Prior Authorization Criteria for Ryoncil

Date: September 29, 2025

Attention: All Providers

Subject: Prior Authorization Criteria for Ryoncil

Effective date: October 1, 2025

Call to action: Texas Children’s Health Plan (TCHP) would like to inform providers that on October 1, 2025, Ryoncil, will become a benefit of Medicaid and CHIP. HHSC requires prior authorization for Ryoncil (procedure code J3402) for Medicaid and CHIP, effective for dates of service on or after November 1, 2025.

Ryoncil (remestemcel-L-rknd) is an allogenic bone marrow-derived mesenchymal stromal cell (MSC) therapy approved to treat steroid-refractory acute graft versus host disease (SR-aGVHD) in pediatric patients 2 months of age and older.

Prior Authorization Requirements

Prior authorization approval for an intravenous infusion of Ryoncil (remestemcel-L-rknd) J3402, will be considered when the following criteria are met:

Patient is at least 2 months or older;
Patient has a confirmed diagnosis of aGVHD (diagnosis code – D89.810) following an allogenic hematopoietic stem cell transplant;
Patient has no known hypersensitivity to dimethyl sulfoxide or porcine and bovine proteins; and
Patient’s aGVHD is steroid-refractory, as documented by the following:
Progression of acute GVHD within three days of consecutive treatment with 2 mg/kg/day of methylprednisolone or equivalent.
No signs of improvement within 7 days of therapy with 2mg/kg/day of methylprednisolone or equivalent treatment.

Continuation Therapy

For continuation of Ryoncil therapy, providers must monitor the patient for the parameters listed below:

Patient has received Ryoncil for at least 28 days;
Patient has documentation of partial or mixed response to Ryoncil treatment; and
Patient is currently receiving or has received Ryoncil without any serious or life-threatening reactions.

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.