A permanent code is expected in the third quarter of 2021.
Oncopeptides has announced that the Centers for Medicare and Medicaid Services (CMS) has established a specific C code for Pepaxto (melphalan flufenamide). The code, C9080, went into effect on July 1, 2021, and will be active through June of 2024.
C-codes are temporary pricing codes established for the Prospective Payment System for the hospital outpatient setting. The C code is intended to encourage the use of newly FDA-approved drugs to increase Medicare patients’ access to new therapies. Officials anticipate that a permanent J code will be assigned in the third quarter of 2021.
“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,” Mohamed Ladha, general manager of Oncopeptides’ US Business Unit, said in a statement.
The FDA approved Pepaxto in February 2021 to treat 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.
The approval was based on the results of the HORIZON study evaluating intravenous melflufen in combination with dexamethasone in heavily pre-treated patients with a poor prognosis. This multi-center single arm study evaluated 157 patients with relapsed or refractory multiple myeloma. The overall response rate for the patients within this group of patients with refractory multiple myeloma was 23.7% and the median duration of response was 4.2 months.
In March, the National Comprehensive Cancer Network included Pepaxto on its multiple myeloma guidelines.