Heron Therapeutics Secures Pass-through Payment Status for ZYNRELEF® from Centers for Medicare & Medicaid Services, Expanding Separate Reimbursement into the Hospital Outpatient Setting of Care
- ZYNRELEF is the only local anesthetic with separate reimbursement in both the Hospital Outpatient and Ambulatory Surgical Center settings of care -
CMS grants pass-through status to certain new and innovative medical devices, drugs, and biological products. Drugs that are administered in the HOPD and Ambulatory Surgical Center (ASC) settings can have pass-through and be reimbursed accordingly by Medicare. By having pass-through status, ZYNRELEF will be separately reimbursed by Medicare at Average Sales Price (ASP) +6% in both the HOPD and ASC settings of care. In the ASC setting, since
"With almost 60% of our indicated procedures occurring in the HOPD and our primary competitor no longer having reimbursement in this setting, receiving pass-through status from CMS is a hugely important milestone in the successful launch of ZYNRELEF," said
ZYNRELEF is approved by the
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 constipation, vomiting, 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).
Please see full Prescribing Information, including Boxed Warning.
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 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
Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.
About Heron Therapeutics, Inc.
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, including, but not limited to, the potential market opportunity for ZYNRELEF in the
Investor Relations and Media Contact:
Executive Vice President, Chief Operating Officer
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