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Camzyos (mavacamten) — Medica

Obstructive hypertrophic cardiomyopathy (NYHA Class II or III)

Initial criteria

  • age ≥ 18 years
  • Patient has at least one symptom associated with obstructive hypertrophic cardiomyopathy (e.g., shortness of breath, chest pain, lightheadedness, fainting, fatigue, reduced ability to perform physical exercise)
  • Patient has New York Heart Association Class II or III symptoms of heart failure
  • Patient with left ventricular hypertrophy meets ONE of the following: maximal left ventricular wall thickness ≥ 15 mm OR familial hypertrophic cardiomyopathy with maximal left ventricular wall thickness ≥ 13 mm
  • Patient has a peak left ventricular outflow tract gradient ≥ 50 mmHg (at rest or after provocation [Valsalva maneuver or post exercise])
  • Patient has a left ventricular ejection fraction ≥ 55%
  • Medication is prescribed by a cardiologist

Reauthorization criteria

  • Patient has been established on therapy for at least 8 months
  • age ≥ 18 years
  • Currently or prior to starting therapy, patient has or has experienced at least one symptom associated with obstructive hypertrophic cardiomyopathy (e.g., shortness of breath, chest pain, lightheadedness, fainting, fatigue, reduced ability to perform physical exercise)
  • Currently or prior to starting therapy, patient is in or was in New York Heart Association Class II or III heart failure
  • Patient has a current left ventricular ejection fraction ≥ 50%
  • Patient experienced a beneficial clinical response assessed by at least one objective measure (e.g., improved peak oxygen consumption/mixed venous oxygen tension; decreases in left ventricular outflow tract gradient; reductions in N-terminal pro-B-type natriuretic peptide levels; decreased high-sensitivity cardiac troponin I levels; reduced ventricular mass index; reduction in maximum left atrial volume index) OR stabilization or improvement in at least one symptom related to obstructive hypertrophic cardiomyopathy (e.g., shortness of breath, chest pain, lightheadedness, fainting, fatigue, ability to perform physical exercise, favorable changes in KCCQ-23 CSS or HCMSQ Shortness of Breath domain score)
  • Medication is prescribed by a cardiologist

Approval duration

Initial: 8 months; Reauthorization: 1 year