CurrentUnitedHealthcarePolicy CSOH2026D0064.C

Luxturna (Voretigene Neparvovec) — Ohio medical benefit drug policy (coverage criteria)

State-specific UnitedHealthcare medical benefit drug policy governing coverage and authorization requirements for Luxturna in Ohio for patients with confirmed biallelic RPE65 mutation-associated retinal dystrophies; applies to providers requesting treatment and to claims adjudication.

Policy Summary

PayerUnitedHealthcare

PolicyLuxturna (Voretigene Neparvovec) — Ohio medical benefit drug policy

Policy CodePolicy CSOH2026D0064.C

Change TypeRevised coverage criteria

Effective DateFeb 1, 2026

Next Review Date

Key ActionObtain prior authorization and document age, genetic testing showing biallelic RPE65 mutations, and OCT demonstrating posterior pole retinal thickness ≥100 µm; avoid requesting inpatient admission solely to administer Luxturna.

SourceLink

POLICY UPDATE CHANGES

Revised coverage criteria; added criterion requiring the provider does not request a planned inpatient admission for the sole purpose of administering Luxturna.

1 per eyeauthorization limit

>=100 µmOCT thickness

>12 monthsminimum age

J3398administration code

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Coverage Criteria

Coverage Criteria (Initial)

Covered when ALL of the following are met:

Primary coverage criteria: Patient is greater than 12 months of age; diagnosis of a confirmed biallelic RPE65 mutation-associated retinal dystrophy (e.g., Leber's congenital amaurosis, retinitis pigmentosa, early onset severe retinal dystrophy); genetic testing documenting biallelic mutations of the RPE65 gene; sufficient viable retinal cells as determined by optical coherence tomography (OCT) confirming an area of retina within the posterior pole of > 100 µm thickness; prescribed and administered by an ophthalmologist or retinal surgeon with experience providing sub‑retinal injections; patient has not previously received Luxturna treatment in the intended eye; provider does not request a planned inpatient admission for the sole purpose of administering Luxturna; authorization will be issued for no more than one treatment per lifetime per eye and for no longer than 45 days from approval.

All listed conditions must be satisfied for coverage.

Coverage for Luxturna (voretigene neparvovec) is limited to patients who meet all policy criteria, including a minimum age of greater than 12 months. Requests that indicate a planned inpatient admission solely for the purpose of administering Luxturna are not permitted and may result in denial; approvals are issued for no more than one treatment per lifetime per eye and are valid for up to 45 days from approval.

Treatment is not medically necessary when genetic testing does not document biallelic RPE65 mutations. Similarly, patients who do not demonstrate sufficient viable retinal tissue on OCT—specifically an area within the posterior pole with retinal layer thickness of < 100 µm—do not meet coverage criteria.

Coding

Procedure / HCPCSHCPCS

J3398

Injection, voretigene neparvovec-rzyl, 1 billion vector genomes

Diagnosis / ICD-10ICD-10

H35.50	Unspecified hereditary retinal dystrophy
H35.52	Pigmentary retinal dystrophy
H35.54	Dystrophies primarily involving the retinal pigment epithelium

inv-06: OCT posterior pole retinal thickness — numeric threshold for viable retina

OCT posterior pole retinal thickness>= 100 µm (area of retina within the posterior pole)

Measurement methodOptical coherence tomography (OCT) confirming posterior pole retinal layer thickness

Clinical importanceIndicates sufficient remaining photoreceptor structure for potential benefit from gene therapy

inv-07: Minimum patient age for treatment — age threshold

Minimum patient age> 12 months (patient must be greater than 12 months of age)

ReasoningNot recommended for patients younger than 12 months due to ongoing retinal cell proliferation which may dilute gene therapy

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Luxturna (voretigene neparvovec). Approval will be issued for no more than one treatment per lifetime per eye and the authorization validity period is up to 45 days from approval.

Authorization limit: 1 treatment per lifetime per eye
Authorization validity: up to 45 days from approval

Step Therapy

No step therapy requirements specified for this policy.

Documentation Required

Definitions

inv-13: Viable retinal cells — defines OCT thickness threshold in the posterior pole (≥100 µm)

Definition (viable retinal cells)Retinal tissue within the posterior pole demonstrating OCT thickness of >= 100 µm indicating sufficient remaining photoreceptor structure for potential benefit from gene therapy

Assessment methodMeasured by OCT (optical coherence tomography) documenting a retinal layer >= 100 µm thick

Therapeutic relevanceBecause gene therapy does not produce new tissue, adequate pre-existing viable cells are required for expected benefit

Background

Leber's congenital amaurosis (LCA) and autosomal recessive retinitis pigmentosa (RP) are early-onset inherited retinal dystrophies that cause severe visual impairment beginning in childhood. Biallelic mutations in the RPE65 gene disrupt the retinoid isomerase function required to regenerate 11-cis retinal, producing photoreceptor dysfunction and progressive degeneration of rods and cones. Because Luxturna is a one-time subretinal gene augmentation therapy, benefit depends on the presence of remaining viable retinal cells; viability is assessed by OCT and is defined by a posterior pole retinal layer thickness of at least 100 µm. Treatment is not recommended for patients younger than 12 months of age due to ongoing retinal cell proliferation, which could dilute or lose the therapeutic vector.

Policy Summary

PayerUnitedHealthcare

PolicyLuxturna (Voretigene Neparvovec) — Ohio medical benefit drug policy

Policy CodePolicy CSOH2026D0064.C

Change TypeRevised coverage criteria

Effective DateFeb 1, 2026

Next Review Date

SourceLink

On This Page

Clinical implicationAge requirement is part of all coverage criteria that must be met for treatment

Required Documentation

Providers must submit documentation to support medical necessity and eligibility for Luxturna, including genetic testing results, ophthalmic imaging, and provider qualifications.

Genetic testing documentation confirming biallelic RPE65 mutations
Optical coherence tomography (OCT) showing an area of retina within the posterior pole > 100 µm thickness
Clinical diagnosis supporting inherited retinal dystrophy (e.g., LCA, RP, EOSRD) and relevant ICD-10 code(s)
Provider attestation that the drug will be prescribed and administered by an ophthalmologist or retinal surgeon experienced with sub-retinal injections
Documentation that the patient is > 12 months of age
History showing the patient has not previously received Luxturna in the intended eye

Denial Risk

Reasons Authorization May Be Denied

Authorizations may be denied when coverage criteria are not met or when unsafe/unsupported care settings are requested.

Patient is 12 months of age or younger
No documentation of biallelic RPE65 mutations on genetic testing
OCT does not demonstrate sufficient viable retinal cells (no area > 100 µm thickness within the posterior pole)
Provider is not an ophthalmologist or retinal surgeon with experience performing sub-retinal injections
Request is for a planned inpatient admission solely for the purpose of administering Luxturna
Request exceeds one treatment per eye or requests repeat treatment previously received in the intended eye
Required supporting documentation is incomplete or not submitted