Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Afamitresgene autoleucel (Tecelra®) may be considered medically necessary when the following criteria are met:
Synovial Sarcoma
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Individual 18 years of age or older;
and
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Individual diagnosed with synovial sarcoma;
and
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Individual diagnosed with unresectable or metastatic disease;
and
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Disease progression following last regimen or refractory to most recent therapy;
and
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Individual is HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive;
and
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Tumor expresses MAGE-4 antigen as determined by an FDA-approved or cleared companion diagnostic device;
and
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No prior treatment with CAR-T therapy directed at any target;
and
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ECOG scale of performance status less than one (1);
and
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No history of central nervous system (CNS) metastases or other CNS disorders;
and
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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
