Abeona Therapeutics® Announces Favorable Medicare Reimbursement Decisions for Pz-cel

Core Insights - Abeona Therapeutics announced that the Centers for Medicare and Medicaid Services (CMS) has granted a product-specific procedure code ICD-10-PCS for prademagene zamikeracel (pz-cel), an investigational gene therapy for recessive dystrophic epidermolysis bullosa (RDEB) [1] - CMS assigned Medicare reimbursement for pz-cel to Pre-Major Diagnostic Category, Medicare Severity Diagnosis Related Group 018, which is among the highest reimbursement levels for cell and gene therapies, effective October 1, 2024 [2] - The Chief Commercial Officer of Abeona expressed confidence in securing access and reimbursement for RDEB patients following favorable Medicare decisions and positive feedback from commercial payers [3] Product Overview - Prademagene zamikeracel (pz-cel) is an autologous cell-based gene therapy designed to treat RDEB, a rare connective tissue disorder caused by a defect in the COL7A1 gene [4] - Pz-cel aims to incorporate the functional COL7A1 gene into a patient's skin cells, enabling long-term gene expression and facilitating wound healing [4] - The pivotal Phase 3 VIITAL™ study evaluated pz-cel's efficacy, safety, and tolerability in 43 large chronic wound pairs among 11 subjects with RDEB [4] Company Background - Abeona Therapeutics is a clinical-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases [5] - The company operates a fully integrated cGMP manufacturing facility in Cleveland, Ohio, which supports the production of pz-cel for clinical trials and potential commercial use [5] - Abeona's development portfolio includes AAV-based gene therapies for ophthalmic diseases, utilizing next-generation AAV capsids to improve treatment efficacy [5]