CurrentUnitedHealthcarePolicy CS2026D0064P

Luxturna (Voretigene Neparvovec-Rzyl) — Medical Benefit Drug Policy

Defines UnitedHealthcare Medical Benefit Drug Policy coverage criteria for Luxturna (voretigene neparvovec-rzyl) for treatment of biallelic RPE65 mutation-associated inherited retinal dystrophy; applies to commercial plans except where state-specific exceptions noted.

Policy Summary

PayerUnitedHealthcare

PolicyLuxturna (Voretigene Neparvovec-Rzyl) — Medical Benefit Drug Policy

Policy CodePolicy CS2026D0064P

Change TypeTemplate updateremoval of Louisiana-specific language

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain prior authorization (valid up to 45 days) for no more than one treatment per lifetime per eye and document genetic confirmation of biallelic RPE65 mutations and OCT showing posterior pole thickness ≥100 µm.

SourceLink

POLICY UPDATE CHANGES

Template Update and removal of content/language pertaining to the state of Louisiana.

one lifetime per eyeauthorized treatments allowed

>=100 µmminimum OCT retinal thickness required

>=12 monthsminimum patient age

J3398listed HCPCS code

Coverage Criteria

Policy Summary

PayerUnitedHealthcare

PolicyLuxturna (Voretigene Neparvovec-Rzyl) — Medical Benefit Drug Policy

Policy CodePolicy CS2026D0064P

Change TypeTemplate updateremoval of Louisiana-specific language

Effective DateApr 1, 2026

Next Review Date

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Treatment with Luxturna is not recommended for patients younger than 12 months of age because retinal cells are still undergoing proliferation and the therapy could be diluted or lost during that process. Requests that plan a hospital inpatient admission solely for the purpose of administering Luxturna are not permitted and may be denied; authorization is issued for no more than one treatment per lifetime per eye and is valid for no longer than 45 days from approval.

Use of Luxturna that does not meet all of the listed coverage criteria is considered not medically necessary. Examples include absence of genetic confirmation of biallelic RPE65 mutations and insufficient viable retinal tissue on OCT (posterior pole retinal thickness 100 µm), among other unmet criteria required by policy.

Coding

Covered HCPCS/Product CodeHCPCSCovered

J3398

Injection, voretigene neparvovec-rzyl, 1 billion vector genomes.

Diagnosis Codes (examples)ICD-10

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

OCT posterior pole retinal thickness — numeric threshold

Numeric threshold>= 100 µm (posterior pole retinal thickness on OCT)

Measurement methodOptical coherence tomography (OCT) of the posterior pole

Location specifiedArea of retina within the posterior pole

PurposeDefines sufficient viable retinal cells for eligibility for voretigene neparvovec (Luxturna)

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization will be issued for no more than one treatment per lifetime per eye and for no longer than 45 days from approval.

One treatment per lifetime per eye
Authorization duration limit: ≤ 45 days from approval
Prior authorization required prior to administration

Documentation Required

Required Documentation

Submit documentation demonstrating the patient meets all coverage criteria: genetic testing confirming biallelic RPE65 mutations; ophthalmic assessment including optical coherence tomography (OCT) demonstrating an area of retina within the posterior pole with thickness > 100 µm; clinical diagnosis (e.g., Leber congenital amaurosis, retinitis pigmentosa, early onset severe retinal dystrophy); evidence patient is ≥ 12 months of age; and a statement that the patient has not previously received Luxturna in the intended eye. Include provider credentials showing ophthalmologist or retinal surgeon with experience in sub-retinal injections.

Genetic testing report documenting biallelic RPE65 mutations
OCT report showing posterior pole retinal thickness > 100 µm in area of treatment
Clinical diagnosis and relevant ophthalmic exam notes
Patient age documented (≥ 12 months)
Statement confirming no prior Luxturna treatment in intended eye
Provider credentials / attestation of experience with sub-retinal injections

Note

Provider Action

Provider action: do not request a planned inpatient admission solely for administration of Luxturna. Ensure prior authorization is requested and approved before scheduling the procedure. Limit requests to one treatment per lifetime per eye; requests exceeding this or requesting inpatient-only admission for the sole purpose of administration will be denied.

Do not request planned inpatient admission solely for Luxturna administration
Obtain and attach prior authorization approval before scheduling
Requests for >1 treatment per eye or for inpatient-only stays for administration may be denied

Denial Risk

Triggers for Denial or Restriction

Requests will be denied or restricted when the following apply: patient age < 12 months; no documentation of biallelic RPE65 mutations; OCT does not demonstrate sufficient viable retina (posterior pole area ≤ 100 µm thickness); prior Luxturna treatment in the intended eye; planned inpatient admission solely for administration; or when required documentation and provider qualifications are not supplied.

Patient < 12 months of age
No genetic testing confirming biallelic RPE65 mutations
OCT does not show posterior pole retinal thickness > 100 µm
Prior Luxturna treatment in the intended eye
Planned inpatient admission solely for administration
Missing required documentation or provider qualifications

Background

Leber's congenital amaurosis (LCA) and autosomal recessive retinitis pigmentosa (RP) are inherited, early-onset retinal dystrophies that in some patients are caused by pathogenic variants in both alleles of the RPE65 gene. These biallelic RPE65 mutation-associated retinal dystrophies lead to deficient 11-cis retinal production and progressive photoreceptor dysfunction. One-time subretinal gene augmentation with voretigene neparvovec (Luxturna) can improve retinal and visual function when sufficient viable retinal cells remain; viability is assessed by OCT demonstrating an area within the posterior pole with retinal thickness of at least 100 µm.

Definitions

Viable retinal cells — definition

DefinitionArea of retina within the posterior pole with thickness >100 µm on OCT

Assessment toolOptical coherence tomography (OCT)

Clinical roleUsed to determine presence of sufficient viable retinal cells prior to gene therapy

ContextRequired as part of medical necessity criteria for Luxturna: OCT confirming area >100 µm thickness

Biallelic RPE65 mutation-associated retinal dystrophy — definition

DefinitionInherited retinal dystrophy caused by pathogenic variants in both alleles of the RPE65 gene (examples: Leber's congenital amaurosis, retinitis pigmentosa, early-onset severe retinal dystrophy)

Genetic requirementGenetic testing must document biallelic RPE65 mutations for diagnosis

Relevance to treatmentDiagnosis of biallelic RPE65 mutation-associated retinal dystrophy is a required criterion for Luxturna coverage