Effective June 30, 2023, Independence Blue Cross and Independence Administrators will update their medical policy on belantamab mafodotin-blmf (Blenrep) for Commercial and Medicare Advantage members.
GlaxoSmithKline initiated the process for withdrawal of the BLA for this biologic, at the request of the U.S. Food and Drug Administration (FDA). Blenrep was granted accelerated approval on August 5, 2020, based on the primary endpoint of overall response rate (ORR) from the DREAMM-2 study, with full approval contingent upon confirmed clinical benefit from the DREAMM-3 randomized Phase 3 trial. However, this confirmatory trial did not meet its primary endpoint of superior progression-free survival (PFS).
The HCPCS code J9037 will be included in the following medical policies, with Not Medically Necessary coverage, effective July 1, 2023: #00.01.24j: Not Medically Necessary Services (Medical Therapies and Pharmaceutical Products) and Obsolete or Unreliable Diagnostic Tests and #MA00.001c: Not Medically Necessary Services (Medical Therapies and Pharmaceutical Products) and Obsolete or Unreliable Diagnostic Tests.
For more information, please view the following notifications that were published on May 31, 2023: