ZYNRELEF® Added to 2025 Non-Opioid Pain Relief Policy by Heron Therapeutics

SAN DIEGO, July 15, 2024 -- Heron Therapeutics, Inc., a company in the biotechnology sector, announced that its product ZYNRELEF® (bupivacaine and meloxicam) has been included in the proposed 2025 Non-Opioid Policy for Pain Relief under Medicare's Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) payment system. This inclusion, which is set to become effective on April 1, 2025, was detailed in a Proposed Rule by the Centers for Medicare & Medicaid Services (CMS). ZYNRELEF's eligibility is tied to its role in managing postoperative pain and its potential to reduce or eliminate opioid use.

Currently, ZYNRELEF benefits from a CMS reimbursement policy known as pass-through payment status, which will expire on March 31, 2025. The new effective date allows ZYNRELEF to continue receiving separate reimbursements in hospital outpatient and ASC settings without any break. CMS has also proposed that for 2025, payments for qualifying drugs like ZYNRELEF will not face reductions, maintaining Medicare payments at the average sales price plus six percent. Heron expects that this CMS policy will likely influence other commercial payers to adopt similar practices.

Craig Collard, Chief Executive Officer at Heron, expressed his approval of CMS's initiative to broaden access to non-opioid post-surgical pain management solutions. He highlighted that the inclusion of ZYNRELEF in the Proposed Rule is a significant step towards reducing opioid use in the U.S., ensuring that patients and providers have access to effective pain management options after surgical procedures.

ZYNRELEF for Postoperative Pain

ZYNRELEF is a unique dual-acting local anesthetic that combines bupivacaine with a low dose of meloxicam. It is the first extended-release local anesthetic shown in Phase 3 studies to significantly reduce pain and increase the number of patients not requiring opioids for 72 hours post-surgery, compared to the standard bupivacaine solution. Initially approved by the FDA in May 2021 for adult use in certain surgeries, ZYNRELEF received expanded approval in December 2021 to include a broader range of procedures. Further approval was granted on January 23, 2024, for additional soft tissue and orthopedic surgeries, excluding those involving direct exposure to articular cartilage. Its safety and efficacy have not been established for highly vascular surgeries.

Important Safety Information for Patients

ZYNRELEF contains an NSAID, which:
- Can increase the risk of heart attack or stroke, especially with higher doses and prolonged use.
- Is not suitable for use during heart bypass surgery.
- Can elevate the risk of gastrointestinal issues such as bleeding, ulcers, and tears.

ZYNRELEF should not be used if:
- You are allergic to any of its components, similar local anesthetics, aspirin, or other NSAIDs.
- You have had adverse reactions to these medicines.
- It is intended for use as a paracervical block during childbirth.

Common side effects include vomiting in soft tissue procedures, and constipation and headache in orthopedic procedures. The medications in ZYNRELEF may affect the nervous and cardiovascular systems, cause liver or kidney problems, and interact with blood pressure medications. They should be avoided in cases of severe heart failure and during pregnancy from 20 weeks onward.

Patients should inform their healthcare provider about all medical conditions and medications they are taking to determine if ZYNRELEF is appropriate for them. For medical advice on side effects, patients should talk to their healthcare provider. Side effects can be reported to Heron or the FDA.

About Heron Therapeutics, Inc.

Heron Therapeutics, Inc. is a biotechnology company focused on enhancing patient care by developing and commercializing innovative therapies. The company leverages its advanced science, patented technologies, and innovative approach to create products that aim to improve the standard-of-care for acute care and oncology patients.

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