CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Camzyos (mavacamten) — coverage criteria for symptomatic obstructive hypertrophic cardiomyopathy

Covers use of Camzyos (mavacamten) for adults with symptomatic NYHA class II-III obstructive hypertrophic cardiomyopathy under Medicaid when specific approval criteria are met. Applies to prescribers, reviewers, and members under Neighborhood Health Plan of Rhode Island Medicaid scope.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCamzyos (mavacamten) — coverage criteria for symptomatic obstructive hypertrophic cardiomyopathy

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateSep 1, 2022

Next Review DateMay 1, 2025

Key ActionSubmit prior authorization with documentation of required baseline criteria including prescriber REMS enrollment, age/weight, LV wall thickness or genetic confirmation, NYHA class II–III, baseline LVEF ≥55%, and Valsalva LVOT peak gradient ≥50 mm Hg.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial authorization duration

6 mocontinuation authorization duration

1/dayquantity limit

≥55%baseline LVEF required

≥50 mm Hg

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Coverage Criteria for Camzyos (mavacamten)

Initial therapy

Covered when ALL of the following are met

Eligibility and prescriber: Prescribed by a cardiologist enrolled in the CAMZYOS REMS PROGRAM; member age ≥18 years; member weight ≥45 kg.

LV wall thickness: Documentation of either: (i) left ventricular wall thickness ≥15 mm anywhere in the left ventricle; OR (ii) left ventricular wall thickness ≥13 mm anywhere in the left ventricle for members with familial HCM or a positive genetic test (e.g., MYH7, MYBPC3, TNNI3, TNNT2, TPM1, MYL2, MYL3, ACTC1).

Functional and imaging criteria: NYHA functional class II or III; baseline left ventricular ejection fraction (LVEF) ≥55%; baseline Valsalva left ventricular outflow tract (LVOT) peak gradient ≥50 mm Hg.LVEF ≥55%; LVOT ≥50 mm Hg

Prior therapy requirements: Documentation of inadequate response, intolerance, or contraindication to a beta blocker (e.g., metoprolol, propranolol, atenolol), a nondihydropyridine calcium channel blocker (e.g., verapamil, diltiazem), and disopyramide; member is not currently treated with or planning treatment with disopyramide, ranolazine, or dual beta blocker plus calcium channel blocker therapy.

Exclusion of mimicking disorders: Documentation that the member does not have a disorder that causes cardiac hypertrophy that mimics oHCM (e.g., Fabry disease, amyloidosis, Noonan syndrome with LV hypertrophy).

Continuation therapy

Covered for continuation when ALL of the following are met

Clinical benefit: Member has achieved or maintained a positive clinical response to therapy, demonstrated by an increase in peak VO2 (pVO2) or reduction in NYHA functional class.

Safety: Member has a left ventricular ejection fraction (LVEF) ≥50%.LVEF ≥50%

All indications for Camzyos (mavacamten) other than the FDA-approved indication — treatment of adults with symptomatic New York Heart Association (NYHA) class II–III obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms — are considered experimental/investigational and not eligible for coverage.

Use of Camzyos for indications that are not the FDA-approved indication (that is, any use other than treatment of adults with symptomatic NYHA class II–III obstructive HCM to improve functional capacity and symptoms) is considered not medically necessary and will not be covered.

Authorization Durations and Quantity Limits

Authorization durations

Initial authorization durationInitial approval may be granted for 6 months

Continuation authorization durationContinuation approvals may be granted for 6 months

ScopeMedicaid

Quantity limit

Quantity limit (all strengths)1 capsule per day for 2.5 mg, 5 mg, 10 mg, and 15 mg capsules

Affected formulationsCamzyos 2.5 mg, 5 mg, 10 mg, 15 mg capsules

Prescribing noteQuantity limit applies regardless of dose strength prescribed

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization — Initial

Prior authorization is required for initial prescriptions. Initial approvals may be for up to 6 months. The medication must be prescribed by a cardiologist enrolled in the CAMZYOS REMS PROGRAM.

Initial authorization duration: up to 6 months
Prescriber requirement: cardiologist enrolled in CAMZYOS REMS PROGRAM

Denial Risk

Indication Limitation

Requests for uses other than treatment of adults with symptomatic NYHA class II–III obstructive hypertrophic cardiomyopathy (oHCM) are considered experimental/investigational and are not medically necessary.

Indication limited to: symptomatic NYHA class II–III oHCM in adults

Clinical Background

Hypertrophic cardiomyopathy with obstructive physiology (oHCM) is a form of HCM in which patients develop symptomatic left ventricular outflow tract obstruction leading to impaired functional capacity and symptoms. Camzyos (mavacamten) is FDA-approved to treat adults with symptomatic NYHA class II–III oHCM with the goal of improving functional capacity and symptoms.

Key Definitions and Diagnostic Criteria

Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)

DefinitionHypertrophic cardiomyopathy with symptomatic left ventricular outflow tract obstruction in adults (NYHA class II–III) for which mavacamten (Camzyos) is indicated to improve functional capacity and symptoms

Key clinical featuresSymptoms consistent with NYHA class II or III and LV outflow tract obstruction (resting or provoked) documented by imaging or gradients

Prescriber requirementMust be prescribed by a cardiologist enrolled in the CAMZYOS REMS program for initiation

Required LV wall thickness

Primary diagnostic thresholdLeft ventricular wall thickness ≥15 mm anywhere in the left ventricle

Familial/genetic thresholdLeft ventricular wall thickness ≥13 mm anywhere in the left ventricle for members with familial HCM or a positive genetic test (examples: MYH7, MYBPC3, TNNI3, TNNT2, TPM1, MYL2, MYL3, ACTC1)

Documentation Required

Required Documentation and Missing Baseline Risk

Submit documentation of ALL of the following at time of initial request: prescriber REMS enrollment, member demographics, diagnostic and baseline measures, functional status, prior therapy history, and exclusions. Missing required baseline documentation may result in denial.

Prescriber: cardiologist enrolled in CAMZYOS REMS PROGRAM
Age: ≥18 years
Weight: ≥45 kg
LV wall thickness: ≥15 mm (or ≥13 mm with familial HCM/positive genetic test)
Functional status: documented NYHA Class II or III
LVEF: documented ≥55%
Baseline Valsalva LVOT peak gradient: ≥50 mm Hg
Documented prior inadequate response/intolerance/contraindication to: beta blockers, nondihydropyridine calcium channel blockers, and disopyramide
Documentation that member is not currently treated or planned for treatment with disopyramide, ranolazine, or dual beta blocker + calcium channel blocker
Documentation excluding other causes of hypertrophy (e.g., Fabry disease, amyloidosis, Noonan syndrome with LV hypertrophy)