Camzyos (mavacamten) — Obstructive Hypertrophic Cardiomyopathy Coverage Criteria
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Defines recommended prior authorization criteria, approval durations, prescribing clinician requirements, and conditions not recommended for approval for Camzyos (mavacamten) for adults with symptomatic obstructive hypertrophic cardiomyopathy.
No material clinical or coverage changes in this revision.
Recommended Authorization Criteria
Obstructive Hypertrophic Cardiomyopathy — Initial or Ongoing Therapy
Coverage of Camzyos is recommended in those who meet the following criteria. Approve for 1 year.
A or B
A) Initial Therapy
- i: Patient is ≥ 18 years of age
- ii: Patient has at least one symptom associated with obstructive hypertrophic cardiomyopathy AND has New York Heart Association (NYHA) Class II or III symptoms
Examples of symptoms include shortness of breath, chest pain, lightheadedness, fainting, fatigue, and reduced ability to perform physical exercise.
- iii: Left ventricular hypertrophy meets one: maximal LV wall thickness ≥15 mm OR familial HCM with maximal LV wall thickness ≥13 mm
- iv: Peak left ventricular outflow tract (LVOT) gradient ≥30 mmHg at rest OR ≥50 mmHg after provocation (Valsalva maneuver or post-exercise)
- v: Left ventricular ejection fraction ≥55%
- vi: Either tried or currently receiving at least one beta-blocker OR a nondihydropyridine calcium channel blocker for ≥3 months, OR has a contraindication or intolerance to those agents3 months
Examples of beta-blockers: metoprolol, atenolol, bisoprolol. Examples of nondihydropyridine CCBs: verapamil, diltiazem. Examples of contraindications/intolerances described in policy.
- vii: Medication is prescribed by a cardiologist
B) Currently Receiving Camzyos
- i: Patient has been established on therapy for at least 1 year
Patients with <1 year of therapy or restarting are reviewed under Initial Therapy criteria.
- ii: Patient is ≥ 18 years of age
- iii: Currently or prior to starting therapy, patient has or had at least one symptom associated with obstructive hypertrophic cardiomyopathy AND was in NYHA Class II or III
Examples of symptoms include shortness of breath, chest pain, lightheadedness, fainting, fatigue, and reduced ability to perform physical exercise.
- iv: Patient experienced a beneficial clinical response by at least one objective measure OR experienced stabilization or improvement in at least one symptom related to obstructive HCM
Objective measures examples: improved peak VO2, decreased LVOT gradient, reduced NT-proBNP, decreased high-sensitivity cardiac troponin I, reduced ventricular mass index, reduced left atrial volume index, improved KCCQ-23 or HCMSQ scores.
- v: Medication is prescribed by a cardiologist
Coverage is not recommended for circumstances that are not explicitly listed in the Recommended Authorization Criteria. This list of non‑recommended circumstances is not exhaustive and will be updated as new published data become available.
Use of Camzyos (mavacamten) for indications other than those specified in the Recommended Authorization Criteria is not recommended and may be considered not medically necessary.
Clinical Thresholds and Key Parameters
Prescriber, Documentation, and Authorization Requirements
Prior authorization and prescriber specialty
Prior authorization is recommended for pharmacy benefit coverage of Camzyos. Initial approval requires the medication be prescribed by or in consultation with a physician who specializes in the condition being treated (cardiologist).
- All approvals for initial therapy are provided for the initial approval duration noted (approve for 1 year).
- Medication for initial therapy must be prescribed by a cardiologist or prescribed in consultation with a specialist.
Trial of first-line agents (β-blocker or nondihydropyridine CCB ≥3 months)
Before approval for initial therapy, the patient must have tried or be currently receiving at least one beta-blocker or a nondihydropyridine calcium channel blocker for at least 3 months, unless the prescriber documents a contraindication or intolerance.
- Examples of beta-blockers: metoprolol, atenolol, bisoprolol.
- Examples of nondihydropyridine calcium channel blockers: verapamil, diltiazem.
- Examples of contraindications to beta-blockers: bradycardia, severe hypotension, severe reactive airway disease or active bronchospasm.
- Examples of intolerances to beta-blockers: symptomatic fatigue or exercise intolerance, symptomatic bradycardia, hypotension.
- Examples of contraindications to calcium channel blockers: bradycardia, hypotension.
- Examples of intolerances to calcium channel blockers: peripheral edema, dizziness, orthostasis.
Provide records and test results to support medical necessity
The Company may request additional documentation to support medical necessity and requires that requested records be made available upon request.
- Documentation that may be requested includes patient records, test results, and credentials of the provider ordering or performing the service.
- Additional documentation supporting medical necessity must be made available upon request to the Company.
Denial triggers for reimbursement
The Company may deny reimbursement if the drug or services were not medically necessary, were investigational/experimental, were not within the member's benefits, or if a pattern of billing or practice is inappropriate or excessive.
- Denial may occur for services determined to be not medically necessary, investigational/experimental, or outside the scope of member benefits.
- Denial may occur if a pattern of billing or other practice is found to be inappropriate or excessive.
Drug and Disease Background
Camzyos (mavacamten) is a cardiac myosin inhibitor indicated to improve functional capacity and symptoms in adults with symptomatic obstructive hypertrophic cardiomyopathy. Clinical efficacy has been established for patients with symptomatic, obstructive HCM (typically NYHA Class II–III), and treatment and monitoring are generally managed by cardiology specialists given safety and long‑term efficacy considerations.
Key Definitions
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