Is Encelto (revakinagene taroretcel-lwey) intravitreal implant indicated for a patient with macular telangiectasia type 2 (MacTel) and significant visual impairment?

Encelto for Macular Telangiectasia Type 2: Authorization Decision

Direct Recommendation

This request should be DENIED due to insufficient clinical documentation to verify eligibility criteria, specifically the absence of documented ellipsoid zone measurements, fluorescein angiography findings, and baseline ETDRS visual acuity testing required for Encelto approval.

Critical Documentation Deficiencies

The authorization request lacks essential clinical information mandated by the insurance criteria:

• No fluorescein angiography documentation demonstrating the characteristic leakage pattern and specific MacTel features (hyperpigmentation location, retinal opacification, crystalline deposits, right-angle vessels, or lamellar cavities) 1
• No spectral domain-OCT measurements of the photoreceptor inner segment/outer segment break in the ellipsoid zone (required range: 0.16 mm² to 2.00 mm²) 1
• No ETDRS visual acuity documentation confirming 54-letter score or better (20/80 or better) 1
• Only dark OCT images provided without interpretable measurements or office visit notes 1

What Encelto Is and Its Indication

Encelto (revakinagene taroretcel-lwey) is an encapsulated cell-based gene therapy containing allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic factor, approved in March 2025 as the first FDA-approved treatment specifically for idiopathic macular telangiectasia type 2 1. This is a one-time intravitreal implant per affected eye 1.

Required Eligibility Criteria Not Met

Based on the insurance criteria provided, the patient must meet ALL of the following, which cannot be verified:

Diagnostic Confirmation Requirements:

• Fluorescein angiography showing leakage PLUS at least one of five specific features with precise anatomical measurements 1
• Quantified ellipsoid zone break between 0.16-2.00 mm² on SD-OCT 1
• ETDRS visual acuity of 54 letters or better (20/80 or better) 1
• Steady fixation and clear media for quality imaging 1

Critical Exclusion Criteria to Rule Out:

The request must explicitly document absence of:

• Neovascular MacTel (no hemorrhage, hard exudate, subretinal/intraretinal fluid in either eye) 1
• Intraretinal hyperreflectivity on OCT 1
• Recent anti-VEGF therapy (none in affected eye ever; none in fellow eye within 3 months) 1
• Recent intravitreal steroid (within 3 months) 1

Clinical Context: Why This Matters

MacTel type 2 is a bilateral progressive disease causing neurosensory atrophy with characteristic vascular changes 2. For nonproliferative MacTel (which this patient likely has given no mention of neovascularization), there has historically been no proven effective treatment 2. Anti-VEGF agents like bevacizumab have shown no benefit in nonproliferative disease in multiple studies 3, 4, 5.

Encelto represents a paradigm shift as the first approved therapy, but its approval is contingent on precise patient selection criteria based on the pivotal trial parameters 1. The insurance criteria directly mirror these FDA approval parameters.

Common Pitfall: Inadequate Documentation

The most common reason for denial of novel gene therapies is incomplete baseline documentation. The provider submitted only:

• Email communication with diagnosis
• Dark OCT images without measurements
• No formal office visit note
• No fluorescein angiography
• No ETDRS visual acuity testing

Required Next Steps for Resubmission

The provider must submit:

1. Complete office visit note with detailed examination findings 1
2. Fluorescein angiography report with measurements of hyperpigmentation distance from foveal center, documentation of leakage pattern, and identification of specific MacTel features 1
3. SD-OCT with quantified measurements of ellipsoid zone break area in mm² 1
4. ETDRS visual acuity testing (not Snellen) showing 54-letter score or better 1
5. Documentation ruling out all exclusion criteria, particularly:
   • No evidence of neovascularization on FA or OCT 1
   • No intraretinal hyperreflectivity 1
   • Confirmation of no prior anti-VEGF or steroid treatments 1
   • Assessment of lens status per AREDS grading 1
   • Confirmation patient can discontinue antithrombotic therapy perioperatively 1

Medication Interaction Consideration

The patient is on losartan, diltiazem, and atorvastatin, which do not represent absolute contraindications. However, the criteria require ability to temporarily discontinue antithrombotic therapy to reduce implantation-related vitreous hemorrhage risk 1. The documentation does not address whether the patient is on aspirin or other antiplatelet agents, which must be clarified.

Bilateral Treatment Approach

The insurance criteria and FDA approval support one-time treatment per affected eye 1. The patient's plan to treat one eye first, then the fellow eye, is reasonable given this is a novel therapy with limited long-term safety data. However, both eyes must independently meet all eligibility criteria with separate documentation for each authorization request 1.