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.
Isatuximab (Sarclisa) may be considered medically necessary for the following when ALL criteria are met:
Food and Drug Administration (FDA) Indication
Multiple Myeloma
- In combination with pomalidomide and dexamethasone, for the treatment of individuals with a diagnosis of multiple myeloma who have received at least two (2) prior therapies including lenalidomide and a proteasome inhibitor; or
- In combination with carfilzomib and dexamethasone for relapsed or refractory multiple myeloma in individuals who have received at least 1 prior line of therapy; or
National Comprehensive Cancer Network (NCCN) Recommendation
Multiple Myeloma
As therapy for previously treated multiple myeloma for relapsed or progressive disease in combination with:
- Pomalidomide and dexamethasone for individuals who have received at least two (2) prior therapies, including lenalidomide and a proteasome inhibitor; or
- Carfilzomib and dexamethasone
The use of isatuximab (Sarclisa) for any other indication is considered experimental/investigational, and therefore, non-covered. Scientific evidence does not support its use for any other indications not listed above.
Procedure Codes
