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.
Lisocabtagene maraleucel (Breyanzi) may be considered medically necessary when an individual meets ALL of the following criteria:
- The individual has a diagnosis of relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B (note: individual must meet all aspects of the diagnosis as indicated); and
- The individual does NOT have primary central nervous system lymphoma; and
- The individual has relapsed or has refractory large B-cell lymphoma after two or more lines of systemic therapy; and
- ONE of the following:
- The individual is 18 years of age or older; or
- The prescriber has provided information in support of lisocabtagene maraleucel (Breyanzi) for the individual’s age for the requested indication; and
- The individual does NOT have active uncontrolled infection including Hepatitis B, Hepatitis C, or HIV infection; and
- The individual has NOT previously been treated with lisocabtagene maraleucel (Breyanzi) or another CAR-T therapy (e.g., Kymriah, Yescarta); and
- The individual has NOT been treated with other gene therapy.
Lisocabtagene maraleucel (Breyanzi) for any other indication is considered experimental/investigational, and therefore, non-covered. Scientific evidence has not established the effectiveness for any other indication.
Procedure Codes
