Limited Coverage Drugs - rivaroxaban for concomitant coronary artery disease (CAD) and peripheral artery disease (PAD)

Generic Name

rivaroxaban

Strength

2.5 mg

Form

tablet

Special Authority Criteria

Approval Period

Inclusion:

For the prevention of stroke, myocardial infarction, cardiovascular death, or acute limb ischemia and mortality in patients that meet ALL of the following criteria:

Taken in combination with acetylsalicyclic acid (ASA 75 mg to 100 mg daily);

AND

Patient is diagnosed with coronary artery disease (CAD)1;

AND

Patient is diagnosed with concomitant peripheral artery disease (PAD)2.

 

Exclusion:

Patients with concomitant CAD and PAD who have any one of the following characteristics:

  • at high risk of bleeding;
  • a history of stroke within one month of treatment initiation;
  • any history of hemorrhagic or lacunar stroke;
  • severe heart failure with a known ejection fraction less than 30% or New York Heart Association class III or IV symptoms;
  • an estimated glomerular filtration rate less than 15 mL/min;
  • require dual antiplatelet therapy, other non-ASA antiplatelet therapy, or oral anticoagulant therapy.

 

Criteria Requirements:

1. Patients with CAD are defined as having one or more of the following:

  • myocardial infarction within the last 20 years;
  • multi-vessel coronary disease (i.e., stenosis of ≥ 50% in two or more coronary arteries, or in one coronary territory if at least one other territory has been revascularized) with symptoms or history of stable or unstable angina;
  • multi-vessel percutaneous coronary intervention;
  • multi-vessel coronary artery bypass graft surgery;

AND 

Meet at least one of the following criteria:

  • aged 65 years or older; OR
  • aged younger than 65 years with documented atherosclerosis OR revascularization involving at least two vascular beds (coronary and other vascular) OR at least two additional risk factors (current smoker, diabetes mellitus, estimated glomerular filtration rate < 60 mL/min, heart failure, non-lacunar ischemic stroke 1 month or more ago).

2. Patients with PAD are defined as having one or more of the following:

  • previous aorto-femoral bypass surgery, limb bypass surgery, or percutaneous transluminal angioplasty revascularization of the iliac or infrainguinal arteries;
  • previous limb or foot amputation for arterial vascular disease;
  • previous carotid revascularization or asymptomatic carotid artery stenosis greater than or equal to 50%, as diagnosed by duplex ultrasound or angiography;
  • history of intermittent claudication AND one or more of the following:
    • an anklebrachial index less than 0.90; OR
    • significant peripheral artery stenosis (≥ 50%) documented by angiography or by duplex ultrasound.

Indefinite

Practitioner Exemptions

None

Special Notes

  • PharmaCare will not cover rivaroxaban for patients who have CAD or PAD alone.
  • PharmaCare coverage is limited to two tablets per day.

Special Authority Request Forms

5811 - Rivaroxaban for Concomitant Coronary Artery Disease and Peripheral Artery Disease