CurrentMass General Brigham Health PlanPolicy N/A

Camzyos (mavacamten) coverage for obstructive hypertrophic cardiomyopathy

Defines prior authorization, initial approval durations, reauthorization, clinical eligibility, and quantity limits for Camzyos (mavacamten) for adult members with symptomatic obstructive hypertrophic cardiomyopathy under Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyCamzyos (mavacamten) coverage for obstructive hypertrophic cardiomyopathy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization: initial approvals granted for 3 months with reauthorizations for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum patient age

>55%Baseline LVEF requirement

≥15 mmLV wall thickness

3 moInitial authorization

12 moReauthorization

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Coverage Criteria for Camzyos (mavacamtem)

Initial Therapy

Covered when ALL of the following are met:

Initial therapy criteria: Member is 18 years of age or older.

Initial therapy criteria: Physician documents a diagnosis of obstructive hypertrophic cardiomyopathy.

Left ventricular wall thickness ≥ 15 mm.

Left ventricular wall thickness ≥ 13 mm in members with familial hypertrophic cardiomyopathy or with a documented positive genetic test.

Systolic function: Physician documents baseline left ventricular ejection fraction (LVEF) > 55%.

LVOT gradient: Physician documents baseline Valsalva left ventricular outflow tract (LVOT) peak gradient ≥ 50 mmHg.

Documentation requirement: Required supporting documentation (age, diagnosis, LV wall thickness and familial/genetic status when applicable, baseline LVEF, baseline Valsalva LVOT gradient) is provided by the physician.

Continuation Therapy

Reauthorization (Continuation of Therapy) when ALL of the following are met:

Clinical response: Physician documents the member achieves or maintains a positive clinical response to therapy (e.g., increase in pVO2, reduction in NYHA class).

LVEF threshold for continuation: Left ventricular ejection fraction (LVEF) is at or above 50%.LVEF ≥ 50%

Documentation requirement: Physician documents clinical benefit and provides required clinical data for reauthorization.

No specific product exclusions are listed in this policy beyond the standard review applied to members who are new to the plan but are already receiving mavacamten. Authorization for new-to-plan members may still be reviewed when the medication was obtained through usual channels; however, treatment provided as manufacturer samples or via a manufacturer patient assistance program is explicitly noted as an exception to coverage review for continuation under this policy. Providers should be prepared to supply the same documentation required for other requests (diagnosis, age, baseline imaging and hemodynamic measurements, and evidence of response) when seeking authorization for members transferring care into the plan.

Coding, Clinical Thresholds, and Quantity Limits

Quantity limits / Drug unitNDC | mixedCovered

mavacamtem 5mg, 1 = 30 tablets per 30 days

Quantity limit as listed in policy

LVEF threshold

Baseline LVEF requirement (initial)Baseline left ventricular ejection fraction (LVEF) > 55%

Continuation LVEF requirement (reauthorization)LVEF ≥ 50% for continuation of therapy

Context for LVEF valuesPhysician must document baseline LVEF for initial approval and LVEF at or above threshold for reauthorization

Left ventricular wall thickness

Standard LV wall thickness criterionLeft ventricular wall thickness ≥ 15 mm

Familial HCM / positive genetic test exceptionLV wall thickness ≥ 13 mm if familial hypertrophic cardiomyopathy or with a documented positive genetic test

Documentation requirementPhysician must document measured LV wall thickness and note familial history or genetic test when using the 13 mm threshold

Baseline Valsalva LVOT gradient

Baseline Valsalva LVOT gradient requirementBaseline Valsalva left ventricular outflow tract (LVOT) peak gradient ≥ 50 mmHg

Measurement contextPhysician must document baseline Valsalva LVOT peak gradient as part of initial authorization

Relation to coverageMeeting the peak ≥ 50 mmHg LVOT gradient is required for initial authorization for obstructive HCM

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization required for Camzyos (mavacamten). Initial approvals are granted for 3 months; reauthorizations for 12 months. Quantity limits apply (e.g., 30 mg, 1 = 30 tablets per 30 days). Contact plan for prior auth: All Plans Phone: 877-519-1908, Fax: 855-540-3693; Non-Specialty Medications Phone: 800-711-4555, Fax: 844-403-1029.

Initial approval: 3 months
Reauthorization: 12 months
Quantity limit example: 30 mg, 1 = 30 tablets per 30 days
Prior authorization contact: All Plans — Phone: 877-519-1908; Fax: 855-540-3693
Non-Specialty Medications contact: Phone: 800-711-4555; Fax: 844-403-1029

Step Therapy

Step therapy / program type listed: Quantity limit; Pharmacy Benefit; Medical Benefit noted. No specific step-failure sequence is provided in source.

Program Type: Quantity Limit
Benefit: Pharmacy Benefit; Medical Benefit
Step Therapy: Program listed but no step-fail requirements detailed

Documentation Required

Required Clinical Documentation

Physician must provide documentation of diagnosis, age, specific LV wall thickness (and familial history or genetic testing when applicable), baseline LVEF, baseline Valsalva LVOT gradient, and evidence of current treatment when member is new to the plan.

Documentation of diagnosis: obstructive hypertrophic cardiomyopathy
Member age: ≥ 18 years
Left ventricular (LV) wall thickness ≥ 15 mm OR ≥ 13 mm if familial HCM or positive genetic test
Baseline LVEF > 55% (initial) and LVEF ≥ 50% for continuation
Baseline Valsalva LVOT gradient ≥ 50 mmHg (peak)
For members new to plan, provide evidence of ongoing treatment (if applicable)

Denial Risk

Triggers for Denial

Requests may be denied if the member does not meet documented criteria: not meeting age requirement, diagnosis of obstructive HCM, LV wall thickness thresholds, baseline LVEF requirement, or if required clinical documentation is missing.

Denial triggers include: member < 18 years of age
No diagnosis of obstructive hypertrophic cardiomyopathy
LV wall thickness below required thresholds (<15 mm, or <13 mm where familial/genetic criteria would apply)
Baseline LVEF not >55% for initial request or falling below continuation threshold (below 50%)
Missing or incomplete documentation (diagnosis, imaging/measurements, genetic/family history when indicated)

Background on Mavacamten (Camzyos)

Mavacamten (Camzyos) is a selective cardiac myosin inhibitor indicated to improve functional capacity and symptoms in adults with symptomatic obstructive hypertrophic cardiomyopathy corresponding to New York Heart Association (NYHA) class II–III. The drug reduces hypercontractility by modulating myosin-actin cross-bridge formation, thereby reducing left ventricular outflow tract (LVOT) obstruction and improving exercise capacity and symptomatic status.

In the clinical and coverage context, appropriate candidates are adults (age ≥18) with documented obstructive hypertrophic cardiomyopathy, significant left ventricular wall hypertrophy (typically ≥15 mm, or ≥13 mm when familial disease or a positive genetic test is present), and a demonstrable LVOT gradient (baseline Valsalva peak gradient ≥50 mmHg). Baseline left ventricular ejection fraction must exceed 55% prior to initiation, and for continuation the policy requires LVEF be maintained at ≥50% with documented clinical improvement (for example, increased peak VO2 or reduced NYHA class).

Treatment approvals are time-limited: initial authorizations are typically granted for 3 months to establish tolerability and early response, with reauthorizations available for 12 months when continuation criteria and clinical benefit are documented. Providers should document diagnosis, baseline imaging and gradient measurements, age, and objective evidence of clinical response for reauthorization requests.

Definitions and Symptom Classification

Symptomatic obstructive hypertrophic cardiomyopathy (NYHA classes)

Primary symptomatic class for indicationSymptomatic obstructive hypertrophic cardiomyopathy corresponding to NYHA class II–III

NYHA class I descriptionNo limitation of physical activity; ordinary activity does not cause undue fatigue, palpitation, or dyspnea

NYHA class II descriptionSlight limitation of physical activity; comfortable at rest; ordinary activity results in fatigue, palpitation, or dyspnea

NYHA class III descriptionMarked limitation of physical activity; comfortable at rest; less than ordinary activity causes symptoms (fatigue, palpitation, or dyspnea)

NYHA class IV descriptionUnable to carry on any physical activity without discomfort; symptoms of heart failure at rest