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.
Compendia Sources
Obinutuzumab (Gazyva) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations
Obinutuzumab (Gazyva) may be considered medically necessary for ANY of the following indications:
Chronic Lymphocytic Leukemia (CLL)
- In individuals with previously untreated CLL used in combination with chlorambucil; or
Follicular Lymphoma (FL)
- In individuals with FL who relapsed after, or are refractory to, a rituximab-containing regimen, and is used in combination with bendamustine followed by obinutuzumab (Gazyva) monotherapy; or
- In adults with previously untreated stage II bulky, III or IV FL when used in combination with chemotherapy followed by obinutuzumab monotherapy in individuals achieving at least a partial remission.
The use of Obinutuzumab (Gazyva) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
Procedure Codes
