Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today announced that Centers for Medicare & Medicaid
Services (“CMS”) has established a unique, product-specific billing
code and granted transitional pass-through payment status for
Barhemsys (amisulpride) injection. The new Healthcare Common
Procedure Coding System (“HCPCS”) Level II code (“J-code”) is
J-0184 “Injection, amisulpride, per 1 mg” and will be effective on
January 1, 2024, replacing the C-code (C-9153), which will be
discontinued. Beginning October 1, 2023, Barhemsys became eligible
for separate reimbursement outside of the surgical bundled payment
in both the ambulatory surgery center (“ASC”) and hospital
outpatient department (“HOPD”) care settings.
In addition to clinical complications that may negatively affect
patient outcomes, PONV can delay hospital discharge; result in
re-admission after in-patient procedures; and lead to day-case
patients being admitted to the hospital, all of which can increase
healthcare costs.2 By reducing these risks, Barhemsys offers the
potential for significant economic savings to hospitals and
ambulatory centers.
“Receiving pass-through status, as well as a J-code, is an ideal
combination that will facilitate patient access to this important
therapeutic,” stated Scott Tarriff, President and Chief Executive
Officer of Eagle. “Barhemsys is a significant product opportunity
for Eagle, and we are pleased with its growing adoption, giving us
confidence in our ability to build on this momentum.”
“Post operative nausea and vomiting, also known as PONV, is a
common complication of surgery that occurs in approximately 30% of
all surgical patients and 80% of high-risk patients3. Barhemsys is
the only drug with an FDA-approved indication to treat patients who
have failed PONV prophylaxis. With its potential to improve patient
outcomes and enhance throughput, Barhemsys addresses an important
unmet medical need in a space that lacks proven and approved
therapeutics,” said Valentin Curt, MD, Senior Vice President,
Clinical Drug Development and Interim Chief Medical Officer at
Eagle Pharmaceuticals.
J-codes are reimbursement codes used by commercial insurance
plans, Medicare, Medicare Advantage, and other government payers
for physician-administered drugs like Barhemsys and are intended to
simplify the claims submission and documentation process,
facilitating access for patients.
Transitional pass-through payments provide additional payment
for new devices, drugs, and biologicals that meet eligibility
criteria for a period of at least two years but not more than three
years.
The granting of pass-through status helps streamline the
reimbursement process and facilitates patient access to
Barhemsys.
About Eagle Pharmaceuticals, Inc. Eagle is a
fully integrated pharmaceutical company with research and
development, clinical, manufacturing and commercial expertise.
Eagle is committed to developing innovative medicines that result
in meaningful improvements in patients’ lives. Eagle’s
commercialized products include PEMFEXY®, RYANODEX®, BENDEKA®,
BELRAPZO®, TREAKISYM® (Japan), and BYFAVO® and BARHEMSYS® through
its wholly owned subsidiary Acacia Pharma Inc. Eagle’s oncology and
CNS/metabolic critical care pipeline includes product candidates
with the potential to address underserved therapeutic areas across
multiple disease states, and the company is focused on developing
medicines with the potential to become part of the personalized
medicine paradigm in cancer care. Additional information is
available on Eagle’s website at www.eagleus.com.
Forward-Looking Statements This press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended, and
other securities law. Forward-looking statements are statements
that are not historical facts. Words and phrases such as
“anticipated,” “forward,” “will,” “would,” “could,” “may,”
“remain,” “potential,” “prepare,” “expected,” “believe,” “plan,”
“near future,” “belief,” “guidance,” and similar expressions are
intended to identify forward-looking statements. These statements
include, but are not limited to, statements with respect to: the
Company’s ability to develop innovative medicines that address
unmet medical needs; the potential of Barhemsys to offer unique or
meaningful therapeutic benefits to patients and potentially
improving the treatment regimen for patients, and improving patient
outcomes; the maintenance of pass-through status and the
application for a unique J-code with CMS and the benefits
associated therewith. All such statements are subject to certain
risks and uncertainties, many of which are difficult to predict and
generally beyond the Company’s control, that could cause actual
results to differ materially from those expressed in, or implied or
projected by, the forward-looking information and statements. Such
risks and uncertainties include, but are not limited to: the
impacts of the post- COVID-19 environment and geopolitical factors
such as the conflict in Ukraine; delay in or failure to obtain
regulatory approval of the Company's or its partners’ product
candidates and successful compliance with FDA, European Medicines
Agency and other governmental regulations applicable to product
approvals; changes in the regulatory environment; the uncertainties
and timing of the regulatory approval process; whether the Company
can successfully market and commercialize its product candidates;
the success of the Company's relationships with its partners; the
outcome of litigation involving any of its products or that may
have an impact on any of its products; the strength and
enforceability of the Company’s intellectual property rights or the
rights of third parties; competition from other pharmaceutical and
biotechnology companies and the potential for competition from
generic entrants into the market; unexpected safety or efficacy
data observed during clinical trials; clinical trial site
activation or enrollment rates that are lower than expected; the
risks inherent in drug development and in conducting clinical
trials; unanticipated factors in addition to the foregoing that may
impact the Company’s financial and business projections and
guidance and may cause the Company’s actual results and outcomes to
materially differ from its projections and guidance; and those
risks and uncertainties identified in the “Risk Factors” sections
of the Company's Annual Report on Form 10-K for the year ended
December 31, 2022, filed with the Securities and Exchange
Commission (the “SEC”) on March 23, 2023, the Company’s Quarterly
Report on Form 10-Q for the quarter ended March 31, 2023, filed
with the SEC on May 9, 2023, the Company’s Quarterly Report on Form
10-Q for the quarter ended June 30, 2023, filed with the SEC on
August 8, 2023 and its other subsequent filings with the SEC.
Readers are cautioned not to place undue reliance on these
forward-looking statements. All forward-looking statements
contained in this press release speak only as of the date on which
they were made. Except to the extent required by law, the Company
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist after the date on
which they were made.
Investor Relations for Eagle Pharmaceuticals,
Inc.: Lisa M. WilsonIn-Site Communications, Inc. T:
212-452-2793 E: lwilson@insitecony.com
Public Relations for Eagle Pharmaceuticals,
Inc.:Faith Pomeroy-WardT: 817-807-8044E:
faith@eagleus.com
Important Safety Information for
BARHEMSYS® (amisulpride) Injection4
Contraindication
BARHEMSYS is contraindicated in patients with known
hypersensitivity to amisulpride.
QT Prolongation
BARHEMSYS causes dose- and concentration-dependent prolongation
of the QT interval. The recommended dosage is 5 mg or 10 mg as a
single intravenous (IV) dose infused over 1 to 2 minutes.
Avoid BARHEMSYS in patients with congenital long QT syndrome and
in patients taking droperidol.
Electrocardiogram (ECG) monitoring is recommended in patients
with pre-existing arrhythmias/cardiac conduction disorders,
electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia),
congestive heart failure, and in patients taking other medicinal
products (e.g., ondansetron) or with other medical conditions known
to prolong the QT interval.
Adverse Reactions
Common adverse reactions reported in ≥ 2% of adult patients who
received BARHEMSYS 5 mg (n=748) and at a higher rate than placebo
(n=741) in clinical trials for the prevention of PONV were: chills
(4% vs. 3%), hypokalemia (4% vs. 2%), procedural hypotension (3%
vs. 2%), and abdominal distention (2% vs. 1%).
Serum prolactin concentrations were measured in one prophylaxis
study where 5% (9/176) of BARHEMSYS-treated patients had increased
blood prolactin reported as an adverse reaction compared with 1%
(1/166) of placebo-treated patients.
The most common adverse reaction, reported in ≥ 2% of adult
patients who received BARHEMSYS 10 mg (n=418) and at a higher rate
than placebo (n=416), in clinical trials for the treatment of PONV
was infusion site pain (6% vs. 4%).
Use in Specific Populations
Lactation
Amisulpride is present in human milk. There are no reports of
adverse effects on the breastfed child and no information on the
effects of amisulpride on milk production.
BARHEMSYS may result in an increase in serum prolactin levels,
which may lead to a reversible increase in maternal milk
production. In a clinical trial, serum prolactin concentrations in
females (n=112) increased from a mean of 10 ng/mL at baseline to 32
ng/mL after BARHEMSYS treatment and from 10 ng/mL to 19 ng/mL in
males (n=61). No clinical consequences due to elevated prolactin
levels were reported.
To minimize exposure to a breastfed infant, lactating women may
consider interrupting breastfeeding and pumping and discarding
breast milk for 48 hours after receiving a dose of BARHEMSYS.
Pediatric Use
Safety and effectiveness in pediatric patients have not been
established.
Geriatric Use
No overall differences in safety or effectiveness were observed
between these patients and younger patients, and other reported
clinical experience has not identified differences in responses
between the elderly and younger patients, but greater sensitivity
of some older individuals cannot be ruled out.
Renal Impairment
Avoid BARHEMSYS in patients with severe renal impairment
(estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73
m2). The pharmacokinetics of amisulpride in patients with severe
renal impairment have not been adequately studied in clinical
trials. Amisulpride is known to be substantially excreted by the
kidneys, and patients with severe renal impairment may have
increased systemic exposure and an increased risk of adverse
reactions.
No dosage adjustment is necessary in patients with mild to
moderate renal impairment
(eGFR ≥ 30 mL/min/1.73 m2).
Drug Interactions
- BARHEMSYS causes dose- and concentration-dependent QT
prolongation. To avoid potential additive effects, avoid use of
BARHEMSYS in patients taking droperidol.
- ECG monitoring is recommended in patients taking other drugs
known to prolong the QT interval (e.g., ondansetron).
- Reciprocal antagonism of effects occurs between dopamine
agonists (e.g., levodopa) and BARHEMSYS. Avoid using levodopa with
BARHEMSYS.
______________________________
1 FDA labels for other recommended treatments do not include
treatment after failed prophylaxis.
2 Chatterjee S, Rudra A, Sengupta S. Current concepts in the
management of postoperative nausea and vomiting. Anesthesiol Res
Pract. 2011;2011:748031. doi: 10.1155/2011/748031. Epub 2011 Nov 3.
PMID: 22110499; PMCID: PMC3216269.
3 Sébastien Pierre, Rachel Whelan, Nausea and vomiting after
surgery, Continuing Education in Anaesthesia Critical Care &
Pain, Volume 13, Issue 1, February 2013, Pages 28–32,
https://doi.org/10.1093/bjaceaccp/mks046
4 https://bynder.acaciapharma.com/m/5d7c2cd0d58865f7/original/Barhemsys-Prescribing-Information.pdf
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/0aca4744-9df0-46e3-ad86-b623bd1cf0b0
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