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Highlights

  • Mesoblast enters National Drug Rebate Agreement with CMS for Ryoncil® coverage
  • Medicaid coverage expands access to Ryoncil® for children with steroid-refractory aGvHD
  • Treatment for first three pediatric patients with aGvHD to begin this week

Mesoblast (ASX: MSB, Nasdaq: MESO), a leader in allogeneic cellular medicines, has announced that it has entered into a Medicaid National Drug Rebate Agreement (NDRA) with the U.S. Centers for Medicare & Medicaid Services (CMS). This agreement enables the U.S. government to provide access to Ryoncil® (remestemcel-L), a mesenchymal stromal cell (MSC) therapy, for pediatric patients diagnosed with steroid-refractory acute graft versus host disease (SR-aGvHD).

Ryoncil® is the first FDA-approved MSC therapy for any indication and is now available for approximately 40% of U.S. children covered by Medicaid who have SR-aGvHD. The therapy will be accessible to both inpatient and outpatient settings, and U.S. states have the option to immediately begin coverage, with mandatory coverage set to begin on July 1, 2025. The first three children will begin receiving treatment with Ryoncil® this week.

SR-aGvHD is a life-threatening condition with high mortality rates, especially in pediatric patients. Ryoncil® is administered as an intravenous infusion twice a week for four consecutive weeks. Mesoblast's agreement with CMS ensures that all U.S. children suffering from SR-aGvHD, regardless of insurance status, will have access to this important treatment.

Mesoblast's CEO, Dr. Silviu Itescu, expressed satisfaction with this milestone, highlighting the significance of making Ryoncil® available to children across the U.S., including those on Medicaid. This agreement marks a notable achievement in expanding access to treatment for a severe, life-threatening condition.