CurrentColorado Rocky Mountain Health PlansPolicy IEXD0137.02

Encelto (Revakinagene Taroretcel-Lwey) — Medical Benefit Drug Policy (Individual Exchange)

Defines medical benefit drug coverage and prior authorization requirements for Encelto for adults with idiopathic macular telangiectasia type 2 under Individual Exchange plans (excludes MA, NV, NY).

Policy Summary

PayerColorado Rocky Mountain Health Plans

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

Policy CodePolicy IEXD0137.02

Change TypeOperational — HCPCS code updated

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization and submit medical records confirming non-proliferative MacTel type 2; use HCPCS code J3403 and request no more than one treatment per eye per lifetime.

SourceLink

POLICY UPDATE CHANGES

Applicable HCPCS code list updated to replace J3590 with J3403.

1 per eyeauthorized treatment frequency

60 daysauthorization duration

J3403HCPCS code

Adults ≥18age eligibility

excludes MA, NV, NYapplicable states

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Coverage Criteria

Covered Indications

Covered when ALL of the following are met:

Eligibility and documentation: Patient is at least 18 years of age; submission of medical records (e.g., chart notes) confirming a diagnosis of non-proliferative macular telangiectasia type 2 (MacTel) in at least one eye; Encelto is prescribed by an ophthalmologist; dosing is in accordance with the FDA‑approved labeling; 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); authorization is limited to one treatment per eye per lifetime and for no longer than 60 days from approval.

Includes requirement for ophthalmologist prescriber and monitoring for retinal complications.

Coverage under this policy is limited to one treatment per eye, per lifetime. Member-specific benefit plan documents and any applicable state mandates may further restrict or modify coverage; where state mandates apply they supersede this policy. Experimental, investigational, or unproven coverage determinations (including any exceptions to the lifetime limit) must be made in accordance with the member's certificate of coverage and relevant plan provisions.

FDA approval is informational only and FDA approval alone is not a basis for coverage. Coverage decisions must reference the member-specific benefit plan document, and any applicable state mandates or benefit considerations should be applied when determining eligibility or exceptions.

Coding

Applicable HCPCS CodesHCPCSCovered

J3403

Revakinagene taroretcel-lwey, per implant

Relevant ICD-10 Diagnosis CodesICD-10

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

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Frequency/Duration Limits

Prior authorization is required. Authorization will be issued for no more than one treatment per eye per lifetime and for no longer than 60 days from approval. Requests for >1 treatment per eye lifetime or for an authorization duration >60 days will be denied.

Limit: one treatment per eye per lifetime
Authorization duration: maximum 60 days from approval
Requests exceeding these limits will be denied

Step Therapy

Step Therapy / Benefit Considerations

No step therapy is specified in this policy. Coverage decisions for experimental, investigational, or unproven treatments and any applicable mandate for off-label use must follow the member-specific benefit plan document and applicable state laws. Refer to the Policy and Procedure addressing treatment of serious rare diseases when applicable.

Refer to member benefit for coverage of experimental/unproven treatments

Background

Macular telangiectasia type 2 (MacTel) is a neurodegenerative metabolic disorder of the macula that can lead to progressive vision loss. Encelto (revakinagene taroretcel-lwey) is an allogeneic encapsulated cell-based gene therapy implant indicated for adults with idiopathic MacTel and is intended to secrete recombinant human CNTF to potentially support photoreceptor survival. Clinical use of Encelto aims to slow progression of ellipsoid zone (IS/OS) photoreceptor layer loss; treatment must follow FDA-approved dosing and is performed by a qualified ophthalmologist. Benefit considerations and member-specific plan language determine whether coverage applies beyond the conditions set forth in this policy.

Definitions

Encelto — product description, implant details and indication

ProductEncelto (revakinagene taroretcel-lwey)

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).

AdministrationSingle surgical procedure performed by a qualified ophthalmologist to place the implant into the eye (per FDA labeling/trials).

Mechanism (proposed)Implant secretes rhCNTF which is thought to target Müller glia and trigger signaling that may promote photoreceptor survival; exact mechanism not completely understood.

EZ area loss (IS/OS PR break) — measurement definition used in trials

Policy Summary

PayerColorado Rocky Mountain Health Plans

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

Policy CodePolicy IEXD0137.02

Change TypeOperational — HCPCS code updated

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization and submit medical records confirming non-proliferative MacTel type 2; use HCPCS code J3403 and request no more than one treatment per eye per lifetime.

SourceLink

On This Page

State mandates for off-label use may supersede policy language

Documentation Required

Required Documentation for Diagnosis

Submit medical records (e.g., chart notes) confirming the diagnosis of non-proliferative idiopathic macular telangiectasia type 2 (MacTel) for at least one eye. Documentation should clearly support the diagnosis and clinical findings.

Required: medical records/chart notes confirming MacTel type 2 diagnosis in at least one eye
Include supporting clinical findings and diagnostic testing as applicable (e.g., retinal imaging)

Documentation Required

Prescriber and Monitoring Requirements

Encelto must be prescribed by an ophthalmologist. The patient must be monitored for signs and symptoms of retinal tears and/or retinal detachment (for example, acute onset of flashing lights, floaters, and/or loss of visual acuity). Monitoring and follow-up documentation should be maintained in the medical record.

Prescriber: ophthalmologist
Monitoring: watch for retinal tears or retinal detachment (flashing lights, floaters, loss of visual acuity)
Document monitoring and follow-up in the medical record

DefinitionEZ area loss refers to loss area in the ellipsoid zone (IS/OS photoreceptor layer) measured in mm² by SD-OCT and used as the primary efficacy endpoint in trials.

Measurement methodMeasured by Spectral‑Domain Optical Coherence Tomography (SD‑OCT) as the area of photoreceptor IS/OS (EZ) break in mm².

Enrollment eligibility range (trials)Patients enrolled required an IS/OS PR break in EZ between 0.16 and 2.00 mm².

Outcome usePrimary endpoint: rate of change in EZ area loss from baseline to month 24 in randomized trials evaluating Encelto versus sham.