CurrentUnitedHealthcarePolicy CS2026D0137F

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

Defines UnitedHealthcare Medical Benefit Drug Policy coverage and requirements for Encelto, an allogeneic encapsulated cell-based gene therapy for adults with idiopathic macular telangiectasia type 2; applies to commercial community plan members except where state-specific rules override.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS2026D0137F

Change TypeNo material change

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and submit supporting medical records confirming non‑proliferative MacTel type 2 before a single Encelto implant per eye.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

onetreatment per eye, per lifetime authorized

60 daysauthorization duration from approval

≥18 yrsminimum patient age for treatment

J3403HCPCS code listed for product

H35.071-3, H35.079ICD-10 codes listed

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Coverage and Medical Necessity Criteria

Medical necessity criteria

Covered when ALL of the following are met

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

All listed conditions must be satisfied for coverage.

Authorization is limited to one treatment per eye, per lifetime. The policy does not cover multiple lifetime implants in the same eye or uses beyond the United States Food and Drug Administration–approved dosing. Additionally, any approval issued will be for no longer than 60 days from approval.

Encelto is not covered when any of the following apply: the patient is younger than 18 years of age; there is no documentation of a diagnosis of non‑proliferative idiopathic macular telangiectasia type 2 (MacTel) in at least one eye; or the product is used in a population or manner contrary to the FDA‑approved labeling (for example, dosing outside the approved regimen or treatment of proliferative/neovascular MacTel, for which anti‑VEGF agents are the established standard of care).

Billing and Diagnosis Codes

Encelto HCPCSHCPCSCovered

J3403

Revakinagene taroretcel-lwey, per implant.

Diagnosis CodesICD-10

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

What Providers Must Do

Prior Authorization

Prior authorization required — one implant per eye, lifetime limit

Prior authorization is required for Encelto. Authorization is limited to a single surgical implant per eye and will be issued for no more than one treatment per eye, per lifetime.

Applicable HCPCS: J3403 (Revakinagene taroretcel-lwey, per implant).

Step Therapy

Step therapy context — anti‑VEGF standard for proliferative MacTel

Anti‑VEGF agents are the established standard of care for most proliferative (neovascular) forms of MacTel; the policy notes this clinical context but does not mandate a step therapy sequence prior to Encelto.

Documentation Required

Clinical Background

Macular telangiectasia type 2 (MacTel) is a neurodegenerative metabolic disorder that most often affects middle‑aged adults and is associated with diabetes and coronary artery disease. In MacTel type 2, macular blood vessels become dilated and leak, causing retinal swelling and scarring that can damage photoreceptors and lead to progressive vision loss; proliferative disease may involve growth of new blood vessels beneath the macula. Encelto is an allogeneic encapsulated cell‑based implant placed during a single surgical procedure by a qualified ophthalmologist; the implant contains retinal pigment epithelial cells that secrete recombinant human ciliary neurotrophic factor (rhCNTF) intended to slow photoreceptor degeneration, although its precise mechanism of action is not fully understood.

Product and Endpoint Definitions

Encelto — definition

TermEncelto

DescriptionAn allogeneic encapsulated cell-based gene therapy implant containing 200,000 to 440,000 retinal pigment epithelial cells that secrete recombinant human ciliary neurotrophic factor (rhCNTF).

IndicationIndicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel).

ProcedurePlaced via a single surgical procedure performed by a qualified ophthalmologist as an intraocular implant.

MechanismImplant secretes rhCNTF intended to promote photoreceptor survival by targeting Müller glia; exact mechanism not completely understood.

EZ area loss — definition

Policy Revision History

2026-04-01Policy effective dateLatest

Policy effective date established as April 1, 2026 (CS2026D0137F) and archived previous policy version CS2026D0137E.

2026-04-01Application updates

Application section updated to list state-specific applicability (including Arizona, Kansas, North Carolina, Ohio, Texas) and associated guidance.