CurrentUnitedHealthcarePolicy CS2025D0137B

Encelto (Revakinagene Taroretcel-Lwey) — Medical Benefit Drug Policy

Defines UnitedHealthcare's medical benefit drug coverage for a single Encelto implant per eye for adults with idiopathic macular telangiectasia type 2 (MacTel), including documentation and prescribing requirements and monitoring. Affects providers submitting coverage requests for UnitedHealthcare members except where state-specific exceptions apply.

Policy Summary

PayerUnitedHealthcare

PolicyEncelto (Revakinagene Taroretcel-Lwey) — Medical Benefit Drug Policy

Policy CodePolicy CS2025D0137B

Change TypeCoverage cap and coding updates

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization for Encelto and submit medical records confirming MacTel diagnosis; authorizations are limited to one treatment per eye and up to 60 days.

SourceLink

POLICY UPDATE CHANGES

Authorization limited to one treatment per eye per lifetime and for no longer than 60 days from approval.

Policy does not apply to the state of Arizona; refer to the state's Medicaid clinical policy.

Applicable HCPCS codes updated; replaced C9399 and J3590 with J3403.

onetreatment permitted per eye per lifetime

60 daysmaximum authorization duration

J3403HCPCS code for Encelto

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Coverage Criteria

Medical necessity criteria

Covered when ALL of the following are met:

Encelto coverage criteria: 1) Submission of medical records (e.g., chart notes) confirming diagnosis of non-proliferative macular telangiectasia type 2 (MacTel) in at least one eye; 2) Patient is at least 18 years of age; 3) Patient will be monitored for signs and symptoms of retinal tears and/or retinal detachment (e.g., acute onset of flashing lights, floaters, and/or loss of visual acuity); 4) Dosing is in accordance with the United States Food and Drug Administration approved labeling; 5) Encelto is prescribed by an ophthalmologist; 6) Authorization will be issued for no more than one treatment per eye per lifetime and for no longer than 60 days from approval.

This policy does not apply to the state of Arizona. For Encelto coverage determinations in Arizona, refer to the state's Medicaid clinical policy as noted in the application guidance.

Coverage is limited to one treatment per eye per lifetime. Repeat treatments beyond a single implant in the same eye are not authorized under this policy.

Coding

Covered HCPCS CodesHCPCSCovered

J3403

Revakinagene taroretcel-Iwey, per implant

Relevant ICD-10 Diagnosis CodesICD-10

H35.073	Retinal telangiectasis, bilateral
H35.079	Retinal telangiectasis, unspecified eye
H35.071	Retinal telangiectasis, right eye
H35.072	Retinal telangiectasis, left eye

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization will be issued for no more than one Encelto treatment per eye per lifetime and for an authorization duration of no longer than 60 days from approval.

Authorization limit: maximum 1 Encelto treatment per eye per lifetime
Authorization duration: up to 60 days from approval

Step Therapy

There are no step therapy requirements stated for Encelto. Coverage is contingent on meeting the documented clinical criteria and the drug being prescribed by an authorized clinician (ophthalmologist).

No step therapy required
Prescribing clinician: ophthalmologist
Coverage contingent on meeting clinical and documentation criteria

Background

Macular telangiectasia type 2 (MacTel) is a neurodegenerative macular disorder that typically affects middle-aged adults and is characterized by vascular leakage, potential neovascularization, and progressive photoreceptor damage leading to vision loss. Encelto is an allogeneic encapsulated cell-based implant designed to secrete recombinant human ciliary neurotrophic factor (rhCNTF) with the aim of promoting photoreceptor survival. Pivotal phase 3 trials evaluated the effect of Encelto on photoreceptor integrity using the rate of ellipsoid zone (EZ) area loss as the primary endpoint and demonstrated slowing of EZ area loss versus sham over 24 months.

Definitions

Encelto — product definition

ProductEncelto (revakinagene taroretcel-Iwey) — an allogeneic encapsulated cell‑based gene therapy implant containing retinal pigment epithelial cells that secrete recombinant human ciliary neurotrophic factor (rhCNTF)

Implant cell loadContains approximately 200,000 to 440,000 retinal pigment epithelial cells placed into the eye during a single surgical procedure

Mechanism of actionSecretes rhCNTF intended to target Muller glia and trigger signaling cascades that may promote photoreceptor survival; exact mechanism not completely understood

Indication (documented)Indicated for treatment of adults with idiopathic macular telangiectasia type 2 (MacTel)

AdministrationSingle surgical implantation performed by a qualified ophthalmologist (one implant per eye)

Documentation Required

Required Documentation

Submission of medical records (e.g., chart notes) confirming diagnosis and other supporting clinical documentation is required. Documentation must include confirmation of non-proliferative macular telangiectasia type 2 (MacTel) in at least one eye, patient age ≥ 18 years, and monitoring plan for retinal tears or detachment.

Required documentation: medical records confirming diagnosis of non-proliferative MacTel type 2 in ≥1 eye
Required documentation: evidence patient is ≥ 18 years of age
Required documentation: documentation that patient will be monitored for signs/symptoms of retinal tears or detachment (e.g., acute onset of flashing lights, floaters, loss of visual acuity)