CurrentCignaPolicy N/A

Camzyos (mavacamten) prior authorization — Cardiology (Coverage Criteria)

Defines prior authorization requirements, clinical criteria, and coverage stance for Camzyos (mavacamten) for treatment of obstructive hypertrophic cardiomyopathy in adults under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyCamzyos (mavacamten) prior authorization — Cardiology (Coverage Criteria)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJun 11, 2025

Key ActionSubmit prior authorization with documentation of age, symptoms/NYHA class, LV wall thickness, LVOT gradient, LVEF, prior therapy/response, and REMS enrollment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

FDA-approvedIndication covered (obstructive HCM NYHA II-III)

8 monthsInitial approval duration

1 yearContinuation approval

RequiredREMS

Coverage and Medical Necessity Criteria

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Coding, Age, and Key Clinical Thresholds

Coding guidance / generalmixed

affected codes

Policy references that providers must use most appropriate codes; no explicit CPT/ICD-10 codes listed in policy text.

inv-05: Age — minimum age for therapy

Minimum agePatient must be ≥ 18 years of age

Initial therapy age criterionApplies to Initial Therapy branch requiring age ≥ 18

Continuation therapy age criterionApplies to Patient Currently Receiving Camzyos branch requiring age ≥ 18

inv-06: Maximal left ventricular wall thickness — thresholds

General maximal LV wall thickness thresholdMaximal left ventricular wall thickness ≥ 15 mm

Familial hypertrophic cardiomyopathy thresholdIf familial HCM, maximal left ventricular wall thickness ≥ 13 mm

Requirement contextThresholds apply as part of Initial Therapy eligibility criteria

inv-07: LVOT peak gradient — required value (rest or provoked)

Required LVOT peak gradientPeak left ventricular outflow tract (LVOT) gradient ≥ 50 mmHg

Measurement conditionsGradient may be measured at rest or after provocation (Valsalva maneuver or post-exercise)

ApplicabilityThis LVOT gradient requirement is part of Initial Therapy eligibility

inv-08: Left ventricular ejection fraction (initial therapy) — threshold

Initial therapy LVEF thresholdLeft ventricular ejection fraction (LVEF) ≥ 55%

Initiation recommendationInitiation in patients with LVEF < 55% is not recommended (echocardiographic assessment required before use)

Monitoring implicationEchocardiogram assessment of LVEF is required before and during Camzyos use due to risk of systolic dysfunction

inv-09: Left ventricular ejection fraction (continuation) — threshold

Continuation therapy LVEF thresholdCurrent left ventricular ejection fraction (LVEF) ≥ 50%

Interruption criterionTherapy should be interrupted if LVEF falls below 50% or if clinical worsening occurs

Continuation documentationFor continuation approval, current LVEF ≥ 50% must be documented

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Camzyos (mavacamten) prior to coverage. Initial approvals: up to 8 months for patients meeting initial therapy criteria. Continuation approvals: up to 1 year for patients currently receiving Camzyos who meet continuation criteria. Approvals measured in months use 1 month = 30 days. Because of specialized evaluation and monitoring needs, Camzyos must be prescribed by a physician who specializes in the treated condition (cardiologist for obstructive hypertrophic cardiomyopathy).

Initial approval duration: 8 months (measured as 8 × 30 days)
Continuation/renewal approval duration: 1 year (for patients established on therapy ≥ 8 months)
Prescription must be from a specialist (cardiologist)

Denial Risk

Coding and Claims — Noncompliance Risk

Claims submitted without documentation or codes supporting a covered diagnosis, FDA‑approved indication criteria, or required prerequisites (including specialist prescriber and required clinical measurements) may be denied as not medically necessary or noncompliant. Ensure claims include appropriate diagnosis codes, dates and results for required assessments (e.g., peak LVOT gradient, left ventricular ejection fraction, LV wall thickness), and evidence of prior/concurrent therapies as applicable.

Claims lacking covered diagnosis or required clinical data will be denied or returned as noncompliant
Include supporting documentation: echocardiogram/LVEF, LVOT gradient measurement, LV wall thickness, NYHA class documentation

Step Therapy

Expectations for Prior Therapies

Prior therapies must follow guideline‑directed treatment before initiating Camzyos. For symptomatic obstructive hypertrophic cardiomyopathy, documentation that the patient has been tried on and had inadequate response or intolerance to nonvasodilating beta blockers (titrated to effectiveness or maximally tolerated dose) is expected. If beta blockers are not effective or tolerated, substitution with a nondihydropyridine calcium channel blocker (e.g., verapamil, diltiazem) and/or addition of disopyramide should be documented where applicable. Document any contraindicated medications discontinued (e.g., pure vasodilators) and whether septal reduction therapy was considered or is not appropriate.

Document trials and responses/intolerance to: nonvasodilating beta blockers (required initial therapy)
If applicable, document trial or intolerance to nondihydropyridine CCBs (verapamil, diltiazem) and/or disopyramide
Document that medications promoting outflow tract obstruction were discontinued when present
Document consideration/unsuitability of septal reduction therapy when applicable

Clinical Background

Hypertrophic cardiomyopathy (HCM) is characterized by unexplained left ventricular hypertrophy that can produce left ventricular outflow tract (LVOT) obstruction and associated symptoms such as dyspnea, chest pain, syncope, and exercise intolerance. Obstructive HCM refers to cases with symptomatic LVOT obstruction and diagnostic features that may include increased maximal left ventricular wall thickness and a peak LVOT gradient of ≥ 50 mmHg at rest or with provocation. Camzyos (mavacamten) is a cardiac myosin inhibitor indicated to improve functional capacity and symptoms in adults with symptomatic NYHA Class II–III obstructive HCM; its use requires specialist prescribing and echocardiographic monitoring due to the risk of systolic dysfunction and a REMS program.

Definitions

inv-15: Obstructive hypertrophic cardiomyopathy (obstructive HCM) — diagnostic features and definition

DefinitionObstructive hypertrophic cardiomyopathy (obstructive HCM) is HCM with left ventricular outflow tract (LVOT) obstruction causing symptoms; indicated for symptomatic NYHA Class II–III obstructive HCM in adults

Diagnostic features — LV hypertrophyUnexplained maximal left ventricular wall thickness ≥ 15 mm (or ≥ 13 mm if familial) consistent with HCM

Diagnostic features — LVOT obstructionPresence of a peak LVOT gradient ≥ 50 mmHg (measured at rest or after provocation) indicating obstruction

Clinical featuresSymptoms commonly include shortness of breath, chest pain, lightheadedness, fainting, fatigue, and reduced exercise capacity

Policy context (most actionable)Camzyos is indicated for adults with symptomatic NYHA Class II–III obstructive HCM meeting the above diagnostic features (highlighted requirement: LVOT gradient ≥ 50 mmHg and LVEF thresholds apply)