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:
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.
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.
Covered diagnosis codes for procedure code J3398
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.