NEW
YORK, Jan. 31, 2024 /PRNewswire/ -- Delcath
Systems, Inc. (Nasdaq: DCTH), an interventional oncology
company focused on the treatment of primary and metastatic cancers
of the liver, today announced that the Centers for Medicare &
Medicaid Services ("CMS") has established a permanent and
product-specific J-code (J9248) for HEPZATO. The J-code will
become effective on April 1,
2024.
J-codes are a form of Healthcare Common Procedure Coding System
Level II identifiers used by payors to streamline the billing
of Medicare Part B drugs. In its summary of Delcath's
application for the J-code, CMS stated that "[e]xistng melphalan
hydrochloride is FDA approved at 0.25 mg/kg via intravenous
infusion for patients with multiple myeloma and is not
substitutable for the melphalan hydrochloride in the HEPZATO KIT
which is approved at 3.0 mg/kg via intraarterial delivery for
patients with metastatic ocular melanoma."
The HEPZATO KIT is a liver-directed treatment for adult patients
with metastatic uveal melanoma (mUM) with 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 is amenable to resection or
radiation.
"We believe that the establishment of the permanent J-code for
HEPZATO will facilitate patient access to this important
treatment," said Gerard Michel,
Delcath's Chief Executive Officer. "This is a significant step
towards accurate and efficient reimbursement of the HEPZATO KIT,
facilitating access for patients."
About Delcath Systems, Inc., HEPZATO KIT
and CHEMOSAT
Delcath Systems, Inc. is an interventional oncology company
focused on the treatment of primary and metastatic liver cancers.
The company's proprietary products, HEPZATO KIT (Hepzato
(melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT®
Hepatic Delivery System for Melphalan percutaneous hepatic
perfusion (PHP) are designed to administer high-dose chemotherapy
to the liver while controlling systemic exposure and associated
side effects during a PHP procedure.
In the United States, HEPZATO
KIT is considered a combination drug and device product and is
regulated and approved for sale as a drug by the FDA. HEPZATO KIT
is comprised of the chemotherapeutic drug melphalan and Delcath's
proprietary Hepatic Delivery System (HDS). The HDS is used to
surgically isolate the liver while simultaneously filtrating
hepatic venous blood during melphalan infusion and washout. The use
of the HDS results in loco-regional delivery of a relatively high
melphalan dose, which can potentially induce a clinically
meaningful tumor response with minimal hepatotoxicity and reduce
systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed
treatment for adult patients with metastatic uveal melanoma (mUM)
with 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 is
amenable to resection or radiation. Please see the full Prescribing
Information, including BOXED WARNING for the HEPZATO KIT.
In Europe, the device-only
configuration of the HDS is regulated as a Class III medical device
and is approved for sale under the trade name CHEMOSAT Hepatic
Delivery System for Melphalan, or CHEMOSAT, where it has been used
in the conduct of percutaneous hepatic perfusion procedures at
major medical centers to treat a wide range of cancers of the
liver.
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 Securities and
Exchange Commission, including those on Forms 10-K, 10-Q, and 8-K.
However, new risk factors and uncertainties may emerge from time to
time, and it is not possible to predict all risk factors and
uncertainties. Accordingly, you should not place undue reliance on
these forward-looking statements, which speak only as of the date
they are made. We undertake no obligation to publicly update or
revise these forward-looking statements to reflect events or
circumstances after the date they are made.
Contact:
Investor Relations Contact:
Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com
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SOURCE Delcath Systems, Inc.