CurrentBlue Cross Blue Shield - IowaPolicy 05.05.94

Encelto_Medical_Necessity_Criteria

Defines medical necessity criteria for FDA-approved indication of Encelto for adults with idiopathic macular telangiectasia type 2 (MacTel), coverage for initial single implant (3-month authorization) and exclusion of repeat treatment/continuation. Also lists billing J-codes and general dosing limits consistent with labeling.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyEncelto_Medical_Necessity_Criteria

Policy CodePolicy 05.05.94

Change TypeRevised (initial criteria set)

Effective DateJul 31, 2025

Next Review Date

Key ActionAuthorization of up to 3 months may be granted when all initial therapy criteria are met; verify member benefits and exclusions prior to service.

SourceLink

POLICY UPDATE CHANGES

Policy effective date set to July 31, 2025 with criteria reflecting FDA-approved indication for Encelto.

1Covered Indication (MacTel type 2)

1Authorized Implant per member

J3403J-code assigned (effective 2025-10-01)

0Allowed repeat treatments

Scope: Defines medical necessity criteria for the FDA-approved indication of Encelto (revakinagene taroretcel-lwey) for adults with idiopathic macular telangiectasia type 2 (MacTel), authorizing a single initial implant for up to 3 months when criteria are met and excluding repeat treatment. Coverage stance: mixed — initial single implant covered when criteria are met; repeat treatment not covered. Policy statement: Encelto is FDA-approved for treatment of adults with MacTel type 2; authorization of one implant for 3 months may be granted for patients meeting the specified criteria; repeat implants are considered investigational and are not covered. Policy number: 05.05.94. Effective date: 2025-07-31.

Key Thresholds and Treatment Limits

Ellipsoid Zone (EZ) area0.16–2.00 mm^2

Best Corrected Visual Acuity (BCVA)≥54 letters (20/80 or better)

Hyperpigmentation locationOutside 500 micron radius from center of fovea

Authorized implantSingle initial implant — authorization up to 3 months

Repeat treatmentsNot allowed — repeat treatment investigational

Initial Therapy Criteria (Authorization for 3 months)

Initial Therapy (Authorization for 3 months) — Idiopathic MacTel type 2

Authorization of 3 months may be granted for treatment of idiopathic macular telangiectasia type 2 (MacTel) in members 18 years and older when ALL of the following criteria are met:

Top-level: all criteria must be met

Eligibility criteria

Age: Member is 18 years of age or older
implicit from indication and authorization statement
Diagnosis: Member must have a diagnosis of MacTel type 2 in at least one eye with evidence of fluorescein leakage typical of MacTel
diagnosis required in at least one eye
At least one of the following MacTel features
- Hyperpigmentation that is outside of a 500 micron radius from the center of the foveaoutside of 500 micron radius
- Crystalline deposits
- Retinal opacification
- Right-angle vessels
- Inner/outer lamellar cavities
IS/OS and EZ area: Member must have an Inner Segment/Outer Segment (IS/OS) Photoreceptor (PR) break in the affected eye(s) and en face ellipsoid zone (EZ) between 0.16 mm^2 and 2.00 mm^2EZ area 0.16 mm^2 to 2.00 mm^2
BCVA: Member demonstrates a best corrected visual acuity (BCVA) score of 54 letters or better (20/80 or better)BCVA >= 54 letters (>= 20/80)
Prior implant: Member has not previously received an Encelto implant

Continuation / Repeat Treatment

Continuation Therapy

Policy statement on repeat treatment

Repeat treatment with Encelto for any indication is investigational

Safety and efficacy beyond one implant have not been studied; evidence is insufficient

Operational note: Clinical trials demonstrated benefits through 24 months for ellipsoid zone (EZ) area loss and pooled functional measures, but safety and efficacy beyond a single implant have not been established. Therefore, repeat implants are considered investigational and may be denied.

Not Medically Necessary / Exclusions

Not Medically Necessary

Situations where Encelto is not covered

Not medically necessary: Encelto is considered not medically necessary for members who do not meet the criteria set forth above

Provider Actions / Billing Impacts

Prior Authorization

Prior authorization required for Encelto

Authorization of up to 3 months may be granted when all initial therapy criteria are met; verify member benefits and exclusions prior to service.

J3403 (Revakinagene taroretcel-lwey; per implant) — effective 10/1/2025
J3490 (Unclassified drugs)
J3590 (Unclassified biologics)

Documentation Required

Documentation of diagnostic findings

Provider must document diagnosis of MacTel type 2 with evidence of fluorescein leakage, presence of at least one listed MacTel feature (e.g., hyperpigmentation outside a 500 µm radius from the foveal center, crystalline deposits, retinal opacification, right-angle vessels, inner/outer lamellar cavities), an IS/OS photoreceptor break with en face EZ measurement between 0.16 and 2.00 mm^2, best corrected visual acuity (BCVA) measurement (54 letters or better / 20/80 or better), and whether the member has previously received an Encelto implant.

Denial Risk

Repeat implant denial risk

Claims for repeat Encelto implants may be denied because repeat treatment is considered investigational and safety/efficacy beyond one implant has not been established.

J3403
J3490
J3590

Billing Rule

Dosing/administration limits

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

Clinical Evidence

MixedFunctional endpoints: mixed results across studies; pooled analyses show benefit signals in monocular reading speed and retinal sensitivity

68% / ~35%Pooled outcomes: 68% reduction in monocular reading speed loss and ~35% reduction in aggregate retinal sensitivity loss over 2 years

Evidence: Two identically designed Phase 3 trials (~120 patients each) randomized patients to Encelto or placebo and showed a statistically significant reduction in the rate of ellipsoid zone (EZ) area loss from baseline through 24 months. Pooled analyses indicated reductions in monocular reading speed loss (68% reduction over 2 years) and nearly a 35% reduction in aggregate retinal sensitivity loss by microperimetry. However, safety and efficacy beyond a single implant have not been established, and repeat treatment is considered investigational.

Background & Definitions

Background: Encelto (revakinagene taroretcel-lwey) is a therapy approved by the FDA for adults with idiopathic macular telangiectasia type 2 (MacTel). In two Phase 3 trials, treatment with Encelto demonstrated a statistically significant change in the rate of ellipsoid zone (EZ) area loss through 24 months, with pooled benefits in reading speed and retinal sensitivity. There are no data establishing safety or efficacy beyond a single implant; repeat treatment has not been studied and is considered investigational.

Term	Definition
BCVA	Best corrected visual acuity; policy references 54 letters or better (20/80 or better).
EZ	Ellipsoid zone (en face) area measured in mm^2; required between 0.16 and 2.00 mm^2 for eligibility.
IS/OS	Inner Segment/Outer Segment junction line photoreceptor break.

Revision History

2025-07-31policy_effectiveLatest

Policy effective date set to July 31, 2025 with criteria reflecting FDA-approved indication for Encelto; includes initial authorization criteria for a single 3-month implant (age ≥18, MacTel type 2 diagnosis with fluorescein leakage and at least one listed MacTel feature, IS/OS PR break with en face EZ 0.16–2.00 mm², BCVA ≥54 letters/20/80, and no prior Encelto implant), prohibition of repeat treatment as investigational, and assignment of J-code J3403 effective 10/01/2025.

2025-10-01coding_update

HCPCS J-code J3403 (Revakinagene taroretcel-lwey; per implant) becomes effective for billing.