Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Food and Drug Administration (FDA) Indications
Melphalan flufenamide (Pepaxto) may be considered medically necessary when the following criteria are met:
- Individual diagnosed with relapsed or refractory multiple myeloma; and
- Individual has received at least four (4) prior lines of therapy; and
- Disease is refractory to at least one (1) of EACH of the following:
- Proteasome inhibitor; and
- Immunomodulatory agent; and
- CD38-directed monoclonal antibody; and
- Melphalan flufenamide (Pepaxto) will be given in combination with dexamethasone; or
National Comprehensive Cancer Network (NCCN) Recommendations
Multiple Myeloma
- Therapy in combination with dexamethasone for previously treated multiple myeloma for relapse or progressive disease in individuals who:
- Have received at least four (4) prior lines of therapy; and
- Individual has disease that is refractory to at least one (1) of EACH of the following:
- Proteasome inhibitor; and
- Immunomodulatory agent; and
- CD38-directed monoclonal antibody
The use of melphalan flufenamide (Pepaxto) for all other indications is considered experimental/investigational, and therefore, non-covered. Peer reviewed literature does not support the use of melphalan flufenamide (Pepaxto) for any other indications.
Procedure Codes
