Abeona Therapeutics Announces Favorable Medicare Reimbursement Decisions for Pz-cel

CMS grants ICD-10-PCS product-specific procedure code and favorable DRG assignment for pz-cel, supporting efficient hospital billing, reimbursement and patient access

CLEVELAND, Ohio, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the Centers for Medicare and Medicaid Services (CMS) has granted a product-specific procedure code ICD-10-PCS (International Classification of Diseases, 10th Revision, Procedure Coding System) for prademagene zamikeracel (pz-cel), Abeona’s investigational autologous cell-based gene therapy currently in development for recessive dystrophic epidermolysis bullosa (RDEB). If pz-cel receives U.S. marketing approval, this code will allow for efficient and accurate documentation, billing, and analysis of inpatient hospital procedures using pz-cel. The code will go into effect on October 1, 2024.

Abeona also announced, as part of the Inpatient Prospective Payment System (IPPS) Final Rule for fiscal year 2025, CMS assigned Medicare reimbursement of pz-cel to Pre-Major Diagnostic Category, Medicare Severity Diagnosis Related Group 018 (Pre-MDC MS-DRG 018), which is among the highest available inpatient hospital reimbursement levels for cell and gene therapies. The DRG code for pz-cel will go into effect on October 1, 2024.

Madhav Vasanthavada, Chief Commercial Officer of Abeona, said, “We are pleased that CMS has issued a product-specific procedure code and Medicare reimbursement for pz-cel that recognizes the breakthrough nature of this gene therapy technology for RDEB patients. The favorable Medicare decisions complement the positive feedback we have heard from commercial payers, giving us confidence as we seek to secure strong access and reimbursement for all RDEB patients. The CMS coding assignment is a major step in simplifying inpatient hospital billing across all payers and increasing speed to access of pz-cel after its potential FDA approval.”

About prademagene zamikeracel (pz-cel)
Prademagene zamikeracel (pz-cel), Abeona’s investigational autologous cell-based gene therapy, is currently being developed for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). RDEB is a rare connective tissue disorder caused by a defect in the COL7A1 gene that results in the inability to produce Type VII collagen. Pz-cel is designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells and enable long-term gene expression by using a retroviral vector to stably integrate into the dividing target cell genome. Pz-cel is being investigated for its ability to enable normal Type VII collagen expression and to facilitate wound healing and pain reduction in even the toughest-to-treat RDEB wounds after a one-time application procedure. The pivotal Phase 3 VIITAL study is a randomized clinical trial that evaluated the efficacy, safety and tolerability of pz-cel in 43 large chronic wound pairs in 11 subjects with RDEB. Pz-cel has been granted Regenerative Medicine Advanced Therapy, Breakthrough Therapy, Orphan Drug and Rare Pediatric Disease designations by the U.S. FDA. Abeona produces pz-cel for the VIITAL study at its fully integrated gene and cell therapy manufacturing facility in Cleveland, Ohio.