ModifiedCentenePolicy CP PMN.272

Mavacamten (Camzyos) for obstructive hypertrophic cardiomyopathy

Defines medical necessity criteria, prior authorization requirements, dosing limits, and monitoring for mavacamten (Camzyos) for adults with symptomatic NYHA class II-III obstructive hypertrophic cardiomyopathy; applies to Centene lines of business including Commercial, HIM, and Medicaid.

Policy Summary

PayerCentene

PolicyMavacamten (Camzyos) for obstructive hypertrophic cardiomyopathy

Policy CodePolicy CP PMN.272

Change TypeLabeling revisions and state step therapy update

Effective DateApr 28, 2022

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing obstructive HCM diagnosis, NYHA II–III symptoms, cardiology consultation, baseline LVEF ≥55% and required LVOT gradient, and prior trial history.

SourceLink

POLICY UPDATE CHANGES

Per labeling updates, revised Appendix C (removed contraindication with moderate CYP2C19 inhibitors and strong CYP3A4 inhibitors) and revised maintenance echo monitoring frequency for certain patients to every 6 months.

Removed requirement for maximal left ventricular wall thickness per FDA label and aligned symptom provocation wording with label.

Appendix C was revised to remove contraindication with moderate CYP2C19 inhibitors and strong CYP3A4 inhibitors.

For maintenance dosing, frequency of required echocardiographic monitoring changed from every 12 weeks to every 6 months for LVEF ≥ 55% and a Valsalva LVOT gradient < 30 mmHg.

Step therapy bypass for Illinois HIM was added per Illinois HB 5395.

15 mg/daymaximum allowed daily dose

6 moinitial approval duration

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.

12 morenewal approval duration

NYHA II-IIIsymptom class required

LVEF ≥55%baseline LVEF threshold

IL HB 5395state law prompting step therapy bypass

Coverage Criteria for Mavacamten (Camzyos)

Initial Therapy

Covered when ALL of the following are met:

Initial Approval: 1. Diagnosis of obstructive hypertrophic cardiomyopathy (HCM). 2. Member exhibits NYHA Class II–III symptoms (for example, effort‑related dyspnea, chest pain, syncope or near‑syncope attributed to LVOT obstruction). 3. Prescribed by or in consultation with a cardiologist. 4. Age ≥ 18 years. 5. Baseline left ventricular ejection fraction (LVEF) ≥ 55%. 6. Left ventricular outflow tract (LVOT) gradient ≥ 50 mmHg at rest or with provocation (peak). 7. Failure of TWO of the following at up to maximally indicated doses unless contraindicated or not tolerated: a non‑vasodilating beta‑blocker (e.g., atenolol, metoprolol, bisoprolol, propranolol), a non‑dihydropyridine calcium channel blocker (e.g., verapamil, diltiazem), or add‑on disopyramide after failure of beta‑blocker or calcium channel blocker monotherapy. 8. Requested dose does not exceed 15 mg per day.≤ 15 mg/day

Approval duration: 6 months

Continuation Therapy

Covered when ALL of the following are met:

Continuation Therapy: 1. Member is currently receiving the medication through the Centene benefit or has previously met initial approval criteria. 2. Member is responding positively to therapy as evidenced by improvement in obstructive HCM symptoms. 3. Member has not undergone a septal reduction procedure within the last 6 months. 4. If the request is for a dose increase, the new dose does not exceed 15 mg per day.≤ 15 mg/day

Approval duration: 12 months

Maintenance Dosing Monitoring

Covered with monitoring adjustments per labeling:

Maintenance echocardiographic monitoring: For maintenance dosing, echo monitoring frequency is revised to once every 6 months when LVEF ≥ 55% and Valsalva LVOT gradient < 30 mmHg.LVEF >= 55%; Valsalva LVOT gradient < 30 mmHg

Replaces prior requirement of echocardiography every 12 weeks for these patients per labeling update

Contraindications

Labeling update affecting contraindications:

Drug interaction contraindication removal: Appendix C revised to remove the contraindication with moderate CYP2C19 inhibitors and strong CYP3A4 inhibitors per labeling updates.

Change reflected in 3Q 2025 annual review

Requests for use of mavacamten (Camzyos) for indications that are not FDA‑approved and are not specifically addressed in this clinical policy are excluded from coverage unless the request includes sufficient documentation of efficacy and safety consistent with the Plan’s off‑label use policies (for example, CP.CPA.09 for commercial, HIM.PA.154 for marketplace, or CP.PMN.53 for Medicaid) or other applicable evidence of coverage documents.

For Medicaid members, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for specific coverage direction.

Echocardiographic assessment of left ventricular ejection fraction (LVEF) is required before and during treatment with mavacamten. Initiation is not recommended if baseline LVEF is < 55%. Treatment should be interrupted if LVEF is measured at < 50% at any visit or if the patient develops heart failure symptoms or worsening clinical status. These monitoring and interruption requirements reflect the boxed warning for risk of heart failure due to systolic dysfunction and the restricted REMS distribution program.

The reviewed document does not include explicit standalone statements labeled "not medically necessary" for specific scenarios beyond the monitoring and REMS‑related guidance; instead, the policy provides clinical criteria, monitoring requirements, and references to off‑label policies and coverage documents that drive authorization decisions. Providers remain responsible for clinical judgment and must submit supporting documentation to demonstrate that approval criteria are met.

Product Codes, Dosing, and Key Clinical Thresholds

Product strengthsmixed

Capsules: 2.5 mg, 5 mg, 10 mg, 15 mg

Product availability / strengths

Affected Codes (placeholder)mixed

affected codes

placeholder referenced in document for impacted codes

inv-11: Maximum daily dose — 15 mg/day

Maximum daily doseDo not exceed 15 mg per day (maximum allowed daily dose).

Policy approval duration noteInitial approval duration tied to dosing criteria: 6 months when criteria met.

Dose escalation capUp-titration permitted only within approved dose levels up to 15 mg/day (see dosing regimen).

inv-12: Baseline LVEF to initiate — ≥ 55%

Baseline LVEF required to initiateLeft ventricular ejection fraction (LVEF) ≥ 55% is required before initiating therapy.

Initiation warningInitiation of Camzyos in patients with LVEF < 55% is not recommended (boxed warning/reminder).

Provider Requirements, Prior Authorization, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required. Provider must submit documentation (such as office chart notes, laboratory results, echocardiogram reports, and other relevant clinical information) that demonstrates the member meets all approval criteria (e.g., diagnosis of obstructive HCM, NYHA Class II–III symptoms, LVEF and LV wall thickness criteria, LVOT gradient, specialty prescribing requirements, and step therapy failures where applicable).

Affected policy: CP PMN.272
Required documentation: office chart notes, lab results, echocardiogram supporting LVEF and LVOT gradient, genetic test results when applicable, specialist consultation notes
Approval duration: 6 months

Documentation Required

Required Documentation

Required Documentation: Provider must submit chart notes, laboratory results, echocardiogram reports (including LVEF and LVOT gradient measurements), documentation of NYHA class, specialist consultation or that prescription is by/with a cardiologist, documentation of prior medication trials (including agents, doses, durations, and reasons for discontinuation or adverse effects), and genetic test results when applicable.

Background

Mavacamten (Camzyos) is a selective cardiac myosin inhibitor indicated to improve functional capacity and symptoms in adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM) typically presenting with New York Heart Association (NYHA) class II–III symptoms. The product is available in 2.5 mg, 5 mg, 10 mg, and 15 mg capsules. Use of mavacamten requires baseline and ongoing echocardiographic monitoring because of a boxed warning for risk of heart failure due to systolic dysfunction and is available only through a restricted REMS program.

Definitions and Abbreviations

inv-25: Hypertrophic cardiomyopathy (HCM) definition/key term

DefinitionHypertrophic cardiomyopathy (HCM): a condition characterized by unexplained left ventricular hypertrophy; abbreviated as HCM.

Genetic associationCommon familial HCM genes include MYH7 and MYBPC3 (see Appendix D).

Context in policyIn this policy, 'obstructive HCM' refers to HCM with LVOT obstruction meeting specified gradient thresholds and symptoms.

inv-26: NYHA functional classification definition

DefinitionNew York Heart Association (NYHA) functional classification: scale used to describe severity of symptoms; policy requires NYHA Class II–III for initial approval.

Examples of symptomsNYHA Class II–III examples include effort-related dyspnea, chest pain, syncope or near-syncope attributed to LVOT obstruction.

Revision History and Policy Changes

2025-06-24annual_review

3Q 2025 annual review: per labeling updates, revised Appendix C to remove contraindication with moderate CYP2C19 inhibitors and strong CYP3A4 inhibitors; revised Section V maintenance echocardiographic monitoring frequency from once every 12 weeks to once every 6 months for patients with LVEF ≥ 55% and Valsalva LVOT gradient < 30 mmHg.

2025-06-24policy_updateLatest

Added step therapy bypass for Illinois HIM per Illinois HB 5395.

Policy Summary

PayerCentene

PolicyMavacamten (Camzyos) for obstructive hypertrophic cardiomyopathy

Policy CodePolicy CP PMN.272

Change TypeLabeling revisions and state step therapy update

Effective DateApr 28, 2022

Next Review DateN/A

SourceLink

On This Page

Monitoring after initiationEchocardiogram assessments of LVEF are required before and during treatment per REMS guidance.

inv-13: LVOT gradient requirement — ≥ 50 mmHg at rest or with provocation (peak)

LVOT gradient thresholdA left ventricular outflow tract (LVOT) gradient ≥ 50 mmHg at rest or with provocation (peak) is required for coverage.

Measurement contextGradient may be assessed at rest or with provocation (peak) such as Valsalva during echocardiography.

Relation to approval criteriaLVOT gradient ≥ 50 mmHg is one of the required initial approval criteria for obstructive HCM.

inv-14: Echocardiographic monitoring frequency — maintenance: every 6 months if LVEF ≥ 55% and Valsalva LVOT gradient < 30 mmHg (previously every 12 weeks)

Maintenance echo frequency (revised)For maintenance dosing, perform echocardiographic monitoring every 6 months when LVEF ≥ 55% and Valsalva LVOT gradient < 30 mmHg (replaced prior 12-week frequency).

Initial maintenance cycleDuring the first 6-month cycle, check clinical status at 3 months and recheck clinical status and echocardiogram at 6 months.

If LVEF 50–55%If LVEF is 50–55%, maintain dose and follow up with echocardiogram in ~3 months per dosing guidance.

Echocardiogram documentation of baseline and ongoing LVEF assessments per REMS guidance
Medication trial documentation showing failure of two therapies at maximally indicated doses unless contraindicated or intolerant (beta‑blocker, disopyramide, non‑dihydropyridine CCB)
For Illinois HIM requests, see IL step therapy bypass provisions

Denial Risk

No Explicit Denial Triggers Present

No Explicit Denial Triggers Present: The policy contains no single automatic denial trigger text in this section; however, failure to provide required documentation or to meet all approval criteria (including contraindications, LVEF thresholds, and step therapy requirements where applicable) may result in denial. Note that initiation with LVEF <55% is not recommended and interruption is required for LVEF <50% per REMS — failure to adhere to these safety requirements may affect coverage.

Policy is guidance and not a guarantee of payment; coverage subject to plan terms and applicable laws
Illinois step therapy bypass applies per IL HB 5395 (see policy updates)

Policy useNYHA classification is a required element of the initial approval criteria (member exhibits NYHA Class II–III).

inv-27: LVEF — left ventricular ejection fraction definition

DefinitionLeft ventricular ejection fraction (LVEF): the percentage of blood ejected from the left ventricle with each heartbeat; used as baseline and monitoring threshold for therapy.

Policy thresholdsPolicy requires baseline LVEF ≥ 55% to initiate and specifies interrupt/discontinue actions if LVEF falls below 50% or is ≤50% twice while on 2.5 mg.

Monitoring intervalsIf LVEF is 50–55%, follow-up echocardiogram at ~3 months; if LVEF ≥ 55% with low gradient, maintenance ECHO at 6-month intervals.

inv-28: Valsalva LVOT gradient definition

DefinitionValsalva LVOT gradient: peak left ventricular outflow tract gradient assessed with Valsalva maneuver; used to guide dosing and monitoring decisions.

Dosing decisionsValsalva LVOT gradient values influence dose maintenance, down-titration, or withholding (e.g., thresholds at 20 mmHg and 30 mmHg appear in dosing guidance).

Monitoring thresholdMaintenance monitoring guidance references Valsalva LVOT gradient < 30 mmHg for less frequent (6-month) echocardiography when LVEF ≥ 55%.

inv-29: LVEF (alternate) definition/term

Alternate termLVEF (left ventricular ejection fraction) — percentage measure of left ventricular systolic function used throughout the policy for initiation and monitoring.

Clinical implicationsDecreases in LVEF trigger dose interruption and potential permanent discontinuation if thresholds are met (e.g., interrupt if <50%; discontinue if ≤50% twice on 2.5 mg).

Use in maintenanceLVEF ≥ 55% permits less frequent echo monitoring (every 6 months when low gradient), while LVEF 50–55% requires closer follow-up.