RetiredUnitedHealthcarePolicy CSLA2025D0137A

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

Defines UnitedHealthcare Community Plan coverage criteria for Encelto for treatment of adults with idiopathic macular telangiectasia type 2 (MacTel) in Louisiana; indicates single-treatment, per-eye lifetime authorization and associated requirements.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CSLA2025D0137A

Change TypeRetirementinitial issuance

Effective DateDec 1, 2025

Next Review Date

Key ActionObtain prior authorization and submit medical records confirming non-proliferative MacTel; authorization is limited to one treatment per eye per lifetime and issued for no more than 60 days.

SourceLink

POLICY UPDATE CHANGES

Retired policy; Louisiana plan membership disenrolled on Apr. 1, 2026.

New Medical Benefit Drug Policy effective 12/01/2025 establishing coverage criteria for Encelto.

1/eyeauthorized dosing limit

60 daysauthorization duration

J3403HCPCS code

≥18age requirement

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Coverage Criteria for Encelto

Initial Coverage (Medically Necessary) for Encelto

Covered when ALL of the following are met:

Initial authorization criteria: Patient is at least 18 years of age; and Submission of medical records (e.g., chart notes) confirming diagnosis of non-proliferative macular telangiectasia type 2 (MacTel) in at least one eye; and 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); and Encelto is prescribed by an ophthalmologist; and Dosing is in accordance with the United States Food and Drug Administration approved labeling; and 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.

Patients with neovascular (proliferative) macular telangiectasia type 2 (MacTel) were excluded from the clinical trials that support Encelto. For coverage under this policy, the diagnosis must be non-proliferative MacTel, confirmed by submission of medical records (for example, chart notes) documenting the condition in at least one eye. The policy’s enrollment criteria in the pivotal study required specific imaging and functional findings (IS/OS ellipsoid zone [EZ] break on SD‑OCT and adequate best corrected visual acuity), and excluded any patient with neovascular disease.

Requests that do not meet ALL of the policy criteria are not considered medically necessary. Required conditions include: the patient is an adult (age ≥ 18 years); medical records confirming non-proliferative MacTel in at least one eye; a monitoring plan for signs and symptoms of retinal tears or detachment; prescription by an ophthalmologist; dosing consistent with the FDA‑approved labeling; and compliance with the policy limits on treatment and authorization. Failure to satisfy any one of these requirements (including requests that exceed the lifetime limit of one treatment per eye or an authorization period longer than 60 days) will result in denial as not medically necessary.

Coding and Billing

Covered HCPCS Codes (reference)HCPCSCovered

J3403

Revakinagene taroretcel-lwey, per implant

Diagnosis Codes (reference)ICD-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 Requirements and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for Encelto. Authorizations are limited to a single treatment per eye, per lifetime. Approvals are valid for no longer than 60 days from the date of authorization. Ensure prior authorization is obtained before the procedure to avoid claim denials.

Single-treatment per eye, per lifetime
Authorization duration: ≤ 60 days from approval
Prior authorization required before procedure

Step Therapy

No step therapy requirements apply for Encelto; patients are not required to fail other therapies before authorization for this treatment.

Background

Macular telangiectasia type 2 (MacTel) is a neurodegenerative, metabolic disorder of the macula that can produce vessel dilation, leakage, swelling, scarring, and ultimately visual loss; neovascularization may occur in later stages. Encelto is an allogeneic encapsulated cell‑based implant composed of retinal pigment epithelial cells engineered to secrete recombinant human ciliary neurotrophic factor (rhCNTF). It is delivered by a single surgical procedure and evaluated in phase 3 trials for slowing progression of photoreceptor loss as measured by ellipsoid zone (EZ) area loss on spectral‑domain OCT. The pivotal studies enrolled adults with documented EZ breaks and sufficient visual acuity and excluded patients with neovascular MacTel; efficacy was assessed by change in EZ area loss over 24 months.

Definitions

Encelto — therapy overview

Device typeAllogeneic encapsulated cell-based implant administered via a single surgical procedure (subretinal implant)

Active substance / payloadRetinal pigment epithelial cells secreting recombinant human ciliary neurotrophic factor (rhCNTF)

Cell dose per implantContains approximately 200,000 to 440,000 retinal pigment epithelial cells per implant

Proposed mechanism of actionSecreted rhCNTF targets Müller glia and triggers signaling cascades that may promote photoreceptor survival (mechanism not completely understood)

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

EZ area loss — definition & measurement

Documentation Required

Required Documentation to Support Diagnosis

To support the diagnosis and medical necessity for Encelto, submit complete documentation including: chart notes confirming diagnosis of non-proliferative macular telangiectasia type 2 (MacTel) in at least one eye, patient age verification (≥ 18 years), documentation that an ophthalmologist will perform the procedure, and records showing planned monitoring for retinal tears or detachment. Include operative reports, ophthalmic exam findings, imaging (e.g., OCT, fundus photos) when available, and medication/orders showing dosing consistent with FDA labeling.

Chart notes confirming non-proliferative MacTel type 2 in ≥1 eye
Proof of age (≥ 18 years)
Ophthalmologist’s order or prescription
Planned monitoring and follow-up plan for retinal tears/detachment
Operative report and procedure plan
Relevant imaging: OCT, fundus photography when available
Medication/order showing FDA-consistent dosing