Abeona Therapeutics® Announces Favorable Medicare Reimbursement Decisions for Pz-cel
Abeona Therapeutics (Nasdaq: ABEO) announced favorable Medicare reimbursement decisions for its investigational gene therapy, pz-cel, for recessive dystrophic epidermolysis bullosa (RDEB). The Centers for Medicare and Medicaid Services (CMS) granted a product-specific procedure code ICD-10-PCS and assigned Medicare reimbursement to Pre-MDC MS-DRG 018, one of the highest inpatient hospital reimbursement levels for cell and gene therapies. Both codes will be effective from October 1, 2024.
These decisions are expected to simplify inpatient hospital billing across all payers and increase speed to access of pz-cel after potential FDA approval. Abeona's Chief Commercial Officer, Madhav Vasanthavada, expressed confidence in securing strong access and reimbursement for all RDEB patients, citing positive feedback from commercial payers as well.
Abeona Therapeutics (Nasdaq: ABEO) ha annunciato notizie favorevoli riguardanti il rimborso Medicare per la sua terapia genica sperimentale, pz-cel, destinata alla epidermolisi bollosa distrofica recessiva (RDEB). I Centri per i Servizi Medicare e Medicaid (CMS) hanno concesso un codice procedurale specifico per il prodotto ICD-10-PCS e hanno assegnato il rimborso Medicare a Pre-MDC MS-DRG 018, uno dei più alti livelli di rimborso per terapie cellulari e geniche in ospedale. Entrambi i codici entreranno in vigore a partire dal 1 ottobre 2024.
Queste decisioni dovrebbero semplificare la fatturazione ospedaliera per i degenti tra tutti i pagatori e aumentare la velocità di accesso a pz-cel dopo una potenziale approvazione da parte della FDA. Madhav Vasanthavada, Direttore Commerciale di Abeona, ha espresso fiducia nell'assicurare un accesso e un rimborso solidi per tutti i pazienti affetti da RDEB, citando anche feedback positivi da parte dei pagatori commerciali.
Abeona Therapeutics (Nasdaq: ABEO) anunció decisiones favorables de reembolso de Medicare para su terapia génica en investigación, pz-cel, para la epidermólisis bullosa distrófica recesiva (RDEB). Los Centros de Servicios de Medicare y Medicaid (CMS) otorgaron un código de procedimiento específico para el producto ICD-10-PCS y asignaron el reembolso de Medicare a Pre-MDC MS-DRG 018, uno de los niveles de reembolso hospitalario más altos para terapias celulares y genéticas. Ambos códigos serán efectivos a partir del 1 de octubre de 2024.
Se espera que estas decisiones simplifiquen la facturación hospitalaria para los pacientes internados entre todos los pagadores y incrementen la velocidad de acceso a pz-cel después de una posible aprobación por parte de la FDA. Madhav Vasanthavada, Director Comercial de Abeona, expresó confianza en asegurar un acceso y reembolso sólidos para todos los pacientes con RDEB, citando también comentarios positivos de los pagadores comerciales.
Abeona Therapeutics (Nasdaq: ABEO)는 열성형 대사성 피부박리증(RDEB)을 위한 실험적인 유전자 치료 pz-cel에 대한 유리한 메디케어 환급 결정을 발표했습니다. 메디케어 및 메디케이드 서비스 센터(CMS)는 ICD-10-PCS 제품별 절차 코드를 부여하고 메디케어 환급을 Pre-MDC MS-DRG 018으로 배정했습니다. 이는 세포 및 유전자 치료를 위한 입원 병원 환급 수치 중 가장 높은 수준 중 하나입니다. 두 코드는 2024년 10월 1일부터 시행됩니다.
이러한 결정은 모든 지급자에 대해 입원 병원 청구를 간소화하고, pz-cel에 대한 접근 속도를 높일 것으로 예상됩니다 FDA 승인이 가능할 경우. Abeona의 상업 책임자인 Madhav Vasanthavada는 RDEB 환자 모두를 위한 강력한 접근 및 환급 확보에 대한 자신감을 표명하며, 상업적 지급자들의 긍정적인 피드백을 인용했습니다.
Abeona Therapeutics (Nasdaq: ABEO) a annoncé des décisions de remboursement favorables de Medicare pour sa thérapie génique expérimentale, pz-cel, destinée à l'épidermolyse bulleuse dystrophique récessive (RDEB). Les Centres de services Medicare et Medicaid (CMS) ont accordé un code de procédure spécifique au produit ICD-10-PCS et ont assigné le remboursement Medicare au Pre-MDC MS-DRG 018, l'un des niveaux de remboursement hospitalier les plus élevés pour les thérapies cellulaires et géniques. Ces deux codes entreront en vigueur à partir du 1er octobre 2024.
Ces décisions devraient simplifier la facturation hospitalière pour les patients internés auprès de tous les payeurs et accélérer l'accès à pz-cel après une éventuelle approbation de la FDA. Madhav Vasanthavada, directeur commercial d'Abeona, a exprimé sa confiance dans la garantie d'un bon accès et d'un remboursement solide pour tous les patients atteints de RDEB, citant également des retours positifs de payeurs commerciaux.
Abeona Therapeutics (Nasdaq: ABEO) hat günstige Medicare-Erstattungsentscheidungen für seine experimentelle Gentherapie pz-cel bei der rezessiven dystrophen Epidermolysis bullosa (RDEB) bekannt gegeben. Die Centers for Medicare & Medicaid Services (CMS) haben einen produktbezogenen Verfahrenskode ICD-10-PCS vergeben und die Medicare-Erstattung dem Pre-MDC MS-DRG 018 zugewiesen, einem der höchsten Erstattungssätze für Zell- und Gentherapien im Krankenhaus. Beide Codes gelten ab dem 1. Oktober 2024.
Diese Entscheidungen sollen die Abrechnung für stationäre Krankenhausaufenthalte bei allen Kostenträgern vereinfachen und die Zugangszeit zu pz-cel nach einer möglichen FDA-Zulassung erhöhen. Madhav Vasanthavada, Chief Commercial Officer von Abeona, äußerte Vertrauen in die Sicherstellung eines starken Zugangs und einer robusten Erstattung für alle RDEB-Patienten und verwies auch auf positives Feedback von kommerziellen Kostenträgern.
- CMS granted a product-specific procedure code ICD-10-PCS for pz-cel
- Medicare reimbursement assigned to Pre-MDC MS-DRG 018, among the highest available for cell and gene therapies
- New codes expected to simplify inpatient hospital billing and increase speed to access
- Positive feedback received from commercial payers
- None.
Insights
The CMS decision to grant a product-specific ICD-10-PCS code and favorable DRG assignment for pz-cel is a significant development for Abeona Therapeutics. This move streamlines the billing process and potentially accelerates patient access to the therapy, if approved. The assignment to Pre-MDC MS-DRG 018 is particularly noteworthy, as it's among the highest reimbursement levels for cell and gene therapies.
This decision signals CMS's recognition of pz-cel's potential value in treating RDEB, a rare and devastating genetic condition. It also suggests that CMS is adapting its reimbursement structure to accommodate innovative therapies, which could encourage further investment in gene therapies for rare diseases. However, it's important to note that this doesn't guarantee FDA approval or commercial success and Abeona still faces challenges in bringing pz-cel to market.
The favorable CMS decisions are a positive signal for Abeona's commercial prospects. The high-level DRG assignment (018) could potentially lead to robust reimbursement, which is important for expensive gene therapies. This, combined with the product-specific ICD-10-PCS code, may lower barriers to adoption by simplifying the billing process for hospitals.
However, investors should remain cautious. While this news improves the potential commercial viability of pz-cel, it doesn't guarantee FDA approval or market success. The therapy is still investigational and Abeona faces significant clinical and regulatory hurdles. Additionally, the actual pricing and market size for pz-cel remain unknown. The company's financial health and ability to successfully launch the product, if approved, will be critical factors to watch.
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.
About Abeona Therapeutics
Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Prademagene zamikeracel (pz-cel) is Abeona’s investigational autologous cell-based gene therapy currently in development for recessive dystrophic epidermolysis bullosa. The Company’s fully integrated cell and gene therapy cGMP manufacturing facility served as the manufacturing site for pz-cel used in its Phase 3 VIITAL™ trial, and is capable of supporting commercial production of pz-cel upon FDA approval. The Company’s development portfolio also features AAV-based gene therapies for ophthalmic diseases with high unmet medical need. Abeona’s novel, next-generation AAV capsids are being evaluated to improve tropism profiles for a variety of devastating diseases. For more information, visit www.abeonatherapeutics.com.
Forward-Looking Statements
This press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties. We have attempted to identify forward-looking statements by such terminology as “may,” “will,” “believe,” “anticipate,” “expect,” “intend,” “potential,” and similar words and expressions (as well as other words or expressions referencing future events, conditions or circumstances), which constitute and are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited to, the timing and results of ongoing testing and other corrective actions being performed in response to the FDA’s identified deficiencies, which could delay the Company’s BLA resubmission; the timing and outcome of the FDA’s review of our resubmission; the FDA’s grant of a Priority Review Voucher upon approval; continued interest in our rare disease portfolio; our ability to enroll patients in clinical trials; the outcome of future meetings with the FDA or other regulatory agencies, including those relating to preclinical programs; the ability to achieve or obtain necessary regulatory approvals; the impact of any changes in the financial markets and global economic conditions; risks associated with data analysis and reporting; and other risks disclosed in the Company’s most recent Annual Report on Form 10-K and subsequent periodic reports filed with the Securities and Exchange Commission. The Company undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.
Investor and Media Contact:
Greg Gin
VP, Investor Relations and Corporate Communications
Abeona Therapeutics
ir@abeonatherapeutics.com
FAQ
What Medicare reimbursement decisions did Abeona Therapeutics (ABEO) receive for pz-cel?
When will the new Medicare reimbursement codes for Abeona's (ABEO) pz-cel take effect?
What is the significance of the Pre-MDC MS-DRG 018 assignment for Abeona's (ABEO) pz-cel?
How will the new CMS codes impact the billing process for Abeona's (ABEO) pz-cel?
