CurrentPremera BluecrossPolicy N/A

Miscellaneous Intravitreal Drugs — Encelto (revakinagene taroretcel-lwey) coverage criteria

Defines medical necessity, documentation, coding, and approval length for the intravitreal cell‑based implant Encelto in adults with idiopathic macular telangiectasia type 2; applies to medical‑benefit claims and providers administering the therapy.

Policy Summary

PayerPremera Bluecross

PolicyMiscellaneous Intravitreal Drugs — Encelto (revakinagene taroretcel-lwey) coverage criteria

Policy CodePolicy N/A

Change TypeAnnual reviewprior coding and initial additions noted

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain prior authorization for Encelto (J3403); initial approval may be up to 6 months as a one-time implantation per eye.

SourceLink

POLICY UPDATE CHANGES

Annual Review, approved March 23, 2026. No changed to policy statements.

Added coverage criteria for Encelto for the treatment of adults with idiopathic macular telangiectasia type 2.

Coding update: new HCPCS code J3403 effective 10/01/25 replaced J3590.

18+minimum age for coverage

One-timeimplantation allowed per affected eye

Up to 6 monthsinitial authorization duration

J3403HCPCS code for Encelto

Policy Summary

PayerPremera Bluecross

PolicyMiscellaneous Intravitreal Drugs — Encelto (revakinagene taroretcel-lwey) coverage criteria

Policy CodePolicy N/A

Change TypeAnnual reviewprior coding and initial additions noted

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain prior authorization for Encelto (J3403); initial approval may be up to 6 months as a one-time implantation per eye.

SourceLink

On This Page

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Coverage and Medical Necessity Criteria

Medical Necessity (Initial authorization)

Covered when ALL of the following are met:

Encelto medical necessity criteria: Patient selection must meet every child node

Age: Individual is aged 18 years or older

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Diagnosis: Diagnosed with idiopathic macular telangiectasia type 2 (MacTel) by evidence of fluorescein leakage typical of MacTel AND at least one of: hyperpigmentation outside a 500-micron radius from fovea center; retinal opacification; crystalline deposits; right-angle vessels; inner/outer lamellar cavities

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OCT finding: Has an inner segment/outer segment photoreceptor (IS/OS) break (ellipsoid zone loss) measured by spectral domain–OCT between 0.16 and 2.00 mm20.16-2.00 mm2

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Visual acuity: Best corrected visual acuity (BCVA) score of 54 ETDRS letters or better (approximately 20/80 Snellen equivalent)<=54 ETDRS letters

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Exclusions absent: No diagnosis of intraretinal neovascularization or subretinal neovascularization (SRNV), central serous chorio‑retinopathy, or active/suspected ocular or periocular infection

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Pregnancy test: Confirmed negative pregnancy status

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Provider and administration: Encelto is prescribed and administered by an ophthalmologist

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Application limit: Use is limited to a one-time surgical implantation per affected eyeone-time per eye

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Re-authorization

Re-authorization rules:

Re-authorization of Encelto for repeat application to the same affected eye is considered investigational and is not approved

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Initial approval duration: Initial authorization may be approved for up to 6 months as a one-time application per eyeup to 6 months

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Encelto (revakinagene taroretcel-lwey) is covered only for adults with idiopathic macular telangiectasia type 2 (MacTel type 2) when all specified medical necessity criteria are met. Key diagnostic requirements include documented fluorescein angiography demonstrating leakage typical of MacTel plus at least one characteristic retinal sign such as hyperpigmentation outside a 500‑micron radius from the foveal center, retinal opacification, crystalline deposits, right‑angle vessels, or inner/outer lamellar cavities.

Encelto is not covered for indications outside those expressly listed in this policy. Specifically, use for other conditions including macular telangiectasia type 1 and any uses not described here are considered investigational and not medically necessary.

Repeat implantation to the same affected eye is not approved: initial implantation is limited to a one-time surgical implantation per affected eye, and re-authorization for repeat application to the same eye is considered investigational.

Coding and Measurement Criteria

Covered HCPCS CodesHCPCSCovered

J3403

Revakinagene taroretcel-lwey (Encelto), per implant (new code effective 10/01/25)

inv-06: IS/OS (EZ) break area — numeric eligibility thresholds (area in mm2)

IS/OS (EZ) break area — numeric threshold>= 0.16 mm2 and <= 2.00 mm2

Measurement modalityMeasured on spectral domain–optical coherence tomography (SD-OCT)

Anatomic targetInner segment/outer segment photoreceptor (IS/OS) ellipsoid zone (EZ) break (loss)

inv-07: BCVA — Best corrected visual acuity eligibility threshold (ETDRS letters / Snellen equivalent)

BCVA eligibility threshold (ETDRS)54 ETDRS letters or better

Snellen equivalentApproximately 20/80 Snellen

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Encelto (revakinagene taroretcel-lwey) is managed under the medical benefit and must be prior authorized before administration. Initial authorization may be approved for up to 6 months as a one-time application per eye. Re-authorization for repeat application to the same affected eye is considered investigational and will not be approved.

Managed under medical benefit
Initial authorization: up to 6 months, one-time application per eye
Re-authorization for repeat application to same eye: investigational (not approvable)

Step Therapy

There is no step therapy or prior-line requirement specified for Encelto. Coverage is determined by meeting the medical necessity criteria listed in this policy.

Background and Disease Overview

Macular telangiectasia type 2 is a bilateral, typically middle‑age retinal disease in which degenerative changes of the neuroretina and supporting Müller cells can lead to photoreceptor loss and progressive visual decline. Encelto is an intravitreal implant intended for use in select patients with MacTel type 2 to address progressive photoreceptor degeneration; coverage is contingent on meeting the policy's specific diagnostic, imaging, and visual acuity thresholds.

Definitions and Measurement Details

inv-13: BCVA eligibility threshold — definition/translation of 54 ETDRS letters to ~20/80 Snellen

ETDRS-to-Snellen translation54 ETDRS letters corresponds to approximately 20/80 Snellen

ApplicationBCVA must be 54 letters or better to meet eligibility

Measurement methodBCVA measured using ETDRS chart per policy language

inv-14: IS/OS (EZ) break — definition and measurement method for ellipsoid zone loss (area in mm2 on SD-OCT)

DefinitionIS/OS (EZ) break refers to inner segment/outer segment photoreceptor (ellipsoid zone) loss

Measurement methodArea measured in mm2 on spectral domain–optical coherence tomography (SD-OCT)