CurrentCareSourcePolicy N/A

Ophthalmology Gene Therapy — Encelto (revakinagene taroretcel-lwey) Utilization Management Medical Policy

Policy governs prior authorization and medical necessity criteria for coverage of Encelto intravitreal implant for adults with idiopathic macular telangiectasia type 2 (MacTel Type 2) under CareSource in North Carolina.

Policy Summary

PayerCareSource

PolicyEncelto (revakinagene taroretcel-lwey) — Ophthalmology Gene Therapy Utilization Management

Policy CodePolicy N/A

Change TypeDosing addedoverview expanded

Effective DateN/A

Next Review DateMay 21, 2025

Key ActionSubmit prior authorization with documentation that patient is ≥18, has idiopathic MacTel Type 2 without neovascular disease, meets BCVA thresholds, and will receive one Encelto implant per affected eye administered by or under supervision of an ophthalmologist.

SourceLink

POLICY UPDATE CHANGES

Overview section was revised to include additional information about gene therapy.

Document includes dosing recommendation of one Encelto implant per affected eye administered by a single surgical intravitreal procedure.

oneEncelto implant approved per affected eye

18+Minimum patient age for approval (years)

BCVA ≥54 / ≥20/80Visual acuity eligibility thresholds

Prior AuthAuthorization process

2025-05-21Policy review

Coverage and Medical Necessity Criteria

FDA-Approved Indication

Approve one implant per affected eye if ALL of the following are met (A, B, C, and D):

A: Age: Patient is >= 18 years of age>=18 years

B: Disease type: Patient has idiopathic Macular Telangiectasia Type 2 and does not have neovascular (proliferative) MacTel

C: Visual acuity

C.i: BCVA >=54 letters on ETDRS charts>=54 ETDRS letters

Policy Summary

PayerCareSource

PolicyEncelto (revakinagene taroretcel-lwey) — Ophthalmology Gene Therapy Utilization Management

Policy CodePolicy N/A

Change TypeDosing addedoverview expanded

Effective DateN/A

Next Review DateMay 21, 2025

SourceLink

On This Page

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Authorization, Documentation, and Denial Guidance

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended. Approvals are provided for the duration noted in the policy and require that Encelto be prescribed by or in consultation with a physician who specializes in the condition treated (e.g., ophthalmologist). Requests for doses outside the established dosing in this policy will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist). Automation: None.

All approvals require documentation that the patient meets the Recommended Authorization Criteria and Dosing for Macular Telangiectasia (MacTel) Type 2, Idiopathic.
Approvals are provided for the duration noted in the policy and may be extended if the patient continues to meet criteria and dosing.
Requests for non-standard dosing will be reviewed on a case-by-case basis by clinical staff.

Step Therapy

No step therapy requirements specified for Encelto under this policy.

Documentation Required

Documentation Required for Prior Authorization

Approval requires documentation that the patient meets ALL criteria in the Recommended Authorization Criteria, including diagnosis of Idiopathic Macular Telangiectasia (MacTel) Type 2 and supporting clinical information (e.g., best-corrected visual acuity using ETDRS or Snellen, absence of neovascular/proliferative MacTel, and that the medication will be administered by or under the supervision of an ophthalmologist).

Diagnosis: Idiopathic MacTel Type 2.
Age: ≥ 18 years.
Visual acuity: BCVA of 54 ETDRS letters or better OR 20/80 Snellen or better, as specified in criteria.
Documentation that patient does NOT have neovascular (proliferative) MacTel.
Confirmation that dosing/administration will be a single intravitreal implant per affected eye performed or supervised by an ophthalmologist.

Denial Risk

Denial Triggers

Requests that do not meet the Recommended Authorization Criteria, or requests for indications or circumstances not listed in the policy, are not recommended for approval.

Requests for coverage outside the FDA-approved indication (Idiopathic MacTel Type 2) or without required supporting documentation are grounds for denial.
Non-standard dosing requests may be denied if insufficient clinical justification is provided.

Key Definitions

Encelto — definition and formulation

Generic and trade nameEncelto (revakinagene taroretcel-lwey intravitreal implant)

Product typeAllogeneic encapsulated cell-based gene therapy implant containing human ciliary neurotrophic factor (CNTF)

Implant contentEach implant contains approximately 200,000 to 440,000 human CNTF–secreting cells

Route and administrationIntravitreal implant administered by a single surgical intravitreal procedure

MacTel Type 2 — definition and clinical description

Condition nameMacular Telangiectasia Type 2 (MacTel Type 2)

PathologyA rare, slowly progressive neurodegenerative macular disease with abnormal widening of blood vessels around the fovea

Clinical courseProgressive photoreceptor loss and central visual impairment that may produce blurring, distortion, and loss of central vision over 10–20 years

Distinguishing featureType 2 is the more common form characterized by abnormal dilated vessels around the fovea (non-neovascular unless proliferative MacTel is present)

OpenPayer

Ophthalmology Gene Therapy — Encelto (revakinagene taroretcel-lwey) Utilization Management Medical Policy

Coverage and Medical Necessity Criteria

Coding and Clinical Thresholds

Authorization, Documentation, and Denial Guidance

Therapy Background and Context

Key Definitions