Medical Drug Criteria (MDC) Medical Drug Criteria (MDC)
Policy Num: P1.002.016
Policy Name: Revakinagene taroretcel-lwey (Encelto) Intravitreal Implant
Policy ID: [P1.002.016] [Ac/MDC/P+ ] [0.00.00]
Last Review: September 22, 2025
Next Review: September 20, 2026
Related Policies: None
| Popultation Reference No. | Populations |
|---|---|
| 1 | Individuals:
|
Encelto (revakinagene taroretcel-lwey) is a cell-based implant designed to continuously deliver recombinant human ciliary neurotrophic factor (rhCNTF) within the retina. It is indicated for the treatment of adult patients with idiopathic macular telangiectasia type 2, non-proliferative, to slow photoreceptor degeneration and preserve visual function.
To establish the medical necessity criteria for Encelto under Triple-S health plans, consistent with FDA labeling, NCCN recommendations where applicable and Medicare coverage guidance
Coverage of Encelto is provided when ALL the following are met:
1. Patient is 18 years or older.
2. Confirmed diagnosis of idiopathic MacTel Type 2, non-proliferative, by a retina specialist.
3. Evidence on SD-OCT of ellipsoid zone (EZ) loss area between 0.16 mm² and 2.00 mm².
4. Best corrected visual acuity (BCVA) of 20/80 or better (≥ 54 ETDRS letters).
5. At least one of the following clinical features: hyperpigmentation outside 500 μm from the fovea, crystalline deposits, right-angle vessels, retinal opacification, or lamellar cavitations (outer/inner).
Exclusions: Encelto will NOT be covered if:
Evidence of neovascularization or proliferative MacTel.
Active ocular or periocular infection.
Known hypersensitivity to Endothelial Serum Free Media (Endo-SFM).
Severe ocular comorbidities (advanced glaucoma, retinopathy, uncontrolled uveitis).
Recent ocular surgery (lens extraction, vitrectomy, YAG capsulotomy) that interferes with assessment.
Encelto is a one-time implant per affected eye; no repeat implantation is expected.
Implantation must be performed by a qualified retina surgeon under sterile conditions.
Monitoring:
Routine follow-up with OCT and visual acuity testing at regular intervals up to 24 months.
Monitor for retinal tears, detachment, vitreous hemorrhage, infection, or implant extrusion.
FDA Approval: Granted in 2024 for the treatment of idiopathic MacTel Type 2 (non-proliferative).
Clinical trials (Phase 2/3) demonstrated that Encelto significantly slowed the loss of the ellipsoid zone compared with sham implantation, preserving photoreceptor integrity and visual function. Safety signals include ocular surgical complications, risk of retinal detachment, vitreous hemorrhage, and local implant-related events. Long-term monitoring confirms reduced progression of central retinal degeneration in eligible patients.
FDA PI (2024). Encelto is indicated for adult patients with idiopathic MacTel Type 2.
AAO (American Academy of Ophthalmology): Acknowledges novel role of encapsulated cell therapy for retinal degenerative disease.
NCCN: No direct oncology guideline applies; policy aligns with FDA approval and retinal society recommendations.
None
As stated in the policy.
Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.
1. FDA. Encelto (revakinagene taroretcel-lwey) Prescribing Information. 2024. https://www.fda.gov/media/185972/download
2. Encelto Official Site. Clinical Study Design and Efficacy. https://www.encelto.com/ecp/efficacy-study-design/
3. Kaiser Permanente Formulary. Encelto. 2025. https://healthy.kaiserpermanente.org
| Codes | Number | Description |
|---|---|---|
| HCPCS | J9999 | Not otherwise classified, antineoplastic drugs |
| ICD-10 | C43.0 | Malignant melanoma of lip |
| C43.10-C43.122 | Malignant melanoma of eyelid, including canthus | |
| C43.20-C43.22 | Malignant melanoma of ear and external auricular canal | |
| C43.30-C43.39 | Malignant melanoma of other and unspecified parts of face | |
| C43.4 | Malignant melanoma of scalp and neck | |
| C43.51-C43.59 | Malignant melanoma of trunk | |
| C43.60 – C43.62 | Malignant melanoma of upper limb, including shoulder | |
| C43.70 – C43.72 | Malignant melanoma of lower limb, including hip | |
| C43.8 | Malignant melanoma of overlapping sites of skin | |
| C43.9 | Malignant melanoma of skin, unspecified |
As per payment guidelines
| Date | Action | Description |
|---|---|---|
| 9/22/2025 | NEW MDC | Medical Drug Criteria approved at the September 2025 Pharmacy Criteria Meetting. |