Prior Authorization Criteria for Encelto

Date: September 29, 2025

Attention: All Providers

Effective date: October 1, 2025

Call to action: Texas Children’s Health Plan (TCHP) would like to inform providers that on October 1, 2025, Encelto, will become a benefit of Medicaid and CHIP. HHSC requires prior authorization for Encelto (procedure code J3403) for Medicaid and CHIP, effective for dates of service on or after November 1, 2025.

Encelto (revakinagene taroretcel-lwey) is an allogenic encapsulated cell-based gene therapy indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel).

Prior Authorization Requirements

Prior authorization approval for an intravenous infusion of Encelto (J3403), an intravitreal implantation under aseptic conditions will be considered when the following criteria are met:

Patient is 18 years or older;
Patient has a confirmed diagnosis of retinal telangiectasis in at least one eye (diagnosis code – H35.071, H35.072, H35.073, or H35.079);
Patient has MacTel type 2 in at least one eye;
Patient does not have neovascular or proliferative MacTel;
Patient has no ocular or periocular infections;
Patient has no known hypersensitivity to Endothelial Serum Free Media (Endo-SFM);
Patient has temporarily discontinued any antithrombotic medication prior to Encelto insertion surgery; and
Patient has not received a previous Encelto insertion.

Prior authorization is limited to one Encelto treatment per eye per lifetime.

Required Monitoring Parameters

TCHP requires providers to monitor the patient for signs and symptoms of vision loss, infectious endophthalmitis and retinal tear/detachment.

Continuation Therapy

Re-authorization of Encelto is not permitted for a previously treated eye. If the request is for treatment of an eye that has not previously received an ocular implant, the patient must meet the approval criteria listed in the prior authorization requirement section.

Next step for providers: Providers should share this communication with their staff.

If you have any questions, please email Provider Relations at providerrelations@texaschildrens.org.

For access to all provider alerts: www.texaschildrenshealthplan.org/provideralerts.