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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 surgery

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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