CurrentViva Health PlanPolicy IC-0793

Encelto™ (revakinagene taroretcel-lwey) for MacTel Type 2

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This policy governs prior authorization and medical-necessity coverage for Encelto administered by intravitreal implantation in adults with idiopathic macular telangiectasia type 2, including eligibility, exclusions, dosing limits, documentation, coding, and authorization duration.

Policy Summary

PayerViva Health Plan

PolicyEncelto™ (revakinagene taroretcel-lwey) for MacTel Type 2

Policy CodePolicy IC-0793

Change TypeNo material change

Effective DateN/A

Last ReviewSep 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation for one dose per affected eye; authorization may not be renewed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 implantRecommended dose per affected eye

2 unitsMaximum billable units

18+Minimum member age

0.16–2.00 mm²Required EZ loss area

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CurrentViva Health PlanPolicy IC-0793

Encelto™ (revakinagene taroretcel-lwey) for MacTel Type 2

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Sign up for vivahealthplan Policy IC-0793 alerts

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Policy Summary

PayerViva Health Plan

PolicyEncelto™ (revakinagene taroretcel-lwey) for MacTel Type 2

Policy CodePolicy IC-0793

Change TypeNo material change

Effective DateN/A

Last ReviewSep 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation for one dose per affected eye; authorization may not be renewed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 implantRecommended dose per affected eye

2 unitsMaximum billable units

18+Minimum member age

0.16–2.00 mm²Required EZ loss area

Coverage Criteria

Initial Approval Criteria

Covered when all applicable criteria are met.

Initial approval criteria

General eligibility and safety: Member is at least 18 years of age; does not have an FDA-labeled contraindication to Encelto, including ocular or periocular infection or known hypersensitivity to Endo SFM; will be monitored at baseline and periodically during treatment for vision loss and infectious endophthalmitis; will be monitored for retinal tears or retinal detachment; does not have other ocular disease that would preclude MacTel treatment; will temporarily discontinue antithrombotic medications before insertion surgery; and has not received intravitreal steroid or anti-VEGF therapy for non-neovascular MacTel within the previous 3 months.Age ≥18 years; no qualifying intravitreal steroid or anti-VEGF therapy within 3 months
All listed conditions are required.
MacTel type 2 diagnosis
- ONE of the following additional disease features: Hyperpigmentation outside a 500-micron radius from the center of the fovea.
- Retinal opacification.
- Crystalline deposits.
- Right-angle vessels.
- Inner/outer lamellar cavities.
Disease severity and imaging: Member does not have neovascular MacTel or advanced disease that would preclude treatment, such as significant retinal scarring and atrophy with retinal tissue that cannot be preserved; and has an IS/OS photoreceptor break with ellipsoid-zone loss measured by SD-OCT.EZ loss area 0.16–2.00 mm²
Required absence of ocular conditions: Member does not have intraretinal or subretinal neovascularization; central serous chorioretinopathy; pathologic myopia; significant media or corneal opacity; a history of vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty; cortical lens opacity greater than standard 3, posterior subcapsular opacity greater than standard 2, or nuclear opacity greater than standard 3; lens removal within the previous 3 months or YAG laser treatment within 4 weeks; a history of ocular herpes virus; or OCT evidence of intraretinal hyperreflectivity.
Neovascular findings include hemorrhage, hard exudate, subretinal fluid, or intraretinal fluid in either eye.

Renewal Criteria

Renewal is not available; any continued authorization must remain within the initial authorization duration.

Renewal limitation: The duration of authorization has not been exceeded; however, prior authorization validity may not be renewed.

Renewal requests are not authorized.

Other Macular Telangiectasia Types

Other forms of macular telangiectasia are not automatically approved under the listed indication.

Case-by-case review: Requests for use in members with other forms of macular telangiectasia, including type 1 disease, are reviewed on a case-by-case basis.

Case-by-case review does not establish automatic coverage.

Treatment is excluded for members with an FDA-labeled contraindication, including ocular or periocular infection or known hypersensitivity to Endo SFM; neovascular MacTel; or advanced disease that precludes treatment, such as significant retinal scarring and irreversible atrophy. Coverage is also excluded when specified ocular conditions or histories are present, including intraretinal or subretinal neovascularization, central serous chorioretinopathy, pathologic myopia, significant media or corneal opacity, prior vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty, specified lens opacities, recent lens removal or YAG laser treatment, ocular herpes history, or OCT evidence of intraretinal hyperreflectivity.

Coverage is limited to one Encelto implant per affected eye. The maximum is two billable units per dose and over time, based on administration to both eyes. Initial prior authorization may not be renewed.

Coding and Clinical Parameters

Covered HCPCS CodesHCPCSCovered

J3403

Revakinagene taroretcel-lwey, per implant; 1 billable unit = 1 implant

Covered NDC CodesNDCCovered

82958-0501-xx

Encelto single-dose implant that contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing rhCNTF (NTC-201-6A cell line)

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

Minimum Member Age

Minimum ageAt least 18 years

Eligibility statusThe member must be at least 18 years of age for prior authorization validity

Coverage populationCoverage applies to adults meeting the policy’s medical-necessity criteria

SD-OCT IS/OS Photoreceptor Break and EZ Loss

Imaging modalitySpectral-domain optical coherence tomography (SD-OCT)

Required findingIS/OS photoreceptor break with ellipsoid-zone (EZ) loss

Authorization and Provider Requirements

Prior Authorization

Initial Prior Authorization Required

Prior authorization is required for initial treatment. If approved, authorization is valid for one dose per affected eye.

Initial authorization validity: one dose per affected eye.

Documentation Required

Required Clinical Documentation

Every authorization request must include supporting clinical documentation related to the medical-necessity criteria. Submit records by direct upload through the PA web portal or by fax.

Medical records and chart notes.
Laboratory results and confirmatory diagnostic testing.
Documentation of diagnosis, step therapy, and applicable clinical markers, including genetic and mutational testing, supporting initiation.

Treatment Background

Encelto (revakinagene taroretcel-lwey) is an intravitreal implant containing approximately 200,000 to 440,000 allogeneic retinal pigment epithelial cells that express recombinant human ciliary neurotrophic factor (rhCNTF). It is administered by surgical intravitreal implantation to provide the rhCNTF-expressing cells for treatment of idiopathic macular telangiectasia type 2.

Clinical Definition

Idiopathic Macular Telangiectasia (MacTel Type 2)

DiagnosisIdiopathic macular telangiectasia type 2 (MacTel Type 2) in at least one eye

Required diagnostic evidenceTypical fluorescein leakage plus at least one additional disease feature

Additional featuresHyperpigmentation outside a 500-micron radius from the foveal center, retinal opacification, crystalline deposits, right-angle vessels, or inner/outer lamellar cavities

Denial Risk

Failure to Meet Clinical Criteria

Authorization may be denied when any required clinical criterion is not met. The member must meet the age, diagnosis, monitoring, contraindication, treatment-history, and ocular-disease requirements below.

Member is at least 18 years of age.
Member has MacTel type 2 in at least one eye, evidenced by typical fluorescein leakage and at least one additional feature: hyperpigmentation outside a 500-micron radius from the foveal center, retinal opacification, crystalline deposits, right-angle vessels, or inner/outer lamellar cavities.
Member does not have FDA-labeled contraindications, including ocular or periocular infection or known hypersensitivity to Endo SFM.
Member will be monitored at baseline and periodically for vision loss, infectious endophthalmitis, retinal tears, and retinal detachment.
Member has no other ocular disease that would preclude MacTel treatment and no advanced disease that would preclude treatment, such as significant retinal scarring and atrophy with retinal tissue that cannot be preserved.
Member does not have neovascular MacTel, intraretinal or subretinal neovascularization, hemorrhage, hard exudate, subretinal or intraretinal fluid, central serous chorioretinopathy, pathologic myopia, significant media or corneal opacities, or OCT evidence of intraretinal hyperreflectivity.
Member will temporarily discontinue antithrombotic medications, such as oral anticoagulants, aspirin, or NSAIDs, before insertion surgery.
Member has not received intravitreal steroid or anti-VEGF therapy for non-neovascular MacTel within the previous 3 months.
SD-OCT demonstrates an IS/OS photoreceptor break and EZ loss measuring 0.16 mm² to 2.00 mm².
Member has none of the following disqualifying histories or findings: vitrectomy, penetrating keratoplasty, trabeculectomy, trabeculoplasty, specified lens opacities, lens removal within 3 months, YAG laser treatment within 4 weeks, or ocular herpes virus in either eye.