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Coverage criteria policies

Voretigene neparvovec-rzyl (Luxturna™)

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

Voretigene neparvovec-rzyl (Luxturna) is generally covered subject to the indications listed below when all of the following criteria are met, and per your plan documents.

Initial Approvals

  1. Prescribed by an ophthalmologist or retinal surgeon with experience providing sub-retinal injections; and
  2. Patient is ≥4 years old; and
  3. Patient has confirmed biallelic RPE65 mutation-associated retinal dystrophy, supported by chart note documentation; and
  4. Patient has viable retinal cells as determined by treating physicians, supported by chart note documentation of the following:
    1. Area of retina within posterior pole of > 100 μm thickness, or
    2. ≥3 disc areas of retina without atrophy or pigmentary degeneration within the posterior pole, or
    3. Remaining visual field within 30° of fixation as measured by III4e isopter or equivalent.

Reauthorization

Luxturna is a one-time ocular injection, and is not eligible for reauthorization. Repeat administration has not been studied, and is considered investigational and not medically necessary.

Definitions

Luxturna is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. Patients must have viable retinal cells as determined by the treating physician(s).

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

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

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. Luxturna prescribing information. Spark Therapeutics, 2017.

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Policy activity

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

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