Encelto_Medical_Necessity_Criteria
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Defines medical necessity criteria for FDA-approved indication of Encelto for adults with idiopathic macular telangiectasia type 2 (MacTel), coverage for initial single implant (3-month authorization) and exclusion of repeat treatment/continuation. Also lists billing J-codes and general dosing limits consistent with labeling.
Policy effective date set to July 31, 2025 with criteria reflecting FDA-approved indication for Encelto.
Coverage Summary
Scope: Defines medical necessity criteria for the FDA-approved indication of Encelto (revakinagene taroretcel-lwey) for adults with idiopathic macular telangiectasia type 2 (MacTel), authorizing a single initial implant for up to 3 months when criteria are met and excluding repeat treatment. Coverage stance: mixed — initial single implant covered when criteria are met; repeat treatment not covered. Policy statement: Encelto is FDA-approved for treatment of adults with MacTel type 2; authorization of one implant for 3 months may be granted for patients meeting the specified criteria; repeat implants are considered investigational and are not covered. Policy number: 05.05.94. Effective date: 2025-07-31.
Initial Therapy Criteria (Authorization for 3 months)
Initial Therapy (Authorization for 3 months) — Idiopathic MacTel type 2
Authorization of 3 months may be granted for treatment of idiopathic macular telangiectasia type 2 (MacTel) in members 18 years and older when ALL of the following criteria are met:
Eligibility criteria
- Age: Member is 18 years of age or older
implicit from indication and authorization statement
- Diagnosis: Member must have a diagnosis of MacTel type 2 in at least one eye with evidence of fluorescein leakage typical of MacTel
diagnosis required in at least one eye
At least one of the following MacTel features
- Hyperpigmentation that is outside of a 500 micron radius from the center of the foveaoutside of 500 micron radius
- Crystalline deposits
- Retinal opacification
- Right-angle vessels
- Inner/outer lamellar cavities
- IS/OS and EZ area: Member must have an Inner Segment/Outer Segment (IS/OS) Photoreceptor (PR) break in the affected eye(s) and en face ellipsoid zone (EZ) between 0.16 mm^2 and 2.00 mm^2EZ area 0.16 mm^2 to 2.00 mm^2
- BCVA: Member demonstrates a best corrected visual acuity (BCVA) score of 54 letters or better (20/80 or better)BCVA >= 54 letters (>= 20/80)
- Prior implant: Member has not previously received an Encelto implant
Continuation / Repeat Treatment
Continuation Therapy
Policy statement on repeat treatment
Safety and efficacy beyond one implant have not been studied; evidence is insufficient
Operational note: Clinical trials demonstrated benefits through 24 months for ellipsoid zone (EZ) area loss and pooled functional measures, but safety and efficacy beyond a single implant have not been established. Therefore, repeat implants are considered investigational and may be denied.
Not Medically Necessary / Exclusions
Not Medically Necessary
Situations where Encelto is not covered
Applicable Codes
Provider Actions / Billing Impacts
Prior authorization required for Encelto
Authorization of up to 3 months may be granted when all initial therapy criteria are met; verify member benefits and exclusions prior to service.
Documentation of diagnostic findings
Provider must document diagnosis of MacTel type 2 with evidence of fluorescein leakage, presence of at least one listed MacTel feature (e.g., hyperpigmentation outside a 500 µm radius from the foveal center, crystalline deposits, retinal opacification, right-angle vessels, inner/outer lamellar cavities), an IS/OS photoreceptor break with en face EZ measurement between 0.16 and 2.00 mm^2, best corrected visual acuity (BCVA) measurement (54 letters or better / 20/80 or better), and whether the member has previously received an Encelto implant.
Dosing/administration limits
Approvals may be subject to dosing and administration limits consistent with FDA-approved labeling, accepted compendia, and evidence-based practice guidelines.
Clinical Evidence
Evidence: Two identically designed Phase 3 trials (~120 patients each) randomized patients to Encelto or placebo and showed a statistically significant reduction in the rate of ellipsoid zone (EZ) area loss from baseline through 24 months. Pooled analyses indicated reductions in monocular reading speed loss (68% reduction over 2 years) and nearly a 35% reduction in aggregate retinal sensitivity loss by microperimetry. However, safety and efficacy beyond a single implant have not been established, and repeat treatment is considered investigational.
Background & Definitions
Background: Encelto (revakinagene taroretcel-lwey) is a therapy approved by the FDA for adults with idiopathic macular telangiectasia type 2 (MacTel). In two Phase 3 trials, treatment with Encelto demonstrated a statistically significant change in the rate of ellipsoid zone (EZ) area loss through 24 months, with pooled benefits in reading speed and retinal sensitivity. There are no data establishing safety or efficacy beyond a single implant; repeat treatment has not been studied and is considered investigational.
| Term | Definition |
|---|---|
| BCVA | Best corrected visual acuity; policy references 54 letters or better (20/80 or better). |
| EZ | Ellipsoid zone (en face) area measured in mm^2; required between 0.16 and 2.00 mm^2 for eligibility. |
| IS/OS | Inner Segment/Outer Segment junction line photoreceptor break. |
Revision History
Policy effective date set to July 31, 2025 with criteria reflecting FDA-approved indication for Encelto; includes initial authorization criteria for a single 3-month implant (age ≥18, MacTel type 2 diagnosis with fluorescein leakage and at least one listed MacTel feature, IS/OS PR break with en face EZ 0.16–2.00 mm², BCVA ≥54 letters/20/80, and no prior Encelto implant), prohibition of repeat treatment as investigational, and assignment of J-code J3403 effective 10/01/2025.
HCPCS J-code J3403 (Revakinagene taroretcel-lwey; per implant) becomes effective for billing.
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