Mesoblast (ASX:MSB) has reached a pivotal commercial milestone in the United States, with the Centers for Medicare and Medicaid Services (CMS) activating a permanent J-Code for Ryoncil (remestemcel-L-rknd).
The new code, J3402, became effective on 1 October 2025, enabling streamlined billing, reimbursement, and ultimately broader patient access for the life-saving cell therapy.
Ryoncil is the first mesenchymal stromal cell (MSC) therapy ever approved by the US Food and Drug Administration (FDA) and remains the only approved treatment for children under 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD), which is a rare, life-threatening complication following bone marrow transplantation.
Mesoblast Chief Executive Dr Silviu Itescu said the new code represented “a critical element for successful commercialisation of rare disease products,” ensuring hospitals and clinics can “bill more efficiently and deliver timely access” to children battling SR-aGvHD. The CMS designation also signals a green light for private insurers to align their reimbursement frameworks, creating a unified pathway for coverage across the U.S. healthcare system.
Under the US Healthcare Common Procedure Coding System (HCPCS), J-Codes provide unique identifiers for injectable and infusible drugs and biologics, simplifying the process of claiming costs for providers. The permanent J-Code means that hospitals and healthcare providers can begin submitting reimbursement claims for Ryoncil immediately, a crucial step in securing sustainable patient access to novel, high-cost therapies.