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