CurrentSecurity Health Plan of Wisconsin, Inc.Policy IC-0350

Luxturna (voretigene neparvovec-rzyl) Subretinal Injection

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This policy governs prior authorization, dosing limits, coverage criteria, administration, and billing requirements for Luxturna in patients with biallelic RPE65 mutation-associated retinal dystrophy in Wisconsin.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyLuxturna (voretigene neparvovec-rzyl) Subretinal Injection

Policy CodePolicy IC-0350

Change TypeNo material clinical or coverage changes

Effective DateN/A

Last ReviewJan 6, 2026

Next Review DateN/A

Key ActionSubmit supporting clinical documentation with every prior authorization request.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 dose/eyeInitial authorization limit

150 unitsMaximum units per dose

≥12 monthsMinimum patient age

3 monthsRetinoid washout

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CurrentSecurity Health Plan of Wisconsin, Inc.Policy IC-0350

Luxturna (voretigene neparvovec-rzyl) Subretinal Injection

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Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyLuxturna (voretigene neparvovec-rzyl) Subretinal Injection

Policy CodePolicy IC-0350

Change TypeNo material clinical or coverage changes

Effective DateN/A

Last ReviewJan 6, 2026

Next Review DateN/A

Key ActionSubmit supporting clinical documentation with every prior authorization request.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 dose/eyeInitial authorization limit

150 unitsMaximum units per dose

≥12 monthsMinimum patient age

3 monthsRetinoid washout

Surgery-free interval

1.5 × 10^11 vgDose per affected eye

Coverage Criteria

Initial approval criteria

Covered when ALL of the following are met:

Initial approval requirements

General requirements
- The patient is at least 12 months of age; has completed an adequate washout period of at least 3 months from retinoid therapies before receiving voretigene neparvovec-rzyl; has not had intraocular surgery within the preceding 6 months; and has not previously received subretinal administration of a gene therapy vector or Luxturna into the intended eye.Age ≥12 months; retinoid washout ≥3 months; no intraocular surgery within 6 months
  These requirements apply before treatment of the intended eye.
Diagnosis and retinal viability
- ALL of the following
  - At least one viability measure
    An area of retina within the posterior pole has a thickness greater than 100 µm on OCT.>100 µm
    At least 3 disc areas of retina within the posterior pole are without atrophy or pigmentary degeneration.≥3 disc areas
    Remaining visual field is within 30 degrees of fixation as measured by an III4e isopter or equivalent.Within 30 degrees of fixation

Renewal criteria

Renewal is available only when the following condition is met:

Renewal requirement: The duration of authorization has not been exceeded.

Prior authorization validity may not be renewed after the authorized duration has been exceeded.

Initial approval is excluded when the patient has previously received subretinal administration of a gene therapy vector or Luxturna in the intended eye.

Initial approval is excluded when the patient has undergone intraocular surgery within the preceding six months.

Prior authorization cannot be renewed after the authorized duration has been exceeded. Renewal does not extend the original authorization period.

Coding and Billing Requirements

HCPCS CodeHCPCSCovered

J3398

Injection, voretigene neparvovec-rzyl, 1 billion vector genomes; 1 billable unit = 10 9 vector genomes

NDCNDCCovered

71394-0415-xx

Luxturna carton: one single-dose vial of Luxturna and two vials of diluent

Covered Diagnosis CodesICD-10Covered

H35.50

Unspecified hereditary retinal dystrophy

Maximum billable units

Maximum allowance150 billable units

Dose basisOne dose per eye

Billing unitHCPCS billable units

Minimum patient age

Minimum ageAt least 12 months

Requirement typeInitial approval condition

Application

Provider Requirements and Authorization Actions

Prior Authorization

Initial Prior Authorization Required

Prior authorization is required for initial Luxturna treatment. The initial authorization is time-limited and permits one dose per eye; submit the request with the required clinical documentation before treatment.

Initial authorization: one dose per eye.
Authorization is valid only for the authorized duration.

Denial Risk

No Renewal Beyond Authorized Duration

Prior authorization validity may not be renewed after the authorized duration has been exceeded. Confirm that the requested treatment remains within the applicable authorization period.

Renewal is not permitted once the authorized duration has been exceeded.

Unsupported block type: documentation

Policy Background

Luxturna (voretigene neparvovec-rzyl) is an adeno-associated virus vector-based gene therapy for patients with biallelic RPE65 mutation-associated retinal dystrophy. Treatment is delivered by subretinal injection and requires sufficient viable retinal cells, assessed through non-invasive retinal evaluation such as OCT and/or ophthalmoscopy.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyLuxturna (voretigene neparvovec-rzyl) Subretinal Injection

Policy CodePolicy IC-0350

Change TypeNo material clinical or coverage changes

Effective DateN/A

Last ReviewJan 6, 2026

Next Review DateN/A

Key ActionSubmit supporting clinical documentation with every prior authorization request.

SourceLink

On This Page

Must be met before receipt of voretigene neparvovec-rzyl

Retinoid washout

Required washoutMinimum 3 months

TherapyRetinoid therapies

TimingBefore receipt of voretigene neparvovec-rzyl

Interval since intraocular surgery

Required intervalNo intraocular surgery within six months

Requirement typeInitial approval condition

Reference periodThe six months preceding treatment

Posterior-pole retinal thickness

Minimum thickness>100 µm

LocationAn area of retina within the posterior pole

Assessment methodShown on optical coherence tomography (OCT)

Preserved posterior-pole retina

Minimum preserved areaAt least 3 disc areas

Required conditionWithout atrophy or pigmentary degeneration

LocationWithin the posterior pole

Remaining visual field

Visual-field requirementWithin 30 degrees of fixation

MeasurementIII4e isopter or equivalent

Clinical roleOne measure of viable retinal cells

Dose per affected eye

Dose per affected eye1.5 × 10^11 vector genomes

Total administration volume0.3 mL

RouteSubretinal injection

Interval between eye administrations

Minimum intervalAt least 6 days

Administration scheduleEach eye is treated on separate days

Treatment contextSubretinal administration of Luxturna

Documentation Required

Diagnosis and Retinal Viability Evidence

Document a definitive diagnosis of biallelic RPE65 mutation-associated retinal dystrophy and evidence that viable retinal cells remain, as determined by non-invasive evaluation.

Definitive diagnosis confirming biallelic RPE65 mutation-associated retinal dystrophy.
Viable retinal cells demonstrated by OCT and/or ophthalmoscopy.
Acceptable evidence includes a posterior-pole retinal area thicker than 100 µm on OCT, at least 3 disc areas without atrophy or pigmentary degeneration within the posterior pole, or a remaining visual field within 30 degrees of fixation measured by an III4e isopter or equivalent.

Denial Risk

Missing Medical Necessity Documentation

Failure to submit supporting medical records may result in denial because medical necessity cannot be established in accordance with policy guidelines.

Submit the records with the authorization request.
Documentation must support the diagnosis and applicable medical-necessity criteria.

Denial Risk

Criteria or Authorization Limit Not Met

The request may be denied or not approved when initial authorization criteria are not satisfied, or when renewal is requested after the authorized duration has been exceeded.

Initial requests must meet all applicable policy criteria, including age, retinoid washout, intraocular-surgery history, prior gene-therapy exposure, diagnosis, and retinal viability requirements.
Renewal is not available after the authorized duration has been exceeded.