NEW YORK, Oct. 8, 2015 /PRNewswire/ -- Delcath
Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and
medical device company focused on oncology with an emphasis on the
treatment of primary and metastatic liver cancers, announces the
establishment of a national reimbursement code for procedures
performed with the Delcath Hepatic CHEMOSAT® Delivery System
(CHEMOSAT) in Germany. The German
Institute for the Hospital Remuneration System (InEK) issued a ZE
diagnostic-related group (DRG) code, which permits hospitals in
Germany to obtain reimbursement
for CHEMOSAT procedures beginning in 2016. This new nationwide code
replaces the previous Neue Untersuchungs und
Behandlungsmethoden (NUB) procedure that required patients in
Germany to apply individually for
reimbursement of their CHEMOSAT treatment. The decision
represents the first national reimbursement mechanism for CHEMOSAT
procedures in Europe.
"The receipt of ZE reimbursement represents an important step
towards increased commercialization of CHEMOSAT and highlights the
role our therapy has been playing in Germany for the treatment of patients with
cancers in the liver," said Jennifer K.
Simpson, Ph.D., MSN, CRNP, CEO & President of Delcath
Systems, Inc. "The application for coverage under the ZE scheme was
made by the German Radiology Society and has been widely supported
by major German cancer hospitals, which also speaks to the
confidence the German clinical community has in the therapy. With a
ZE DRG code established, an application under the annual NUB
process is no longer required. We look forward to supporting
participating hospitals in their negotiations with insurers in the
coming year and are pleased that this new reimbursement will make
CHEMOSAT treatment more easily accessible to patients in
Germany suffering with cancers in
the liver."
ZE is a national reimbursement code that augments existing DRG
codes until a specific new DRG code can be created. With the
establishment of a ZE code for CHEMOSAT, the procedure is now
permanently represented in the DRG catalog in Germany. The establishment of ZE coverage by
InEK was made in response to an application made by the German
Radiology Society for CHEMOSAT in March
2015.
About Delcath Systems
Delcath Systems, Inc. is a
specialty pharmaceutical and medical device company focused on
oncology with an emphasis on the treatment of primary and
metastatic liver cancers. Our proprietary Melphalan Hydrochloride
for Injection for use with the Delcath Hepatic Delivery System
(Melphalan/HDS) is designed to administer high-dose chemotherapy to
the liver while controlling systemic exposure. In April 2012 we obtained authorization to affix a
CE Mark to our second-generation system, which is currently
marketed in Europe as a device
under the trade name Delcath Hepatic CHEMOSAT® Delivery System for
Melphalan (CHEMOSAT). In the U.S. the Melphalan/HDS system is
considered a combination drug and device product, and is regulated
as a drug by the U.S. Food and Drug Administration (FDA). The
Melphalan/HDS system has not been approved for sale in the U.S. We
have commenced a global Phase 2 clinical trial in Europe and the U.S. to investigate the
Melphalan/HDS system for the treatment of primary liver cancer
(HCC) and intrahepatic cholangiocarcinoma (ICC), and expect to
initiate a global Phase 3 trial in ocular melanoma (OM) that has
metastasized to the liver.
Private Securities Litigation Reform Act of 1995 provides a
safe harbor for forward-looking statements made by the Company or
on its behalf. This news release contains forward-looking
statements, which are subject to certain risks and uncertainties
that can cause actual results to differ materially from those
described. Factors that may cause such differences include, but are
not limited to, uncertainties relating to: future patient outcomes
and clinical trial results consistent with the data contained in
the SSO abstract, acceptance and publication of the Phase 3 trial
manuscript and the impact of publication to support the Company's
efforts, the timing and results of the Company's
clinical trials including without limitation the HCC, ICC and
OM clinical trial programs timely enrollment and
treatment of patients in the global Phase 2 HCC and ICC clinical
trial, FDA approval of the global Phase 3 OM clinical trial
protocol, IRB or ethics committee clearance of the Phase 2
HCC/ICC and/or Phase 3 OM protocols from
participating sites and the timing of site activation and subject
enrollment in each trial, the impact of the presentations at ESSO
and future clinical results consistent with the data presented,
approval of Individual Funding Requests for reimbursement of the
CHEMOSAT procedure, the impact, if any of ZE reimbursement on
potential CHEMOSAT product use and sales in Germany, clinical adoption, use and resulting
sales, if any, for the CHEMOSAT system to deliver and filter
melphalan in Europe including the
key markets of Germany and the UK,
the Company's ability to successfully commercialize the Melphalan
HDS/CHEMOSAT system and the potential of the Melphalan HDS/CHEMOSAT
system as a treatment for patients with primary and metastatic
disease in the liver, our ability to obtain reimbursement for the
CHEMOSAT system in various markets, the Company's ability to
satisfy the requirements of the FDA's Complete Response Letter and
provide the same in a timely manner, approval of the current or
future Melphalan HDS/CHEMOSAT system for delivery and filtration of
melphalan or other chemotherapeutic agents for various indications
in the U.S. and/or in foreign markets, actions by the FDA or other
foreign regulatory agencies, the Company's ability to successfully
enter into strategic partnership and distribution arrangements in
foreign markets and the timing and revenue, if any, of the same,
uncertainties relating to the timing and results of research and
development projects, our ability to maintain NASDAQ listing, and
uncertainties regarding the Company's ability to obtain financial
and other resources for any research, development, clinical trials
and commercialization activities. These factors, and others, are
discussed from time to time in our filings with the Securities and
Exchange Commission. 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 Information:
Investor Contact:
LHA
Anne Marie Fields,
afields@lhai.com
212-838-3777
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SOURCE Delcath Systems, Inc.