Currentculinary health fundPolicy N/A

Encelto (revakinagene taroretcel-lwey) intravitreal implant - Coverage Criteria

This policy governs prior authorization and medical necessity criteria for coverage of Encelto intravitreal implants to treat idiopathic macular telangiectasia type 2 in adults for members of the payer.

Policy Summary

Payerculinary health fund

PolicyEncelto (revakinagene taroretcel-lwey) intravitreal implant - Coverage Criteria

Policy CodePolicy N/A

Change TypeClarified dosing and retreatment exclusionsrevised approval duration

Effective DateN/A

Next Review DateMar 4, 2026

Key ActionObtain prior authorization demonstrating age ≥18, eligible BCVA, no prior Encelto treatment to request one implant per affected eye.

SourceLink

POLICY UPDATE CHANGES

Policy intent was clarified to approve one implant per affected eye(s) and added requirement that patient is not receiving re-treatment of eyes previously treated with Encelto.

Dosing verbiage updated to state 'one Encelto implant per affected eye(s) [two implants per patient]' administered by a single surgical intravitreal procedure.

Approval duration was changed from 1 month (30 days) to 3 months (90 days).

1maximum dosing per eye

2maximum implants per patient

≥18minimum patient age

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage & Medical Necessity Criteria

Initial Therapy - FDA-Approved Indication

Covered when ALL of the following are met

FDA-Approved Indication: MacTel Type 2: Approve a one-time use in each treated eye (one implant per affected eye; total of two implants per patient) if the patient meets ALL of the following (A–E)

[chunk 6]

A: Patient is ≥ 18 years of age

[chunk 6]

B: Patient is not receiving re-treatment of eye(s) previously treated with Encelto

[chunk 6]

C: Patient does not have neovascular (or proliferative) MacTel

[chunk 6]

E: Medication is administered by or under the supervision of an ophthalmologist

[chunk 4,6]

Requests for coverage that fall outside the stated authorization criteria will generally be denied. The policy explicitly states that retreatment of previously treated eye(s) is excluded, and coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. Prior authorization is recommended and approvals are limited to the parameters described in the FDA-approved indication (one implant per affected eye; up to two implants per patient) and supporting documentation must demonstrate that the request meets all required criteria.

Repeat implantation (re‑treatment) of an eye that has previously received an Encelto implant is not approved. The policy specifies that Encelto is authorized as a one-time use in each treated eye (one implant per affected eye) and notes that there are no data regarding re‑treatment, so requests to re‑implant an eye previously treated with Encelto will not be approved.

Coding, Age, and Visual Acuity Thresholds

Coding referencedmixed

N/A	No explicit CPT/HCPCS/ICD codes listed in document

Best-corrected visual acuity (BCVA) — Eligibility

BCVA (ETDRS)≥ 54 ETDRS letters

BCVA (Snellen)≥ 20/80 Snellen

Measurement methodEarly Treatment Diabetic Retinopathy Study (ETDRS) chart or Snellen chart

Age — Minimum age for coverage

Minimum age≥ 18 years

Age requirement sourceFDA‑Approved Indication criteria

ApplicabilityApplies to initial one-time implant per affected eye

Provider Requirements, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Encelto. Approvals are for one implant per affected eye and are issued for a 90-day (3-month) duration to allow for the one-time treatment of the affected eye(s). Encelto must be prescribed by or in consultation with an ophthalmologist or a physician who specializes in the condition being treated. Requests for doses outside the established dosing in this policy will be reviewed case-by-case by a clinician (e.g., Medical Director or Pharmacist).

One implant per affected eye (maximum two implants per patient)
Authorization duration: 90 days (3 months)
Medication must be administered by or under supervision of an ophthalmologist

Step Therapy

No step therapy is required for Encelto.

Clinical Background

Macular telangiectasia type 2 (MacTel) is a rare, slowly progressive neurodegenerative disease of the macula that can lead to photoreceptor loss and central visual impairment over years. Encelto is an allogeneic, encapsulated cell‑based intravitreal implant delivering retinal pigment epithelial cells that express recombinant CNTF intended to promote photoreceptor survival. Clinical development and the FDA indication focus on adult patients with idiopathic MacTel type 2; eligibility in the authorization criteria includes adult age (≥18 years) and preserved central vision as defined by best‑corrected visual acuity thresholds used in trials (e.g., ≥54 ETDRS letters or ≈20/80 Snellen).

Definitions & Product Details

Encelto — Product description

Product typeAllogeneic encapsulated cell-based intravitreal implant

Cell content200,000 to 440,000 allogeneic retinal pigment epithelial cells per implant

Active substanceCells express recombinant human ciliary neurotrophic factor (CNTF)

Route of administrationSingle surgical intravitreal procedure

Documentation Required

Required Documentation for Prior Authorization

Documentation to support prior authorization must be provided and should include patient age, diagnosis (Macular Telangiectasia Type 2, idiopathic), BCVA using ETDRS or Snellen (document BCVA of ≥54 ETDRS letters or ≥20/80 Snellen as applicable), confirmation that the request is for initial treatment (not re-treatment of an eye previously treated with Encelto), absence of neovascular/proliferative MacTel, administration plan (to be performed by or under supervision of an ophthalmologist), and prior treatment history if relevant.

Patient age (≥ 18 years)
Diagnosis: Macular Telangiectasia Type 2, idiopathic
BCVA measurement (ETDRS or Snellen) with documented value
Statement confirming this is not retreatment of an eye previously treated with Encelto
Documentation that neovascular/proliferative MacTel is absent
Planned administrator: ophthalmologist or under ophthalmologist supervision
Prior ocular treatment history, if applicable