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Luxturna (voretigene neparvovec-rzyl)


Code: J3398

Description: N/A

Unit: N/A

Payment: Claims for J3398 must be manually adjudicated

Pay quarter: N/A

Medicare history

Dosage and Frequency

Biallelic RPE65 mutation-associated retinal dystrophy

• 1.5 x 10^11 vector genomes per eye subretinal

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Prior Authorization

Prior auth criteria for Luxturna may include but is not limited to:

1. Diagnosis of confirmed biallelic RPE65 mutation-associated retinal dystrophy.
2. Patients must be 6 months of age or older.
3. Patients must have vision in both eyes that is 20/200 or worse as measured by an eye exam within the previous 6 months.
4. Patients must demonstrate evidence of significant functional impairment due to their disease.
5. Patients must have received genetic counseling.
6. Patients must have received an ophthalmologic evaluation within the previous 6 months.
7. Patients must have received adequate systemic evaluation including laboratory tests.
8. Patients must be willing and able to comply with all follow-up evaluations and laboratory tests.
9. Patients must be able to receive the injection in an appropriate setting.
10. Patients must be enrolled in the Luxturna Prescription Assistance Program.

Insurance prior auth guidelines:


United Healthcare


Billable NDCs