Voretigene Neparvovec-rzyl (Luxturna)

Policy ID: I-183-006

Section: Injections

Effective Date: June 01, 2019

Revised Date: March 13, 2023

Revision Effective Date: May 01, 2023

Last Reviewed: March 23, 2023

Applies To: Commercial Only

Description

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.

Criteria

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
Individual has not previously received RPE65 gene therapy in intended eye.

Note: Coverage for voretigene neparvovec-rzyl (Luxturna) is limited to one (1) subretinal injection per eye, administered on separate days within a close interval, but no fewer than six (6) days apart (six (6)-18 days per available body of evidence).

The use of Voretigene neparvovec-rzyl (Luxturna) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

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.

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

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

Internal Medical Policy Committee 5-20-2021 Annual review, no clinical content change

Internal Medical Policy Committee 3-23-2022

Removed procedure code 67299 from the policy, and
Updated experimental/investigational statement

Internal Medical Policy Committee 3-23-2023 Effective May 01, 2023

Updated experimental/investigational statement

Links

References (PDF)

Disclaimer

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.

Policy ID: I-183-005

Section: Injections

Effective Date: June 01, 2019

Revised Date: March 09, 2022

Revision Effective Date: May 01, 2022

Last Reviewed: March 23, 2022

Archived Date: April 30, 2023

Applies To: Commercial Only

Description

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.

Criteria

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

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
Individual has not previously received RPE65 gene therapy in intended eye.

The use of Voretigene neparvovec-rzyl (Luxturna) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

J3398

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

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

Internal Medical Policy Committee 5-20-2021 Annual review, no clinical content change

Internal Medical Policy Committee 3-23-2022 Removed code 67299 from the policy, updated experimental/investigational statement

Links

References (PDF)

Disclaimer

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