Camzyos™

Drug - Camzyos™ (mavacamten) [Myokardia, Inc.]

March 2025

Therapeutic Area - Cardiovascular, Other

Initial approval criteria

Patient is at least 18 years of age; AND
Patient has a diagnosis of obstructive hypertrophic cardiomyopathy (oHCM) consistent with current guidelines; AND
Patient has documented left ventricular ejection fraction (LVEF) ≥ 55%; AND
Patient will be monitored for LVEF, Valsalva left ventricular outflow tract (LVOT) gradient assessment, and heart failure symptoms (e.g., shortness of breath, chest pain, arrhythmia, heart palpitations, fatigue, swelling in the leg); AND
Patient has New York Heart Association (NYHA) Class 2 or Class 3; AND
Patient has adequate echocardiogram or cardiovascular magnetic resonance imaging (CMR); AND
Patient will avoid concomitant use with moderate to strong CYP2C19 inhibitors, strong CYP3A4 inhibitors, and moderate to strong CYP2C19 and CYP3A4 inducers; AND
Patient will avoid concomitant dual therapy with a beta-blocker and calcium channel blocker or monotherapy with disopyramide or ranolazine; AND
For patients of childbearing potential, a pregnancy test is performed before starting therapy; AND
Camzyos is prescribed by or in consultation with a cardiologist; AND
Patient must have an adequate trial and failure of ≥ 1 beta-blocker

Patient must have disease improvement and/or stabilization of disease from baseline (e.g., at least 1 NYHA class decrease, ≥ 1.5 mL/kg/min in pVO2 increase or ≥ 3 mL/kg/min in pVO2 without NYHA class worsening); AND
Patient has not experienced any treatment-restricting adverse effects (e.g., heart failure, LVEF < 50%); AND
Patient must be monitored for LVEF, Valsalva LVOT gradient, and NYHA class 2 or 3

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