparinux sodium) is a Factor Xa inhibitor (anticoagulant) indicated for: 1 Prophylaxis of DVT Treatment of DVT Treatment of acute PE

Lovenox (enoxaparin) is a low molecular weight heparin (LMWH) indicated for: 2 Prophylaxis of DVT in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness Inpatient treatment of acute DVT with or without pulmonary embolism Outpatient treatment of acute DVT without pulmonary embolism Prophylaxis of ischemic complications of unstable angina and non–Q-wave MI Treatment of acute ST-segment elevation MI managed medically or with subsequent percutaneous coronary intervention

Fragmin (dalteparin) is a low molecular weight heparin (LMWH) indicated for: 3 Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction Prophylaxis of DVT in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients 1 month of age and older Limitations of Use - FRAGMIN is not indicated for the acute treatment of VTE

Centers for Medicare and Medicaid Services (CMS)

Injectable Anticoagulants Arixtra® (Fondaparinux), Lovenox® (Enoxaparin), Fragmin® (Dalteparin) Page 4 of 5 UnitedHealthcare Value & Balance Exchange Medical Benefit Drug Policy Effective 01/01/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

Medicare does not have a National Coverage Determination (NCD) for low molecular weight heparins Arixtra® (fondaparinux), Lovenox® (enoxaparin), Fragmin® (dalteparin)]. Local Coverage Determinations (LCDs)/Local Coverage Articles (LCAs) do not exist.

In general, Medicare covers outpatient (Part B) drugs that are furnished "incident to" a physician's service provided that the drugs are not usually self-administered by the patients who take them. Refer to the Medicare Benefit Policy Manual, Chapter 15, §50 - Drugs and Biologicals. (Accessed July 9, 2020)

References

1. Arixtra [prescribing information]. Rockford, IL: Mylan Institutional LLC; June 2020. 2. Lovenox [prescribing information]. Bridgewater, NJ: -Aventis; May 2020. 3. Fragmin [prescribing information]. New York, NY: Pfizer Labs; April 2020. 4. Micromedex Healthcare Series [database on the internet]. Greenwood Village (CO): Thomson Reuters (Healthcare) Inc.; Updated periodically. Available by subscription at: http://www.thomsonhc.com/ Accessed July 5, 2020. 5. Clinical Pharmacology Available by subscription at http://clinicalpharmacology-ip.com/Default.aspx Accessed July 5, 2020.

Policy History/Revision Information

Date Summary of Changes 01/01/2021 • New Medical Benefit Drug Policy

Instructions for Use

This Medical Benefit Drug Policy provides assistance in interpreting UnitedHealthcare benefit plans. When deciding coverage, the member specific benefit plan document must be referenced as the terms of the member specific benefit plan may differ from the standard benefit plan. In the event of a conflict, the member specific benefit plan document governs. Before using this policy, please check the member specific benefit plan document and any applicable federal or state mandates. UnitedHealthcare reserves the right to modify its Policies and Guidelines as necessary. This Medical Benefit Drug Policy is provided for informational purposes. It does not constitute medical advice.

UnitedHealthcare may also use tools developed by third parties, such as the InterQual® criteria, to assist us in administering health benefits. UnitedHealthcare Medical Benefit Drug Policies are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice.

Injectable Anticoagulants Arixtra® (Fondaparinux), Lovenox® (Enoxaparin), Fragmin® (Dalteparin) Page 5 of 5 UnitedHealthcare Value & Balance Exchange Medical Benefit Drug Policy Effective 01/01/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.