Injectable Anticoagulants Arixtra (Fondaparinux), Lovenox (Enoxaparin), Fragmin (Dalteparin)
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UnitedHealthcare® Individual Exchange
Medical Benefit Drug Policy
Injectable Anticoagulants Arixtra® (Fondaparinux),
Lovenox® (Enoxaparin), Fragmin® (Dalteparin)
Policy Number: IEXD0210.02
Effective Date: January 1, 2022 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
References ..................................................................................... 4
Policy History/Revision Information ............................................. 5
Instructions for Use ....................................................................... 5
Applicable States
This Medical Benefit Drug Policy only applies to the states of Alabama, Arizona, Florida, Georgia, Illinois, Louisiana, Maryland,
Michigan, North Carolina, Oklahoma, Tennessee, Texas, 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 (CrClMedication 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
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.
Injectable Anticoagulants Arixtra® (Fondaparinux), Lovenox® (Enoxaparin), Fragmin® (Dalteparin) Page 2 of 5
UnitedHealthcare Individual Exchange Medical Benefit Drug Policy Effective 01/01/2022
Proprietary Information of UnitedHealthcare. Copyright 2022 United HealthCare Services, Inc.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.
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.
Injectable Anticoagulants Arixtra® (Fondaparinux), Lovenox® (Enoxaparin), Fragmin® (Dalteparin) Page 3 of 5
UnitedHealthcare Individual Exchange Medical Benefit Drug Policy Effective 01/01/2022
Proprietary Information of UnitedHealthcare. Copyright 2022 United HealthCare Services, Inc.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 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
References
1. Arixtra [package insert]. Morgantown, WV: Mylan Institutional LLC; August 2020.
2. Lovenox [package insert]. Bridgewater, NJ: Sanofi-Aventis; May 2020.
3. Fragmin [package insert]. New York, NY: Pfizer Labs; June 2020.
Injectable Anticoagulants Arixtra® (Fondaparinux), Lovenox® (Enoxaparin), Fragmin® (Dalteparin) Page 4 of 5
UnitedHealthcare Individual Exchange Medical Benefit Drug Policy Effective 01/01/2022
Proprietary Information of UnitedHealthcare. Copyright 2022 United HealthCare Services, Inc.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 October 25,
2021.
Policy History/Revision Information
Date Summary of Changes
01/01/2022 Template Update
Updated policy header to reflect the most current product branding for UnitedHealthcare Individual
Exchange Plans
Applicable States
Revised list of applicable states to encompass new benefit plans effective Jan. 1, 2022; added
language to indicate this policy applies to the states of Alabama, Florida, Georgia, Illinois, Louisiana,
Michigan, and Texas
Supporting Information
Updated References section to reflect the most current information
Removed CMS section
Archived previous policy version IEXD0210.01
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 Individual Exchange Medical Benefit Drug Policy Effective 01/01/2022
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