Polatuzumab vedotin-piiq (Polivy®) is a novel CD79b-directed antibody-drug conjugate with activity against dividing B cells, consisting of humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for human CD79b, the small molecule anti-mitotic agent monomethyl auristatin E (MMAE), and a protease-cleavable linker that covalently attaches MMAE to the antibody. Polatuzumab vedotin (Polivy) binds to CD78b of the B-cell receptor; upon binding polatuzumab vedotin (Polivy) is internalized and the linker is cleaved by lysosomal proteases enabling intracellular delivery of MMAE. MMAE binds to microtubules, inhibits cell division, and induces apoptosis, thus killing dividing cells.
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:
Polatuzumab vedotin (Polivy) may be considered medically necessary for adults in combination with bendamustine and a rituximab product for the treatment of relapsed or refractory diffuse large B cell lymphoma (DLBCL) when ALL of the following criteria are met:
National Comprehensive Cancer Network (NCCN) Recommendations:
Polatuzumab vedotin (Polivy) may be considered medically necessary for adults in combination with bendamustine and a rituximab product as second-line or subsequent therapy for partial response, no response, relapsed, progressive or refractory disease after at least two (2) prior therapies in non-candidates for transplant for ANY of the following conditions:
The use of polatuzumab vedotin (Polivy) for any other indication is considered experimental/investigational as the published peer reviewed literature does not support its efficacy or safety for any other indications.
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.
Professional Statements and Societal Positions Guidelines