CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Luxturna (voretigene neparvovec-rzyl) (Subretinal Injection)

Policy governs coverage and medical necessity criteria for Luxturna (voretigene neparvovec-rzyl) for treatment of confirmed biallelic RPE65 mutation-associated retinal dystrophy for Neighborhood Health Plan of Rhode Island members across Medicaid, Commercial, and Medicare-Medicaid plans.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLuxturna (voretigene neparvovec-rzyl) (Subretinal Injection)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 13, 2019

Next Review Date

Key ActionObtain prior authorization with submission of medical records demonstrating all initial approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 dose/eyemaximum administrations allowed

150HCPCS max units/eye

J3398HCPCS code

≥12 mominimum age

≥3 moretinoid washout

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Coverage Criteria for Luxturna (voretigene neparvovec-rzyl)

Initial Approval

Covered when ALL of the following are met:

Initial Approval: Submission of medical records related to the medical necessity criteria is REQUIRED on all requests for authorization; records will be reviewed at time of submission.

Documentation must be provided with the prior authorization request.

Patient is at least 12 months of age.

Patient has had an adequate washout period from retinoid therapies prior to receipt of voretigene (minimum 3 months).

Patient has not had intraocular surgery within the prior 6 months.

Definitive diagnosis confirming biallelic RPE65 mutation-associated retinal dystrophy.

ALL of the following

ONE of: An area of retina within the posterior pole >100 µm thickness on OCT.
>= 3-disc areas of retina without atrophy or pigmentary degeneration within the posterior pole.
Remaining visual field within 30 degrees of fixation as measured by an III4e isopter or equivalent.

Patient has not previously received subretinal administration of a gene therapy vector or Luxturna in the intended eye.

Patient has not exceeded the program limit of one injection per eye per lifetime.

Neighborhood Health Plan of Rhode Island considers repeat administration of Luxturna (voretigene neparvovec-rzyl) in the same eye to be experimental and investigational and therefore not covered. This determination is based on the lack of established evidence for effectiveness of repeat subretinal administration to the same eye.

Repeat administration of Luxturna beyond one injection per eye per lifetime is considered not medically necessary / not covered. Coverage cannot be renewed for additional administrations to the same eye.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for voretigene (Luxturna). Submission of medical records related to the medical necessity criteria is REQUIRED on all authorization requests. Records will be reviewed at the time of request and must demonstrate age, diagnosis, washout period, retinal viability assessments, prior intraocular surgery status, and prior gene therapy exposure as applicable.

Required records: documentation of biallelic RPE65 mutation, age verification, retinal imaging (OCT/ophthalmoscopy) demonstrating viable retina, visual field testing (e.g., III4e isopter) when applicable, medication history showing ≥3 month washout from retinoid therapies, and surgical history confirming no intraocular surgery within 6 months.
Authorization limits: program limit of one injection per eye per lifetime; requests for repeat administration in the same eye will be reviewed as experimental/investigational and are not covered.
Clinical review: all documentation will be evaluated at time of submission; incomplete requests lacking required medical records will be denied.

Documentation Required

All authorization requests must include the supporting medical records listed below. Requests submitted without the required documentation will be denied.

Diagnosis documentation confirming biallelic RPE65 mutation-associated retinal dystrophy.
Patient age/date of birth to confirm ≥ 12 months of age.
Evidence of retinal viability: OCT images and/or ophthalmoscopy reports showing ≥100 µm thickness in an area of the posterior pole, or ≥3 disc areas without atrophy/pigmentary degeneration in the posterior pole, or remaining visual field within 30 degrees of fixation measured by III4e isopter or equivalent.
Medication history confirming a minimum 3-month washout from retinoid therapies prior to administration.
Ophthalmic surgical history documenting no intraocular surgery within the prior 6 months.
Documentation that the patient has not previously received sub-retinal administration of a gene therapy vector or Luxturna in the intended eye, unless documenting eligibility per program limits.

Step Therapy

Step Therapy Exception for Recent Recipients

Step therapy requirements do not apply to members who have received this medication within the past 365 days.

MMP members with prior receipt of voretigene (Luxturna) within the past 365 days are exempt from step therapy.
Clinical documentation of prior receipt (date and administration site/eye) must be provided to substantiate the exception.

Denial Risk

Repeat Administration Denial Risk

Requests for repeat administration in the same eye or exceeding one injection per eye per lifetime will be denied as experimental/investigational or not medically necessary.

Neighborhood considers repeat administration of Luxturna in the same eye experimental and investigational; repeat administration requests will be denied.
Program limit: one injection per eye per lifetime — documentation exceeding this limit will be denied.

Definitions and Clinical Terms

Luxturna definition

Proprietary name and genericLuxturna (voretigene neparvovec-rzyl)

Therapeutic classAdeno-associated virus (AAV) vector–based gene therapy

Indication summaryTreatment of confirmed biallelic RPE65 mutation-associated retinal dystrophy

Clinical benefitImproves functional vision on tests such as the MLMT and FST with sustained benefits on long-term follow-up

Viable retinal cells — definition/criteria

OCT thickness criterionAn area of retina within the posterior pole >100 µm thickness shown on OCT

Fundus/ophthalmoscopy criterion≥3-disc areas of retina without atrophy or pigmentary degeneration within the posterior pole

Visual field criterionRemaining visual field within 30 degrees of fixation as measured by an III4e isopter or equivalent

OpenPayer

Luxturna (voretigene neparvovec-rzyl) (Subretinal Injection)

Coverage Criteria for Luxturna (voretigene neparvovec-rzyl)

Coding and Billing

Provider Actions and Authorization Requirements

Background

Definitions and Clinical Terms