CurrentCignaPolicy IP0824

Otolaryngology - Gene Therapy - Otarmeni

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This policy governs prior authorization and coverage of Otarmeni (lunsotogene parvec-cwha) intracochlear infusion for pediatric patients and adults with severe-to-profound or profound OTOF-related sensorineural hearing loss. It applies to providers requesting coverage and requires specialist prescribing, clinical documentation, and adherence to lifetime per-ear dosing limits.

Policy Summary

PayerCigna

PolicyOtolaryngology - Gene Therapy - Otarmeni

Policy CodePolicy IP0824

Change TypePolicy revision

Effective DateOctober 16, 2026

Last ReviewOct 8, 2026

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation showing that all medical-necessity criteria are met before administering Otarmeni.

SourceLink

POLICY UPDATE CHANGES

CPT 1056T was added for cochlear infusion of a pharmacologic agent, including the surgical components of gene therapy vector administration.

The prescribing requirement was revised to require an otolaryngologist or physician specializing in the condition being treated, removing the prior option to prescribe in consultation with an otolaryngologist.

Approval was clarified as up to two total lifetime doses, limited to one dose per ear, with claims-history verification for retreatment.

Documentation requirements were added for molecularly confirmed biallelic OTOF variants, hearing-loss severity, preserved outer hair-cell function, preoperative imaging, and feasible inner-ear access.

1 dose/earMaximum dosing per treated ear

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CurrentCignaPolicy IP0824

Otolaryngology - Gene Therapy - Otarmeni

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Sign up for Cigna Policy IP0824 alerts

Get alerted when Policy IP0824 changes without checking for updates manually.

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Policy Summary

PayerCigna

PolicyOtolaryngology - Gene Therapy - Otarmeni

Policy CodePolicy IP0824

Change TypePolicy revision

Effective DateOctober 16, 2026

Last ReviewOct 8, 2026

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation showing that all medical-necessity criteria are met before administering Otarmeni.

SourceLink

POLICY UPDATE CHANGES

CPT 1056T was added for cochlear infusion of a pharmacologic agent, including the surgical components of gene therapy vector administration.

Approval was clarified as up to two total lifetime doses, limited to one dose per ear, with claims-history verification for retreatment.

1 dose/earMaximum dosing per treated ear

Up to 2Maximum total doses

90 daysApproval duration

>90 dB HLHearing-loss threshold

7.2 × 10^13Vector genome amount

Medical Necessity and Coverage Criteria

Initial Therapy Criteria

Covered when ALL of the following criteria are met:

FDA-approved indication: sensorineural hearing loss

No retreatment: The patient is not receiving retreatment of an ear previously treated with Otarmeni.
Verify in claims history. If claims are absent or unavailable, the prescribing physician must confirm that the patient has not previously received Otarmeni in the ear being treated.
Molecular diagnosis: The patient has molecularly confirmed biallelic variants in the otoferlin (OTOF) gene.
Documentation required.
Hearing-loss severity: The patient has severe-to-profound or profound hearing loss.> 90 dB HL
Documentation required.
Preserved outer hair-cell function: The patient has preserved outer hair-cell function, as determined by the prescriber.
Documentation required.
No prior cochlear implant in treated ear: According to the prescribing physician, the patient did not have a prior cochlear implant in the ear to be treated with Otarmeni.
Preoperative imaging and feasible access
- Preoperative imaging: The patient had preoperative imaging.
  Documentation required.
- Feasible inner-ear access: Access to the inner ear is feasible.
  Documentation required. Abnormal mastoid pneumatization or clinically significant anatomic variations of the middle ear or inner ear may make access infeasible.
Specialist prescriber: The medication is prescribed by an otolaryngologist.
Authorized dosing and administration: If criteria A through G are met, approve up to two doses of Otarmeni—one dose per ear per lifetime—to be given as an intracochlear infusion.7.2 × 10^13 vector genomes in 0.24 mL per dose

Otarmeni is not recommended when preoperative imaging shows that access to the inner ear is not feasible. This includes abnormal mastoid pneumatization or clinically significant anatomic variations of the middle or inner ear.

Otarmeni used for purposes other than the listed indication is considered not medically necessary. This includes use in patients who do not meet the specified patient population and patients with prior receipt of gene therapy.

Otarmeni is considered not medically necessary for patients who previously received gene therapy because patients with prior gene therapy were excluded from the Otarmeni pivotal study.

Retreatment of an ear previously treated with Otarmeni is not covered. Coverage is limited to one dose per ear per lifetime, with up to two total doses per patient.

Covered Codes and Clinical Parameters

Covered CPT CodesCPTCovered

1056T

Cochlear infusion of pharmacologic agent (ie, gene therapy vector), including mastoidectomy, labyrinthotomy, and repair of fenestrations

Covered HCPCS CodesHCPCSCovered

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

Severe-to-profound or profound hearing loss

Hearing-loss threshold> 90 dB HL

Otarmeni dose

Vector genome amount7.2 × 10^13 vector genomes

Total volume per intracochlear dose0.24 mL per dose

Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for benefit coverage of Otarmeni. Approval is recommended only when the patient meets the applicable medical-necessity criteria, and the request must be submitted in accordance with those criteria by an otolaryngologist who specializes in the condition being treated.

Request coverage for the FDA-approved indication and include the required patient-specific clinical information.
Approval is limited to one dose per ear per lifetime, up to two doses per patient.

Note

Approval Duration and Review

Each approval is valid for 90 days to allow adequate time to administer Otarmeni. All approvals and denials are forwarded to the Medical Director for evaluation.

Approval duration: 90 days.
Medical Director review applies to both approvals and denials.

Therapy Background

Otarmeni (lunsotogene parvec-cwha) is an adeno-associated virus vector-based gene therapy for OTOF-related auditory synaptopathy. It is indicated for pediatric patients and adults with severe-to-profound or profound sensorineural hearing loss—defined as any frequency greater than 90 dB HL—associated with molecularly confirmed biallelic OTOF variants, preserved outer hair-cell function, and no prior cochlear implant in the ear to be treated. The therapy is administered as an intracochlear infusion.

Policy Summary

PayerCigna

PolicyOtolaryngology - Gene Therapy - Otarmeni

Policy CodePolicy IP0824

Change TypePolicy revision

Effective DateOctober 16, 2026

Last ReviewOct 8, 2026

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation showing that all medical-necessity criteria are met before administering Otarmeni.

SourceLink

On This Page

Documentation Required

General Supporting Documentation

For criteria marked documentation required, submit patient-specific supporting information. Acceptable materials may include chart notes, laboratory results, medical test results, claims records, prescription receipts, and other relevant information.

All documentation must include patient-specific identifying information.
Claims-history verification is required where the criteria specify it.

Documentation Required

Clinical Eligibility Evidence

Document the clinical evidence supporting eligibility for the FDA-approved indication, including molecular confirmation of biallelic OTOF variants, hearing-loss severity, preserved outer-hair-cell function, and feasible inner-ear access.

Molecularly confirmed biallelic variants in the otoferlin (OTOF) gene.
Severe-to-profound or profound sensorineural hearing loss, defined as any frequency greater than 90 dB HL.
Preserved outer-hair-cell function as determined by the prescriber.
Preoperative imaging and documentation that access to the inner ear is feasible.
No prior cochlear implant in the ear to be treated.
Prescription by an otolaryngologist.

Billing Rule

Use Covered Codes and Diagnosis

Use the applicable covered diagnosis and procedure codes when submitting claims. Claims may be denied as not covered when the required covered code(s) are absent or when the service is billed for a condition or diagnosis unrelated to a covered indication.

Use the most appropriate codes in effect on the submission date.
Reimbursement is not allowed for diagnoses or conditions not covered under the policy.

Denial Risk

Noncovered Uses and Retreatment

Otarmeni is not medically necessary for uses outside its FDA-approved indication. Do not request retreatment of an ear previously treated with Otarmeni, and do not request treatment for a patient with prior gene therapy.

Coverage is limited to one dose per ear per lifetime, up to two total doses per patient.
Prior receipt of gene therapy is not covered; patients with prior gene therapy were excluded from the pivotal study.
Retreatment of a previously treated ear is not covered; verify treatment history through claims or provider confirmation when claims are unavailable.

Denial Risk

Infeasible Inner-Ear Access

Coverage may be denied when preoperative imaging demonstrates that access to the inner ear is not feasible. Review imaging before requesting authorization and document the feasibility of access.

Examples that may make access infeasible include abnormal mastoid pneumatization or clinically significant anatomic variations of the middle ear or inner ear.