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Prior Authorization Criteria for Revakinagene Taroretcel-lwey (Encelto) Effective November 1, 2025

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Effective for dates of service on or after November 1, 2025, prior authorization will be required for revakinagene taroretcel-lwey (Encelto) (procedure code J3403).

Revakinagene taroretcel-lwey (Encelto) is an allogeneic encapsulated cell-based gene therapy indicated for the treatment of adults who have type 2 idiopathic macular telangiectasia (MacTel).

Treatment with revakinagene taroretcel-lwey (Encelto) is limited to one implant per eye, per lifetime.

Prior Authorization Criteria

Prior authorization requests for revakinagene taroretcel-lwey (Encelto) treatment will only be considered for an eye that has not previously received an ocular implant.

Prior authorization requests for revakinagene taroretcel-lwey (Encelto) must be submitted on a Special Medical Prior Authorization (SMPA) Request Form.

Revakinagene taroretcel-lwey (Encelto) is administered as an intravitreal implantation under aseptic conditions and is indicated for clients who meet all the following criteria:

  • The client is 18 years of age and older.
  • The client has a confirmed diagnosis of retinal telangiectasis in at least one eye (diagnosis code H35071, H35072, H35073, or H35079).
  • The client has type 2 MacTel in at least one eye.
  • The client does not have neovascular or proliferative MacTel.
  • The client has no ocular or periocular infections.
  • The client has no known hypersensitivity to endothelial serum-free media (Endo-SFM).
  • The client has temporarily discontinued any antithrombotic medication before revakinagene taroretcel-lwey (Encelto) insertion surgery.
  • The client has not previously received revakinagene taroretcel-lwey (Encelto) insertion in the eye designated for treatment.

Clients must be monitored for signs and symptoms of vision loss, infectious endophthalmitis, and retinal tear or detachment.

For more information, call the TMHP Contact Center at 800-925-9126.

Note: Texas Medicaid managed care organizations (MCOs) must provide all medically necessary, Medicaid-covered services to Medicaid members who are enrolled in their MCO. Administrative procedures, such as prior authorization, precertification, referrals, and claims and encounter data filing, may differ from traditional Medicaid (fee-for-service) and from MCO to MCO. Providers should contact the member’s specific MCO for details.