CurrentColorado Rocky Mountain Health Plans | UnitedHealthcare Community PlanPolicy CS2026D0137F

Encelto™ (Revakinagene Taroretcel-Lwey) – Community Plan Medical Benefit Drug Policy

Defines UnitedHealthcare Community Plan medical benefit coverage for Encelto (revakinagene taroretcel-lwey) including eligibility/clinical criteria, monitoring, prescribing provider, dosing requirements, quantity limits (one treatment per eye per lifetime), and applicable procedure and diagnosis codes.

Policy Summary

PayerColorado Rocky Mountain Health Plans | UnitedHealthcare Community Plan

PolicyEncelto™ (Revakinagene Taroretcel-Lwey) – Community Plan Medical Benefit Drug Policy

Policy CodePolicy CS2026D0137F

Change TypeApplication/state language removal; archived prior version

Effective DateApr 1, 2026

Next Review Date

Key ActionAuthorization must be obtained and will be issued for no more than one treatment per eye, per lifetime and for no longer than 60 days from approval.

SourceLink

POLICY UPDATE CHANGES

Application section updated to remove Indiana and Louisiana language and to archive previous policy version CS2026D0137E.

1 per eye lifetimeAuthorized treatments per eye

>=18Minimum patient age

J3403Primary billing code

Coverage Summary

Coverage stance: covered_with_criteria. Scope summary: Defines UnitedHealthcare Community Plan medical benefit coverage for Encelto (revakinagene taroretcel-lwey) including eligibility/clinical criteria, monitoring, prescribing provider, dosing requirements, quantity limits (one treatment per eye per lifetime), and applicable procedure and diagnosis codes. Policy number: CS2026D0137F. Status: CURRENT. This policy covers a single surgical implant indication for adults with MacTel and is covered with specified criteria and limits.

Thresholds and key stats

Age>= 18 years

Authorization duration<= 60 days from approval

Lifetime treatments per eye<= 1 treatment per eye per lifetime

Authorized treatments per eye (stat)1 per eye lifetime

Minimum patient age (stat)>=18 years

Primary billing code (stat)J3403

Initial Therapy Criteria

Coverage Rationale / Proven Medical Necessity

Encelto is proven and medically necessary for one treatment per eye, per lifetime for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel) who meet ALL of the following:

Coverage Rationale / Proven Medical Necessity - Top Level

Age: Patient is at least 18 years of age>= 18 years
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 requirement: 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)
Monitoring requirement must be documented
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 approval<= 60 days from approval; <= 1 treatment per eye per lifetime
Limits both per-eye lifetime dose and authorization duration

Limits and Exclusions

Authorization limits: one treatment per eye per lifetime; authorizations issued for no more than 60 days from approval. Dosing: single surgical implant and dosing must follow the United States Food and Drug Administration approved labeling (billable as HCPCS J3403 per implant). Exclusions/setting limits: none explicitly listed in the brief; no specific excluded populations or settings are specified.

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required with limits

Authorization must be obtained and will be issued for no more than one treatment per eye, per lifetime and for no longer than 60 days from approval.

J3403
Limit: 1 per eye, per lifetime
Authorization duration: <= 60 days from approval

Documentation Required

Document diagnosis and monitoring plan

Provider must submit medical records/chart notes confirming diagnosis of non-proliferative MacTel type 2 in at least one eye and document plan for monitoring signs/symptoms of retinal tears/detachment.

Submit medical records (e.g., chart notes) confirming diagnosis of non-proliferative macular telangiectasia type 2 in at least one eye
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)

Documentation Required

Prescriber specialty requirement

Encelto must be prescribed by an ophthalmologist; prescriber specialty should be documented in the request.

Billing Rule

Dosing and billing

Dosing must follow FDA-approved labeling for Encelto; billing should reflect per-implant reporting (J3403).

Dosing per FDA labeling
Bill using HCPCS code J3403 (Revakinagene taroretcel-lwey, per implant)

Clinical Evidence Summary

-0.091Study 1: difference in EZ area loss (mm^2) at 24 months; Encelto 0.075 vs sham 0.166; p<0.0001

-0.049Study 2: difference in EZ area loss (mm^2) at 24 months; Encelto 0.111 vs sham 0.160; p<0.0186

≥2%Most common adverse reactions (≥2%): conjunctival hemorrhage; delayed dark adaptation; foreign body sensation; eye pain; suture complications; miosis; conjunctival hyperemia; vitreous hemorrhage; blurred vision; headache; cataract progression; severe vision loss

Background and evidence: Encelto is an allogeneic encapsulated cell-based gene therapy implant that secretes recombinant human ciliary neurotrophic factor (rhCNTF) indicated for adults with idiopathic macular telangiectasia type 2 (MacTel). Efficacy was demonstrated in two randomized, sham-controlled phase 3 trials conducted over 24 months.

Evidence - Primary endpoint results: Study 1 showed EZ area loss of 0.075 mm2 with Encelto versus 0.166 mm2 with sham (difference -0.091, 95% CI: -0.13, -0.06; p < 0.0001). Study 2 showed EZ area loss of 0.111 mm2 with Encelto versus 0.160 mm2 with sham (difference -0.049, 95% CI: -0.089, -0.008; p < 0.0186).

Evidence - Adverse reactions: The most common adverse reactions (≥2%) included conjunctival hemorrhage, delayed dark adaptation, foreign body sensation, eye pain, suture-related complications, miosis, conjunctival hyperemia, vitreous hemorrhage, blurred vision, headache, cataract progression, severe vision loss, and others; serious adverse reactions occurred in ~5% (suture-related complications and implant extrusion).

Background & Definitions

Encelto is administered as a single surgical implant performed by a qualified ophthalmologist; the implant contains retinal pigment epithelial cells that secrete rhCNTF. The therapy is intended to slow photoreceptor (EZ) area loss in adults with idiopathic MacTel; its mechanism is believed to involve targeting Müller glia to promote photoreceptor survival, though the full mechanism is not completely understood. Two phase 3 randomized, sham-controlled trials evaluated Encelto over 24 months.

MacTel: Macular telangiectasia type 2 is a neurodegenerative metabolic retinal disorder causing vascular changes, leakage, swelling, scarring, and photoreceptor damage in the macula; it most often occurs in middle-aged adults and can lead to vision loss.