CurrentBlue Cross Blue Shield - MassachusettsPolicy N/A

Coverage criteria for ocular cell and gene therapies Encelto and Luxturna

Defines clinical documentation, prior authorization process, and specific medical necessity criteria (inclusion and contraindications) for Encelto (revakinagene taroretcel-lwey) for MacTel and Luxturna (voretigene neparvovec-rzyl) for biallelic RPE65 retinal dystrophy, and specifies applicable billing HCPCS/J-codes and submission instructions.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyCoverage criteria for ocular cell and gene therapies Encelto and Luxturna

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders must use Authorization Manager to submit initial authorization requests, complete the Prior Authorization Request Form for Cell and Gene Therapy for Ocular Diseases (926), enter facility and servicing surgeon NPIs, and provide clinical documentation supporting the listed medical necessity criteria (or submit a letter of medical necessity requesting a Clinical Exception).

POLICY UPDATE CHANGES

No material clinical/coverage changes in this update.

2Therapies covered with criteria

6Key inclusion thresholds/criteria listed

5Contraindications listed for Luxturna

Coverage Summary

This policy provides prior authorization and medical necessity criteria for two ocular gene/cell therapies: Encelto (revakinagene taroretcel-lwey) for idiopathic macular telangiectasia (MacTel) and Luxturna (voretigene neparvovec-rzyl) for biallelic RPE65-associated retinal dystrophy. The overall coverage stance is covered_with_criteria. The policy defines the required clinical documentation, prior authorization submission process (including use of Authorization Manager and a specific prior authorization form), and therapy-specific inclusion criteria and contraindications.

Medical Necessity Criteria

Documentation and Submission

Clinical documentation that supports the medical necessity criteria for Encelto and Luxturna must be submitted. If patient does not meet all criteria, submit letter of medical necessity requesting Clinical Exception.

ALL of the following

Use Authorization Manager to submit initial authorization requests for services (providers must enter facility NPI/provider ID and servicing surgeon's NPI/provider ID).
Complete Prior Authorization Request Form for Cell and Gene Therapy for Ocular Diseases (926) using Authorization Manager.
For out-of-network providers, requests should be faxed to 888-973-0726.

ENcELTO (revakinagene taroretcel-lwey) - Coverage Criteria (Idiopathic macular telangiectasia - MacTel)

Covered when ALL of the following are met:

ALL of the following

Diagnosis: Idiopathic macular telangiectasia (MacTel).
Age: Adult (age ≥ 18 years).
Imaging: Patient has a photoreceptor inner segment/outer segment (IS/OS PR) break (loss) in ellipsoid zone (EZ) measured by spectral domain-optical coherence tomography (SD-OCT).EZ break size between 0.16 and 2.00 mm2
Visual acuity: Best corrected visual acuity (BCVA) as measured by ETDRS at screening.BCVA ≥ 54-letter score (20/80 or better)

LUXTURNA (voretigene neparvovec-rzyl) - Coverage Criteria (RPE65-associated retinal dystrophy)

Covered when ALL of the following are met:

ALL of the following

Diagnosis: Vision loss due to biallelic RPE65 pathogenic or likely pathogenic variant-associated retinal dystrophy.
Age: Is an adult (age <65 years) or child (age ≥ 3 years).
Genetic confirmation: Genetic test confirming presence of biallelic RPE65 pathogenic or likely pathogenic variant(s) either as a single RPE65 pathogenic/likely pathogenic variant in homozygous state OR two RPE65 pathogenic/likely pathogenic variants in trans (compound heterozygous) by segregation analysis.
Viable retinal cells
- Viable retinal cells options

Provider Actions

Prior Authorization

Submit prior authorization via Authorization Manager

Use Authorization Manager to submit initial authorization requests. Enter the facility's NPI or provider ID for where services are being performed and enter the appropriate servicing surgeon's NPI or provider ID. Complete the Prior Authorization Request Form for Cell and Gene Therapy for Ocular Diseases (926) in Authorization Manager.

Authorization Manager (online submission)
Prior Authorization Request Form for Cell and Gene Therapy for Ocular Diseases (926) via Authorization Manager

Documentation Required

Submit clinical documentation supporting medical necessity

Submit clinical documentation that supports the medical necessity criteria for Encelto and Luxturna. If the patient does not meet all listed criteria, submit a letter of medical necessity requesting a Clinical Exception that explains why an exception is justified.

Include clinical records and imaging demonstrating eligibility criteria.
If criteria are unmet, include a detailed letter of medical necessity requesting Clinical Exception.

Billing Rule

For out-of-network prior authorization submissions

For out-of-network prior authorization submissions, fax requests to the designated fax number for out-of-network providers.

Fax number for out-of-network providers: 888-973-0726

Documentation Required

Indicate administering provider qualifications for Encelto

Document that the drug will be administered by a board-certified or board-eligible ophthalmologist when requesting Encelto.

Include administering provider's board certification or board-eligible status in documentation.

Background

This policy covers prior authorization and medical necessity criteria for two ocular gene/cell therapies: Encelto for idiopathic macular telangiectasia (MacTel) and Luxturna for vision loss due to biallelic RPE65 pathogenic or likely pathogenic variant-associated retinal dystrophy. Clinical documentation supporting medical necessity must be submitted; if a patient does not meet all criteria, a letter of medical necessity requesting a Clinical Exception is required. Providers are instructed to use Authorization Manager to submit requests and to complete the Prior Authorization Request Form for Cell and Gene Therapy for Ocular Diseases (926); out-of-network providers may fax requests to 888-973-0726.

For Encelto the policy requires: diagnosis of idiopathic MacTel in an adult (age ≥ 18 years); presence of an IS/OS photoreceptor ellipsoid zone (EZ) break measuring between 0.16 and 2.00 mm2 on SD-OCT; best corrected visual acuity (BCVA) of ≥54-letter ETDRS score (20/80 or better) at screening; administration by a board-certified or board-eligible ophthalmologist; and absence of neovascular MacTel.

For Luxturna the policy requires: diagnosis of vision loss due to biallelic RPE65 pathogenic or likely pathogenic variants with genetic confirmation (either a single variant in the homozygous state or two variants in trans by segregation analysis); patient age eligibility (adult <65 years or child ≥3 years); demonstration of viable retinal cells by the treating physician as assessed by OCT and/or ophthalmoscopy with at least one of the following: retinal thickness >100 μm within the posterior pole on OCT, ≥3 disc areas without atrophy or pigmentary degeneration within the posterior pole, any remaining visual field within 30° of fixation (III4e/V4e isopter equivalent), or measurable full-field light sensitivity threshold (FST). The policy also lists contraindications that must be absent for Luxturna (pregnancy, breastfeeding, recent prescription retinoid use within 3 months, recent intraocular surgery within 3 months, and preexisting eye/systemic conditions that would prevent benefit).

Definitions

BCVABest corrected visual acuity measured by ETDRS chart; policy specifies ≥54-letter score (20/80 or better) for Encelto.

FSTFull-field light sensitivity threshold; measurable FST is an eligibility criterion for Luxturna.

SD-OCTSpectral domain-optical coherence tomography; used to measure EZ break size for Encelto and retinal thickness for Luxturna.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyCoverage criteria for ocular cell and gene therapies Encelto and Luxturna

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

On This Page

OCT thickness: An area of retina within the posterior pole of >100 μm thickness shown on optical coherence tomography.retinal thickness >100 μm within posterior pole
Disc area preservation: ≥3 disc areas of retina without atrophy or pigmentary degeneration within the posterior pole.≥3 disc areas without atrophy/pigmentary degeneration
Visual field: Any remaining visual field within 30° of fixation as measured by III4e/V4e isopter equivalent.visual field remaining within 30° of fixation
FST: Measurable full-field light sensitivity threshold (FST).measurable FST

C9399	Unclassified drugs or biological
J3403	Revakinagene taroretcel-lwey, per implant
J3398	Injection, voretigene neparvovec-rzyl, 1 billion vector genomes
J3490	Unclassified drugs
J3590	Unclassified biologics

OpenPayer

Coverage criteria for ocular cell and gene therapies Encelto and Luxturna

Coverage Summary

Medical Necessity Criteria

Coding

Provider Actions

Background

Revision History