Medexus's Grafapex add-on payment okayed by Medicare

Executive Summary

• Medexus Pharmaceuticals Inc. received approval from the U.S. Centers for Medicare & Medicaid Services (CMS) for a New Technology Add-on Payment (NTAP) for its product Grafapex (treosulfan) for injection for CMS Fiscal Year 2026 (Oct 1, 2025 – Sept 30, 2026).
• The NTAP provides temporary supplemental reimbursement to hospitals using designated new, higher-cost medical technologies, requiring demonstration of substantial clinical improvement over existing alternatives.
• This approval follows previous milestones including transitional pass-through status and the assignment of a permanent HCPCS Level 2 coding system (J code) for Grafapex.

Key Details

• Reimbursement Amount: Eligible cases involving Grafapex will benefit from a maximum NTAP of $21,411 for CMS Fiscal Year 2026.
• Eligibility Codes: Cases eligible for NTAP are identified by ICD-10-PCS codes XW03388 or XW04388.
• Approval Context: Grafapex was one of only five approvals for FY2026 under the new technology add-on payment traditional pathway, selected out of 13 applications considered by CMS.
• Commercial Uptake (as of June 30, 2025):
  • Nine large commercial payers, covering an estimated 48 million patient lives, have made positive formulary inclusion determinations.
  • 14 individual healthcare institutions (representing 8% of the 180 transplant centers in the U.S.) have made positive formulary inclusion determinations.
  • An additional 29 commercial payers have added Grafapex to their prior authorization lists.
  • Wholesaler data indicates that 37 of the 180 transplant centers have already ordered Grafapex for procedures.
• Product Launch: Grafapex was commercially launched in the U.S. in February 2025.

Notable Quotes

• "This development is an important reimbursement milestone for Grafapex... Together, these actions will help ensure Medicare beneficiaries can more consistently receive Grafapex in both inpatient and outpatient settings." — Virginie Bernier PhD, Vice-President, Hemato-oncology, Medexus Pharmaceuticals Inc.