Ryoncil (remestemcel-L-rknd) - Medicare Advantage

This policy addresses coverage for Ryoncil (remestemcel‑L‑rknd), an allogeneic mesenchymal stem cell therapy for steroid‑refractory acute graft‑versus‑host disease (SR‑aGVHD) in pediatric patients aged 2 months to 17 years with Grade B–D aGVHD requiring systemic corticosteroids. Coverage requires documented failure of first‑line steroid therapy (progression within 3 days or no improvement within 7 days on ≥2 mg/kg/day methylprednisolone or equivalent), meets GI involvement/stool‑volume and organ‑grade criteria, and shows adequate renal function and performance status (CrCl >30 mL/min/1.73 m2; Karnofsky/Lansky ≥30); response is reassessed at 28±2 days to determine repeat dosing, with pregnancy/breastfeeding and nonresponse prompting alternative management and billing via unclassified biologic codes.

"Individual is 2 months to 17 years of age ${ }^{5,11}$; AND"

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