CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Camzyos (mavacamten) for obstructive hypertrophic cardiomyopathy - Coverage Criteria

Covers use of Camzyos (mavacamten) for adults with symptomatic NYHA class II-III obstructive hypertrophic cardiomyopathy under Rhode Island Medicaid when all approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCamzyos (mavacamten) for obstructive hypertrophic cardiomyopathy - Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization with documentation that all initiation criteria are met; initial authorization may be granted for 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial auth

6 monthscontinuation auth

1/dayqty limit

≥55%baseline LVEF

≥50 mm HgLVOT gradient

Coverage Criteria for Camzyos (mavacamten)

Initial Therapy (oHCM)

Covered when ALL of the following are met for initiation (authorization of 6 months may be granted):

Initiation criteria for oHCM

Prescriber and demographics: Medication prescribed by a cardiologist enrolled in the CAMZYOS REMS PROGRAM; member age ≥18 years; member weight ≥45 kg.
Left ventricular wall thickness: Documentation of either left ventricular wall thickness ≥15 mm anywhere OR ≥13 mm anywhere in members with familial HCM or a positive genetic test (e.g., MYH7, MYBPC3, TNNI3, TNNT2, TPM1, MYL2, MYL3, ACTC1).
Functional and hemodynamic criteria: NYHA Class II or III AND baseline left ventricular ejection fraction (LVEF) ≥55% AND baseline Valsalva LVOT peak gradient ≥50 mm Hg.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCamzyos (mavacamten) for obstructive hypertrophic cardiomyopathy - Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization with documentation that all initiation criteria are met; initial authorization may be granted for 6 months.

SourceLink

On This Page

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Product Codes, Limits, and Key Clinical Thresholds

Covered NDC/product strengths (listed as capsules with quantity limit)mixedCovered

Camzyos 2.5mg	Camzyos 2.5 mg capsule
Camzyos 5mg	Camzyos 5 mg capsule
Camzyos 10mg	Camzyos 10 mg capsule
Camzyos 15mg	Camzyos 15 mg capsule

inv-06: Age and weight — Age ≥18 years; weight ≥45 kg

Age requirementMember is at least 18 years of age.

Weight requirementMember's weight is at least 45 kg.

PrescriberMedication must be prescribed by a cardiologist enrolled in the CAMZYOS REMS PROGRAM.

inv-07: Baseline LVEF — LVEF ≥55% for initiation

Baseline LVEF for initiationDocumentation of LVEF ≥55% is required prior to initiation.

Associated criteriaBaseline LVEF requirement must be documented along with NYHA class II–III and LVOT gradient ≥50 mm Hg.

Source contextRequired as part of initiation criteria for symptomatic oHCM therapy authorization.

inv-08: Continuation LVEF — LVEF ≥50% for continued therapy

LVEF for continuationMember must have LVEF ≥50% to qualify for continued therapy.

Clinical benefit requirementContinuation also requires documented clinical benefit (increase in pVO2 or reduction in NYHA class).

Authorization durationContinuation authorization may be granted for 6 months when criteria are met.

inv-09: LV wall thickness — ≥15 mm anywhere OR ≥13 mm if familial HCM or positive genetic test

Standard LV wall thickness thresholdLeft ventricular wall thickness ≥15 mm anywhere in the left ventricle.

Familial HCM / positive genetic test thresholdLeft ventricular wall thickness ≥13 mm anywhere if familial HCM or a positive genetic test (examples: MYH7, MYBPC3, TNNI3, TNNT2, TPM1, MYL2, MYL3, ACTC1).

DocumentationImaging or report must document wall thickness meeting the applicable threshold.

inv-10: LVOT gradient — Valsalva LVOT peak gradient ≥50 mm Hg

LVOT gradient thresholdBaseline Valsalva left ventricular outflow tract (LVOT) peak gradient ≥50 mm Hg is required.

Measurement contextGradient must be the baseline Valsalva LVOT peak gradient documented prior to initiation.

Associated initiation criteriaMust be documented along with NYHA class II–III and LVEF ≥55% for initiation eligibility.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required with documentation that all initiation criteria are met; initial authorization may be granted for 6 months.

Authorization length: up to 6 months
Scope: Medicaid

Step Therapy

Step therapy / Prior Agents

Documented inadequate response, intolerance, or contraindication to beta blockers, nondihydropyridine calcium channel blockers, and disopyramide (if used) required before starting therapy.

Examples: beta blockers (metoprolol, propranolol, atenolol); nondihydropyridine CCBs (verapamil, diltiazem); disopyramide

Documentation Required

Required Clinical Documentation

Provide documentation of patient age (≥18 years), weight (≥45 kg), NYHA class II or III status, LV wall thickness criteria, baseline LVEF (≥55%), baseline Valsalva LVOT peak gradient (≥50 mm Hg), and prior therapy/intolerance.

Left ventricular wall thickness ≥15 mm anywhere OR ≥13 mm with familial HCM or positive genetic test (e.g., MYH7, MYBPC3, TNNI3, TNNT2, TPM1, MYL2, MYL3, ACTC1)
Document absence of disorders that mimic oHCM (e.g., Fabry disease, amyloidosis, Noonan syndrome with LV hypertrophy)

Documentation Required

Prescriber Requirement

Prescriber must be a cardiologist enrolled in the CAMZYOS REMS program.

Denial Risk

Non‑FDA Indications

Use for indications other than the FDA‑approved indication (adults with symptomatic NYHA class II-III oHCM) is considered experimental/investigational.

Definitions and REMS

inv-17: Obstructive hypertrophic cardiomyopathy (oHCM) — definition including Valsalva LVOT peak gradient ≥50 mm Hg and LV wall thickness criteria.

oHCM definitionObstructive hypertrophic cardiomyopathy (oHCM) is HCM with left ventricular outflow tract obstruction evidenced by a baseline Valsalva LVOT peak gradient ≥50 mm Hg.

LV wall thickness requirementoHCM includes increased LV wall thickness meeting criteria (≥15 mm anywhere, or ≥13 mm with familial HCM or positive genetic test).

Clinical symptom requirementoHCM in this policy applies to symptomatic adults with NYHA class II–III functional status.

inv-18: REMS enrollment — Prescribing cardiologist must be enrolled in the CAMZYOS REMS PROGRAM as a condition of therapy initiation.

REMS enrollment requirementThe prescribing cardiologist must be enrolled in the CAMZYOS REMS PROGRAM as a condition of therapy initiation.

DocumentationREMS enrollment must be documented at the time of prior authorization request for initiation.

ScopeREMS enrollment is required specifically for initiation of Camzyos for oHCM under this policy.

OpenPayer

Camzyos (mavacamten) for obstructive hypertrophic cardiomyopathy - Coverage Criteria

Coverage Criteria for Camzyos (mavacamten)

Product Codes, Limits, and Key Clinical Thresholds

Provider Requirements and Prior Authorization

Background

Definitions and REMS