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
- For the treatment of individuals with a diagnosis of multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor; and
- Individual is 18 years of age and older; and
- Is administered in combination with pomalidomide and dexamethasone; or
National Comprehensive Cancer Network (NCCN) Recommendation
- 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 2 prior therapies, including lenalidomide and a proteasome inhibitor.
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.