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Eagle Pharmaceuticals Granted Unique J-Code and Pass-Through Status for BARHEMSYS® from CMS-- J-code is effective January 1, 2024, and transitional pass-through status became effective October 1, 2023, facilitating patient access -- -- BARHEMSYS is the first and only antiemetic approved by the FDA for rescue treatment of postoperative nausea and vomiting (“PONV”) despite prophylaxis1 and is also approved for the treatment of PONV in patients who have not received prophylaxis and for the prevention of PONV -- WOODCLIFF LAKE, N.J., Oct. 23, 2023 (GLOBE NEWSWIRE) -- 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. Forward-Looking Statements Investor Relations for Eagle Pharmaceuticals, Inc.: Public Relations for Eagle Pharmaceuticals, Inc.: 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
______________________________ 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 |