CurrentPremera BluecrossPolicy N/A

Encelto (revakinagene taroretcel-Iwey) intravitreal implant — coverage criteria

Defines medical necessity, coverage limits, coding, and documentation requirements for Encelto intravitreal implanted therapy for adults with idiopathic macular telangiectasia type 2 under Premera BlueCross medical benefit.

Policy Summary

PayerPremera Bluecross

PolicyEncelto intravitreal implant — coverage criteria

Policy CodePolicy N/A

Change TypeAdded coverage criteriacoding update

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization and submit medical records demonstrating diagnostic findings (fluorescein angiography, SD‑OCT measurements, BCVA ETDRS score) to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for Encelto (revakinagene taroretcel-Iwey) for the treatment of adults with idiopathic macular telangiectasia type 2.

Coding update: HCPCS code J3403 added for Encelto to match policy criteria.

one-timeimplantation limit

18+minimum age

BCVA ≥54BCVA requirement

0.16–2.00 mmEZ break size

J3403

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Encelto (revakinagene taroretcel-Iwey)

Medical necessity criteria for Encelto

Covered when ALL of the following are met:

Primary coverage criteria: Patient is aged 18 years or older AND diagnosed with idiopathic macular telangiectasia type 2 (MacTel) by evidence of fluorescein leakage typical of MacTel AND has at least one of the following retinal features: hyperpigmentation outside a 500-micron radius from the fovea center; retinal opacification; crystalline deposits; right-angle vessels; inner or outer lamellar cavities AND has an inner segment/outer segment photoreceptor (IS/OS) ellipsoid zone (EZ) break between 0.16 and 2.00 mm measured by spectral domain-optical coherence tomography (SD-OCT) AND has a best corrected visual acuity (BCVA) score of 54 ETDRS letters or better (20/80 Snellen equivalent) AND has not been diagnosed with intraretinal neovascularization or subretinal neovascularization (SRNV), central serous chorioretinopathy, or active/suspected ocular or periocular infection AND has confirmed negative pregnancy status AND Encelto (revakinagene taroretcel-Iwey) is prescribed and administered by an ophthalmologist AND use is limited to a one-time surgical implantation per affected eyeage >=18; EZ break 0.16-2.00 mm; BCVA >=54 letters

Meets medical necessity only when all elements present

Length of approval and investigational uses

Usage limits and investigational statements:

Usage and investigational: Use of Encelto is limited to a one-time surgical implantation per affected eye. Re-authorization (repeat implantation) to the same affected eye is considered investigational. All other uses of Encelto for conditions not outlined in this policy (including macular telangiectasia type 1) are considered investigational.

Initial non-formulary exception authorizations may be approved for up to 12 months; other reviews may be approved for up to 6 months as a one-time application.

Use of Encelto (revakinagene taroretcel-Iwey) is limited by approval duration and investigational status. Initial non-formulary exception authorizations may be approved for up to 12 months. All other reviews may be approved for up to 6 months as a one-time application. Re-authorization for repeat implantation to the same affected eye is considered investigational and is not permitted under routine coverage.

Any use of Encelto that is not specifically described in this policy is considered investigational and not medically necessary. This includes treatment of conditions not outlined here, for example macular telangiectasia type 1. In addition, repeat surgical implantation of Encelto in the same affected eye (re-authorization for a subsequent implant) is explicitly considered investigational and is not covered; coverage is limited to a one-time surgical implantation per affected eye.

Coding and Clinical Thresholds

Covered HCPCS CodesHCPCSCovered

J3403

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

Historical coding entryHCPCS

J3590

Historically listed HCPCS code for Encelto (noted in history entry)

inv-07: Ellipsoid zone (IS/OS) photoreceptor break size by SD-OCT

Ellipsoid zone (IS/OS) photoreceptor (EZ) break size>= 0.16 mm and <= 2.00 mm measured by spectral domain-optical coherence tomography (SD-OCT)

Measurement modalitySpectral domain–optical coherence tomography (SD-OCT)

Anatomic locationInner segment/outer segment photoreceptor (IS/OS) ellipsoid zone (EZ)

Role in eligibilityRequired finding for medical necessity of Encelto when present with other clinical criteria

inv-08: Best corrected visual acuity (BCVA)

BCVA threshold

What Providers Must Do

Prior Authorization

Prior authorization and benefit application

Prior authorization is required for Encelto; requests are managed under the medical benefit. Initial non-formulary exception reviews may be approved for up to 12 months; all other reviews may be approved up to 6 months as a one-time authorization. Re-authorization for repeat implantation in the same affected eye is considered investigational.

Encelto is managed under the medical benefit.
Initial non-formulary exception reviews: up to 12 months.
Other reviews: up to 6 months as a one-time application.
Repeat implantation to the same affected eye is investigational (re-authorization not appropriate).

Step Therapy

Step therapy

This policy does not impose any step therapy requirements. Use is limited to the indications in this policy and to a one-time surgical implantation per affected eye.

Clinical Background

Macular telangiectasia type 2 (MacTel type 2) is a bilateral, typically middle-age neurodegenerative retinal disease characterized by abnormalities of retinal blood vessels and loss of retinal support cells. The condition can progress to proliferative vascular changes and macular degeneration. Encelto is an intravitreal, cell-based implanted delivery system intended to release recombinant human ciliary neurotrophic factor (rhCNTF) to the retina with the goal of reducing photoreceptor loss and slowing disease progression.

Definitions

inv-15: Encelto (revakinagene taroretcel-Iwey) — product description

Product name and active ingredientEncelto (revakinagene taroretcel-Iwey)

DescriptionCell-based intravitreal therapy delivered via an implanted drug delivery system containing genetically modified cells in a semipermeable hollow fiber membrane that release recombinant human ciliary neurotrophic factor (rhCNTF) to the retina.

Intended effectrhCNTF release to reduce photoreceptor cell loss and potentially slow disease progression

AdministrationSurgical intravitreal implantation of the drug delivery device performed by an ophthalmologist (one-time implantation per affected eye as limited by policy)

inv-16: MacTel type 2 — disease definition

Definition

Policy Summary

PayerPremera Bluecross

PolicyEncelto intravitreal implant — coverage criteria

Policy CodePolicy N/A

Change TypeAdded coverage criteriacoding update

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization and submit medical records demonstrating diagnostic findings (fluorescein angiography, SD‑OCT measurements, BCVA ETDRS score) to support medical necessity.

SourceLink

On This Page

Best corrected visual acuity (BCVA) >= 54 ETDRS letters (20/80 Snellen equivalent)

Assessment chartETDRS visual acuity chart (report letter score)

Timing/documentationBCVA score must be documented in the medical record to support prior authorization

inv-09: Age

Minimum age for coverageAge >= 18 years

DocumentationAge must be documented in the medical record (e.g., date of birth)

ApplicabilityPolicy applies to adults with idiopathic macular telangiectasia type 2

No step therapy specified within this policy.

One-time implantation per affected eye only.

Documentation Required

Required documentation

Submit medical records that document the diagnosis and evidence that all medical necessity criteria are met, including objective diagnostic testing and relevant clinical notes.

Office visit notes with diagnosis, relevant history, medication history, and physical evaluation.
Objective test results demonstrating fluorescein leakage typical of MacTel, SD-OCT measurement of IS/OS EZ break (0.16–2.00 mm), and BCVA (ETDRS letters).
Documentation of negative pregnancy status when applicable.

Denial Risk

Triggers for denial

Denials may be triggered when required diagnostic findings or eligibility criteria are missing or contraindications are present.

No evidence of fluorescein leakage typical of MacTel.
Absence of required additional retinal features (hyperpigmentation, retinal opacification, crystalline deposits, right-angle vessels, inner/outer lamellar cavities).
IS/OS ellipsoid zone break not between 0.16 and 2.00 mm on SD-OCT.
BCVA worse than 54 ETDRS letters (worse than 20/80).
Diagnosis of intraretinal or subretinal neovascularization, central serous chorioretinopathy, or active/suspected ocular or periocular infection.
Repeat implantation (re-authorization) for the same affected eye.

Idiopathic macular telangiectasia type 2 (MacTel type 2) is a typically middle-age, bilateral neurodegenerative retinal disease characterized by retinal blood vessel abnormalities and loss of Müller cells, which may progress to proliferative vessel changes and macular degeneration.

Laterality and demographicsTypically bilateral and more common in females; often diagnosed in middle age

PathophysiologyAssociated with loss of Müller cells leading to impaired growth factor secretion, angiogenesis regulation, neurotransmitter metabolism, neuroprotection, and photoreceptor survival

Clinical progressionMay progress to proliferative forms with vessel dilation, leakage, and macular degeneration