Aficamten (Myqorzo) coverage
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Defines medical necessity and prior authorization criteria for Aficamten (Myqorzo) for adults with symptomatic obstructive hypertrophic cardiomyopathy across QualChoice lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria for Aficamten (Myqorzo)
inv-01: Initial Therapy — Obstructive Hypertrophic Cardiomyopathy
Covered when ALL of the following are met:
Approval duration 12 months
inv-02: Continued Therapy — Obstructive Hypertrophic Cardiomyopathy
Covered when ALL of the following are met:
Approval duration 12 months
inv-03: Other Diagnoses/Indications
Requests for uses not specifically listed
Refer to the listed formulary/non-formulary or off-label policies as applicable
Coverage is not authorized for non-FDA approved indications that are not specifically addressed in this policy unless there is sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.
Use of aficamten (Myqorzo) for non-FDA approved indications is considered not medically necessary unless the provider supplies sufficient clinical evidence or documentation consistent with the insurer's off‑label use policies. Initiation of therapy is not recommended when left ventricular ejection fraction (LVEF) is < 55% per the boxed warning and REMS requirements; dose reductions or interruptions are required at lower LVEF thresholds as specified by the product labeling.
Dosing, Thresholds, and Coding Details
Required Provider Actions and Documentation
Prior authorization required
Prior authorization is required. Submit documentation demonstrating all approval criteria are met, including diagnosis of obstructive HCM, NYHA Class II–III symptoms, that the prescriber is a cardiologist or consulted with one, age ≥18, LV measurements (wall thickness and LVOT gradients), LVEF, prior therapy failures, and that Myqorzo is not prescribed concurrently with Camzyos; approval duration is 12 months.
- Documentation must show LV hypertrophy criteria, LVEF ≥55%, and peak LVOT gradients (≥30 mmHg at rest and ≥50 mmHg with provocation).
- Ensure absence of concurrent Camzyos® use and that dose does not exceed 20 mg/day.
Step therapy — failure of 2 medication classes
Initial approval requires documented failure of TWO agents at up to maximally indicated doses (unless contraindicated or adverse effects): a non-vasodilating beta-blocker, a non-dihydropyridine calcium channel blocker, or add-on disopyramide after beta-blocker or CCB monotherapy failure.
- Examples include atenolol, metoprolol, bisoprolol, propranolol (beta-blockers) and verapamil or diltiazem (non-dihydropyridine CCBs).
- For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.
Submit required clinical documentation
Provider must submit supporting clinical documentation with the prior authorization request such as office chart notes, laboratory results, and echocardiogram reports that document LVEF, LV wall thickness, and peak LVOT gradients, as well as records of prior therapies and NYHA symptom class.
- Include echocardiogram assessments showing LVEF and LVOT gradients and documentation of maximal wall thickness (≥15 mm or ≥13 mm with familial HCM/positive genetic test).
- Provide evidence of prior therapy attempts and the member’s NYHA Class II–III symptoms.
LVEF must meet initiation and monitoring thresholds
Requests may be denied if LVEF is below policy thresholds; initiation is not recommended when LVEF <55%. REMS requires baseline and ongoing echocardiographic LVEF monitoring with specified dose adjustments for reduced LVEF.
- Do not initiate Myqorzo if LVEF <55%. Decrease dose if LVEF <50% and ≥40%; interrupt dosing if LVEF <40% or if worsening clinical status.
- Echocardiogram assessments of LVEF are required before and during Myqorzo use per the REMS program.
Denial risk if clinical criteria are not documented
Requests may be denied if documentation does not demonstrate required clinical criteria, including NYHA Class II–III symptoms, LV wall thickness, peak LVOT gradients, or required prior therapy failures.
- Ensure documentation of NYHA symptom class attributed to LVOT obstruction and LV hypertrophy (≥15 mm or ≥13 mm with familial HCM/positive genetic test).
- Provide peak LVOT gradients showing ≥30 mmHg at rest and ≥50 mmHg with provocation, and evidence of two failed therapies unless contraindicated.
Background
Aficamten (Myqorzo) is a cardiac myosin inhibitor approved to improve functional capacity and symptoms in adults with symptomatic obstructive hypertrophic cardiomyopathy. The drug carries a boxed warning for risk of heart failure due to systolic dysfunction and is available only through the Myqorzo REMS Program. Baseline and ongoing echocardiographic monitoring of LVEF is required; initiation is not recommended if LVEF < 55%, decrease dose if LVEF is <50% and ≥40%, and interrupt dosing if LVEF is <40% or if there is worsening clinical status.
Definitions and Clinical Classifications
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