CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Encelto (revakinagene taroretcel-lwey) (Intravitreal Implant) coverage criteria

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Defines coverage, authorization, and clinical criteria for Encelto intravitreal implant for members (Medicaid, Commercial, Medicare) with MacTel type 2; applies to providers and authorized treatment facilities performing implantation.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEncelto (revakinagene taroretcel-lwey) (Intravitreal Implant) coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNov 1, 2025

Last ReviewAug 20, 2025

Next Review DateAug 20, 2025

Key ActionObtain prior authorization demonstrating all coverage criteria; coverage limited to one Encelto implant per affected eye per lifetime.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1maximum doses covered

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CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Encelto (revakinagene taroretcel-lwey) (Intravitreal Implant) coverage criteria

Customize your policy alerts

Sign up for all Neighborhood Health Plan of Rhode Island policy alerts

Know when Neighborhood Health Plan of Rhode Island releases new policies or updates existing guidance.

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Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEncelto (revakinagene taroretcel-lwey) (Intravitreal Implant) coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNov 1, 2025

Last ReviewAug 20, 2025

Next Review DateAug 20, 2025

Key ActionObtain prior authorization demonstrating all coverage criteria; coverage limited to one Encelto implant per affected eye per lifetime.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1maximum doses covered

Coverage Criteria for Encelto (revakinagene taroretcel-lwey)

Initial coverage (one-time implant)

Covered when ALL of the following are met:

General and administrative requirements: Member age between 18 and 65; free of ocular and/or peri‑ocular infection; no known hypersensitivity to Endothelial Serum Free Media (Endo SFM); Encelto prescribed by an ophthalmologist; implantation performed at an authorized treatment facility by an ophthalmologist; member will be monitored for vision loss and for infectious endophthalmitis at baseline and periodically during treatment; member will be monitored for signs/symptoms of retinal tears or retinal detachment; temporary discontinuation of antithrombotic medications prior to insertion surgery; no prior Encelto implant in the treatment eye; Medicare members who previously received this medication within the past 365 days are not subject to Step Therapy requirements.

Diagnosis and disease-specific inclusion: Diagnosis of idiopathic macular telangiectasia type 2 in at least one eye as evidenced by typical fluorescein leakage AND at least one supportive feature: hyperpigmentation outside a 500‑micron radius from foveal center, retinal opacification, crystalline deposits, right‑angle vessels, or inner/outer lamellar cavities; presence of an IS/OS photoreceptor break and ellipsoid zone (EZ) loss measured by SDOCT between 0.16 mm2 and 2.00 mm2; best corrected visual acuity (BCVA) of 54 ETDRS letters or better (≈20/80) on ETDRS chart.

Exclusionary ocular conditions: No neovascular MacTel; no evidence of advanced disease that would preclude treatment (e.g., significant retinal scarring or atrophy); no intraretinal or subretinal neovascularization; no central serous chorioretinopathy; no pathologic myopia; no significant media or corneal opacities; no history of vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty; lens opacities not exceeding specified standards and no lens removal within prior 3 months or YAG laser within 4 weeks; no history of ocular herpes virus; no intraretinal hyperreflectivity by OCT; no foveal involvement.

Coverage excludes eyes with neovascular MacTel and any condition suggesting advanced retinal damage that would prevent clinical benefit. Specifically excluded findings include intraretinal or subretinal neovascularization (e.g., hemorrhage, hard exudate, subretinal or intraretinal fluid), central serous chorioretinopathy, pathologic myopia, significant media or corneal opacities, evidence of prior vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty, recent lens removal (within 3 months) or recent YAG laser (within 4 weeks), history of ocular herpes, intraretinal hyperreflectivity on OCT, or foveal involvement.

Encelto implantation is a one-time procedure per affected eye. Coverage cannot be renewed and repeat implantation or renewal is considered not medically necessary.

Billing and Coding

HCPCSHCPCS

J3590

Unclassified biologics

NDCNDC

82958-0501-xx

Encelto single-dose implant that contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing rhCNTF

Covered Diagnosis CodesICD-10Covered

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

inv-07: Ellipsoid zone (EZ) loss measured by SDOCT — eligibility range

Ellipsoid zone (EZ) loss eligibility rangeEZ loss measured by SDOCT between 0.16 mm2 and 2.00 mm2

Required OCT findingPresence of an inner segment–outer segment (IS/OS) photoreceptor break on SDOCT

Measurement modalitySpectral domain optical coherence tomography (SDOCT)

Exclusion if outside rangeRequests excluded if EZ loss is <0.16 mm2 or >2.00 mm2

inv-08: Best corrected visual acuity (BCVA) — threshold (54 ETDRS letters / 20/80)

BCVA threshold (ETDRS)54 letters or better on ETDRS chart

Provider Requirements, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Encelto. Authorization is limited to one dose per affected eye (one single‑dose implant containing 200,000–440,000 allogeneic retinal pigment epithelial cells expressing rhCNTF) and may not be renewed.

Prior authorization required
Limit: Max 1 dose per eye per lifetime

Denial Risk

Denial Risk / Exclusion Triggers

Requests may be denied if the member does not meet age, prior‑treatment, disease, or surgical eligibility criteria, or if there is prior evidence that would preclude benefit from implantation.

Denial triggers include: age outside 18–65 years; previous Encelto implant in the same eye; presence of neovascular MacTel; evidence of advanced retinal scarring or atrophy that precludes treatment; intraretinal or subretinal neovascularization, central serous chorioretinopathy, pathologic myopia, significant media or corneal opacities, history of vitrectomy or certain ocular surgeries, recent lens removal or YAG laser, ocular herpes history, intraretinal hyperreflectivity by OCT, or foveal involvement.

Definitions and Diagnostic Features

inv-14: Encelto — implant description and product details

Product descriptionEncelto is a single-dose intravitreal implant containing 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic factor (rhCNTF)

Cell lineNTC-201-6A cell line

Dose and administrationRecommended dose: one Encelto implant per affected eye; surgically implanted intravitreally by a qualified ophthalmologist in an operating room under aseptic conditions

MechanismAllogeneic encapsulated cell-based delivery of rhCNTF to the retina to slow MacTel type 2 progression

FDA contextFirst FDA-approved treatment for MacTel type 2 supported by Phase 3 studies showing reduced rate of EZ area loss over 24 months

inv-15: MacTel Type 2 diagnostic features — required fluorescein leakage plus supportive signs

Background

Encelto is an allogeneic, encapsulated cell‑based intravitreal implant that delivers recombinant human ciliary neurotrophic factor (rhCNTF) via retinal pigment epithelial cells (NTC-201-6A cell line). The implant is a single‑dose surgical device containing approximately 200,000–440,000 allogeneic retinal pigment epithelial cells engineered to release rhCNTF into the vitreous, intended to slow progression of macular telangiectasia type 2 by reducing ellipsoid zone area loss.

Documentation Required

Documentation submitted with the prior authorization request should include evidence supporting the diagnosis and eligibility for treatment, and details of planned administration and monitoring.

Diagnosis: documentation of MacTel type 2 in at least one eye, including fluorescein angiography showing typical fluorescein leakage.
Supporting findings: at least one additional feature such as hyperpigmentation >500 µm from foveal center, retinal opacification, crystalline deposits, right angle vessels, or inner/outer lamellar cavities.
Imaging: spectral domain OCT (SD‑OCT) demonstrating IS/OS photoreceptor break and ellipsoid zone loss area between 0.16 mm² and 2.00 mm²; absence of intraretinal or subretinal neovascularization.
Visual acuity: BCVA score documented (54 letters or better / ~20/80 ETDRS equivalent).
Treatment plan: prescribing ophthalmologist and authorized treatment facility for implantation; confirmation no prior Encelto in treatment eye; plan for perioperative monitoring for vision loss, endophthalmitis, retinal tears/detachment; plan to temporarily discontinue antithrombotic medications prior to surgery.
Prior treatments: dates of any intravitreal steroid or anti‑VEGF therapies (must be >3 months prior for non‑neovascular MacTel).