CurrentUnitedHealthcarePolicy 2025D0137B

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

Medical benefit drug policy governing coverage criteria and coding for Encelto for adults with idiopathic macular telangiectasia type 2 (MacTel); intended for UnitedHealthcare commercial plans and providers seeking prior authorization for this therapy.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy 2025D0137B

Change TypeOperationalcode list updated

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and submit medical records confirming diagnosis of non-proliferative MacTel type 2; authorization is limited to one treatment per eye per lifetime and no longer than 60 days from approval.

SourceLink

POLICY UPDATE CHANGES

Updated list of applicable HCPCS codes to reflect quarterly edits; replaced C9399 and J3590 with J3403.

Archived previous policy version 2025D0137A.

1lifetime implant allowed per eye

60authorization duration (days)

>=18minimum patient age

J3403HCPCS code

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Coverage Criteria for Encelto (revakinagene taroretcel-lwey)

Initial Therapy — Encelto

Encelto is proven and medically necessary for adults with idiopathic MacTel who meet ALL of the following for initial therapy:

Initial therapy criteria: Patient is at least 18 years of age; submission of medical records (e.g., chart notes) confirming diagnosis of non-proliferative macular telangiectasia type 2 (MacTel) in at least one eye; 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); Encelto is prescribed by an ophthalmologist; dosing is in accordance with the United States Food and Drug Administration approved labeling; authorization will be issued for no more than one treatment per eye per lifetime and for no longer than 60 days from approval.

All conditions must be met for coverage

Coverage determinations for Encelto are subject to the terms of the member’s specific benefit plan and any applicable state mandates. Some Certificates of Coverage may allow otherwise experimental or investigational therapies under defined conditions, and certain state laws can require coverage for off‑label uses in specific circumstances. When a state mandate applies, it takes precedence over the member’s benefit document. Providers should consult the member’s plan document and relevant state requirements when requesting authorization or submitting claims for Encelto.

This policy documents clinical criteria and administrative limits used by UnitedHealthcare for Encelto (revakinagene taroretcel‑lwey), but those rules may be superseded or modified by the member‑specific benefit plan or state law; confirm coverage eligibility prior to scheduling implantation or related services.

FDA approval status is provided for informational purposes only and does not by itself establish coverage. Encelto (revakinagene taroretcel‑lwey) is described in FDA materials as an allogeneic encapsulated cell‑based gene therapy indicated for adults with idiopathic macular telangiectasia type 2 (MacTel), but coverage under this policy requires that the member meet the medical necessity criteria and any applicable plan or legal requirements.

Providers must ensure that prescribing and use of Encelto conform to the FDA approved labeling and to the member’s benefit plan rules; the policy’s clinical criteria and administrative limits (for example, age, documentation, and authorization constraints) determine whether a given request will be covered.

Applicable Codes

Applicable HCPCS / drug codeHCPCSCovered

J3403

Revakinage taroretcel-lwey, per implant.

Relevant diagnosis codes (ICD-10)ICD-10

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

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

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

Prior authorization required
Authorization limit: maximum one treatment per eye per lifetime
Authorization duration limit: up to 60 days from approval

Step Therapy

No step therapy requirements are specified in this policy. Plan-specific or state-mandated requirements may differ and should be verified with the member's benefit document.

Background

Macular telangiectasia type 2 (MacTel) is a neurodegenerative metabolic disorder of the macula characterized by telangiectatic retinal vessels, leakage, retinal swelling, scarring, and potential neovascularization that can lead to progressive vision loss. Type 2 MacTel most often affects middle‑aged adults and can damage photoreceptors over time.

Encelto is an implantable allogeneic encapsulated cell‑based gene therapy that contains retinal pigment epithelial cells engineered to secrete recombinant human ciliary neurotrophic factor (rhCNTF). It is delivered via a single surgical implantation by a qualified ophthalmologist and is intended to support photoreceptor survival in patients with idiopathic MacTel. Coverage under this policy is limited to adults meeting the clinical criteria and monitoring requirements specified in the policy.

Definitions

Encelto — therapy definition

TermEncelto (revakinagene taroretcel-lwey)

Therapy typeAllogeneic encapsulated cell-based gene therapy implant

Mechanism / active agentImplant contains 200,000 to 440,000 retinal pigment epithelial cells that secrete recombinant human ciliary neurotrophic factor (rhCNTF)

IndicationTreatment of adults with idiopathic macular telangiectasia type 2 (MacTel)

DeliverySingle surgical implantation performed by a qualified ophthalmologist

Idiopathic macular telangiectasia type 2 (MacTel) — definition

Term

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy 2025D0137B

Change TypeOperationalcode list updated

Effective DateOct 1, 2025

Next Review DateN/A

SourceLink

On This Page

Documentation Required

Required Documentation

Submit supporting medical records (e.g., chart notes) confirming diagnosis of non‑proliferative macular telangiectasia type 2 (MacTel) in at least one eye. Documentation should also confirm: patient is ≥18 years of age, ophthalmologist prescribing the product, planned monitoring for retinal tears/detachment, and dosing consistent with FDA‑approved labeling.

Required: medical records/chart notes confirming non‑proliferative MacTel type 2 in ≥1 eye
Required: documentation of age (≥18 years)
Required: documentation that prescriber is an ophthalmologist
Required: documentation of monitoring plan for retinal tears/detachment
Required: dosing plan consistent with FDA labeling

Denial Risk

Triggers for Potential Denial

Potential reasons for denial include lack of required documentation (diagnostic records, prescriber type, monitoring plan), patient age <18 years, diagnosis not consistent with non‑proliferative macular telangiectasia type 2 (MacTel), or requests exceeding the lifetime/authorization-duration limits.

Denial trigger: Missing or insufficient medical records to confirm MacTel diagnosis
Denial trigger: Patient under 18 years of age
Denial trigger: Diagnosis not non‑proliferative MacTel type 2
Denial trigger: Request exceeds one treatment per eye per lifetime
Denial trigger: Request exceeds approved authorization duration (>60 days)

Idiopathic macular telangiectasia type 2 (MacTel)

DescriptionA neurodegenerative metabolic disorder of the macula characterized by telangiectatic (enlarged, leaky) retinal vessels leading to fluid leakage, swelling, scarring, potential neovascularization, and photoreceptor damage that can result in vision loss.

EpidemiologyMost common type of macular telangiectasia; often affects middle-aged adults; estimated ~0.1% prevalence (~250,000 people in the U.S.)

Associated conditionsLinked to diabetes and coronary artery disease; both sexes equally affected