CMS Issues Preliminary Recommendation to Establish a New J-Code for Triferic® Powder Packet
May 01 2019 - 4:30PM
Rockwell Medical, Inc. (NASDAQ:RMTI) (the "Company"), a global
biopharmaceutical company dedicated to improving outcomes for
patients with end-stage renal disease (ESRD) and chronic kidney
disease (CKD), today announced that the Centers for Medicare &
Medicaid Services (CMS) has issued a preliminary recommendation
that, if finalized, would establish a new Level II Healthcare
Common Procedure Coding System (HCPCS) code, or J-code (J1444), for
the Company’s Triferic® powder packet. If finalized, this unique
J-code for the powder packet would be separate and distinct from
the existing J-code (J1443) that describes Triferic® solution.
In its preliminary recommendation, CMS proposes an effective
date of July 1, 2019 for establishing J1444, and proposes the
following descriptor: "Injection, ferric pyrophosphate citrate
powder, 0.1 mg of iron". Rockwell Medical plans to participate in
the CMS HCPCS Public Meeting on May 15, 2019, during which CMS’
preliminary HCPCS coding recommendations will be discussed.
“We are pleased that CMS has issued a preliminary recommendation
to establish a new J-code to identify the Triferic powder packet.
If finalized, the recommended J-code would help provide additional
clarity for coding and claims processing in connection with
distinct Triferic products. We look forward to continuing our work
and discussions with CMS regarding coding considerations for our
Triferic products,” said Stuart Paul, President and Chief Executive
Officer of Rockwell Medical.
About Triferic Triferic is the only
FDA-approved therapy indicated to replace iron and maintain
hemoglobin in hemodialysis patients via dialysate during each
dialysis treatment, Triferic delivers approximately 5-7 mg iron
with every hemodialysis treatment to the bone marrow and maintains
hemoglobin without increasing irons stores (ferritin). Unlike IV
iron products, Triferic binds iron immediately and completely to
transferrin (carrier of iron in the body) upon entry into the blood
and is then transported directly to the bone marrow to be
incorporated into hemoglobin, with no increase in ferritin (stored
iron and inflammation) and no anaphylaxis, addressing a significant
medical need in overcoming Functional Iron Deficiency (FID) in ESRD
patients. Please visit www.triferic.com to view the Triferic
mode-of-action (MOA) video and for more information.
Important Safety InformationSerious
hypersensitivity reactions, including anaphylactic-type reactions,
some of which have been life-threatening and fatal, have been
reported in patients receiving parenteral iron products. Patients
may present with shock, clinically significant hypotension, loss of
consciousness, and/or collapse. Monitor patients for signs and
symptoms of hypersensitivity during and after hemodialysis until
clinically stable. Personnel and therapies should be immediately
available for the treatment of serious hypersensitivity reactions.
Hypersensitivity reactions have been reported in 1 (0.3%) of 292
patients receiving Triferic in two randomized clinical trials.
Iron status should be determined on pre-dialysis blood samples.
Post dialysis serum iron parameters may overestimate serum iron and
transferrin saturation.
The most common adverse reactions (≥3% and at least 1% greater
than placebo) in controlled clinical studies include:
procedural hypotension (21.6%), muscle spasms (9.6%), headache
(9.2%), pain in extremity (6.8%), peripheral edema (6.8%), dyspnea
(5.8%), back pain (4.5%), pyrexia (4.5%), urinary tract infection
(4.5%), asthenia (4.1%), fatigue (3.8%), arteriovenous (AV) fistula
thrombosis (3.4%), and AV fistula site hemorrhage (3.4%).
https://www.triferic.com/wp-content/uploads/2019/01/final-labeling-text-March-2018.pdf
About Rockwell Medical, Inc. Rockwell Medical
is a biopharmaceutical company targeting end-stage renal disease
(ESRD) and chronic kidney disease (CKD). Rockwell Medical’s
exclusive renal drug therapies support disease management
initiatives to improve the quality of life and care of dialysis
patients and are intended to deliver safe and effective therapy,
while decreasing drug administration costs and improving patient
convenience. Rockwell Medical’s anemia drug Triferic is the only
FDA-approved product indicated for iron replacement and maintenance
of hemoglobin in hemodialysis patients. Rockwell Medical is also an
established manufacturer, supplier and leader in delivering
high-quality hemodialysis concentrates/dialysates (used to maintain
human life by removing toxins and replacing critical nutrients in
the dialysis patient’s bloodstream) to dialysis providers and
distributors in the U.S. and abroad. Please visit
www.rockwellmed.com for more information.
Forward-Looking Statements Certain statements
in this press release may constitute "forward-looking statements"
within the meaning of the federal securities laws, including, but
not limited to, Rockwell Medical’s intention to bring to market
Triferic, and I.V. Triferic. Words such as "may," "might," "will,"
"should," "believe," "expect," "anticipate," "estimate,"
"continue," "could," "plan," "potential," "predict," "forecast,"
"project," "plan", "intend" or similar expressions, or statements
regarding intent, belief, or current expectations, are
forward-looking statements. While Rockwell Medical believes these
forward-looking statements are reasonable, undue reliance should
not be placed on any such forward-looking statements, which are
based on information available to us on the date of this release.
These forward-looking statements are based upon current estimates
and assumptions and are subject to various risks and uncertainties
(including, without limitation, those set forth in Rockwell
Medical's SEC filings), many of which are beyond our control and
subject to change. Actual results could be materially different.
Risks and uncertainties include: statements about the issuance of a
unique J code for our Triferic Powder Packet; timing and success of
our planned NDA submission for I.V. Triferic; the potential market
opportunity for I.V. Triferic and other Rockwell products; pricing
and reimbursement status for I.V. Triferic, Triferic and other
Rockwell products, including eligibility for add-on reimbursement
under TDAPA; liquidity and capital resources; expected duration of
Rockwell Medical's existing working capital; plans and timing
relating to the planned commercialization of Triferic; and timing
and success of our efforts to renegotiate economic terms of our
concentrate business Rockwell Medical expressly disclaims any
obligation to update or alter any statements whether as a result of
new information, future events or otherwise, except as required by
law.
Contact Investor Relations: Lisa M. Wilson,
In-Site Communications, Inc. T: 212-452-2793 E:
lwilson@insitecony.com
Rockwell Medical (NASDAQ:RMTI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Rockwell Medical (NASDAQ:RMTI)
Historical Stock Chart
From Apr 2023 to Apr 2024