CMS Provides Billing Code for Pepaxto

The Centers for Medicare and Medicaid Services (CMS) has provided a permanent J code for Pepaxto (melphalan flufenamide). 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. The Code, J9247, “injection, melphalan flufenamide, 1mg” will go into effect on October 1, 2021.

"Having a permanent J code will help to ease the administrative burden of billing for our drug in hospitals as well as community clinics,” Mohamed Ladha, general manager of Oncopeptides’ U.S. business unit, said in a statement. Oncopeptides is a Swedish company that is marketing Pepaxto in the U.S. “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.”

The FDA approved Pepaxto in February 2021 in combination with dexamethasone, 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. Pepaxto is the first anticancer peptide-drug conjugate approved by the FDA. The product has been granted accelerated approval based on the phase 2 HORIZON study in relapsed or refractory multiple myeloma.

In March, the National Comprehensive Cancer Network (NCCN) included Pepaxto on the new Multiple Myeloma Clinical Practice Guidelines. NCCN is an alliance of 30 cancer centers in the United States that issues influential guidelines for cancer treatment.