DELCATH ANNOUNCES REIMBURSEMENT STATUS FOR CHEMOSAT IN GERMANY
January 31 2014 - 10:30AM
Interim Reimbursement Value 4 Status Confirmed for
2014
NEW
YORK, January 31,
2014 - Delcath Systems, Inc. (NASDAQ: DCTH) today announced
that the Institut für das Entgeltsystem im Krankenhaus (InEk), the
German federal reimbursement agency, has reiterated the Value 4
coverage status for the treatment of patients with liver metastases
with the Delcath Hepatic CHEMOSAT® Delivery
System. Under the Neue Untersuchungs und Behandlungsmethoden (NUB)
reimbursement scheme, Value 4 Status, while not mandating
reimbursement, allows participating cancer centers to negotiate
reimbursement coverage for the CHEMOSAT procedure with all insurers
serving their region.
The InEk determines three status
levels for medical procedures submitted for its review: Value 1
(mandated reimbursement), Value 2 (declined for reimbursement), and
Value 4 (negotiated reimbursement). The InEk may also decline to
make determination regarding an application. For 2014
reimbursement, a total of 618 medical procedures were submitted to
the InEk for consideration under the NUB scheme, with 16% or 96
procedures receiving Value 1 Status, 6% or 36 procedures receiving
Value 4, and the remaining 78% denied coverage or un-evaluated. The
CHEMOSAT application was submitted by 71 hospitals in Germany,
which represents a significant increase in the level of
institutional support the procedure received over 2013.
InEk first established NUB Value 4
status for CHEMOSAT procedures in 2013, and participating cancer
centers in Germany have been and are expected to continue pursuing
reimbursement under Value 4 status, providing hospitals the
opportunity to submit Individual Funding Requests (IFR) to obtain
reimbursement for the CHEMOSAT procedure. While IFRs are evaluated
on a case-by-case basis, the majority of these applications have
been approved in recent months. The Company expects that IFRs will
be the key reimbursement vehicle in the German market in 2014.
"The number of applications denied
or not evaluated by InEk illustrates how challenging the
reimbursement environment is for new procedures in Germany," said
Jennifer K. Simpson, Interim Co-President and Co-CEO of Delcath.
"With the broad institutional support for our product this year, an
existing network of seven cancer centers in Germany offering the
CHEMOSAT procedure, and a reimbursement mechanism via the IFR
process, we believe we are well positioned to continue driving
clinical adoption of CHEMOSAT in the German market. As local
experience and clinical data continue to build in Germany, we also
believe our prospects for achieving NUB Value 1 Status will
improve."
About Delcath Systems
Delcath Systems, Inc. is a
specialty pharmaceutical and medical device company focused on
oncology. Our proprietary drug/device combination product, the
Delcath Hepatic Delivery System, is designed to administer high
dose chemotherapy and other therapeutic agents to the liver, while
controlling the systemic exposure of those agents. The Company's
initial focus is on the treatment of primary and metastatic liver
cancers. Outside of the United States, our proprietary product to
deliver and filter melphalan hydrochloride is marketed under the
trade name Delcath Hepatic CHEMOSAT® Delivery System for melphalan
hydrochloride. The Company obtained authorization to affix a CE
Mark for the Generation Two CHEMOSAT Delivery System for Melphalan
in April 2012. The right to affix the CE mark allows the Company to
market and sell the CHEMOSAT Delivery System for Melphalan in
Europe. The Delcath Hepatic Delivery System for Melphalan has not
been approved for sale in the United States by the United States
Food and Drug Administration. The Company has initiated plans to
investigate Melphalan Hydrochloride for Injection for use with the
Delcath Hepatic Delivery System for primary liver cancer.
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: the ability of
hospitals in Germany to successfully negotiate and receive
reimbursement for the CHEMOSAT procedure in their region under
Value 4 status and the amount of reimbursement, if any, to be
provided under Value 4 status in 2014, approval of Individual
Funding Requests for reimbursement of the CHEMOSAT procedure, the
impact of Value 4 status on potential CHEMOSAT product use and
sales in Germany, the Company's ability to regain compliance with
the NASDAQ Marketplace Rules and maintain its listing on the NASDAQ
Capital market,, the timing and results of future clinical trials
including without limitation the HCC trials, clinical adoption, use
and resulting sales, if any, for the CHEMOSAT system to deliver and
filter melphalan in Europe, our ability to successfully
commercialize the chemosaturation system and the potential of the
chemosaturation 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 chemosaturation system for delivery and
filtration of melphalan, doxorubicin or other chemotherapeutic
agents for various indications in the US and/or in foreign markets,
actions by the FDA or other foreign regulatory agencies, our
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,, and
uncertainties regarding our 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: |
Media Contact: |
Michael Polyviou/Patty Eisenhaur |
John Carter |
EVC Group |
EVC Group |
212-850-6020/951-316-0577 |
212-850-6021 |
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Source: Delcath Systems, Inc via Globenewswire
HUG#1758433