CurrentCignaPolicy N/A

Camzyos (mavacamten) prior authorization

Defines prior authorization requirements and medical necessity criteria for coverage of Camzyos (mavacamten) for adults with obstructive hypertrophic cardiomyopathy under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyCamzyos (mavacamten) prior authorization

Policy CodePolicy N/A

Change TypeCriteria and operational updates

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document age, symptoms/NYHA class II–III, LV wall thickness, LVOT gradient, LVEF, prior guideline therapies, and that a cardiologist prescribed the medication.

SourceLink

POLICY UPDATE CHANGES

Specialist requirement was clarified to state the medication could be prescribed in consultation with a cardiologist.

Approval duration for initial therapy changed to 1 year (previously 8 months).

Peak left ventricular outflow tract gradient requirement changed to ≥ 30 mmHg at rest or ≥ 50 mmHg after provocation.

For patients currently receiving Camzyos, required duration on therapy to be 'established on therapy' changed from at least 8 months to at least 1 year.

Specialist prescribing requirement was updated to only allow a cardiologist to prescribe the medication; previously consultation with a cardiologist was allowed.

Updated guidelines in the Overview section.

≥18minimum age for coverage

≥55% / ≥50%LVEF requirement

≥30 / ≥50obstruction threshold

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Camzyos (mavacamten)

FDA-Approved Indication: Obstructive Hypertrophic Cardiomyopathy

Covered when ALL of the following are met for the FDA-approved indication of obstructive hypertrophic cardiomyopathy:

Indication: Patient has obstructive hypertrophic cardiomyopathy (FDA-approved indication).

Initial Therapy (approve 1 year)

Age: Patient is ≥ 18 years of age.
Symptoms: Patient has at least one symptom associated with obstructive hypertrophic cardiomyopathy AND is New York Heart Association (NYHA) Class II or III.
Examples of symptoms include shortness of breath, chest pain, lightheadedness, fainting, fatigue, and reduced ability to perform physical exercise.
LV wall thickness: Maximal left ventricular wall thickness ≥ 15 mm OR ≥ 13 mm if familial hypertrophic cardiomyopathy.
LVOT gradient: Peak left ventricular outflow tract (LVOT) gradient ≥ 30 mmHg at rest OR ≥ 50 mmHg after provocation (Valsalva maneuver or post-exercise).
LVEF: Left ventricular ejection fraction (LVEF) ≥ 55%.
Initiation not recommended if LVEF <55%.
Prescriber: Medication is prescribed by a cardiologist.

Patient Currently Receiving Camzyos (approve 1 year)

Established therapy: Patient has been established on therapy for at least 1 year.
Patients with <1 year of therapy or restarting are reviewed as Initial Therapy.
Age: Patient is ≥ 18 years of age.
Symptoms history: Currently or prior to starting therapy, patient has or experienced at least one symptom associated with obstructive hypertrophic cardiomyopathy AND was NYHA Class II or III.
Examples of symptoms include shortness of breath, chest pain, lightheadedness, fainting, fatigue, and reduced ability to perform physical exercise.
LVEF continuing: Current left ventricular ejection fraction (LVEF) ≥ 50%.
Interrupt therapy if LVEF <50% or with clinical worsening.

Uses of Camzyos (mavacamten) that fall outside the policy’s specified coverage criteria are not covered. The policy’s "Conditions Not Covered" section explicitly lists the product for non-covered uses, which implies that any indications, patient populations, or treatment situations not meeting the detailed criteria for obstructive hypertrophic cardiomyopathy are not eligible for coverage.

Camzyos carries a Boxed Warning for risk of heart failure due to systolic dysfunction; echocardiographic monitoring of left ventricular ejection fraction (LVEF) is required before and during therapy. Initiation is not recommended if LVEF < 55%. For patients on therapy, treatment should be interrupted if LVEF falls to < 50% or if there is clinical worsening. Additional REMS program requirements apply (prescriber, patient, and dispensing pharmacy certification) and certain CYP450 inhibitors/inducers are contraindicated.

Coding, Clinical Thresholds, and Measurement Criteria

Covered codesmixed

No codes listed

LVOT gradient threshold — numeric thresholds for rest and provoked measurements

Rest LVOT gradientPeak LVOT gradient ≥ 30 mmHg at rest

Provoked LVOT gradientPeak LVOT gradient ≥ 50 mmHg after provocation (Valsalva maneuver or post-exercise)

Measurement methodsProvocation examples specified: Valsalva maneuver or post-exercise assessment

Left ventricular wall thickness

General thresholdMaximal left ventricular wall thickness ≥ 15 mm

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

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Camzyos (mavacamten) prescription benefit coverage. Approvals are time-limited (typically granted for 1 year for initial and continuation therapy per policy criteria) and will only be issued when the prescriber is a cardiologist or a physician who specializes in hypertrophic cardiomyopathy and all medical-necessity criteria are met.

Approve duration: typically 1 year for both initial therapy and patients currently receiving therapy (see criteria).
Prescriber requirement: must be prescribed by a cardiologist or specialist in the treated condition.
Camzyos is available only through a REMS program — prescriber, patient, and pharmacy certification required.

Denial Risk

Coding / Coverage Mismatch — Denial Risk

Claims submitted with diagnoses or procedure codes that do not match covered indications or that lack documentation demonstrating that policy criteria are met will be denied as not covered. Providers must bill using the most appropriate and supported codes as of the date of service.

Definitions and Therapy Status

Obstructive HCM definition

DefinitionObstructive HCM: hypertrophic cardiomyopathy with left ventricular outflow tract obstruction causing symptoms and elevated LVOT gradients

Clinical consequencesCan cause dyspnea, chest pain, syncope, atrial fibrillation, and heart failure

Relation to LVOT gradient/symptomsPolicy requires elevated peak LVOT gradients and NYHA II–III symptoms for treatment eligibility

Initial therapy vs continuing therapy

Initial therapy (definition)Patient starting Camzyos — reviewed under Initial Therapy criteria; approvals are for 1 year

Established on therapy (definition)Patient who has been established on therapy for at least 1 year — reviewed under 'Patient Currently Receiving Camzyos' criteria

Background

Hypertrophic cardiomyopathy (HCM) is a frequently inherited myocardial disorder characterized by left ventricular hypertrophy that can produce symptoms from outflow tract obstruction, including dyspnea, chest pain, syncope, atrial fibrillation, and heart failure. Camzyos (mavacamten) is a cardiac myosin inhibitor that reduces actin–myosin cross-bridge formation, improves diastolic function, and lowers left ventricular outflow tract (LVOT) gradients, providing symptomatic benefit for adults with obstructive HCM (NYHA Class II–III).

Policy Revision History and Material Changes

2026-01-14policy revisionLatest

Selected revision: approval duration for initial therapy changed to 1 year (previously 8 months); peak LVOT gradient requirement clarified to ≥30 mmHg at rest or ≥50 mmHg after provocation; required duration on therapy for continuing patients changed to ≥1 year; specialist prescribing requirement updated to cardiologist-only (previously allowed consultation).

2025-12-30policy clarification

Selected revision: specialist requirement clarified to state medication could be prescribed in consultation with a cardiologist (later updated).

2025-07-15

Documentation Required

Required Clinical Documentation

To support a prior authorization request, include clear clinical documentation addressing all policy criteria. Provide objective measurements and historical data where applicable to demonstrate medical necessity.

Patient age (≥ 18 years).
Symptoms attributable to obstructive hypertrophic cardiomyopathy and NYHA class (II or III).
Left ventricular wall thickness (maximal LV wall thickness in mm) and whether familial HCM is present.
Peak LVOT gradient at rest or with provocation (include values and method: resting, Valsalva, or post-exercise).
Left ventricular ejection fraction (baseline and current; note initiation contraindication <55% and interruption threshold <50%).
For patients currently on Camzyos: duration of prior therapy (≥ 1 year to qualify under continuation criteria) and objective evidence of beneficial clinical response (examples: reduced LVOT gradient, improved peak VO2, decreased NT-proBNP, reduced LV mass/left atrial volume, or decreased hs-cTnI).
Documentation of prior or concurrent guideline-directed therapy (e.g., trial and intolerance or inadequate response to non-vasodilating beta blockers and/or nondihydropyridine calcium channel blockers such as verapamil or diltiazem), including doses and reason for discontinuation if applicable.
Confirmation that prescriber is certified in the Camzyos REMS program and that the patient is enrolled in REMS.
Relevant safety information: concomitant medications (notably CYP inhibitors/inducers), baseline and ongoing echocardiogram reports, and any adverse event history (including signs of systolic dysfunction).