Background

Encelto is an allogeneic encapsulated cell-based gene therapy delivered via an intravitreal implant for adults with idiopathic macular telangiectasia type 2 (MacTel). It continually delivers CNTF (ciliary neurotrophic factor) to preserve photoreceptor function and slow retinal degeneration.

Policy (Criteria)

• Patient has a diagnosis of macular telangiectasia, type 2, in at least one eye, as evidenced by typical fluorescein leakage and at least one (1) other of the following features of disease:
  • hyperpigmentation outside a 500-micron radius from the center of the fovea
  • retinal opacification
  • crystalline deposits
  • right angle vessels
  • inner/outer lamellar cavities; AND
• Patient is at least 18 years of age; AND
• Patient is free of ocular and/or peri-ocular infections; AND
• Patient does not have a known hypersensitivity to Endothelial Serum Free Media (Endo SFM); AND
• Patient’s will be monitored for signs and symptoms of vision loss (e.g., BCVA, etc.) and infectious endophthalmitis at baseline and periodically during treatment; AND
• Patient will be monitored for signs and symptoms of retinal tears and/or retinal detachment (e.g., acute onset of flashing lights, floaters, and/or loss of visual acuity); AND
• Patient does not have evidence of other ocular disease that would preclude treatment of MacTel; AND
• Patient will temporarily discontinue antithrombotic medications (e.g., oral anticoagulants, aspirin, nonsteroidal anti-inflammatory drugs, etc.) prior to the insertion surgery; AND
• Patient has not received intravitreal steroid therapy or intravitreal anti–vascular endothelial growth factor (VEGF) therapy, for non-neovascular MacTel within the last 3 months; AND
• Patient does NOT have neovascular macular telangiectasia; AND
• Patient does not have evidence of advanced disease that would preclude treatment of MacTel (e.g., significant retinal scarring and atrophy with retinal tissue that cannot be preserved); AND
• Patient has an inner segment–outer segment junction line (IS/OS) photoreceptor break and area of ellipsoid zone (EZ) loss, as measured by spectral domain optical coherence tomography (SD-OCT), at between 0.16 mm2 and 2.00 mm2: AND
• Patient does not have evidence of any of the following:
  • Intraretinal neovascularization or subretinal neovascularization (SRNV), as evidenced by hemorrhage, hard exudate, subretinal fluid, or intraretinal fluid in either eye
  • Central serous chorioretinopathy in either eye
  • Pathologic myopia in either eye
  • Significant media or corneal opacities in either eye
  • History of vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty
  • Any of the following lens opacities: cortical opacity > standard 3, posterior subcapsular opacity > standard 2, or nuclear opacity > standard 3
  • Lens removal in previous 3 months or yttrium-aluminum-garnet (YAG) laser treatment within 4 weeks
  • History of ocular herpes virus in either eye
  • Evidence of intraretinal hyperreflectivity by optical coherence tomography (OCT)

References

1. Encelto [package insert]. Cumberland, RI; Neurotech Pharm., Inc; March 2025.
2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2025. URL www.clinicalpharmacilogy-ip.com Accessed 4/30/25.
3. DRUGDEX System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2025 April 30].
4. DynaMed [database online]. Ipswich, MA: EBSCO Information Services.; 2025. URL http://www.dynamed.com. Accessed 4/30/25.
5. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2025 [cited 2025 April 30]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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