Low Molecular Weight Heparins (LMWH): LOVENOX (enoxaparin), FRAGMIN (dalteparin), ARIXTRA (fondaparinux)

Low Molecular Weight Heparins (LMWH): LOVENOX (enoxaparin), FRAGMIN (dalteparin), ARIXTRA (fondaparinux)

Self-Administration – injectable

Diagnosis considered for coverage:

Lovenox

• Indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
  • in patients undergoing abdominal surgery who are at risk for thromboembolic complications
  • in patients undergoing hip replacement surgery, during and following hospitalization
  • in patients undergoing knee replacement surgery
  • in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness
• Indicated for:
  • the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium
  • the outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium
• Indicated for the prophylaxis of ischemic complications of unstable angina and non–Q-wave myocardial infarction, when concurrently administered with aspirin
• Lovenox, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction (STEMI) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (PCI)

Fragmin

• Indicated for the prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin therapy
• Indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
  • In patients undergoing hip replacement surgery
  • In patients undergoing abdominal surgery who are at risk for thromboembolic complications
  • In medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness
• Indicated for the extended treatment of symptomatic venous thromboembolism (VTE) (proximal DVT and/or PE), to reduce the recurrence of VTE in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months
• Indicated for the treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in pediatric patients 1 month of age and older
• Limitations of Use: FRAGMIN is not indicated for the acute treatment of VTE

Arixtra

• Indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
  • in patients undergoing hip fracture surgery, including extended prophylaxis;
  • in patients undergoing hip replacement surgery;
  • in patients undergoing knee replacement surgery;
  • in patients undergoing abdominal surgery who are at risk for thromboembolic complications
• Indicated for the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium
• Indicated for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital

Coverage Criteria:

Request for an additional 35 day supply of enoxaparin (Lovenox), Fragmin, fondaparinux (Arixtra):

• Dose does not exceed FDA label maximum; AND
• Patient meets one of the following:
  • Superficial vein thrombosis > 5 cm in length 
  • A second surgery requiring venous thromboembolism (VTE) prophylaxis 
  • Bridging therapy for acute deep vein thrombosis (DVT) or pulmonary embolism (PE)

Request for greater than 35 days of enoxaparin (Lovenox), Fragmin:

• Dose does not exceed FDA label maximum; AND
• Patient meets one of the following:
  • Pregnancy when anticoagulation is required
  • Ovarian hyperstimulation syndrome
  • Cancer patient requiring treatment of DVT or PE
  • Cancer patient with additional risk factors for VTE requiring prophylaxis of DVT or PE
  • Trail and failure, contraindication or intolerance to warfarin for any of the following indications:
    • Prophylaxis and/or treatment of DVT and PE 
    • Prophylaxis and/or treatment of thromboembolic complications associated with atrial fibrillation, left ventricular thrombus and/or dysfunction with or without congestive heart failure (CHF), and/or mechanical cardiac valve replacement 
    • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) 
    • Treatment of ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) 
    • Child requiring anticoagulation

Request for greater than 35 days of fondaparinux (Arixtra):

• Dose does not exceed FDA label maximum; AND
• Patient meets one of the following (A or B):
  • A) Patient meets both of the following:
    • Pregnancy when anticoagulation is required
    • Patient has had a severe allergic reaction to heparin
  • B) Trial and failure, contraindication or intolerance to warfarin for any of the following indications:
    • Prophylaxis and/or treatment of DVT and PE 
    • Prophylaxis and/or treatment of thromboembolic complications associated with atrial fibrillation, left ventricular thrombus and/or dysfunction with or without congestive heart failure (CHF), and/or mechanical cardiac valve replacement 
    • Prevention of thromboembolic events in patients with recurrent MI

Coverage Duration: 

• Superficial vein thrombosis > 5 cm in length, second surgery requiring VTE prophylaxis, bridging therapy for acute DVT or PE:
  • One 35 day supply
• All other indications:
  • 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• FRAGMIN is not indicated for the acute treatment of VTE

Policy Updates:

• 7/21/2016 – New policy approved by P&T.
• 3/1/2023 – Updated QL and QL policy for Lovenox, Fragmin, Arixtra updated. Removed Innohep from LMWH policy. 

References:

• Arixtra Prescribing Information. Mylan Institutional LLC. Rockford, IL. August 2020. 
• Fragmin Prescribing Information. Pfizer Inc. New York, New York. June 2020. 
• Lovenox Prescribing Information. Sanofi-Aventis U.S. LLC. Bridgewater, NJ. May 2020. 
• Lexi-Comp Online [internet database]. Hudson, OH. Lexi-Comp, Inc. Updated periodically. Available by subscription at: http://online.lexi.com/. Accessed May 1, 2020.