Pharmacy Prior Authorization Criteria

Ryoncil (remestemcel-l-rknd) - PA, NF

Indications for Prior Authorization

Ryoncil (remestemcel-L-rknd)

• For diagnosis of Graft versus host disease
  Indicated for the treatment of steroid refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older.

Criteria

Ryoncil

Prior Authorization, Non Formulary (Initial Authorization)

Length of Approval: 1 Month(s)

• Submission of medical records (e.g., chart notes) confirming diagnosis of acute graft versus host disease (aGVHD)
AND
• Submission of medical records (e.g., chart notes) confirming one of the following:
• Patient has Grade C or D aGVHD involving the skin, liver, and/or GI tract
OR
• Patient has Grade B aGVHD involving the liver and/or GI tract with or without concomitant skin disease
AND
• Submission of medical records (e.g., chart notes) confirming disease is steroid refractory as defined by progression of aGVHD within 3 days or no improvement within 7 days of consecutive treatment with 2 mg/kg/day methylprednisolone or equivalent
AND
• Patient is 2 months of age to less than or equal to 17 years of age
AND
• Patient has not received any second line therapy to treat aGVHD (e.g., Jakafi, mycophenolate mofetil, etc.)
AND
• Both of the following;
• Prescribed by a provider at a transplant center with expertise in gene therapy
AND
• Prescribed by one of the following:
• Hematologist/oncologist
• Bone marrow transplant specialist
• Specialist with expertise in the diagnosis and management of steroid-refractory aGvHD (SR-aGvHD)

Ryoncil

Prior Authorization, Non Formulary (Reauthorization)

Length of Approval: 1 Month(s)

• Submission of medical records (e.g., chart notes) confirming one of the following:
• Both of the following:
• Patient has had a partial or mixed response to current Ryoncil treatment course
• Patient has not received more than 12 infusions
OR
• Patient is experiencing a recurrence of GvHD after complete response with Ryoncil therapy
AND
• Both of the following:
• Prescribed by a provider at a transplant center with expertise in gene therapy
AND
• Prescribed by one of the following:
• Hematologist/oncologist
• Bone marrow transplant specialist
• Specialist with expertise in the diagnosis and management of steroid-refractory aGvHD (SR-aGvHD)

P & T Revisions

2026-06-03

References

1. Ryoncil Prescribing Information. Mesoblast Inc. New York, NY. September 2025.

---

Revision History

• 2026-06-03: New Program

---