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Coverage criteria policies

Voretigene neparvovec-rzyl (Luxturna™) – Minnesota Health Care Programs

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Voretigene neparvovec-rzyl (Luxturna) requires prior authorization from HealthPartners Pharmacy Administration.

Coverage

All requests for doses exceeding the FDA-approved regimen will not be covered.

Initial Authorizations:
  1. Patient must be at least 12 months old; and,
  2. The provider requesting prior authorization for Luxturna must be an enrolled provider in Minnesota Health Care Programs (MHCP); and,
  3. Provider must attest that the patient did not previously participate or is not currently participating in any clinical trials for Luxturna; and,
  4. At time of request, provider must provide a comprehensive treatment plan and follow-up care plan which include but are not limited to all needed ancillary services (e.g., transportation and lodging, etc); and,
  5. Patient has a definitive diagnosis confirming biallelic RPE65 mutation-associated retinal dystrophy; and,
  6. 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:
    1. An area of retina within the posterior pole of >100 μm thickness shown on OCT
    2. ≥ 3 disc areas of retina without atrophy or pigmentary degeneration within the posterior pole
    3. Remaining visual field within 30 degrees of fixation as measured by a III4e isopter or equivalent; and,
  7. Patient must have one or more of the following in each eye:
    1. Best corrected visual acuity of 20/60 or worse; or,
    2. Visual field less than 20 degrees in any meridian as measured by a III4e isopter or equivalent; or,
    3. Significant visual loss if patient is unable to complete one or both assessments above and
  8. Patient has not had intraocular surgery within six months; and,
  9. Patient must have an adequate washout period from retinoid therapies prior to receipt of Luxturna

Quantity limit:

1 treatment per eye per lifetime; may not be renewed.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

The services associated with these codes require prior authorization:
HCPCS

Codes

Description

C9032

Injection, voretigene neparvovec-rzyl, 1 billion vector genome (For Hospital OPPS billing prior to 7/1/18 use C9399)

J3398

Injection, voretigene neparvovec-rzyl, 1 billion vector genomes (effective 1/1/2019)

J3590

Unclassified biologics (use before 1/1/2019)

NDC

Codes

Description

71394006501

LUXTURNA VIAL

71394041501

LUXTURNA VIAL

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. https://mn.gov/dhs/partners-and-providers/policies-procedures/minnesota-health-care-programs/provider/types/rx/pa-criteria/luxturna.jsp

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Policy activity

  • 05/07/2018 - Date of origin
  • 10/01/2018 - Effective date

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