July 13, 2021
BOSTON— July 13, 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) have established a specific C-Code for PEPAXTO®, C9080. The code went into effect on July 1, 2021, and will be active through June of 2024.
“Roughly three-quarters of current PEPAXTO use is in the hospital outpatient site of care which is consistent with well-known trends in patient care for Relapsed or Refractory Multiple Myeloma,” said Mohamed Ladha, General Manager of oncopeptides’ US Business Unit. ”Medicare provides coverage for all US adults aged 65 or older, and given the average age of diagnosis of a Multiple Myleoma patient is 69, Medicare represents an extremely important payer for Multiple Myeloma patients. CMS awarding Oncopeptides a specific C-code for PEPAXTO is very impactful to our patients and sites of care.”
C-codes are specific temporary pricing codes established for the Prospective Payment System, exclusively for the Hospital Outpatient setting of care. The c-code, and the transitional pass-through status that it confers, is intended to encourage the use of newly FDA-approved drugs to increase Medicare patients’ access to new and innovative therapies by temporarily paying more than established facility fees. Oncopeptides’ anticipates a permanent J-Code will be assigned in the third quarter of 2021.
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
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).