RetiredUnitedHealthcarePolicy CSLA2025D0137A

Encelto (Revakinagene Taroretcel-Lwey) (for Louisiana Only) Retired April 1, 2026

Louisiana-only UnitedHealthcare Medical Benefit Drug Policy governing coverage and medical necessity criteria for Encelto (revakinagene taroretcel-lwey), including applicable HCPCS and ICD-10 codes, dosing/administration limits, and documentation requirements. Policy was effective Dec 1, 2025 to Mar 31, 2026 and retired April 1, 2026.

Policy Summary

PayerUnitedHealthcare

PolicyEncelto (Revakinagene Taroretcel-Lwey) (for Louisiana Only) Retired April 1, 2026

Policy CodePolicy CSLA2025D0137A

Change TypeCreated; Retired

Effective DateDec 1, 2025

Next Review Date

Key ActionObtain authorization prior to treatment; authorization will be issued for no more than one treatment per eye per lifetime and for no longer than 60 days from approval.

POLICY UPDATE CHANGES

New Medical Benefit Drug Policy effective 12/01/2025

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

1Treatments allowed per eye (lifetime)

60 daysAuthorization duration limit

18+Minimum patient age

J3403Primary billing code

Coverage Summary

Louisiana-only UnitedHealthcare Medical Benefit Drug Policy for Encelto (revakinagene taroretcel-lwey), policy number CSLA2025D0137A, effective December 1, 2025 through March 31, 2026 and retired on April 1, 2026. The policy applies only to Louisiana and establishes coverage and medical necessity criteria, applicable HCPCS and ICD-10 codes, dosing/administration limits, and documentation requirements for Encelto.

Coverage stance: covered_with_criteria. High-level coverage summary: Encelto is covered as medically necessary for adults meeting the policy’s criteria for idiopathic macular telangiectasia type 2 (MacTel), limited to one treatment per eye per lifetime with authorization issued for no longer than 60 days from approval.

Medically Necessary (Initial Therapy) Criteria

Medically Necessary (Coverage) Criteria

Encelto is proven and medically necessary for one treatment per eye, per lifetime for adults with idiopathic MacTel who meet ALL of the following:

Age: Patient is at least 18 years of age>= 18
Diagnosis documentation: Submission of medical records (e.g., chart notes) confirming diagnosis of non-proliferative macular telangiectasia type 2 (MacTel) in at least one eye
Monitoring: 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)
Prescriber: Encelto is prescribed by an ophthalmologist
Dosing is in accordance with the United States Food and Drug Administration approved labeling
Authorization limits: Authorization will be issued for no more than one treatment per eye per lifetime and for no longer than 60 days from approvallifetime treatments per eye = 1; authorization duration <= 60 days
Limits both lifetime treatments per eye (1) and authorization duration (≤ 60 days from approval)

Provider Actions & Billing Requirements

Prior Authorization

Authorization required with limits

Obtain authorization prior to treatment; authorization will be issued for no more than one treatment per eye per lifetime and for no longer than 60 days from approval.

J3403
Limits: no more than one treatment per eye per lifetime; authorization duration ≤ 60 days from approval

Documentation Required

Diagnosis and clinical documentation

Submit medical records (e.g., chart notes) confirming diagnosis of non-proliferative macular telangiectasia type 2 (MacTel) in at least one eye and documentation that patient is ≥18 years.

Documentation Required

Monitoring requirement

Document plan for monitoring signs and symptoms of retinal tears and/or retinal detachment (e.g., acute onset of flashing lights, floaters, and/or loss of visual acuity).

Billing Rule

Dosing per FDA labeling

Report dosing consistent with the FDA-approved labeling; implant product billed using J3403 per implant.

J3403

Applicable Codes

HCPCS - drug/implantHCPCSCovered

J3403

Revakinagene taroretcel-lwey, per implant

ICD-10 - diagnoses referencedICD-10

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

Clinical Evidence Summary

0.091 mm2 difference, p < 0.0001Phase 3 study 1 - EZ area loss difference

-0.049 mm2 difference, p < 0.0186Phase 3 study 2 - EZ area loss difference

5%Serious adverse reactions rate

Phase 3 trials demonstrated that Encelto slowed the rate of ellipsoid zone (EZ) area loss over 24 months versus sham: Study 1 reported EZ area loss of 0.075 mm2 with Encelto versus 0.166 mm2 with sham (difference 0.091, p < 0.0001); Study 2 reported EZ area loss of 0.111 mm2 with Encelto versus 0.160 mm2 with sham (difference -0.049, p = 0.0186).

Serious adverse reactions were observed in approximately 5% of patients and included suture-related complications (n = 5) and implant extrusion (n = 1).

Background & Definitions

Encelto is an allogeneic encapsulated cell-based gene therapy implant intended for adults with idiopathic macular telangiectasia type 2 (MacTel). The single surgical implant contains retinal pigment epithelial cells that secrete recombinant human ciliary neurotrophic factor (rhCNTF).

The device is placed via a single surgical procedure performed by a qualified ophthalmologist and is intended to slow retinal degeneration by delivering exogenous CNTF to potentially promote photoreceptor survival, although the mechanism is not completely understood.

Term	Definition
Encelto	Revakinagene taroretcel-lwey, an allogeneic encapsulated cell-based gene therapy implant secreting recombinant human ciliary neurotrophic factor (rhCNTF) for idiopathic MacTel.
MacTel	Macular telangiectasia type 2, a neurodegenerative retinal disease in which macular blood vessels become enlarged and leak, leading to photoreceptor loss and vision impairment.

Revision History

2025-12-01added

New Medical Benefit Drug Policy effective 12/01/2025. Policy created to define coverage criteria for Encelto in Louisiana.

2026-04-01revisedLatest

Retired policy; Louisiana plan membership disenrolled on Apr. 1, 2026. Policy retired effective 04/01/2026.