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    v1.0.30
    OpenPayerPolicy UpdatesClinical/Medical PolicyFlorida AHCA Camzyos Prior Auth Coverage | OpenPay…
    Ask Trek AI about this page
    CurrentAgency for Health Care AdministrationPolicy N/A

    Camzyos (mavacamten) Coverage Criteria

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    This policy governs prior authorization and continuation criteria for Camzyos (mavacamten) in adults with symptomatic obstructive hypertrophic cardiomyopathy and requires participation in the Camzyos REMS program.

    Policy Summary
    PayerAgency for Health Care Administration
    PolicyCamzyos (mavacamten) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization and enroll the patient through the restricted Camzyos REMS program before treatment.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 monthsAuthorization duration
    ≥18 yearsMinimum patient age
    ≥55%Minimum LVEF
    ≥50 mmHgMinimum LVOT gradient
    2.5, 5, 10, 15 mgCapsule strengths

    Camzyos Coverage Criteria

    Initial Therapy

    Covered when ALL of the following criteria are met:

    ALL of the following

    • Patient is 18 years of age or older.>= 18 years
    • Patient has a documented diagnosis of symptomatic New York Heart Association (NYHA) class II to class III obstructive hypertrophic cardiomyopathy.
    • Medication is prescribed by or in consultation with a cardiologist.
    • Patient has a left ventricular ejection fraction (LVEF) of at least 55%.≥ 55%
    Policy Summary
    PayerAgency for Health Care Administration
    PolicyCamzyos (mavacamten) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization and enroll the patient through the restricted Camzyos REMS program before treatment.
    SourceLink
    On This Page
    Camzyos Coverage CriteriaClinical ThresholdsAuthorization and Submission RequirementsCamzyos REMS BackgroundClinical Definitions

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

  1. Patient has a Valsalva left ventricular outflow tract (LVOT) peak gradient of at least 50 mmHg at rest or with provocation.≥ 50 mmHg

  2. For each therapy, ONE of the following applies

    • Beta blocker

      • Documented trial and failure of a beta blocker at the maximally tolerated dosage.
      • Beta blocker is contraindicated.

    • Calcium channel blocker

      • Documented trial and failure of a calcium channel blocker at the maximally tolerated dosage.
      • Calcium channel blocker is contraindicated.

    3. Continuation Therapy

    Continuation therapy is covered when ALL of the following criteria are met:

    ALL of the following

    • Patient met the initial therapy coverage criteria.
    • Documentation demonstrates an improved clinical response.
    • Patient has not experienced any treatment-restricting adverse effects.
    • Dosing is appropriate according to labeling or is supported by compendia.

    Camzyos must not be used concurrently with disopyramide, ranolazine, or calcium channel blocker and beta blocker combination therapy.

    Clinical Thresholds

    Left ventricular ejection fraction
    Required minimum LVEF≥ 55%
    MeasureLeft ventricular ejection fraction
    Applies toInitial therapy review criteria
    Valsalva left ventricular outflow tract peak gradient
    Required minimum gradient≥ 50 mmHg
    MeasureValsalva left ventricular outflow tract peak gradient
    Assessment conditionAt rest or with provocation

    Authorization and Submission Requirements

    Prior Authorization

    Prior Authorization and CAMZYOS REMS Required

    Prior authorization is required for CAMZYOS (mavacamten). Initial authorization is limited to six months, and dispensing requires fulfillment of the CAMZYOS REMS because of the risk of heart failure due to systolic dysfunction.

    • Initial authorization duration: 6 months.
    • CAMZYOS must be dispensed through the restricted CAMZYOS REMS. Further information is available at www.CAMZYOSREMS.com or 1-833-628-7367.
    Step Therapy

    Required Beta Blocker and Calcium Channel Blocker Trials

    Before authorization, the provider must document a trial and failure of both required therapies at the maximally tolerated dosage, unless contraindicated.

    • Beta blocker trial and failure.
    • Calcium channel blocker trial and failure.
    Documentation Required

    Required Clinical Documentation

    The submission must include documentation supporting the initial or continuation request, including the patient’s clinical eligibility, treatment history, and prescriber information.

    • Patient is 18 years of age or older.
    • Documented diagnosis of symptomatic NYHA class II to class III obstructive hypertrophic cardiomyopathy.
    • Prescription by or consultation with a cardiologist.
    • Baseline left ventricular ejection fraction (LVEF) of ≥ 55%.
    • Valsalva left ventricular outflow tract (LVOT) peak gradient of ≥ 50 mmHg at rest or with provocation.
    • Documented treatment history supporting the required maximally tolerated beta blocker and calcium channel blocker trials, including contraindications when applicable.
    • For continuation requests: prior criteria were met; documentation shows improved clinical response; no treatment-restricting adverse effects have occurred; and dosing is consistent with labeling or supported by compendia.
    Denial Risk

    Denial Conditions and Prohibited Concomitant Therapy

    Authorization may be denied when the patient does not meet the clinical criteria or when treatment includes prohibited concomitant therapy.

    • Denial risk applies if any required eligibility, cardiac function, gradient, prescriber, or treatment-history criterion is not met or adequately documented.
    • CAMZYOS must not be used concurrently with disopyramide.
    • CAMZYOS must not be used concurrently with ranolazine.
    • CAMZYOS must not be used concurrently with calcium channel blocker and beta blocker combination therapy.

    Camzyos REMS Background

    Camzyos (mavacamten) is available only through the restricted Camzyos REMS program because of the risk of heart failure due to systolic dysfunction.

    Clinical Definitions

    NYHA class II to III
    TermNew York Heart Association (NYHA) class II to class III
    Required conditionDocumented symptomatic disease
    Diagnosis contextObstructive hypertrophic cardiomyopathy
    LVEF
    AbbreviationLVEF
    DefinitionLeft ventricular ejection fraction
    Policy threshold≥ 55%
    LVOT
    AbbreviationLVOT
    DefinitionLeft ventricular outflow tract
    Policy thresholdValsalva peak gradient ≥ 50 mmHg at rest or with provocation