Currentculinary health fundPolicy N/A

Ophthalmology - Gene Therapy - Encelto Utilization Management Medical Policy

Defines prior authorization and medical necessity criteria for coverage of Encelto for adults with idiopathic macular telangiectasia type 2, including dosing and prescribing provider requirements; applies to claims under Culinary Health Fund.

Policy Summary

Payerculinary health fund

PolicyOphthalmology - Gene Therapy - Encelto Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeMaterial revisions and clarifications

Effective DateN/A

Next Review DateMay 21, 2025

Key ActionObtain prior authorization and document diagnosis, age ≥18, that this is not a re-treatment, baseline BCVA, and that an ophthalmologist will perform or supervise the implant procedure.

SourceLink

POLICY UPDATE CHANGES

Policy intent was clarified to approve one implant per affected eye(s) and dosing verbiage revised to state one implant per affected eye (two implants per patient) administered by a single surgical intravitreal procedure.

A requirement that the patient is not receiving re-treatment of eye(s) previously treated with Encelto was added.

Overview section was revised to include additional information about mechanism, cell counts per implant, and inclusion BCVA in pivotal studies.

one-timeapproved implants per affected eye

200k-440kcells per Encelto implant

BCVA ≥54visual acuity threshold

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Coverage and Medical Necessity Criteria

FDA-Approved Indication

Covered when ALL of the following are met for idiopathic MacTel type 2:

Main criteria

Visual acuity options: Either BCVA ≥54 ETDRS letters OR BCVA 20/80 Snellen or betterBCVA ≥54 ETDRS letters OR Snellen 20/80

(redundant top-level placeholder, not used)

Re-treatment of an eye previously treated with Encelto is explicitly not recommended for approval. Encelto is intended as a one-time use per treated eye (one implant per affected eye), and there are no data regarding re-treatment to support repeat implantation.

Coverage of Encelto is limited to the situations listed in the Recommended Authorization Criteria. Coverage is not recommended for circumstances outside those criteria; the criteria will be updated as new published data become available.

Requests seeking re-treatment of eyes previously treated with Encelto are considered not recommended and unsupported because there are no data regarding re-treatment. Such requests are therefore not recommended for approval.

Billing Codes and Clinical Thresholds

Covered/affected codesmixed

affected codes

No explicit CPT/HCPCS/ICD codes listed in document; policy references 'affected codes' for prior authorization.

Best-corrected visual acuity (BCVA) — coverage threshold

BCVA threshold (ETDRS)≥54 ETDRS letters

BCVA threshold (Snellen)20/80 Snellen or better

ApplicabilityApplies when patient meets ALL FDA‑approved indication criteria for idiopathic MacTel type 2 (adult, not a re‑treatment, no neovascular disease, administered by/under supervision of an ophthalmologist)

Prior Authorization, Documentation, and Denial Conditions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals are for a one-time implant per affected eye (maximum two implants per patient) and are issued for a 30-day (one month) standard approval duration to allow the single surgical intravitreal procedure. Encelto must be prescribed by or in consultation with an ophthalmologist or a physician who specializes in the condition being treated. Requests for doses or regimens outside the dosing documented in policy will be reviewed case-by-case by a clinician (e.g., Medical Director or Pharmacist).

One-time use per affected eye (one implant per eye; up to two implants per patient).
Standard approval duration: 30 days.
Prescriber requirement: ophthalmologist or specialist in the treated condition.
Unlisted dosing/ regimens reviewed case-by-case by clinician.

Note

Reserved

Reserved callout block.

Clinical Background

Macular telangiectasia type 2 (MacTel) is a degenerative macular condition characterized by progressive photoreceptor loss and central vision decline over years. Encelto is an allogeneic, encapsulated retinal pigment epithelial cell implant designed to deliver recombinant human CNTF and is administered as a single intravitreal surgical procedure with one implant per affected eye to promote photoreceptor survival in idiopathic MacTel type 2.

Drug/Product Definition

Encelto product description (revakinagene taroretcel-lwey intravitreal implant)

Product descriptionAllogeneic encapsulated retinal pigment epithelial (RPE) cell implant expressing recombinant human ciliary neurotrophic factor (CNTF)

Cell count per implantEach implant contains 200,000 to 440,000 allogeneic RPE cells

Dose and procedureOne Encelto implant per affected eye delivered via a single surgical intravitreal procedure by a qualified ophthalmologist

IndicationTreatment of idiopathic macular telangiectasia type 2 (MacTel) in adults

Documentation Required

Required Documentation

Documentation required at time of request: diagnosis of Macular Telangiectasia Type 2 (idiopathic); patient age ≥ 18 years; statement that this is not a re‑treatment of an eye previously treated with Encelto; baseline best‑corrected visual acuity (BCVA) using ETDRS letters or Snellen equivalent and indicate which chart was used; confirmation patient does not have neovascular/proliferative MacTel; and documentation that administration will be by or under supervision of an ophthalmologist.

Diagnosis: Macular Telangiectasia Type 2, idiopathic.
Age: ≥ 18 years.
Not a re‑treatment of an eye previously treated with Encelto.
Baseline BCVA documented: ETDRS (letters) or Snellen (e.g., 20/80) and chart specified.
Documentation that patient does not have neovascular (proliferative) MacTel.
Administration will be by or under supervision of an ophthalmologist.