Delcath Systems (DCTH) Announces Revised NICE Guidance for CHEMOSAT in the United Kingdom

April 21, 2021 8:39 AM EDT
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Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that the United Kingdom’s (UK) National Institute for Health and Care Excellence (NICE), through the Interventional Procedures Advisory Committee, has updated its guidance for the Delcath CHEMOSAT® Hepatic Delivery System for Melphalan (CHEMOSAT) in the treatment of patients with metastases in the liver from Ocular Melanoma.

Previously, the NICE guidance recommended CHEMOSAT only be used in the context of formal research studies. Due to that guidance, both private insurance and regional funding were generally not available for treatments with CHEMOSAT, nor was it possible to apply for national coverage. Under the revised NICE guidance, CHEMOSAT has been categorized under a Special Arrangement designation. Under this designation, private insurance may be more likely to fund treatment with CHEMOSAT, some regional funding may be more accessible, and a process is now available to seek national reimbursement.

The revised guidance which formed the basis in the designation change can be found at https://www.nice.org.uk/guidance/ipg691.

“We welcome this Special Arrangements designation from NICE for the treatment of patients with metastases in the liver from ocular melanoma and the recommendations within the final guidance. We look forward to working with specialist treatment centers to increase the availability of this treatment to patients with metastases in the liver from ocular melanoma in the UK” said Gerard Michel, CEO of Delcath. “This change in designation, combined with the recently announced positive preliminary results from the FOCUS trial, is further evidence of the potential value of the HEPZATO and CHEMOSAT platform to patients worldwide suffering from metastatic ocular melanoma.”



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