Image source: Shutterstock

Highlights

  • Medicaid Coverage Secured: Mesoblast signs a National Drug Rebate Agreement (NDRA) with U.S. Medicaid for Ryoncil®.

  • Expanded Access: Ryoncil® will be available to 40% of U.S. children covered by Medicaid with steroid-refractory acute graft versus host disease (SR-aGvHD).

  • First Patients Treated: The initial three pediatric patients will receive treatment this week.

Mesoblast (Nasdaq:MESO; ASX:MSB), a global leader in allogeneic cellular medicines, has announced a major milestone for its FDA-approved mesenchymal stromal cell (MSC) therapy, Ryoncil® (remestemcel-L). The company has entered into a National Drug Rebate Agreement (NDRA) with the U.S. Centers for Medicare & Medicaid Services (CMS), ensuring Medicaid coverage for pediatric patients suffering from steroid-refractory acute graft versus host disease (SR-aGvHD).

Medicaid Coverage Expands Access for Pediatric Patients

The NDRA agreement enables immediate state-level coverage for Ryoncil®, with mandatory Medicaid coverage beginning July 1, 2025. This development ensures that approximately 40% of U.S. children with SR-aGvHD covered by Medicaid can access this life-saving treatment, alongside those covered by private insurance.

First Patients Begin Treatment

Mesoblast confirmed that the first three pediatric patients with SR-aGvHD will start their treatment with Ryoncil® this week. The recommended treatment course involves:

  • Twice-weekly intravenous infusions of 2×10⁶ MSC/kg body weight

  • Administered over four consecutive weeks

SR-aGvHD is a severe condition with high mortality rates, making timely and effective treatment critical. The approval and expanded coverage of Ryoncil® mark a significant step forward in addressing this urgent medical need.

Mesoblast’s Commitment to Advancing Cellular Therapies

Mesoblast continues to be a pioneer in allogeneic cellular medicines, focusing on treatments for inflammatory diseases. The company’s latest achievement with Medicaid coverage for Ryoncil® underscores its dedication to making innovative therapies more accessible to vulnerable pediatric patients.