Pharmacy Prior Authorization Criteria

Otarmeni (lunsotogene parvec-cwha) – PA, NF

For diagnosis of Sensorineural hearing loss
Indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear. This indication is approved under accelerated approval based on the improvement of hearing sensitivity assessed by average pure tone audiometry (PTA) at Week 2. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory clinical trial. Limitations of Use: Otarmeni is not recommended in patients in whom preoperative imaging demonstrates that access to the inner ear is not feasible including those with abnormal mastoid pneumatization or clinically significant anatomic variations of the middle ear and inner ear.

Prior Authorization, Non Formulary

Length of Approval: 3 Month(s)
For diagnosis of Sensorineural hearing loss

Submission of medical records (e.g., chart notes) confirming diagnosis of severe-to-profound or profound sensorineural hearing loss defined as any frequency greater than 90 decibel hearing level (dB HL)

AND

Submission of medical records (e.g., chart notes) confirming both of the following:

AND

Submission of medical records (e.g., chart notes, laboratory values) confirming presence of biallelic variants in the OTOF gene

AND

Prescribed by or in consultation with one of the following with shared-decision-making regarding treatment risks:

AND

Will be administered at an authorized treatment center by a surgeon experienced in intracochlear surgery and trained in administration

AND

Provider attests that patient has never received Otarmeni treatment in the target ear in their lifetime

2026-08-21

Otarmeni Prescribing Information. Regeneron Pharmaceuticals, Inc. Tarrytown, NY. April 2026.
Valayannopoulos V, Bance M, Carvalho DS, et. al. DB-OTO Gene Therapy for Inherited Deafness. N Engl J Med. 2026 Mar 12;394(11):1074-1083. doi: 10.1056/NEJMoa2400521.
Clinical consult with Otologist/Neurotologist on July 29, 2026.