CurrentNorth Carolina MedicaidPolicy N/A

Camzyos Coverage for Obstructive Hypertrophic Cardiomyopathy

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This policy governs North Carolina Medicaid outpatient pharmacy prior approval for Camzyos (mavacamten) in beneficiaries with obstructive hypertrophic cardiomyopathy and establishes initial and continuation therapy criteria, monitoring requirements, medication restrictions, and approval duration.

Policy Summary

PayerNorth Carolina Medicaid

PolicyCamzyos Coverage for Obstructive Hypertrophic Cardiomyopathy

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateMarch 1, 2024

Next Review DateN/A

Key ActionObtain prior approval before prescribing Camzyos and document an adequate trial and failure of at least one beta-blocker for initial approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum age for initial approval

≥55%LVEF for treatment initiation

≥50%LVEF for continuation

NYHA 2–3Initial functional status

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CurrentNorth Carolina MedicaidPolicy N/A

Camzyos Coverage for Obstructive Hypertrophic Cardiomyopathy

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Policy Summary

PayerNorth Carolina Medicaid

PolicyCamzyos Coverage for Obstructive Hypertrophic Cardiomyopathy

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateMarch 1, 2024

Next Review DateN/A

Key ActionObtain prior approval before prescribing Camzyos and document an adequate trial and failure of at least one beta-blocker for initial approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum age for initial approval

≥55%LVEF for treatment initiation

≥50%LVEF for continuation

NYHA 2–3Initial functional status

Maximum approval duration

≥1 failedBeta-blockers required before initial therapy

Camzyos Coverage Criteria

Initial Therapy

Covered when ALL of the following criteria are met:

ALL of the following

Beneficiary is 18 years of age or older.
Beneficiary has a diagnosis of obstructive hypertrophic cardiomyopathy (oHCM) consistent with current guidelines (e.g., American College of Cardiology Foundation/American Heart Association or European Society of Cardiology guidelines).
Beneficiary has New York Heart Association (NYHA) Class 2 or Class 3.
Beneficiary has documented left ventricular ejection fraction (LVEF) ≥ 55% for initiation of treatment only.≥ 55% LVEF
Beneficiary will be monitored for LVEF, Valsalva left ventricular outflow tract (LVOT) gradient assessment, and heart failure symptoms, including shortness of breath, chest pain, arrhythmia, heart palpitations, fatigue, or swelling in the legs.
Beneficiary has an adequate echocardiogram or cardiovascular magnetic resonance imaging (CMR).
Beneficiary will avoid concomitant use with moderate to strong CYP2C19 inhibitors, strong CYP3A4 inhibitors, and moderate to strong CYP2C19 and CYP3A4 inducers.
For females of childbearing potential, a pregnancy test is performed confirming that the beneficiary is not pregnant.
Mavacamten is prescribed by or in consultation with a cardiologist.
Beneficiary has had an adequate trial and failure of at least one beta-blocker.≥ 1 beta-blocker

Continuation Therapy

Covered for continuation when ALL of the following criteria are met:

ALL of the following

Beneficiary continues to meet the initial approval criteria, excluding the prerequisite for an adequate trial and failure of at least one beta-blocker.
Beneficiary has disease improvement and/or stabilization from baseline, such as improvement in NYHA class (e.g., Class 3 to Class 2), an increase in peak oxygen consumption (pVO2) of at least 1.5 mL/kg/min, or an increase in pVO2 of at least 3 mL/kg/min without worsening of NYHA class.
Beneficiary has documented left ventricular ejection fraction (LVEF) ≥ 50%.
Beneficiary has not experienced any treatment-restricting adverse effects, including heart failure.

Concomitant use is restricted: the beneficiary must avoid moderate to strong CYP2C19 inhibitors, strong CYP3A4 inhibitors, and moderate to strong CYP2C19 and CYP3A4 inducers. Examples include carbamazepine, cimetidine, esomeprazole, omeprazole, phenobarbital, phenytoin, rifampin, and St. John’s wort.

For females of childbearing potential, a pregnancy test must be performed and must confirm that the beneficiary is not pregnant.

Clinical Thresholds and Response Measures

Initial LVEF

Required thresholdLVEF ≥ 55%

Applies toInitiation of Camzyos treatment

Approval contextRequired for initial approval in beneficiaries with NYHA Class 2 or Class 3 obstructive hypertrophic cardiomyopathy

Continuation LVEF

Required thresholdLVEF ≥ 50%

Applies toContinuation of Camzyos treatment

Additional requirementDisease improvement and/or stabilization from baseline with no treatment-restricting adverse effects

Prior Approval and Documentation Requirements

Prior Authorization

Initial Prior Approval Required

Prior approval is required for initial Camzyos therapy. When approved, initial therapy may be authorized for up to 12 months.

Prior Authorization

Continuation Prior Approval

Continuation of Camzyos requires prior approval and documentation that the beneficiary continues to meet the initial criteria, except for the prerequisite beta-blocker therapy. Approval may be granted for up to 12 months.

Document disease improvement and/or stabilization from baseline.
Document LVEF ≥ 50%.
Confirm no treatment-restricting adverse effects, such as heart failure.
Continuation criteria do not include the initial beta-blocker prerequisite.

Therapy Overview

Camzyos (mavacamten) is a cardiac myosin inhibitor used for adults with symptomatic obstructive hypertrophic cardiomyopathy. The policy addresses initial and continuation coverage through assessment of NYHA functional class, left ventricular ejection fraction, LVOT obstruction, heart failure symptoms, medication interactions, and clinical response or stabilization during ongoing therapy.

Clinical Definitions

Obstructive Hypertrophic Cardiomyopathy (oHCM)

DefinitionObstructive hypertrophic cardiomyopathy diagnosed consistently with current applicable cardiology guidelines

Guideline examplesAmerican College of Cardiology Foundation/American Heart Association or European Society of Cardiology guidelines

Policy requirementThe diagnosis is required for initial approval

NYHA Class 2 or 3

Required statusNew York Heart Association functional Class 2 or Class 3

Applies toInitial approval

Related baseline criterion

Policy Summary

PayerNorth Carolina Medicaid

PolicyCamzyos Coverage for Obstructive Hypertrophic Cardiomyopathy

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateMarch 1, 2024

Next Review DateN/A

Key ActionObtain prior approval before prescribing Camzyos and document an adequate trial and failure of at least one beta-blocker for initial approval.

SourceLink

On This Page

pVO2 Improvement Option 1

Qualifying improvementPeak oxygen uptake (pVO2) increase of ≥ 1.5 mL/kg/min

Applies toContinuation therapy disease-improvement criteria

Baseline comparisonThe increase is assessed from baseline

pVO2 Improvement Option 2

Alternative qualifying improvementPeak oxygen uptake (pVO2) increase of ≥ 3 mL/kg/min

NYHA conditionNo worsening of NYHA class

Applies toContinuation therapy disease-improvement criteria

Note

EPSDT Does Not Waive Prior Approval

Beneficiaries under 21 remain subject to prior approval when the service, product, or procedure requires it. EPSDT eligibility does not eliminate the prior approval requirement.

Step Therapy

Beta-Blocker Prerequisite

Before initial Camzyos approval, the beneficiary must have an adequate trial of and failure of at least one beta-blocker.

Adequate trial and failure of ≥ 1 beta-blocker are required for initial therapy.
The beta-blocker prerequisite is not required as a continuation criterion.

Documentation Required

Diagnosis and Baseline Cardiac Status

For initial approval, document obstructive hypertrophic cardiomyopathy consistent with current clinical guidelines and the beneficiary’s baseline functional and cardiac status.

Diagnosis: obstructive hypertrophic cardiomyopathy (oHCM).
Diagnosis must be consistent with current guidelines, including applicable ACCF/AHA or ESC guidelines.
NYHA functional class must be Class 2 or Class 3.
Document baseline LVEF ≥ 55% for initiation of treatment.

Documentation Required

Imaging and Monitoring Plan

Initial approval requires adequate cardiac imaging and a plan to monitor cardiac function and heart failure symptoms during treatment.

Provide an adequate echocardiogram or cardiovascular magnetic resonance imaging (CMR).
Plan monitoring of LVEF.
Plan Valsalva left ventricular outflow tract (LVOT) gradient assessment.
Plan monitoring for heart failure symptoms, including shortness of breath, chest pain, arrhythmia, palpitations, fatigue, or leg swelling.

Documentation Required

Specialist Involvement and Prior Therapy

Mavacamten must be prescribed by or in consultation with a cardiologist, with required prior-treatment documentation submitted for initial approval.

Document cardiologist prescribing or consultation.
Document adequate trial and failure of at least one beta-blocker.

Documentation Required

Pregnancy and Medication Safety

For females of childbearing potential, document pregnancy testing confirming that the beneficiary is not pregnant and that restricted concomitant medications will be avoided.

A pregnancy test must be performed for females of childbearing potential.
The test must confirm the beneficiary is not pregnant.

Documentation Required

Continuation Response and Safety Documentation

Continuation approval requires documented disease improvement and/or stabilization from baseline, LVEF ≥ 50%, and no treatment-restricting adverse effects.

Examples of response include NYHA improvement from Class 3 to Class 2.
Alternatively, document a pVO2 increase of ≥ 1.5 mL/kg/min, or ≥ 3 mL/kg/min without worsening of NYHA class.
Document LVEF ≥ 50%.
Document no treatment-restricting adverse effects, such as heart failure.

Denial Risk

Initial Clinical Criteria Not Met

Initial therapy may be denied when the required clinical criteria are not met or the required documentation is not provided.

Beneficiary is under 18 years of age.
Diagnosis is not oHCM consistent with current guidelines.
NYHA class is not 2 or 3.
Baseline LVEF is below 55%.
Required monitoring, imaging, cardiologist involvement, pregnancy testing, or adequate beta-blocker trial and failure is not documented.

Denial Risk

Prohibited Concomitant Medications

Initial approval is at risk of denial when the beneficiary cannot avoid restricted concomitant medications.

Moderate to strong CYP2C19 inhibitors.
Strong CYP3A4 inhibitors.
Moderate to strong CYP2C19 and CYP3A4 inducers.
Examples include carbamazepine, cimetidine, esomeprazole, omeprazole, phenobarbital, phenytoin, rifampin, and St. John’s wort.

Denial Risk

Pregnancy Status Not Established

Initial approval is at risk of denial when pregnancy status is not established for a female of childbearing potential. A pregnancy test must confirm that the beneficiary is not pregnant.

Document performance of the pregnancy test.
Document a negative result confirming the beneficiary is not pregnant.

Denial Risk

Continuation Criteria Not Met

Continuation therapy may be denied when the beneficiary does not meet the continuation requirements, including documented response or stabilization, LVEF ≥ 50%, and absence of treatment-restricting adverse effects.

The beneficiary must continue to meet the initial criteria, excluding the beta-blocker prerequisite.
Disease improvement and/or stabilization from baseline must be documented.
LVEF must be ≥ 50%.
Treatment-restricting adverse effects, such as heart failure, must not be present.

Required along with documented LVEF ≥ 55% for treatment initiation

Valsalva LVOT Gradient Assessment

DefinitionAssessment of the Valsalva left ventricular outflow tract (LVOT) gradient

RolePart of cardiac monitoring during treatment

Monitoring contextMonitored along with LVEF and heart failure symptoms