Heron Therapeutics Secures Direct Payment Status for ZYNRELEF® from Medicare and Medicaid Service Centers, Extending Separate Reimbursement to the Hospital’s Ambulatory Care Setting
– ZYNRELEF is the only local anesthetic with separate reimbursement for hospital outpatient care and day surgery centers –
SAN DIEGO, March 25, 2022 /PRNewswire/ — Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most unmet needs. patients, today announced that the Centers for Medicare & Medicaid Services (CMS) has approved transitional transfer status for ZYNRELEF (bupivacaine and meloxicam) extended-release solution, which will be established for three years from April 1, 2022, for a separate reimbursement apart from the payment of the surgical package within the framework of care of the outpatient department of the hospital (HOPD). This CMS approval makes ZYNRELEF the only local anesthetic with separate reimbursement on the hospital outpatient consultation market.
The CMS grants transfer status to certain new and innovative medical devices, drugs and biologicals. Medications administered at HOPD and Ambulatory Surgical Center (ASC) facilities may be transferred and reimbursed accordingly by Medicare. With transfer status, ZYNRELEF will be reimbursed separately by Medicare at the Average Selling Price (ASP) + 6% at HOPD and ASC facilities. In the ASC setting, since January 1, 2022, ZYNRELEF, under C code C9088, was reimbursed at ASP + 6% due to recent changes in payment policies for non-opioid drugs for pain management and Medicare biologics. Based on third-party claims data, 72% of procedures reported by ZYNRELEF were performed on an outpatient basis in 2021, with 59% in the HOPD market and 13% in ASC care.
“With nearly 60% of our Indicated Procedures occurring in HOPD and our primary competitor no longer having reimbursement in this setting, receiving CMS Passed Status is an extremely important step in the successful launch of ZYNRELEF,” said said Barry Quart, Pharm .D., President and CEO of Heron. “The transfer status will help expedite access to ZYNRELEF for the millions of patients seeking superior postoperative pain relief for 72 hours by providing outpatient care providers with superior reimbursement when administering ZYNRELEF . »
ZYNRELEF is approved by the United States Food and Drug Administration (FDA) for use in adults for soft tissue or periarticular instillation to produce post-surgical analgesia for up to 72 hours after foot and ankle , small to medium open abdomen and total joint lower extremity joint replacement surgeries.
Important Patient Safety Information
ZYNRELEF contains an NSAID (nonsteroidal anti-inflammatory drug), a type of medicine that:
- May increase the risk of heart attack or stroke which can lead to death. This risk increases with higher doses and longer use of an NSAID.
- Cannot be used during heart bypass surgery.
- May increase the risk of gastrointestinal bleeding, ulcers and tears.
ZYNRELEF should also not be used:
- if you are allergic to any of the ingredients of ZYNRELEF, similar local anaesthetics, aspirin or other NSAIDs (such as ibuprofen or naproxen), or if you 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) can affect the nervous and cardiovascular systems; may cause liver or kidney problems; may reduce the effects of certain blood pressure medications; should be avoided if you have severe heart failure; may have 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 can 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 action local anesthetic that delivers a fixed dose combination of the local anesthetic bupivacaine and a low dose of meloxicam, a nonsteroidal anti-inflammatory drug. ZYNRELEF is the first and only sustained-release local anesthetic to be shown in Phase 3 studies to significantly reduce pain and significantly increase the proportion of patients requiring no opioids in the first 72 hours after surgery by compared to bupivacaine solution, the current reference local anesthetic for postoperative pain control. ZYNRELEF was originally approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce post-surgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and joint replacement total knee. In December 2021, the FDA has approved an extension of the indication for ZYNRELEF. ZYNRELEF is now indicated in the United States in adults for soft tissue or periarticular instillation to provide post-surgical analgesia for up to 72 hours after total foot and ankle arthroplasty, the open abdomen of small to medium size and lower limbs. Safety and effectiveness have not been established in highly vascular surgeries, such as intrathoracic procedures, multilevel spine, and head and neck procedures. In September 2020, the European Commission granted marketing authorization for ZYNRELEF for the treatment of postoperative somatic pain in small to medium sized surgical wounds in adults. As of January 1, 2021, ZYNRELEF is approved in 31 European countries including European Union and European Economic Area countries and the United Kingdom. In March 2022Health Canada has issued a Notice of Compliance for ZYNRELEF for surgical wound instillation for postoperative analgesia following bunionectomy, open inguinal herniorrhaphy and total knee replacement surgery.
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 best-in-class treatments to address some of the greatest unmet patient needs. Our advanced science, patented technologies and innovative approach to drug discovery and development have enabled us to create and commercialize a portfolio of products aimed at advancing the standard of care for acute care and oncology patients. For more information, visit www.herontx.com.
This press 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 press 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 United States; the extent of the impact of the current coronavirus disease 2019 pandemic on our business; and other risks and uncertainties identified in the Company’s filings with the United States Securities and Exchange Commission. Forward-looking statements reflect our analysis only as of the date indicated, and Heron undertakes no obligation to update or revise these statements, except as required by law.
Investor Relations and Media Contact:
Executive Vice President, Chief Operating Officer
Heron Therapeutics, Inc.
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