CurrentmhnPolicy CP.PHAR.372

Voretigene Neparvovec-rzyl (Luxturna)

Defines medical necessity, initial and continued therapy criteria, dosing limits, and coding implications for Luxturna for commercial, HIM, and Medicaid lines of business for patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.

Policy Summary

Payermhn

PolicyVoretigene Neparvovec-rzyl (Luxturna)

Policy CodePolicy CP.PHAR.372

Change TypeNo material changes

Effective DateMar 1, 2018

Next Review Date

Key ActionProvider must obtain prior authorization, submit required supporting documentation (office notes, genetic test results, imaging, FST results, operative history), and requests will undergo medical director review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 lifetime dose per eyemaximum dosing allowance

Age ≥ 3 yearsminimum patient age for coverage

≤ 1.5 x 10^11 vg/eyemaximum permitted dose per eye

4 weeksauthorization duration

Medical Necessity Criteria

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Initial Approval 2D Retinal Dystrophy

Covered when ALL of the following are met:

ALL of the following

Diagnosis of retinal dystrophy confirmed by genetic diagnosis of biallelic RPE65 gene mutations
Prescribed by or in consultation with an ophthalmologist
Age ≥ 3 years>= 3 years
Member has not previously been treated with Luxturna in the requested treatment eye(s)
Viable retinal cells (both a and b required)
- Retinal thickness on spectral domain optical coherence tomography with areas > 100 microns within the posterior pole> 100 microns
- Fundus photography showing presence of neural retina
Significant vision loss (at least one required)
- Visual acuity of 20/60 or worse in both eyes
  See Appendix D for VA measurement methods
- Visual field less than 20 degrees in any meridian
  Measured by III4e isopter or equivalent
Member has not received intraocular surgery within prior 6 monthsno intraocular surgery within 6 months
Baseline full-field stimulus testing (FST) for blue and red light score > -2.00 log10(cd/m2)> -2.00 log10(cd/m2
Dose does not exceed 1.5 x 10^11 vector genomes (vg) per eye<= 1.5 x 10^11 vg/eye

Approval duration: 4 weeks (1 lifetime dose per eye)

What Providers Must Do

Prior Authorization

Prior authorization and medical director review required

Obtain prior authorization for Luxturna; all requests require medical director review and submission of supporting documentation for coverage determination.

Affected code: J3398

Documentation Required

Submit supporting documentation

Submit documentation demonstrating the member meets all approval criteria; documentation must include clinical records and test results to support medical necessity.

Office chart notes
Genetic test results confirming biallelic RPE65 mutations
Imaging (OCT, fundus photography) showing viable retinal cells
Full-field stimulus testing (FST) results
Operative history (intraocular surgery within prior 6 months)

Denial Risk

Denial risk for repeat administration or excessive dose

Requests for repeat treatment of a previously treated eye or doses above the policy maximum are not authorized and may be denied.

Repeat treatment of a previously treated eye is not authorized (risk of denial)
Dose must not exceed 1.5 x 10^11 vector genomes (vg) per eye — doses exceeding this are not authorized

Documentation Required

Document timing for second-eye treatment (6–18 days)

When treating both eyes, document that second-eye treatment is planned within 6–18 days after the first eye due to immunogenicity and safety concerns; requests outside this window may not meet continued therapy criteria.

Inter-eye interval must be >6 days but ≤18 days
Rationale: safety concerns related to immunogenicity against the vector and/or expressed protein

Numeric and Clinical Thresholds

Coverage Thresholds

Minimum age>= 3 years

Retinal thickness (OCT)> 100 microns in areas within posterior pole

Visual acuity20/60 or worse in both eyes

Visual fieldLess than 20 degrees in any meridian

FST baseline score> -2.00 log10(cd/m2)

Dose per eye<= 1.5 x 10^11 vector genomes (vg) per eye

Inter-eye treatment windowGreater than 6 days and no more than 18 days between eyes

Clinical Context

Luxturna (voretigene neparvovec-rzyl) is an AAV2-based (adeno-associated virus serotype 2) gene therapy indicated for patients with a confirmed biallelic RPE65 mutation–associated retinal dystrophy. Treatment requires the presence of viable retinal cells, as determined by the treating physician, because the therapy’s mechanism of action depends on surviving neurosensory retina (e.g., fundus photography showing neural retina and OCT showing adequate retinal thickness).

Policy Summary

Payermhn

PolicyVoretigene Neparvovec-rzyl (Luxturna)

Policy CodePolicy CP.PHAR.372

Change TypeNo material changes

Effective DateMar 1, 2018

Next Review Date

SourceLink

On This Page

OpenPayer

Voretigene Neparvovec-rzyl (Luxturna)

Medical Necessity Criteria

Billing and Coding

What Providers Must Do

Numeric and Clinical Thresholds

Clinical Context

Terminology

Policy Dates

Voretigene Neparvovec-rzyl (Luxturna)

Medical Necessity Criteria

Billing and Coding

What Providers Must Do

Numeric and Clinical Thresholds

Clinical Context

Terminology

Cross-References

Policy Dates