Voretigene Neparvovec-rzyl (Luxturna)

Section: Injections
Effective Date: June 01, 2020
Revised Date: May 05, 2020
Last Reviewed: May 19, 2020


Voretigene neparvovec-rzyl (Luxturna™) is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic retinal pigment epithelium-specific 65 kDa protein (RPE65) mutation-associated retinal dystrophy. The RPE65 gene provides instructions for making a protein that is essential for normal vision. The RPE65 protein is produced in a thin layer of cells at the back of the eye called the retinal pigment epithelium (RPE). This cell layer supports and nourishes the retina, which is the light-sensitive tissue that lines the back of the eye.


Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Voretigene neparvovec-rzyl (Luxturna) may be considered medically necessary when ALL of the following criteria are met:

  • Individual age 12 months to 65 years of age; and
  • Individual has vision loss due to biallelic RPE65 mutation-associated retinal dystrophy; and
  • Confirmed diagnosis of inherited retinal disease caused by RPE65 gene mutations demonstrated by documented mutation in both copies of the RPE65 gene; and
  • Voretigene neparvovec-rzyl (Luxturna) is prescribed by a retinal specialist; and
  • Individual has sufficient viable retinal cells as determined by the treating physician and assessed via optical coherence tomography (OCT) imaging and/or ophthalmoscopy, demonstrating EITHER of the following:
    • Retinal thickness on spectral domain optical coherence tomography is greater than 100 microns within the posterior pole; or
    • Clinical exam, noting greater than or equal to three (3) disc areas of retina without atrophy or pigmentary degeneration within the posterior pole; and
  • No intraocular surgery in the past six (6) months; and
  • Individual is not currently pregnant or breastfeeding; and
  • Patient has not previously received RPE65 gene therapy in intended eye.

Note: Coverage for voretigene neparvovec-rzyl (Luxturna) is limited to one subretinal injection per eye, administered on separate days within a close interval, but no fewer than six (6) days apart (6-18 days per available body of evidence).

Voretigene neparvovec-rzyl (Luxturna) is considered experimental/investigational for any other indications. Scientific evidence does not support its efficacy or safety for any other indications than those listed on this policy.

Procedure Codes

67299 J3398

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Covered diagnosis codes for procedure code J3398

H35.50 H35.52 H35.54

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Original Effective Date June 1, 2019

Internal Medical Policy Committee 5-19-2020 Update age criteria



Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.