REDWOOD CITY, Calif., Nov. 05, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences(Coherus, Nasdaq: CHRS), today announced that the Centers for Medicare & Medicaid Services (CMS) will continue to provide increased Medicare reimbursement in the 340B outpatient hospital setting through year-end 2022 for 28 drugs, biologics and devices impacted by the COVID-19 public health emergency, including UDENYCA (pegfilgrastim-cbqv).
We applaud CMS for continuing its support for patients, providers and hospitals impacted by the COVID-19 pandemic, said Denny Lanfear, CEO of Coherus.
After transitional pass-through payment status expires for UDENYCA on March 31, 2022,CMS will provide a separate payment through the end of 2022 to maintain the same reimbursement levels for UDENYCA in the 340B outpatient hospital setting as determined through the pass-through payment program.Pass-through payment status was established by Congress to incentivize access for Medicare patients to biosimilars and other important therapeutics and devices in the hospital outpatient setting. Under the program, reimbursement for UDENYCA in the 340B hospital outpatient setting is calculated at the CMS Average Sales Price (ASP) for UDENYCA plus 6% of the ASP for Neulasta (pegfilgrastim). By comparison, Neulasta is currently reimbursed in the 340B hospital setting at the Neulasta ASP less 22.5%.
About UDENYCA UDENYCA is the #1 prescribed pegfilgrastim pre-filled syringe in the United States.
UDENYCAis a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Limitations of Use: UDENYCAis not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Contraindications: Patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis
Warnings and Precautions:
Fatal splenic rupture:Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCAin patients with ARDS.
Serious allergic reactions, including anaphylaxis: The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue UDENYCAin patients with serious allergic reactions.
Sickle cell crises:Severe and sometimes fatal crises have occurred. Discontinue UDENYCAif sickle cell crisis occurs.
Glomerulonephritis:The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events resolved after dose reduction or discontinuation. Evaluate and consider dose-reduction or interruption of UDENYCAif causality is likely.
Leukocytosis:White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during UDENYCAtherapy is recommended.
Thrombocytopenia:Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts.
Capillary Leak Syndrome:Has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care.
Potential for Tumor Growth Stimulatory Effects on Malignant Cells:The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer:MDS and AML have been associated with the use of pegfilgrastim in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for sign and symptoms of MDS/AML in these settings.
Aortitis:Has been reported in patients receiving pegfilgrastim products, occurring as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis when signs and symptoms develop without known etiology. Discontinue UDENYCA if aortitis is suspected.
Nuclear Imaging:Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. Consider when interpreting bone imaging results.
Adverse Reactions:Most common adverse reactions ( 5% difference in incidence compared to placebo) are bone pain and pain in extremity.
To report SUSPECTED ADVERSE REACTIONS, contactCoherus BioSciencesat 1-800-4-UDENYCA (1-800-483-3692)orFDAat 1-800-FDA-1088 orwww.fda.gov/medwatch.
Full Prescribing Information available atwww.UDENYCA.com
About Coherus BioSciences
Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients lives and to deliver significant savings to the health care system. Coherus strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. For additional information, please visit http://www.coherus.com.
Coherus markets UDENYCA (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis, Humira, and Avastin, if approved.
UDENYCA is a trademark of Coherus BioSciences, Inc.
Neulasta is a registered trademark of Amgen, Inc.
Avastin and Lucentis are registered trademarks of Genentech, Inc.
Humira is a registered trademark of AbbVie Inc.
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus ability to generate cash flow from its UDENYCA business; the reimbursement of UDENYCA by CMS in the 340B hospital at the rate of UDENYCA Average Sale Price + 6% of the Neulasta ASP through year-end 2022; Coherus plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus ability to prepare for projected launches through 2023 of toripalimab or of biosimilars of Humira, Avastin and Lucentis, if approved.
Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review and the timing of Coherus regulatory filings; the risk of FDA review issues; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus business in general, see Coherus Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021,its Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, filed with the Securities and Exchange Commission on August 5, 2021 and its future periodic reports to be filed with the Securities and Exchange Commission. Results for the quarter ended June 30, 2021 are not necessarily indicative of our operating results for any future periods.
Coherus Contact Information: IR Contact: Cheston Turbyfill Coherus BioSciences, Inc. IR@coherus.com
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