GRAFAPEX (treosulfan) for Injection Receives CMS Approval of New Technology Add-On Payment (NTAP) for Eligible Cases in CMS's Fiscal Year 2026

Core Insights - The US Centers for Medicare & Medicaid Services (CMS) has approved New Technology Add-On Payment (NTAP) for GRAFAPEX™ (treosulfan) for Injection for fiscal year 2026, which runs from October 1, 2025, to September 30, 2026 [2][3] - GRAFAPEX™ will receive a maximum NTAP reimbursement of $21,411 for eligible cases, identified by specific ICD-10-PCS codes [2] - This approval is significant as GRAFAPEX™ was one of only five technologies approved for NTAP out of 13 applications considered by CMS [2] Company Developments - Medexus Pharmaceuticals has seen a positive response to GRAFAPEX™ since its US commercial launch in February 2025, with nine large commercial payers covering approximately 48 million patient lives making positive formulary inclusion determinations [3] - As of June 30, 2025, 37 out of 180 transplant centers in the US have ordered GRAFAPEX™ for procedures, indicating strong initial uptake and demand [3] - The company continues to work on expanding GRAFAPEX™'s market presence, with additional commercial payers adding it to their prior authorization lists [3] Product Information - GRAFAPEX™ is indicated for use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) [6] - The product holds Orphan Drug Designation, providing it with a seven-year period of regulatory exclusivity in its FDA-approved indication [6] - Efficacy data from a clinical trial showed a hazard ratio for overall survival of 0.67 compared to busulfan, indicating a significant clinical improvement [8]