Delcath Systems Announces CMS Approval for NTAP for HEPZATO KIT™
The NTAP designation under the CMS Inpatient Prospective Payment System (IPPS) is designed to support the adoption of innovative medical technologies that provide substantial clinical improvement over existing treatments. HEPZATO KIT™ is used primarily in the outpatient setting, however there are instances where it is used in the inpatient setting. This additional payment will help to cover the costs associated with the HEPZATO KIT for eligible Medicare inpatients, ensuring that more patients can benefit from this advanced liver-directed therapy.
"The NTAP approval for HEPZATO KIT is a significant milestone that underscores the clinical value of our therapy. This will facilitate broader access to HEPZATO KIT for eligible patients and support the oncology community in delivering this important treatment," stated
The HEPZATO KIT is a combination product that delivers melphalan, a chemotherapeutic agent, directly to the liver using Delcath’s proprietary Hepatic Delivery System (HDS). This system isolates the liver during the infusion process, allowing for high-dose chemotherapy administration while minimizing systemic exposure. The HEPZATO KIT is indicated for the treatment of adult patients with unresectable hepatic-dominant metastatic uveal melanoma.
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Safe Harbor / Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This press release contains forward-looking statements, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the Company's commercialization plans and its ability to successfully commercialize the HEPZATO KIT; the Company's successful management of the HEPZATO KIT supply chain, including securing adequate supply of critical components necessary to manufacture and assemble the HEPZATO KIT; successful FDA inspections of the facilities of the Company and those of its third-party suppliers/manufacturers; the Company's successful implementation and management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the potential benefits of the HEPZATO KIT as a treatment for patients with primary and metastatic disease in the liver; the Company's ability to obtain reimbursement for the HEPZATO KIT; and the Company's ability to successfully enter into any necessary purchase and sale agreements with users of the HEPZATO KIT. For additional information about these factors, and others that may impact the Company, please see the Company's filings with the
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Investor Relations:
ICR Westwicke
investorrelations@delcath.com
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