CurrentBlue Cross Blue Shield - IowaPolicy N/A

Encelto (revakinagene taroretcel-lwey) for idiopathic macular telangiectasia type 2 — Coverage Criteria

Policy governing prior authorization, coverage criteria, and documentation requirements for Encelto implants to treat adults with idiopathic macular telangiectasia type 2 (MacTel) under Blue Cross Blue Shield - Iowa.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyEncelto for idiopathic macular telangiectasia type 2 — Coverage Criteria

Policy CodePolicy N/A

Change TypeNew policy with material additions

Effective DateDec 19, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with confirmation of diagnosis, SD-OCT results, and BCVA for review.

SourceLink

POLICY UPDATE CHANGES

Coverage criteria for Encelto for MacTel type 2 with specific diagnostic and imaging requirements were specified.

Repeat treatment with Encelto is considered investigational and not covered.

Required documentation and prescriber specialty requirements for prior authorization were defined.

18+age requirement (adults)

3 monthsinitial authorization period

54 lettersBCVA minimum

0.16-2.00 mm²EZ area (SD-OCT)

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Coverage Criteria for Encelto (revakinagene taroretcel-lwey)

Initial Therapy

Covered when ALL of the following are met for members 18 years and older:

Initial coverage conditions

Diagnosis requirement: Member has a diagnosis of MacTel type 2 in at least one eye with evidence of fluorescein leakage typical of MacTel and at least one of: hyperpigmentation outside a 500 micron radius from the center of the fovea; retinal opacification; crystalline deposits; right-angle vessels; or inner/outer lamellar cavities.
Imaging requirement: Presence of an IS/OS photoreceptor (Inner Segment–Outer Segment) break in the affected eye(s) and en face ellipsoid zone (EZ) area between 0.16 mm^2 and 2.00 mm^2 measured by spectral domain–optical coherence tomography (SD-OCT).EZ area 0.16–2.00 mm^2
Visual acuity requirement: Best corrected visual acuity (BCVA) score of 54 letters or better (20/80 or better).>= 54 letters
Treatment history: Member has not previously received an Encelto implant (no prior Encelto implants).
Prescriber: Medication is prescribed by or in consultation with an ophthalmologist.

Operational requirements for prior authorization: Submit medical records (chart notes and/or laboratory reports) documenting confirmation of diagnosis, SD-OCT results, and BCVA results as part of the prior authorization request.

Prior authorization may be granted for an initial period of 3 months when all criteria are met.

Continuation Therapy

Continuation of therapy

Repeat treatment with Encelto for any indication is considered investigational because safety and efficacy beyond one implant have not been studied; the evidence is insufficient to determine effect on net health outcomes.

Repeat implants are not covered/considered investigational.

Encelto (revakinagene taroretcel-lwey) is not medically necessary for members who do not meet the specific coverage criteria detailed in this policy. Members must satisfy all required diagnostic, imaging, visual acuity, treatment-history, and prescriber conditions for coverage consideration; failure to meet those criteria will result in a determination of nonmedical necessity.

Repeat implants of Encelto are considered investigational and are not covered because safety and efficacy beyond a single implant have not been established. Accordingly, any request for additional Encelto implants or for members who do not meet the policy’s specified criteria will be determined to be not medically necessary.

Billing and Coding

Billing HCPCS codesHCPCS

J3403	Revakinagene taroretcel-lwey, per implant (effective 10/1/2025)
J3490	unclassified drugs
J3590	unclassified biologics

En face ellipsoid zone (EZ) area — measurement range

Required measurement rangeEn face ellipsoid zone (EZ) area measured by SD-OCT must be between 0.16 mm^2 and 2.00 mm^2 (inclusive)

Measurement methodMeasured on en face view using spectral domain-optical coherence tomography (SD-OCT)

Associated imaging findingPresence of an IS/OS photoreceptor (Inner Segment–Outer Segment) break in the affected eye(s) is required in addition to EZ area criteria

Best corrected visual acuity (BCVA) — eligibility threshold

BCVA thresholdBest corrected visual acuity (BCVA) score of 54 letters or better (20/80 or better)

Test requiredBCVA must be documented as best corrected visual acuity (standard ETDRS/letters or Snellen equivalent)

Prior Authorization and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Include confirmation of diagnosis, SD-OCT results, and BCVA in the submission. Approvals for idiopathic macular telangiectasia type 2 may be granted for up to 3 months when all clinical criteria are met.

Diagnosis confirmation required
Spectral domain-optical coherence tomography (SD-OCT) results required
Best corrected visual acuity (BCVA) results required
Authorization may be for up to 3 months when criteria are met

Billing Rule

Dosing Limits May Apply

Approvals may be subject to dosing limits consistent with FDA-approved labeling, accepted compendia, and evidence-based practice guidelines.

Background

Idiopathic macular telangiectasia type 2 (MacTel type 2) is a primarily bilateral, neurodegenerative macular disease that most commonly presents in middle age and can progress to a proliferative form with macular vascular proliferation and leakage leading to central vision loss. Prior to the availability of Encelto, there were no FDA‑approved therapies specifically for nonproliferative MacTel; vascular endothelial growth factor (VEGF) inhibitors are used to treat proliferative disease but do not address earlier neurodegenerative stages. The policy reflects that evidence for safety and efficacy of repeat Encelto implants beyond a single implant is currently insufficient.

Key Definitions

En face ellipsoid zone (EZ) area — definition

DefinitionEn face ellipsoid zone (EZ) area is the area of EZ disruption measured on en face SD-OCT imaging (spectral domain–optical coherence tomography)

Required accompanying findingAn IS/OS photoreceptor (Inner Segment–Outer Segment) break in the affected eye(s) must be present

Coverage rangeRequired numeric range for eligibility: 0.16 mm^2 to 2.00 mm^2 measured on SD-OCT

Best corrected visual acuity (BCVA) — definition and threshold

DefinitionBest corrected visual acuity (BCVA) is the member's best corrected visual acuity score used for eligibility assessment

Coverage thresholdPolicy requires BCVA of 54 letters or better, equivalent to 20/80 or better