SAN
DIEGO, July 15, 2024 /PRNewswire/ -- Heron
Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a
commercial-stage biotechnology company, today announced that
ZYNRELEF® (bupivacaine and meloxicam) is included in the proposed
2025 Non-Opioid Policy for Pain Relief under the Medicare hospital
Outpatient Prospective Payment System ("OPPS") and the Medicare
Ambulatory Surgical Center ("ASC") payment system (the "Proposed
Rule") as a qualifying product effective April 1, 2025. This Proposed Rule for payment
within hospital outpatient departments ("HOPDs") and ASCs was
issued by the Centers for Medicare & Medicaid Services ("CMS").
Under the Proposed Rule, ZYNRELEF qualified based on its
postoperative pain indication and potential to reduce or eliminate
the need for opioids.
Currently, ZYNRELEF is reimbursed by CMS through a special
payment policy referred to as pass-through payment status. This
pass-through payment status will expire on March 31, 2025. The Proposed Rule's April 1, 2025 effective date for ZYNRELEF is
expected to allow ZYNRELEF to continue to maintain separate
reimbursement in the HOPD and ASC settings without disruption.
Additionally, for calendar year 2025, CMS proposed that payments
for qualifying drugs, like ZYNRELEF, will not be reduced by an
offset which means Medicare payments will remain at average sales
price plus six percent. Given the significant influence of CMS
policy on other payer policies, Heron expects that most commercial
payers will follow suit.
"We applaud the efforts of CMS to expand access to non-opioid
postsurgical pain management options. The inclusion of ZYNRELEF in
the Proposed Rule is an important step in ongoing efforts to reduce
opioid utilization in the U.S. and ensures patients and providers
have access to ZYNRELEF following these often very painful surgical
procedures," said Craig Collard,
Chief Executive Officer at Heron.
About ZYNRELEF for Postoperative Pain
ZYNRELEF is the first and only dual-acting local anesthetic that
delivers a fixed-dose combination of the local anesthetic
bupivacaine and a low dose of nonsteroidal anti-inflammatory drug
meloxicam. ZYNRELEF is the first and only extended-release local
anesthetic to demonstrate in Phase 3 studies significantly reduced
pain and significantly increased proportion of patients requiring
no opioids through the first 72 hours following surgery compared to
bupivacaine solution, the current standard-of-care local anesthetic
for postoperative pain control. ZYNRELEF was initially approved by
the U.S. Food and Drug Administration ("FDA") in May 2021 for use in adults for soft tissue or
periarticular instillation to produce postsurgical analgesia for up
to 72 hours after bunionectomy, open inguinal herniorrhaphy and
total knee arthroplasty. In December
2021, the FDA approved an expansion of ZYNRELEF's indication
to include foot and ankle, small-to-medium open abdominal, and
lower extremity total joint arthroplasty surgical procedures. On
January 23, 2024, the FDA approved
ZYNRELEF for soft tissue and orthopedic surgical procedures
including foot and ankle, and other procedures in which direct
exposure to articular cartilage is avoided. Safety and efficacy
have not been established in highly vascular surgeries, such as
intrathoracic, large multilevel spinal, and head and neck
procedures.
Important Safety Information for Patients
ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory
drug), a type of medicine which:
- can increase the risk of a heart attack or stroke that can
lead to death. This risk increases with higher doses and longer use
of an NSAID.
- cannot be used during heart bypass surgery.
- can increase the risk of gastrointestinal bleeding, ulcers,
and tears.
ZYNRELEF should also not be used:
- if you are allergic to any component of ZYNRELEF, similar local
anesthetics, aspirin or other NSAIDs (such as ibuprofen or
naproxen), or have had an asthma attack, hives, or other allergic
reaction after taking any of these medicines.
- as a paracervical block, during childbirth.
The most common side effects of ZYNRELEF are soft tissue
procedures: vomiting and orthopedic procedures: constipation and
headache.
The medicines in ZYNRELEF (a local anesthetic and an NSAID) may
affect the nervous and cardiovascular system; may cause liver or
kidney problems; may reduce the effects of some blood pressure
medicines; should be avoided if you have severe heart failure; may
cause adverse effects on cartilage; may cause a rare blood
disorder, or life-threatening skin or allergic reactions; may harm
your unborn baby if received at 20 weeks of pregnancy or later; and
may cause low red blood cells (anemia).
Tell your healthcare provider about all your medical conditions
and about all the medicines you take including prescription or
over-the-counter medicines, vitamins, or herbal supplements to
discuss if ZYNRELEF is right for you.
Talk to your healthcare provider for medical advice about side
effects. Report side effects to Heron at 1-844-437-6611 or to FDA
at 1-800-FDA-1088 or www.fda.gov/medwatch.
The information provided here is not comprehensive. Please see
full Prescribing Information, including Boxed Warning, at
www.ZYNRELEF.com.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a commercial-stage biotechnology
company focused on improving the lives of patients by developing
and commercializing therapeutic innovations that improve medical
care. Our advanced science, patented technologies, and innovative
approach to drug discovery and development have allowed us to
create and commercialize a portfolio of products that aim to
advance the standard-of-care for acute care and oncology patients.
For more information, visit www.herontx.com.
Forward-looking Statements
This news release contains "forward-looking statements" as
defined by the Private Securities Litigation Reform Act of 1995.
Heron cautions readers that forward-looking statements are based on
management's expectations and assumptions as of the date of this
news release and are subject to certain risks and uncertainties
that could cause actual results to differ materially. Therefore,
you should not place undue reliance on forward-looking statements.
Examples of forward-looking statements include, among others,
statements we make regarding the potential market opportunities for
ZYNRELEF®, APONVIE®, CINVANTI® and
SUSTOL®; revenue, adjusted EBITDA and other financial
guidance provided by the Company; the results of the commercial
launch of APONVIE; the potential additional market opportunity for
the expanded U.S. label for ZYNRELEF or inclusion of ZYNRELEF under
the OPPS and the ASC payment system; the timing of the Company's
development of the VAN program and receipt of required regulatory
approvals, including any potential delays in the anticipated PDUFA
goal date; our ability to establish and maintain successful
commercial arrangements like our co-promotion agreement with
CrossLink; the realization of anticipated benefits from our
co-promotion agreement with CrossLink; the outcome of the Company's
pending abbreviated new drug application litigation; whether the
Company is required to write-off any additional inventory in the
future; the expected future balances of Heron's cash, cash
equivalents and short-term investments; the expected duration over
which Heron's cash, cash equivalents and short-term investments
balances will fund its operations and the risk that future equity
financings may be needed; and any inability or delay in achieving
profitability. Important factors that could cause actual results to
differ materially from those in the forward-looking statements are
set forth in our most recent Annual Report on Form 10-K and any
subsequent Quarterly Reports on Form 10-Q, and in our other reports
filed with the Securities and Exchange Commission, including under
the caption "Risk Factors." Forward-looking statements reflect our
analysis only on their stated date, and Heron takes no obligation
to update or revise these statements except as may be required by
law.
Investor Relations and Media Contact:
Ira Duarte
Executive Vice President, Chief Financial Officer
Heron Therapeutics, Inc.
iduarte@herontx.com
858-251-4400
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SOURCE Heron Therapeutics, Inc.