Encelto (revakinagene taroretcel-lwey) for idiopathic macular telangiectasia type 2 — Coverage Criteria
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Policy governing prior authorization, coverage criteria, and documentation requirements for Encelto implants to treat adults with idiopathic macular telangiectasia type 2 (MacTel) under Blue Cross Blue Shield - Iowa.
Coverage criteria for Encelto for MacTel type 2 with specific diagnostic and imaging requirements were specified.
Repeat treatment with Encelto is considered investigational and not covered.
Required documentation and prescriber specialty requirements for prior authorization were defined.
Coverage Criteria for Encelto (revakinagene taroretcel-lwey)
Initial Therapy
Covered when ALL of the following are met for members 18 years and older:
Initial coverage conditions
- Diagnosis requirement: Member has a diagnosis of MacTel type 2 in at least one eye with evidence of fluorescein leakage typical of MacTel and at least one of: hyperpigmentation outside a 500 micron radius from the center of the fovea; retinal opacification; crystalline deposits; right-angle vessels; or inner/outer lamellar cavities.
- Imaging requirement: Presence of an IS/OS photoreceptor (Inner Segment–Outer Segment) break in the affected eye(s) and en face ellipsoid zone (EZ) area between 0.16 mm^2 and 2.00 mm^2 measured by spectral domain–optical coherence tomography (SD-OCT).EZ area 0.16–2.00 mm^2
- Visual acuity requirement: Best corrected visual acuity (BCVA) score of 54 letters or better (20/80 or better).>= 54 letters
- Treatment history: Member has not previously received an Encelto implant (no prior Encelto implants).
- Prescriber: Medication is prescribed by or in consultation with an ophthalmologist.
Prior authorization may be granted for an initial period of 3 months when all criteria are met.
Continuation Therapy
Continuation of therapy
Repeat implants are not covered/considered investigational.
Encelto (revakinagene taroretcel-lwey) is not medically necessary for members who do not meet the specific coverage criteria detailed in this policy. Members must satisfy all required diagnostic, imaging, visual acuity, treatment-history, and prescriber conditions for coverage consideration; failure to meet those criteria will result in a determination of nonmedical necessity.
Repeat implants of Encelto are considered investigational and are not covered because safety and efficacy beyond a single implant have not been established. Accordingly, any request for additional Encelto implants or for members who do not meet the policy’s specified criteria will be determined to be not medically necessary.
Billing and Coding
Prior Authorization and Provider Requirements
Prior Authorization Required
Prior authorization is required. Include confirmation of diagnosis, SD-OCT results, and BCVA in the submission. Approvals for idiopathic macular telangiectasia type 2 may be granted for up to 3 months when all clinical criteria are met.
- Diagnosis confirmation required
- Spectral domain-optical coherence tomography (SD-OCT) results required
- Best corrected visual acuity (BCVA) results required
- Authorization may be for up to 3 months when criteria are met
Dosing Limits May Apply
Approvals may be subject to dosing limits consistent with FDA-approved labeling, accepted compendia, and evidence-based practice guidelines.
- Dosing limits aligned with FDA labeling and evidence-based guidelines
Required Documentation for Prior Authorization
Submit medical records (e.g., chart notes and/or laboratory reports) documenting confirmation of diagnosis, SD-OCT results (including IS/OS PR break and en face EZ measurements when applicable), and BCVA results to support the prior authorization review.
- Medical records (chart notes and/or lab reports) documenting diagnosis confirmation
- SD-OCT results, including measurements relevant to MacTel when applicable
- Best corrected visual acuity (BCVA) results
Prescriber Specialty Required
Medication must be prescribed by or in consultation with an ophthalmologist. Documentation should include the prescriber specialty or evidence of ophthalmology consultation.
- Prescriber must be an ophthalmologist or document consultation with an ophthalmologist
- Include prescriber specialty in submission
Not Medically Necessary If Criteria Not Met
Encelto is considered not medically necessary for members who do not meet the policy criteria.
- Denial risk for members who do not meet coverage criteria
Background
Idiopathic macular telangiectasia type 2 (MacTel type 2) is a primarily bilateral, neurodegenerative macular disease that most commonly presents in middle age and can progress to a proliferative form with macular vascular proliferation and leakage leading to central vision loss. Prior to the availability of Encelto, there were no FDA‑approved therapies specifically for nonproliferative MacTel; vascular endothelial growth factor (VEGF) inhibitors are used to treat proliferative disease but do not address earlier neurodegenerative stages. The policy reflects that evidence for safety and efficacy of repeat Encelto implants beyond a single implant is currently insufficient.
Key Definitions
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