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Luxturna® (voretigene neparvovec-rzyl)
Policy Number: PH-0350
Subretinal Injection
Last Review Date: 01/04/2024
Date of Origin: 01/03/2018
Dates Reviewed: 01/2018, 03/2018, 07/2018, 01/2019, 01/2020, 01/2021, 01/2022, 01/2023, 01/2024
FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill. |
- Length of Authorization
Coverage will be provided for one dose per eye and may not be renewed
- Dosing Limits
A. Quantity Limit (max daily dose) [NDC Unit]:
- N/A
B. Max Units (per dose and over time) [HCPCS Unit]:
- 150 billable units per eye
- Initial Approval Criteria 1,2
Submission of documentation regarding genetic testing and criteria is required. All requests will be reviewed by a retinal specialist. |
Submission of medical records related to the medical necessity criteria is REQUIRED on all requests for authorizations. Records will be reviewed at the time of submission. Please provide documentation via direct upload through the PA web portal or by fax. |
Coverage is provided in the following conditions:
- Patient is at least 4 years of age; AND
- Patient must have an adequate washout period, defined as a minimum of 3 months, from retinoid therapies prior to receipt of voretigene; AND
- Patient has not had intraocular surgery within six months; AND
- Patient has not previously received subretinal administration of a gene therapy vector, or Luxturna, into the intended eye; AND
Retinal Dystrophy † Ф 1,2
- Patient has a definitive diagnosis confirming biallelic RPE65 mutation-associated retinal dystrophy; AND
- Patient must have viable retinal cells as determined by non-invasive means, such as optical coherence tomography (OCT) and/or ophthalmoscopy indicating one or more of the following:
- An area of retina within the posterior pole of >100 µm thickness shown 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
† FDA Approved Indication(s); ‡ Compendium Recommended Indication(s); Ф Orphan Drug
- Renewal Criteria 1
Coverage cannot be renewed.
- Dosage/Administration 1
Indication |
Dose |
Biallelic RPE65 mutation-associated retinal dystrophy |
For subretinal injection only. Preparing for Administration:
Luxturna Injection:
|
- Store Luxturna and Diluent frozen at ≤ -65 °C. Thaw prior to infusion.
- Luxturna is an adeno-associated virus vector-based gene therapy. Follow universal biohazard precautions for handling.
- Billing Code/Availability Information
HCPCS code:
- J3398 - Injection, voretigene neparvovec-rzyl, 1 billion vector genomes: 1 billable unit = 109 vector genomes
NDC:
- Luxturna carton (one single-dose vial of Luxturna and two vials of diluent): 71394-0415-xx
- References
- Luxturna [package insert]. Philadelphia, PA; Spark Therapeutics, Inc., May 2022. Accessed December 2023.
- Russell S, Bennett J, Wellman JA, et al. Efficacy and safety of voretigene neparvovec (AAV2-hRPE65v2) in patients with RPE65-mediated inherited retinal dystrophy: a randomised, controlled, open-label, phase 3 trial. Lancet. 2017 Aug 26;390(10097):849-860. doi: 10.1016/S0140-6736(17)31868-8. Epub 2017 Jul 14. Erratum in: Lancet. 2017 Aug 26;390(10097):848.
- Palmetto GBA. Local Coverage Article: Billing and Coding: Voretigene Neparvovec-rzyl (Luxturna®) (A56419). Centers for Medicare & Medicaid Services, Inc. Updated on 04/10/2023 with effective date of 04/20/2023. Accessed December 2023.
Appendix 1 – Covered Diagnosis Codes
ICD-10 |
ICD-10 Description |
H35.50 |
Unspecified hereditary retinal dystrophy |
Appendix 2 – Centers for Medicare and Medicaid Services (CMS)
The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.
Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD):
Medicare Part B Covered Diagnosis Codes |
||
Jurisdiction |
NCD/LCA/LCD Document (s) |
Contractor |
J, M |
A56419 |
Palmetto GBA |
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
||
Jurisdiction |
Applicable State/US Territory |
Contractor |
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
J (10) |
TN, GA, AL |
Palmetto GBA, LLC |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA, LLC |
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
15 |
KY, OH |
CGS Administrators, LLC |