CurrentAdvanced HealthPolicy N/A

Cardiac Myosin Inhibitors Drug Use Criteria

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This policy governs prior authorization, initial approval, renewal, dosing, dispensing, and monitoring requirements for Myqorzo (aficamten) and Camzyos (mavacamten) in members requesting therapy for symptomatic obstructive hypertrophic cardiomyopathy, including eligible adults and pediatric Camzyos patients weighing at least 30 kg.

Policy Summary

PayerAdvanced Health

PolicyCardiac Myosin Inhibitors Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionSubmit a baseline echocardiogram showing LVEF of at least 55% and peak LVOT gradient of at least 50 mmHg at rest or with provocation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Products addressed

6 moInitial authorization

12 moRenewal authorization

≥55%Baseline LVEF

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CurrentAdvanced HealthPolicy N/A

Cardiac Myosin Inhibitors Drug Use Criteria

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Policy Summary

PayerAdvanced Health

PolicyCardiac Myosin Inhibitors Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionSubmit a baseline echocardiogram showing LVEF of at least 55% and peak LVOT gradient of at least 50 mmHg at rest or with provocation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Products addressed

6 moInitial authorization

12 moRenewal authorization

≥55%Baseline LVEF

Medical Necessity and Coverage Requirements

Initial Therapy

Initial requests are covered when all applicable criteria are met.

Initial therapy eligibility

FDA-labeled population: Myqorzo is requested for an adult; or Camzyos is requested for an adult or pediatric member weighing at least 30 kg.Camzyos pediatric weight ≥30 kg
An age- or weight-inappropriate product may be denied or changed to an appropriate product.
Clinical disease and specialist care: The selected product is prescribed by or in consultation with a cardiologist experienced in hypertrophic cardiomyopathy, symptomatic obstructive hypertrophic cardiomyopathy is documented, and adult symptoms are NYHA class II or III when applicable.Adult NYHA class II or III
The adult NYHA requirement does not apply to an otherwise qualifying pediatric Camzyos request.
Cardiac measurements: A baseline echocardiogram documents LVEF of at least 55% and peak LVOT gradient of at least 50 mmHg at rest or with provocation.LVEF ≥55%; LVOT-G ≥50 mmHg at rest or with provocation
Initiation when LVEF is below 55% is not recommended in FDA labeling.
Step therapy
- First-line agents: Beta-blocker and non-dihydropyridine calcium channel blocker therapy are addressed.
  Both therapy categories are required unless intolerance or contraindication applies.
- Adult disopyramide pathway: For an adult request, disopyramide was tried, not tolerated, contraindicated, or determined clinically inappropriate; or the request is for pediatric Camzyos.
  Pediatric Camzyos requests bypass this step.
Safety and administration: The prescriber and member are enrolled in the applicable REMS, dispensing will occur through a certified pharmacy, pregnancy and interaction considerations have been reviewed, and the strength, starting dose, titration, and echocardiographic monitoring schedule comply with current FDA labeling and REMS.
Initial authorization is approved for 6 months with a quantity limit of 1 dosage unit per day and dispensing through the applicable REMS-certified specialty pharmacy.

Continuation and Renewal Therapy

Renewal requests are covered when all renewal criteria are met.

Renewal eligibility

Prior approval and clinical benefit: The member met initial approval criteria and demonstrates clinical benefit, such as reduced symptoms, improved or stable NYHA class, improved functional capacity, or reduced LVOT obstruction.
If initial criteria were not met, review under initial authorization criteria.
Ongoing specialty and REMS care: The member remains under continued care of a cardiologist and is compliant with the applicable product-specific REMS.
Failure to meet these requirements may result in denial until satisfied.
Ongoing cardiac safety: Current echocardiographic results and clinical status support continued treatment, with product-specific dose adjustment or interruption performed when required.Myqorzo: reduce dose when LVEF is below 50% and at least 40%; interrupt below 40% or with worsening clinical status due to systolic dysfunction. Camzyos: interrupt when LVEF is below 50% or clinical status worsens.

Monitoring Requirements

Echocardiographic monitoring must follow the selected product's FDA-labeled schedule and REMS authorization process.

Required echocardiographic monitoring: For Myqorzo, perform an echocardiographic assessment 2–8 weeks after initiation or dose adjustment; after maintenance is established, assess every 6 months, or every 3 months when LVEF is below 55% and at least 50%. For Camzyos, follow the current CAMZYOS label and REMS schedule, including additional monitoring after clinically significant interaction changes or when heart-failure risk increases.

Product-specific monitoring and dose-interruption requirements apply throughout treatment.

Coverage requires review of product-specific safety restrictions. Myqorzo is contraindicated with rifampin. Camzyos has separate CYP-related contraindications and requires consideration of embryo-fetal toxicity precautions. Pregnancy considerations and all medications and supplements must be reviewed against the selected product’s FDA interaction and contraindication requirements.

Myqorzo and Camzyos are not interchangeable dosage forms. Substitution from one product to the other requires a new product-specific review of safety, dosing, and applicable REMS requirements; the products must not be treated as automatically substitutable.

Initial treatment does not meet coverage criteria when the baseline left ventricular ejection fraction (LVEF) is below 55%. Initiation below this threshold is not recommended in FDA labeling and is subject to denial as not meeting criteria.

Coverage requires documented symptomatic obstructive hypertrophic cardiomyopathy. For applicable adult requests, symptoms must be NYHA class II or III, and the baseline echocardiogram must document a peak LVOT gradient of at least 50 mmHg at rest or with provocation. A request without the documented disease or required obstruction does not meet coverage criteria and may be denied.

Clinical Thresholds and Quantity Limits

Baseline left ventricular ejection fraction

Required baseline LVEFAt least 55%

Evidence requiredBaseline echocardiogram

Below thresholdInitiation when LVEF is below 55% does not meet coverage criteria

Peak left ventricular outflow tract gradient

Required peak LVOT-GAt least 50 mmHg

Measurement conditionsAt rest or with provocation

Evidence requiredDocumentation of the peak left ventricular outflow tract gradient

Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization and Duration

Prior authorization is required for cardiac myosin inhibitor therapy. Initial authorization is approved for 6 months; renewal authorization is approved for 12 months when applicable criteria are met.

Initial authorization: 6 months
Renewal authorization: 12 months

Billing Rule

Specialty Pharmacy and Quantity Limit

Dispense the requested product only through the specialty pharmacy certified for that product’s REMS. Limit dispensing to 1 dosage unit per day.

MYQORZO: REMS-certified specialty pharmacy; quantity limit of 1 capsule per day

Policy Background

Cardiac myosin inhibitors are used to treat symptomatic obstructive hypertrophic cardiomyopathy and to improve functional capacity and symptoms. Coverage is focused on members with documented symptomatic disease and clinically significant left ventricular outflow tract obstruction, with ongoing cardiology management and product-specific safety monitoring.

Key Clinical and Program Terms

Symptomatic obstructive hypertrophic cardiomyopathy

ConditionSymptomatic obstructive hypertrophic cardiomyopathy

Adult symptomsNYHA class II or III symptoms when applicable

Product and patient applicabilityMyqorzo applies to adults; Camzyos applies to adults or qualifying pediatric members weighing at least 30 kg

LVOT-G

DefinitionPeak left ventricular outflow tract gradient of at least 50 mmHg

Measurement conditionsMeasured at rest or with provocation

Coverage use

Policy Summary

PayerAdvanced Health

PolicyCardiac Myosin Inhibitors Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionSubmit a baseline echocardiogram showing LVEF of at least 55% and peak LVOT gradient of at least 50 mmHg at rest or with provocation.

SourceLink

On This Page

Follow the selected product's current FDA labeling and REMS schedule.

Labeled dose and monitoring: The requested dose remains within FDA-labeled dosing and monitoring requirements.

Approve renewal for 12 months when all criteria are met.

Adult symptom class

Required adult symptom classNYHA class II or III

ApplicabilityApplies to adult requests

Pediatric exceptionThe adult NYHA requirement does not apply to an otherwise qualifying pediatric Camzyos request

Camzyos pediatric weight

Minimum weightAt least 30 kg

ProductCamzyos

PopulationPediatric members weighing at least 30 kg may meet the FDA-labeled population requirement

Myqorzo dose reduction range

ProductMyqorzo

Dose reduction rangeReduce the dose when LVEF is below 50% and at least 40%

Lower thresholdInterrupt below 40% or with worsening clinical status due to systolic dysfunction

Treatment interruption threshold

Myqorzo interruptionInterrupt when LVEF is below 40% or when clinical status worsens due to systolic dysfunction

Camzyos interruptionInterrupt when LVEF is below 50%

Clinical statusInterrupt treatment when clinical status worsens as specified by the selected product

Quantity limit

Quantity limit1 dosage unit per day

Initial authorizationApproved for 6 months when applicable criteria are met

Renewal authorizationApproved for 12 months when renewal criteria are met

CAMZYOS: CAMZYOS REMS-certified specialty pharmacy; quantity limit of 1 capsule per day

Documentation Required

Product-Specific Review Required

If the cardiac myosin inhibitor product is substituted, complete a new safety and dosing review specific to the replacement product. Myqorzo and Camzyos are not interchangeable dosage forms.

Reevaluate product-specific FDA labeling, contraindications, dosing, titration, REMS, and monitoring before substitution

Step Therapy

First-Line Therapy Requirement

Document an adequate trial of, intolerance to, contraindication to, or other qualifying clinical pathway for first-line therapy before initiating a cardiac myosin inhibitor.

Required first-line agents: a beta-blocker and a non-dihydropyridine calcium channel blocker (verapamil or diltiazem)
If therapy is clinically inappropriate, document the qualifying reason

Step Therapy

Adult Disopyramide Requirement

For an adult request, document an adequate trial of, intolerance to, contraindication to, or clinical inappropriateness of disopyramide. This proposed step does not automatically apply to pediatric Camzyos requests.

Adult requests: disopyramide is required unless clinically inappropriate
Pediatric Camzyos requests bypass the adult disopyramide step

Unsupported block type: documentation

Denial Risk

Product Population Mismatch

Coverage may be denied when the selected product does not match the FDA-labeled age or weight population.

Myqorzo: adults only
Camzyos: adults and pediatric members weighing at least 30 kg
Request correction or a product appropriate for the member’s age and weight

Denial Risk

Insufficient Symptomatic Disease

Coverage may be denied when symptomatic obstructive hypertrophic cardiomyopathy is not documented or when an adult member does not have the required NYHA class II or III symptoms.

Document symptomatic oHCM
Adults require NYHA class II or III symptoms
The adult NYHA requirement does not apply to an otherwise qualifying pediatric Camzyos request

Denial Risk

Cardiac Measurements Not Met

Coverage may be denied when baseline cardiac measurements do not meet the required thresholds. Initiating therapy with LVEF below 55% is not recommended in FDA labeling.

Deny if baseline LVEF is 55%
Deny if peak LVOT-G is less than 50 mmHg at rest or with provocation

Denial Risk

Step Therapy Not Met

Coverage may be denied when required step therapy has not been met. This includes the first-line beta-blocker and non-dihydropyridine calcium channel blocker requirements and, for adults, the disopyramide requirement unless clinically inappropriate.

Required first-line therapy: beta-blocker and verapamil or diltiazem
Adult disopyramide trial is required unless clinically inappropriate
Document intolerance, contraindication, or other qualifying exception

Denial Risk

REMS Requirements Incomplete

Approval may be denied or held until all applicable REMS requirements are satisfied for the prescriber, member, and certified dispensing pharmacy.

Prescriber enrollment must be documented
Member enrollment must be documented
Dispensing must occur through the pharmacy certified for the requested product

Denial Risk

Safety or Dosing Requirements Not Met

Approval may be denied or returned for clarification when pregnancy precautions, interaction review, requested dosing, titration, or monitoring requirements are incomplete or inconsistent with the selected product’s labeling.

Resolve medication and supplement interactions and contraindications
Address embryo-fetal toxicity precautions for Camzyos
Correct the requested strength, starting dose, titration plan, or monitoring schedule when needed

Denial Risk

Renewal Requirements Not Met

Renewal may be denied when clinical benefit, cardiology follow-up, REMS compliance, current echocardiography, or other renewal requirements are not documented.

Document ongoing clinical benefit and cardiology care
Document continued product-specific REMS compliance
Provide current echocardiographic results and clinical status
Confirm the requested dose remains within FDA-labeled dosing and monitoring requirements

Denial Risk

Safety Monitoring Indicates Interruption

Continuation may be denied or interrupted when echocardiographic results or clinical status meet product-specific interruption criteria. Apply the selected product’s current FDA labeling and REMS requirements.

Myqorzo: reduce dose when LVEF is below 50% and at least 40%; interrupt below 40% or when clinical status worsens due to systolic dysfunction
Camzyos: interrupt when LVEF is below 50% or clinical status worsens
Obtain clarification or deny continuation when required dose adjustment or interruption is not documented

The gradient must be documented to meet the cardiac measurement criterion

REMS

DefinitionProduct-specific Risk Evaluation and Mitigation Strategy

Requirements coveredEnrollment, dispensing, authorization, and monitoring

ProductsApplicable to Myqorzo or Camzyos