Isatuximab-irfc (Sarclisa®) is an IgG1-derived monoclonal antibody that binds to CD38 expressed on the surface of hematopoietic and tumor cells, including multiple myeloma cells. Isatuximab (Sarclisa) in combination with pomalidomide induces apoptosis of tumor cells and activates immune effector mechanisms.
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
National Comprehensive Cancer Network (NCCN) Recommendation
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.
NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.
Original Effective Date 5-15-2020
Internal Medical Policy Committee 5-19-2020 New Policy
Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.