Delcath Systems Gains CMS NTAP Approval for HEPZATO KIT™

Delcath Systems, Inc., a company specializing in interventional oncology and focused on treating primary and metastatic liver cancers, has announced that the Centers for Medicare & Medicaid Services (CMS) has granted New Technology Add-on Payment (NTAP) status for its HEPZATO KIT™ (melphalan/Hepatic Delivery System). This approval will be effective starting from the fiscal year on October 1, 2024.

The NTAP designation under the CMS Inpatient Prospective Payment System (IPPS) aims to support the adoption of innovative medical technologies that offer significant clinical improvements over existing treatments. Although the HEPZATO KIT™ is primarily used in outpatient settings, there are occasions where it is utilized in inpatient settings as well. This additional payment will help cover the costs associated with the HEPZATO KIT for eligible Medicare inpatients, thus ensuring that a greater number of patients can benefit from this advanced liver-directed therapy.

Gerard Michel, the CEO of Delcath Systems, emphasized the importance of the NTAP approval, stating that it is a significant milestone that highlights the clinical value of their therapy. This approval is expected to facilitate broader access to the HEPZATO KIT for eligible patients and support the oncology community in delivering this critical treatment.

The HEPZATO KIT is a combination product that administers 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, which allows for high-dose chemotherapy administration while minimizing systemic exposure. The HEPZATO KIT is specifically indicated for the treatment of adult patients with unresectable hepatic-dominant metastatic uveal melanoma.

Delcath Systems, Inc. focuses on the treatment of primary and metastatic liver cancers through its proprietary products, HEPZATO KIT™ and CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP). These products are designed to deliver high-dose chemotherapy to the liver while controlling systemic exposure and side effects during the PHP procedure.

In the United States, the HEPZATO KIT is considered a combination drug and device product, regulated and approved for sale as a drug by the FDA. The kit comprises the chemotherapeutic drug melphalan and Delcath's proprietary Hepatic Delivery System (HDS). The HDS is employed to surgically isolate the liver and simultaneously filter hepatic venous blood during the melphalan infusion and washout process. This mechanism results in loco-regional delivery of a high dose of melphalan, potentially inducing a significant tumor response with minimal hepatotoxicity and reduced systemic exposure. The HEPZATO KIT is approved in the U.S. as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) having unresectable hepatic metastases affecting less than 50% of the liver, and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that can be treated with resection or radiation.

In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is marketed under the trade name CHEMOSAT Hepatic Delivery System for Melphalan. It has been utilized in major medical centers to conduct percutaneous hepatic perfusion procedures for treating a variety of liver cancers.

This recent NTAP approval is expected to play a key role in enabling broader access to this liver-directed therapy, thereby providing significant benefits to patients suffering from complex liver cancers.

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