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.
Idecabtagene vicleucel (Abecma) may be considered medically necessary when an individual meets ALL of the following criteria:
- The individual has a diagnosis of relapsed or refractory multiple myeloma as confirmed by ONE of the following: (medical records required)
- Serum M-protein at least 1.0 g/dL; or
- Urine M-protein at least 200 mg/24 hours; or
- Serum free light chain (FLC) assay level at least 10 mg/dL (100 mg/L) provided the serum FLC ration is abnormal; and
- The individual has received four or more lines of therapy (note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen); and
- The individual has been previously treated with ALL of the following (either combination or monotherapy) for at least 2 consecutive cycles of treatment for each regimen (unless disease progression was the best response to the regimen) for multiple myeloma:
- An immunomodulatory agent (e.g., lenalidomide, thalidomide); and
- A proteasome inhibitor (e.g., bortezomib, carfilzomib, Ixazomib); and
- An anti-CD38 monoclonal antibody (e.g., daratumumab); and
- ONE of the following:
- The individual’s age is within FDA labeling for idecabtagene vicleucel (Abecma); or
- The prescriber has provided information in support of idecabtagene vicleucel (Abecma) for the individual’s age; and
- The individual does not have active uncontrolled infection including Hepatitis B, Hepatitis C, or HIV infection; and
- The individual does not have any FDA labeled contraindications to idecabtagene vicleucel (Abecma); and
- The individual has not previously been treated with idecabtagene vicleucel (Abecma) or another CAR-T therapy (e.g., Kymriah, Yescarta); and
- The individual has NOT been treated with other gene therapy.
Idecabtagene vicleucel (Abecma) 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
