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    Direct Oral Anticoagulants (DOAC)

    Preferred Drugs -
    Pradaxa (dabigatran)
    Xarelto (rivaroxaban) 10mg, 15mg, 20mg

    Nonpreferred Drugs -
    Xarelto (rivaroxaban) 2.5mg
    Eliquis (apixaban)
    Savaysa (edoxaban)

    April 2019

    Therapeutic area - Anticoagulants

    Preferred drug: Pradaxa and Xarelto 10mg, 15mg, 20mg

    • No prior authorization is required
    • Quantity limits apply

    Nonpreferred drugs – Approval criteria

    Xarelto 2.5mg

    Chronic coronary artery disease (CAD)

    Patient must have at least ONE of the following:

    • Documented myocardial infarction in the past 20 years
    • Multivessel coronary artery disease (defined as stenosis of 50% or more in 2 or more coronary arteries or in 1 coronary territory if at least 1 other territory has been revascularized) with symptoms or with history of stable or unstable angina
    • Multivessel percutaneous coronary intervention
    • Multivessel coronary artery bypass graft (CABG) surgery

    AND

    • Documented atherosclerosis or revascularization in two vascular beds (coronary vascular bed plus one additional vascular bed – e.g, aorta, brain, gastrointestinal tract, limbs, kidneys) OR
    • Patient must have 2 or more of the following:
      • Current smoker (within the past year)
      • Diabetes
      • Renal impairment (estimated GFR less than 60mL/min)
      • Atherosclerotic ischemic stroke at least one month ago

    AND

    • Must be used in combination with aspirin 75-100 mg daily

    AND

    Patient must NOT have any of the following:

    • Indication for non-aspirin antiplatelet therapy including dual antiplatelet therapy (e.g., aspirin plus clopidogrel, ticagrelor or prasugrel)
    • Indication for therapeutic dose of an oral anticoagulant (e.g., atrial fibrillation, venous thromboembolism treatment, etc.)
    • Recent stroke (within 1 month) or any history of hemorrhagic stroke
    • Heart failure (ejection fraction less than 40% or NYHA class III or IV symptoms)
    • Estimated eGFR less than 15 mL/min
    • Known hepatic disease associated with coagulathy
    • Pregnancy
    • Breastfeeding

    Chronic peripheral artery disease (PAD)

    Patient must have at least ONE of the following:

    • Prior revascularization for the treatment of PAD
    • History of limb or foot amputation due to PAD
    • Symptomatic PAD, including history of intermittent claudication or critical limb threatening ischemia with objective clinical confirmation (i.e., ankle-brachial index [ABI] ration measures, peripheral angiography)

    AND

    • Must be used in combination with aspirin 75-100 mg daily

    AND

    Patient must NOT have any of the following:

    • Indication for non-aspirin antiplatelet therapy including dual antiplatelet therapy (e.g., aspirin plus clopidogrel, ticagrelor or prasugrel)
    • Indication for therapeutic dose of an oral 
    • Recent stroke (within 1 month) or any history of hemorrhagic stroke
    • Heart failure (ejection fraction less than 40% or NYHA class III or IV symptoms)
    • Estimated eGFR less than 15 mL/min
    • Known hepatic disease associated with coagulathy
    • Pregnancy
    • Breastfeeding

    Eliquis

    Reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation (AF)

    Patient must have at least ONE of the following:

    • Diagnosis of non-valvular AF or flutter documented by electrocardiogram

    AND

    Patient must have at least ONE of the following additional risk factors:

    • CHA2DS2-VASc score ≥ 2 or CHADS2 score ≥ 1 
    • Prior TIA, stroke or systemic embolism

    AND

    • Intolerance or contraindication to Pradaxa and Xarelto or have a condition where Pradaxa and Xarelto are not preferred or are not recommended, such as history of GI bleed or end-stage chronic kidney disease

    AND

    Patient must NOT have any of the following:

    • Mechanical heart valve
    • Clinically significant valvular disease (e.g., moderate to severe mitral valve stenosis)
    • Active endocarditis
    • Active pathological bleeding
    • Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis, LFT > 2-3 X upper limit of normal, Child-Pugh B or C or any hepatic disease associated with coagulopathy)
    • Severe renal impairment (CrcL< 25mL/min or SCr > 2.5mg/dl)
    • Pregnancy
    • Breastfeeding

    Prophylaxis of DVT following hip or knee replacement surgery

    Patient must have at least ONE of the following:

    • DVT prophylaxis in patients undergoing:
      • Knee replacement surgery: treatment duration is 12 days OR
      • Hip replacement surgery: treatment duration is 35 days

    AND

    • Intolerance or contraindication to Xarelto

    AND

    Patient must NOT have any of the following:

    • Active endocarditis
    • Active pathological bleeding
    • Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis, LFT > 2-3 X upper limit of normal, Child-Pugh B or C or any hepatic disease associated with coagulopathy)
    • Severe renal impairment (CrcL< 30mL/min)
    • Pregnancy

    Treatment of DVT and PE

    Patient must have at least ONE of the following:

    • Documented diagnosis of venous thromboembolism (DVT and/or PE) 

    AND

    • Intolerance or contraindication to Xarelto

    AND

    Patient must NOT have any of the following:

    • Mechanical heart valve
    • Active endocarditis
    • Active pathological bleeding
    • Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis, LFT > 2-3 X upper limit of normal, Child-Pugh B or C or any hepatic disease associated with coagulopathy)
    • Severe renal impairment (CrcL< 25mL/min or SCr > 2.5mg/dl)
    • Pregnancy
    • Breastfeeding

    Reduction in the risk of recurrent DVT and PE following initial therapy

    Patient must have at least ONE of the following:

    • Documented diagnosis of venous thromboembolism (DVT and/or PE) 

    AND

    • Intolerance or contraindication to Pradaxa or Xarelto

    AND

    Patient must NOT have any of the following:

    • Mechanical heart valve
    • Active endocarditis
    • Active pathological bleeding
    • Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis, LFT > 2-3 X upper limit of normal, Child-Pugh B or C or any hepatic disease associated with coagulopathy)
    • Severe renal impairment (CrcL< 30mL/min)
    • Pregnancy
    • Breastfeeding

    Savaysa

    Reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation (AF)

    Patient must have at least ONE of the following:

    • Diagnosis of non-valvular AF or flutter documented by electrocardiogram

    AND

    Patient must have at least ONE of the following additional risk factors:

    • CHA2DS2-VASc score ≥ 2 or CHADS2 score ≥ 1 OR
    • Prior TIA, stroke or systemic embolism

    AND

    • Estimated CrCL ≤ 95mL/min

    AND

    • Intolerance or contraindication to Pradaxa, Xarelto and Eliquis or have a condition where Pradaxa and Xarelto are not preferred, such as history of GI bleed 

    AND

    Patient must NOT have any of the following:

    • Mechanical heart valve
    • Clinically significant valvular disease (e.g., moderate to severe mitral valve stenosis)
    • Active endocarditis
    • Active pathological bleeding
    • Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis, LFT > 2-3 X upper limit of normal, Child-Pugh B or C or any hepatic disease associated with coagulopathy)
    • Pregnancy
    • Breastfeeding

    Treatment of DVT and PE

    Patient must have at least ONE of the following:

    • Documented diagnosis of venous thromboembolism (DVT and/or PE) 

    AND

    • Patient must receive enoxaparin for a minimum of 5 days before starting Savaysa

    AND

    • Intolerance or contraindication to Xarelto

    AND

    Patient must NOT have any of the following:

    • Mechanical heart valve
    • Active endocarditis
    • Active pathological bleeding
    • Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis, LFT > 2-3 X upper limit of normal, Child-Pugh B or C or any hepatic disease associated with coagulopathy)
    • Severe renal impairment (CrcL< 30mL/min)
    • Pregnancy
    • Breastfeeding

    Quantity limits

    • Xarelto 10mg, 20mg: 34 tablets per 34 days (unless indicated for shorter duration)
    • Xarelto 15mg: 42 tablets per 21 days
    • Xarelto 2.5mg: 68 tablets per 34 days
    • Eliquis 2.5mg, 5mg: 68 tablets per 34 days (unless indicated for shorter duration)
    • Savaysa 15mg, 30mg, 60mg: 34 tablets per 34 days

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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