August 16, 2021
BOSTON— August 16, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announced that the Centers for Medicare and Medicaid Services (CMS) has established a specific billing Level II Healthcare Common Procedure Coding System (HCPCS) code for PEPAXTO®. J codes are product-specific reimbursement codes assigned to outpatient and physician administered “buy and bill” products under Medicare Part B. Claims submission and payment are standardized with a J-code, thereby facilitating and clarifying billing and reimbursement from Medicare, Medicaid, and commercial insurance. The Code, J9247, “Injection, melphalan flufenamide, 1mg” will go into effect on October 1, 2021.
“Having a permanent J-code for PEPAXTO will help to ease the administrative burden of billing for our drug in hospitals as well as community clinics,” said Mohamed Ladha, General Manager of Oncopeptides’ U.S. Business Unit. “This J code will help to increase reimbursement confidence among providers and their practice management staff and enable more eligible patients to gain access to therapy.”
PEPAXTO® in combination with dexamethasone was approved by the FDA under accelerated approval on February 26, 2021, based upon the HORIZON study for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.
Limitation of Use
PEPAXTO is not indicated and is not recommended for use as a conditioning regimen for transplant outside of controlled clinical trials.
To view the full prescribing information, please visit https://pepaxto.com/docs/pepaxto_pi.pdf.The FDA issued a safety communication that showed an increased risk of death associated with PEPAXTO® on July 28, 2021. The Company has an ongoing dialogue with the FDA and will provide updated information as soon as it is available. Please refer to this press release. Oncopeptides plans to submit data from the OCEAN study to the International Myeloma Workshop meeting in Vienna, Austria on September 8-11, 2021.
For more information, please contact:
Sarah Connors, Head of U.S. Corporate Communications, Oncopeptides, Inc.
Cell phone: 508-654-2277
Oncopeptides is a global biotech company committed to developing targeted therapies for patients facing hard-to-treat hematological diseases. Oncopeptides has one U.S. FDA approved product, PEPAXTO® (melphalan flufenamide), which is approved for some patients with triple-class refractory multiple myeloma. Oncopeptides’ headquarters is in Stockholm, Sweden, with a U.S. headquarters in Boston, Massachusetts. In addition to Boston, Oncopeptides has a footprint in San Francisco, California, another U.S. biotech hub. For more information, please visit our corporate website at https://oncopeptides.se/en/. You may also visit our U.S. website at https://www.oncopeptides-us.com/en and follow us on our U.S. social media channels, Twitter and LinkedIn.
PEPAXTO® is a trademark of Oncopeptides AB (publ).