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Prior Authorization Criteria for Remestemcel-L-rknd (Ryoncil) 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 remestemcel-l-rknd (Ryoncil) (procedure code J3402).

Remestemcel-l-rknd (Ryoncil) is an allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy that is approved to treat steroid-refractory acute graft versus host disease (SR-aGVHD) in pediatric clients who are 2 months of age or older.

Prior Authorization Criteria

Prior authorization requests for remestemcel-l-rknd (Ryoncil) must be submitted on a Special Medical Prior Authorization (SMPA) Request Form.

Requests for Initial Therapy

Initial therapy for remestemcel-l-rknd (Ryoncil) is an intravenous infusion that may be approved for clients who meet all of the following requirements:

  • The client is 2 months of age or older.
  • The client has a confirmed diagnosis of acute graft versus host disease (aGVHD) (diagnosis code D89810) following an allogenic hematopoietic stem cell transplant.
  • The client’s aGVHD is steroid refractory, as documented by the following:
    • The progression of acute GVHD within three days of consecutive treatment with 2mg/kg/day of methylprednisolone or equivalent.
    • There are no signs of improvement within seven days of therapy with 2mg/kg/day of methylprednisolone or equivalent treatment.
  • The client has no known hypersensitivity to dimethyl sulfoxide or porcine and bovine proteins.

Requests for Renewal or Continuation of Therapy

For renewal or continuation of therapy of remestemcel-l-rknd (Ryoncil), the client must meet the following requirements:

  • Has received remestemcel-l-rknd (Ryoncil) for at least 28 days
  • Has documentation of partial or mixed response to remestemcel-l-rknd (Ryoncil) treatment
  • Is currently receiving or has received remestemcel-l-rknd (Ryoncil) without any serious or life-threatening reactions

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.