CurrentAetnaPolicy N/A

Luxturna (voretigene neparvovec-rzyl) Precertification/Notification Form and Instructions

This document is Aetna's precertification/notification form and instructions for requesting coverage and administration of Luxturna (voretigene neparvovec-rzyl) for members; it governs submission requirements for providers requesting start or continuation of therapy. It applies to Aetna members (including guidance for Medicare Advantage Part B use of a different form).

Policy Summary

PayerAetna

PolicyLuxturna precertification/notification form and instructions

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the completed precertification form with genetic test documentation confirming bi-allelic pathogenic/likely pathogenic RPE65 variants and retinal specialist evidence of viable retinal cells for review prior to treatment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 pagesform length

bi-allelic RPE65required diagnosis confirmation

viable retinal cellsrequired clinical viability assessment

ACMGvariant interpretation standard referenced

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Initial therapy eligibility

Covered when ALL of the following are met and documented:

Genetic confirmation: Patient has diagnosis of bi-allelic RPE65 mutation-associated retinal dystrophy with confirmation of bi-allelic pathogenic and/or likely pathogenic RPE65 mutation by genetic testing (single gene or multigene panel)ACMG classification; affirmation within last 12 months where requested

Form requests type of genetic test, date of test, and whether variant classifications follow ACMG standards and whether pathogenicity was affirmed within the last 12 months

Viable retinal cells: Patient has viable retinal cells in the eye(s) to be treated as confirmed by a retinal specialistOne or more of: OCT showing >100 µm posterior pole thickness; >= 3 disc areas of retina without atrophy or pigmentary degeneration within the posterior pole; remaining visual field within 30 degrees of fixation measured by a III4e isopter or equivalent

Form lists OCT and ophthalmoscopy and requests the specific result(s) that demonstrate viability

Administrative documentation: Completed precertification form with all required administrative fields: patient demographics, insurance/member ID, prescriber and dispensing provider information, eye(s) to be treated, prior administration dates if applicable, product dose/frequency, designated ocular gene therapy treatment center, and signature/dateAll fields must be completed and legible

Form states required clinical and administrative information must be completed in its entirety for precertification review

The form implicitly excludes requests that lack documented genetic confirmation of RPE65-mediated disease or objective evidence of retinal viability. Specifically, coverage requires documentation confirming bi-allelic pathogenic and/or likely pathogenic RPE65 mutations and evidence that the eye(s) to be treated have viable retinal cells as assessed by a retinal specialist; requests that do not provide these items are not consistent with the form’s required information and may be declined or subject to additional review.

The form’s clinical questions make clear why certain requests would be excluded: absence of confirmation that RPE65 variants are bi-allelic pathogenic or likely pathogenic (including documentation of the type of genetic test and ACMG-based interpretation) fails the genetic eligibility requirement. Likewise, lack of documented retinal viability — for example, no OCT showing >100 µm posterior pole thickness, no documentation of ≥3 disc areas without atrophy/pigmentary degeneration, and no remaining visual field within 30° by a III4e isopter or equivalent — fails the viability requirement and would render the request unsupported by the submitted evidence.

Coding and Clinical Thresholds

Administration codesCPT

Administration code(s) (CPT)

Form requests that CPT administration code(s) be provided

ICD-10 codesICD-10

Primary ICD Code	Primary ICD diagnosis code to be provided by requester
Secondary ICD Code	Secondary ICD diagnosis code to be provided by requester
Other ICD Code	Any other ICD codes applicable

inv-06: OCT thickness — clinical threshold for posterior pole (> 100 µm).

OCT thickness thresholdAn area of retina within the posterior pole of greater than 100 µm thickness shown on optical coherence tomography (OCT)

Measurement locationPosterior pole (area of retina)

Imaging modalityOptical coherence tomography (OCT)

inv-07: Visual field remaining — remaining visual field within 30 degrees of fixation as measured by a III4e isopter or equivalent.

Visual field criterionRemaining visual field within 30 degrees of fixation as measured by a III4e isopter or equivalent

Test method exampleIII4e isopter per Goldmann visual field testing or equivalent kinetic/automated assessment

ScopeWithin 30 degrees of fixation (central field)

inv-08: Retinal area without atrophy/pigmentary degeneration — >= 3 disc areas within the posterior pole.

Retinal area without atrophy threshold>= 3 disc areas of retina without atrophy or pigmentary degeneration within the posterior pole

Anatomic locationPosterior pole

Assessment methodOphthalmoscopy (fundus exam) or documentation on clinical exam/imaging

Provider Actions and Submission Requirements

Prior Authorization

Precertification required

Precertification/notification is required for Luxturna; providers must submit the completed form (all fields must be completed and legible) to Aetna via phone or fax for review prior to treatment. Medicare Advantage Part B requests should use the Medicare request form.

Step Therapy

Administration site and CPT codes

No step therapy requirements are listed on the form. Providers must indicate the place of administration and provide administration CPT code(s) where requested on the form.

Place of Administration: self-administered, physician's office, outpatient infusion center, home infusion center (form checkboxes).
Administration code(s) (CPT) — field provided on the form.

Documentation Required

Required genetic and retinal documentation

Attach genetic testing documentation confirming bi-allelic pathogenic and/or likely pathogenic RPE65 variants (single gene or multigene panel), include the test date and indicate whether variant classifications follow ACMG standards and were affirmed within the last 12 months; provide retinal specialist confirmation of viable retinal cells with supporting test results (OCT, ophthalmoscopy, visual field/isopter).

Specify which genetic test was performed (single gene or multi-gene panel) and test date.
Document ACMG-based variant classification and whether pathogenicity was affirmed within the last 12 months.
Provide results demonstrating viable retinal cells (OCT thickness >100 µm, ≥3 disc areas without atrophy, or remaining visual field within 30° by III4e isopter).

Billing Rule

Complete administrative documentation

Complete administrative fields on the precertification form including patient demographics, insurance/member ID, prescriber and dispensing provider information, product dose and frequency, ICD diagnosis codes, laterality and prior administration dates if applicable, and designated ocular gene therapy treatment center.

Patient name, DOB, phone, and which eye(s) to be treated.
Prescriber info: name, license, NPI, contact details and specialty.
Dispensing provider/pharmacy and place of administration details.
Product information: Luxturna dose and frequency.
Diagnosis information: primary and other ICD codes.
Prior administration dates (if any) and designated treatment center name.

Denial Risk

Denial triggers for missing genetic or viability evidence

Requests missing confirmation of bi-allelic pathogenic or likely pathogenic RPE65 mutations or lacking documentation demonstrating viable retinal cells (per listed OCT, ophthalmoscopy, or visual field criteria) may lead the plan to request additional information or result in denial.

Absence of documented bi-allelic pathogenic/likely pathogenic RPE65 mutations (single gene or panel) is a denial trigger.
Lack of retinal specialist confirmation of viable retinal cells or missing supporting test results (OCT >100 µm, ≥3 disc areas without atrophy, or III4e isopter within 30°) is a denial trigger.
Incomplete or illegible required clinical information may prompt requests for clarification or denial.

Definitions

inv-15: Bi-allelic RPE65 mutation-associated retinal dystrophy — defined term entry.

DefinitionBi-allelic RPE65 mutation-associated retinal dystrophy

Genetic requirementDiagnosis requires confirmation of bi-allelic pathogenic and/or likely pathogenic RPE65 mutations

DocumentationGenetic testing may be single gene or multigene panel per form items

inv-16: ACMG variant classification — variant interpretation standard referenced.

Referenced standardAmerican College of Medical Genetics and Genomics (ACMG) standards and guidelines for the interpretation of sequence variants

Documentation requestedIndicate whether RPE65 variant classifications are based on current ACMG standards

Recency checkForm asks whether pathogenic/likely pathogenic classification was affirmed within the last 12 months

OpenPayer

Luxturna (voretigene neparvovec-rzyl) Precertification/Notification Form and Instructions

Coverage Criteria

Coding and Clinical Thresholds

Provider Actions and Submission Requirements

Background

Definitions