CurrentCignaPolicy IP0480

Cardiology - Camzyos

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

Policy Summary

PayerCigna

PolicyCardiology - Camzyos

Policy CodePolicy IP0480

Change TypeCriteria and duration updates

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document diagnostic evidence (NYHA II–III symptoms, LV wall thickness, LVOT gradient, baseline and ongoing LVEF) to support approval.

SourceLink

POLICY UPDATE CHANGES

For patients currently receiving Camzyos, requirement added that patients should be established on therapy for at least 8 months; patients with <8 months or restarting are reviewed under Initial Therapy criteria.

Approval durations specified: Initial therapy approvals for 8 months; continuing therapy approvals for 1 year.

Policy name updated from 'Mavacamten' to 'Cardiology - Camzyos.'

≥18minimum patient age for coverage

≥50 mmHgLVOT gradient required

≥55% / ≥50%LVEF thresholds

8 mo / 1 yrauthorized coverage durations

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Coverage Criteria for Camzyos (mavacamten)

inv-01: Initial Therapy

Approve for the FDA‑approved indication of obstructive hypertrophic cardiomyopathy when ALL of the following are met:

Initial Therapy criteria: i. Patient is ≥ 18 years of age;

Initial Therapy criteria: ii. Patient meets BOTH of the following: a) has at least one symptom associated with obstructive hypertrophic cardiomyopathy (examples: shortness of breath, chest pain, lightheadedness, fainting, fatigue, reduced exercise capacity); AND b) is New York Heart Association (NYHA) Class II or III;

Initial Therapy criteria: iii. Patient with left ventricular hypertrophy meets ONE of the following: a) maximal left ventricular wall thickness ≥ 15 mm; OR b) familial hypertrophic cardiomyopathy with maximal left ventricular wall thickness ≥ 13 mm;

Initial Therapy criteria: iv. Patient has a peak left ventricular outflow tract (LVOT) gradient ≥ 50 mmHg (at rest or after provocation, e.g., Valsalva or post-exercise);

Initial Therapy criteria: v. Left ventricular ejection fraction (LVEF) ≥ 55%;

Initial Therapy criteria: vi. Medication is prescribed by a cardiologist;

If all criteria A(i–vi) are met, approve for 8 months.

inv-02: Continuation Therapy (Patients currently receiving Camzyos)

Approve for patients currently receiving Camzyos when ALL of the following are met:

Continuation Therapy criteria: i. Patient has been established on therapy for at least 8 months;

Patients who have received < 8 months of therapy or who are restarting therapy are reviewed under Initial Therapy criteria.

Continuation Therapy criteria: ii. Patient is ≥ 18 years of age;

Continuation Therapy criteria: iii. Patient meets BOTH of the following: a) currently or prior to starting therapy has or had at least one symptom associated with obstructive hypertrophic cardiomyopathy (examples: shortness of breath, chest pain, lightheadedness, fainting, fatigue, reduced exercise capacity); AND b) currently or prior to starting therapy was in NYHA Class II or III;

Continuation Therapy criteria: iv. Current left ventricular ejection fraction (LVEF) ≥ 50%;

Camzyos (mavacamten) is not medically necessary for any use outside the treatment of symptomatic obstructive hypertrophic cardiomyopathy as defined in this policy. Requests for Camzyos for diagnoses or indications other than obstructive HCM do not meet coverage criteria and are subject to denial.

Use of Camzyos for indications not specified in the coverage criteria is considered not medically necessary. Coverage decisions will follow the policy’s specified clinical criteria and will be updated if new evidence emerges supporting other indications.

Clinical Thresholds and Key Parameters

inv-05: LVOT peak gradient

LVOT peak gradient threshold≥ 50 mmHg (measured at rest or after provocation such as Valsalva or post-exercise)

Measurement contextAcceptable when measured at rest or with provocation (Valsalva maneuver or post-exercise)

Role in initial approvalRequired for Initial Therapy approval (one of the mandatory criteria)

inv-06: Maximal left ventricular wall thickness

General maximal LV wall thickness≥ 15 mm

Familial HCM exceptionIf familial hypertrophic cardiomyopathy, threshold is ≥ 13 mm

Authorization, Positioning, and Documentation Requirements

Prior Authorization

Prior Authorization and Approval Durations

Prior Authorization Required. Prior authorization is recommended for Camzyos. Approvals: initial therapy = 8 months; continuation = 1 year. Prescriber requirement: must be prescribed by a cardiologist or a physician who has consulted with or specializes in obstructive hypertrophic cardiomyopathy.

Initial approval duration: 8 months (1 month = 30 days).
Continuation approval duration: 1 year for patients established on therapy ≥ 8 months.
Prescription must be by a cardiologist or physician specialized/consulted in the condition.

Note

Place in Therapy

Place in therapy: Camzyos is indicated for adult patients with symptomatic obstructive hypertrophic cardiomyopathy who remain symptomatic despite guideline-directed therapy. Recommended first-line therapy is titration of non-vasodilating beta blockers; if not effective or not tolerated, switch to nondihydropyridine calcium channel blockers (e.g., verapamil, diltiazem). If symptoms persist despite beta blockers and nondihydropyridine CCBs, adding a myosin inhibitor (Camzyos) or disopyramide or considering septal reduction at experienced centers is recommended. Camzyos is only for adults and is contraindicated in pregnancy.

Key Definitions

inv-13: Obstructive hypertrophic cardiomyopathy (HCM)

DefinitionObstructive hypertrophic cardiomyopathy (HCM) is HCM with left ventricular hypertrophy not due to other causes and frequently associated with left ventricular outflow tract (LVOT) obstruction (measurable LVOT gradient).

Relation to LVOT gradientObstruction is characterized by an elevated peak LVOT gradient (eg, ≥ 50 mmHg at rest or with provocation) used in eligibility criteria.

Clinical significanceObstructive HCM produces symptoms (eg, dyspnea, chest pain, syncope, fatigue) and is the FDA‑approved indication for Camzyos.

inv-14: NYHA Class II–III

NYHA Class IIMild symptoms with ordinary/moderate physical activity and some exercise limitations (eligible class for coverage)

NYHA Class III

Background on Hypertrophic Cardiomyopathy and Camzyos

Hypertrophic cardiomyopathy (HCM) is an often inherited cardiac condition characterized by left ventricular hypertrophy, impaired ventricular filling, and frequently obstruction of the left ventricular outflow tract leading to symptoms such as dyspnea, chest pain, syncope, fatigue, and exercise intolerance. Camzyos (mavacamten) is a cardiac myosin inhibitor indicated specifically to improve functional capacity and symptoms in adults with symptomatic NYHA Class II–III obstructive HCM; use outside this context is addressed under the medical necessity and exclusions sections of this policy.

Policy Summary

PayerCigna

PolicyCardiology - Camzyos

Policy CodePolicy IP0480

Change TypeCriteria and duration updates

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document diagnostic evidence (NYHA II–III symptoms, LV wall thickness, LVOT gradient, baseline and ongoing LVEF) to support approval.

SourceLink

On This Page

Continuation Therapy criteria: v. Patient meets ONE of the following: a) experienced a beneficial clinical response assessed by at least one objective measure (examples: improved peak VO2; decreased LVOT gradient; reductions in NT-proBNP; decreased hs-cTnI; reduced ventricular mass index; reduced max left atrial volume index); OR b) experienced stabilization or improvement in at least one symptom related to obstructive HCM (examples: shortness of breath, chest pain, lightheadedness, fainting, fatigue, improved exercise capacity, or favorable KCCQ-23/HCMSQ scores);

Continuation Therapy criteria: vi. The medication is prescribed by a cardiologist;

If all continuation criteria (i–vi) are met, approve for 1 year.

Role in initial approvalMeets one of the mandatory criteria for left ventricular hypertrophy in Initial Therapy

inv-07: Left ventricular ejection fraction (LVEF)

LVEF for initiation (Initial Therapy)Left ventricular ejection fraction ≥ 55% required for initial approval

LVEF for continuation (Patients currently receiving Camzyos)Current left ventricular ejection fraction ≥ 50% required for continuation approval

Monitoring requirementBaseline and ongoing LVEF measurements are required documentation for initiation and continuation

First-line: non-vasodilating beta blockers titrated to effectiveness or maximum tolerated dose.
Alternative: nondihydropyridine CCBs (verapamil, diltiazem) if beta blockers ineffective or not tolerated.
If persistent severe symptoms despite above therapies: consider Camzyos (myosin inhibitor), disopyramide (with AV nodal blocker), or septal reduction.

Documentation Required

Required Documentation and Monitoring

Required documentation and monitoring: must document obstructive HCM diagnosis, symptoms and NYHA class, LV wall thickness, LVOT gradient, and baseline LVEF ≥ 55% for initiation (continuation requires current LVEF ≥ 50%). Ongoing echocardiographic LVEF monitoring is required during therapy. Camzyos prescribing and dispensing requires enrollment in the Camzyos REMS program (prescriber, patient, and pharmacy certification). Interrupt therapy if LVEF drops < 50% or if clinical status worsens.

Diagnostic evidence: LVH with maximal wall thickness ≥ 15 mm (or ≥ 13 mm for familial HCM) and peak LVOT gradient ≥ 50 mmHg (rest or provocation).
Symptom evidence: at least one symptom attributable to obstructive HCM and NYHA class II or III.
Baseline LVEF: ≥ 55% for initiation; continuation requires current LVEF ≥ 50%.
Monitoring: echocardiogram assessment of LVEF before initiation and during therapy; interrupt therapy if LVEF < 50% or clinical worsening.
REMS: prescribers, patients, and pharmacies must be enrolled and comply with REMS requirements.

Denial Risk

Triggers for Denial

Triggers for denial. Use of Camzyos for any indication other than the FDA-approved indication for obstructive hypertrophic cardiomyopathy in adults is not medically necessary and will be denied. Denial may also occur if required criteria are not met (age < 18, insufficient diagnostic or symptom documentation, baseline LVEF below required threshold for initiation, lack of cardiology prescribing/consultation, or failure to meet REMS requirements).

Not covered: Camzyos for any non‑obstructive HCM or other off‑label uses.
Denial triggers: patient < 18 years; missing documentation of symptoms/NYHA class; absent LV wall thickness or LVOT gradient meeting thresholds; baseline LVEF < 55% for initiation; current LVEF < 50% for continuation; prescriber not a cardiologist or not specialized/consulted; noncompliance with REMS enrollment.

Marked limitation with minimal physical activity; comfortable only at rest (eligible class for coverage)

Use in criteriaCoverage is limited to patients who are NYHA Class II or III (current or prior to starting therapy), as required in Initial and Continuation criteria.