Overview

Tecelra (afamitresgene autoleucel) is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy FDA indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen. MAGE-A4 is an intracellular cancer-testis antigen with limited expression in normal tissues and is found in synovial sarcoma. Tecelra, when activated by the TCR-peptide-HLA-A02 complex, induces T cell proliferation, cytokine release, and the destruction of MAGE-A4/HLA-A02 expressing synovial sarcoma cells.

Policy

Tecelra (afamitresgene autoleucel) are considered MEDICALLY NECESSARY when the following criteria is met:

1. Individual has a diagnosis of unresectable or Stage IV synovial sarcoma; AND
2. Individual is 18 years of age or older; AND
3. Individual must be ALL of the following:
   1. A. Human Leukocyte Antigen (HLA)-A02:01P, -A02:02P, -A02:03P, or -A02:06P positive; AND
4. MAGE-A4 antigen positive; AND
5. Individual must have progressed following ≥1 prior systemic chemotherapy; AND
6. V. Individual must have an Eastern Cooperative Oncology Group Performance Status of 0-1; AND
7. VI. Individual is using as a one-time, single administration dose per lifetime.

Tecelra (afamitresgene autoleucel) is considered NOT medically necessary for the following:

1. Repeat administration
2. Individual is heterozygous or homozygous for HLA-A*02:05P positive

References

1. Tecelra (afamitresgene autoleucel) for intravenous infusion [prescribing information]. Philadelphia, PA. Adaptimmune; August 2024. Available at: https://www.fda.gov/media/180565/download?attachment.
2. Coverage Policy Manual - Arkansas Blue Cross and Blue Shield. (n.d.). Retrieved from https://secure.arkansasbluecross.com/members/report.aspx?policyNumber=2024078&viewIntro=yes

Coding

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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