ModifiedCignaPolicy N/A

Cardiology - Myqorzo Prior Authorization Policy

Defines Cigna prior authorization criteria for coverage of Myqorzo (aficamten) for adults with symptomatic obstructive hypertrophic cardiomyopathy, including initial and continuation (current therapy) approvals, excluded indications, prescriber requirements, approval durations, and safety/monitoring notes.

Policy Summary

PayerCigna

PolicyCardiology - Myqorzo Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMODIFIED

Effective Date

Next Review DateDec 30, 2025

Key ActionPrior authorization is recommended for Myqorzo; document age, symptoms/NYHA class, LV wall thickness, LVOT gradient, LVEF, and that the prescriber is a cardiologist.

POLICY UPDATE CHANGES

The approval duration for initial therapy was changed to 1 year (previously 8 months).

For patients currently receiving Myqorzo, requirement changed to being established on therapy for at least 1 year (previously 8 months).

Specialist requirement updated to only allow a cardiologist to prescribe the medication; previously consultation with a cardiologist was allowed.

The Note defining Class II and Class III heart failure was removed.

1Covered Indication (obstructive HCM)

≥18Minimum Age

1 yrApproval Duration (initial & continuation)

≥55% / ≥50%

LVEF thresholds (initial / continuation)

Coverage Summary

Policy covers Myqorzo (aficamten) for adults with symptomatic obstructive hypertrophic cardiomyopathy per the FDA‑approved indication. Coverage is provided with prior authorization and requires prescription by a cardiologist; approvals are granted for 1 year for both initial therapy and continuation when criteria are met. The policy notes a boxed warning for risk of heart failure due to systolic dysfunction and requires enrollment in the Myqorzo REMS program with certified prescribers, patients, and pharmacies. Scope: defines Cigna prior authorization criteria for Myqorzo for adults with symptomatic obstructive HCM, including initial and continuation approvals, excluded indications, prescriber requirements, approval durations, and safety/monitoring notes.

Key thresholds and quick facts

Minimum age≥ 18 years

LVEF required for initial therapy≥ 55%

LVEF required for continuation≥ 50%

Maximal LV wall thickness≥ 15 mm (general) or ≥ 13 mm with familial HCM

Peak LVOT gradient≥ 30 mmHg at rest or ≥ 50 mmHg after provocation (Valsalva or post exercise)

Approval duration (initial & continuation)1 year

REMS requirementAvailable only through Myqorzo REMS — prescribers, patients, and pharmacies must be certified; baseline and on-therapy LVEF monitoring required

Boxed warningBoxed warning for risk of heart failure due to systolic dysfunction; interrupt therapy if LVEF < 50%; initiation not recommended if LVEF < 55%

Authorization Criteria

FDA-Approved Indication - Obstructive Hypertrophic Cardiomyopathy

Myqorzo is covered as medically necessary when the patient meets ONE of the following (A or B):

A) Initial Therapy

Patient is ≥ 18 years of age
Symptoms and NYHA class
- Patient has at least one symptom associated with obstructive hypertrophic cardiomyopathy
- Patient has New York Heart Association (NYHA) Class II or III symptoms of heart failure
Left ventricular hypertrophy criteria (ONE of)

Provider Actions and Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for prescription benefit coverage of Myqorzo; approvals provided for specified duration (1 year).

Approval duration: 1 year

Documentation Required

Clinical documentation for initiation

Document age, symptoms attributable to obstructive HCM, NYHA class II or III, LV wall thickness (including familial criteria if applicable), LVOT gradient measurements (rest and/or provoked), LVEF, and prescriber specialty (cardiologist).

Age (≥ 18 years)
Symptoms attributable to obstructive HCM (examples: shortness of breath, chest pain, lightheadedness, fainting, fatigue, reduced exercise capacity)

Coding

No specific procedure or diagnosis codes listed in policy body; billing must use most appropriate codesmixed

No codes listed

Background and Evidence

Myqorzo (aficamten) is a cardiac myosin inhibitor indicated to improve functional capacity and symptoms in adults with symptomatic obstructive hypertrophic cardiomyopathy. It carries a Boxed Warning for the risk of heart failure due to systolic dysfunction; initiation is not recommended if LVEF < 55% and therapy should be interrupted if LVEF < 50% or if clinical worsening occurs. Myqorzo is available only through the Myqorzo REMS program. The REMS requires certification/enrollment of prescribers, patients, and pharmacies (and limits distribution to certified pharmacies).

Evidence

Definitions

Revision History

01/14/2026policy_revisionLatest

Selected revision approved on 01/14/2026: approval duration for initial therapy changed from 8 months to 1 year; continuation requirement changed to established on therapy for at least 1 year (previously 8 months); specialist prescriber requirement updated to cardiologist-only; Note defining NYHA Class II and III heart failure removed. (Material changes: initial therapy duration, continuation duration, prescriber restriction)

12/30/2025policy_creation

New policy created with review date 12/30/2025. Initial published criteria include approval durations, NYHA class requirements, LVEF thresholds, REMS requirements, and cardiologist prescriber requirement; initial therapy previously authorized for 8 months (per history) prior to revision.

Policy Summary

PayerCigna

PolicyCardiology - Myqorzo Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMODIFIED

Effective Date

Next Review DateDec 30, 2025

Key ActionPrior authorization is recommended for Myqorzo; document age, symptoms/NYHA class, LV wall thickness, LVOT gradient, LVEF, and that the prescriber is a cardiologist.

On This Page

Maximal left ventricular wall thickness ≥ 15 mm

Familial hypertrophic cardiomyopathy with maximal left ventricular wall thickness ≥ 13 mm

Peak left ventricular outflow tract (LVOT) gradient ≥ 30 mmHg at rest or ≥ 50 mmHg after provocation (Valsalva maneuver or post exercise)

Left ventricular ejection fraction (LVEF) ≥ 55%

Initiation not recommended if LVEF < 55% (safety note)

Medication is prescribed by a cardiologist

Specialist prescriber requirement

Approval duration: 1 year1 year

Initial therapy approvals are for 1 year

B) Patient Currently Receiving Myqorzo (Continuation)

Patient has been established on therapy for at least 1 year≥ 1 year
Patients who have received <1 year or are restarting are reviewed under Initial Therapy criteria
Patient is ≥ 18 years of age
Symptom history and NYHA class
- Currently or prior to starting therapy, patient has or has experienced at least one symptom associated with obstructive hypertrophic cardiomyopathy
- Currently or prior to starting therapy, patient is in or was in NYHA Class II or III heart failure
  Definitions of Class II and III provided in notes (informational)
Left ventricular ejection fraction (LVEF) ≥ 50%≥ 50%
Therapy should be interrupted if LVEF < 50% (safety note)
Response criteria (ONE of)
- Patient experienced a beneficial clinical response when assessed by at least one objective measure
  Examples: improved peak oxygen consumption; decreases in LVOT gradient; reductions in NT-proBNP; decreased hs-cTnI; reduced ventricular mass index; reduction in max left atrial volume index
- Patient experienced stabilization or improvement in at least one symptom related to obstructive hypertrophic cardiomyopathy
  Examples: shortness of breath, chest pain, lightheadedness, fainting, fatigue, ability to perform physical exercise, favorable changes in KCCQ-23 CSS or HCMSQ SOB domain scores
Medication is prescribed by a cardiologist
Specialist prescriber requirement
Approval duration: 1 year1 year
Continuation approvals are for 1 year

Conditions Not Covered

Not medically necessary when criteria below are not met:

Use of Myqorzo for any indication other than those listed in the Recommended Authorization Criteria is considered not medically necessary

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria

NYHA Class II or III

Left ventricular wall thickness (≥ 15 mm, or ≥ 13 mm with familial HCM)

LVOT gradient (≥ 30 mmHg at rest or ≥ 50 mmHg with provocation)

LVEF (≥ 55% for initial therapy)

Prescriber specialty: cardiologist

Documentation Required

Documentation for continuation

Document duration of prior therapy (≥1 year), prior or current symptoms and NYHA class history, current LVEF (≥50%), and objective evidence of benefit or stabilization in symptoms or objective measures.

Established on therapy ≥ 1 year
Age (≥ 18 years)
Prior or current symptoms and NYHA Class II or III history
Current LVEF ≥ 50%
Objective evidence of benefit (e.g., improved peak VO2, decreased LVOT gradient, reductions in NT-proBNP, decreased hs‑cTnI, reduced ventricular mass index, reduced max left atrial volume index) or stabilization/improvement in symptoms

Documentation Required

Specialist prescriber requirement

Myqorzo must be prescribed by a cardiologist (approval requires prescription by a cardiologist).

Prescribing restricted to cardiologists
Change from prior allowance of cardiology consultation to cardiologist-only prescriber requirement

Documentation Required

Safety monitoring and REMS enrollment

Prescribers, patients, and dispensing pharmacies must be enrolled and compliant with the Myqorzo REMS program; baseline and on-therapy LVEF assessment by echocardiogram required, and therapy should be interrupted if LVEF < 50% or if clinical worsening occurs; initiation not recommended if LVEF < 55%.

Enrollment and certification in Myqorzo REMS: prescribers, patients, and pharmacies
Baseline and on-therapy LVEF assessment by echocardiogram
Interrupt therapy if LVEF < 50% or if clinical worsening occurs
Initiation not recommended if LVEF < 55%

Denial Risk

Denial if criteria not met

Claims will be denied as not covered when services are billed for conditions or diagnoses not covered under this policy or when authorization criteria are not satisfied.

Denial for services billed for noncovered indications
Denial when authorization criteria (initial or continuation) are not met

2026-01-14document_metadataLatest

Document last review date: 2026-01-14; next review date listed as 2025-12-30 in brief metadata.

administrative_change

Removal of explanatory note for NYHA classes (administrative/clarifying): the policy history notes the Note defining Class II and Class III heart failure was removed.