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.
Afamitresgene autoleucel (Tecelra®) may be considered medically necessary when the following criteria are met:
Synovial Sarcoma
-
Individual 18 years of age or older;
and
-
Individual diagnosed with synovial sarcoma;
and
-
Individual diagnosed with unresectable or metastatic disease;
and
-
Disease progression following last regimen or refractory to most recent therapy;
and
-
Individual is HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive;
and
-
Tumor expresses MAGE-4 antigen as determined by an FDA-approved or cleared companion diagnostic device;
and
-
No prior treatment with CAR-T therapy directed at any target;
and
-
ECOG scale of performance status less than one (1);
and
-
No history of central nervous system (CNS) metastases or other CNS disorders;
and
-
Individual does not have any active or serious infections;
and
- Cardiac ejection fraction (EF) greater than 50%.
Additional infusions of afamitresgene autoleucel (Tecelra) or infusion of alternative CAR-T products after an initial infusion of one product are considered experimental/investigational and therefore, non-covered. Scientific evidence does not support more than one (1) dose of a single CAR-T product per lifetime.
The use of afamitresgene autoleucel (Tecelra) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Code
