Medical Drug Criteria (MDC) Medical Drug Criteria (MDC)
Policy Num: P1.002.026
Policy Name: TECELRA® (afamitresgene autoleucel) suspension
Policy ID: [P1.002.026] [Ac L M+ P+]
Last Review: September 22, 2025
Next Review: September 26, 2026
| Popultation Reference No. | Populations |
|---|---|
| 1 | Individuals:
|
TECELRA (afamitresgene autoleucel) is a melanoma-associated antigen A4 (MAGEA4)-directed genetically modified autologous T cell immunotherapy product consisting of CD4 and CD8 positive T cells transduced with a self-inactivating lentiviral vector (LV) expressing an affinity-enhanced T cell receptor (TCR) specific for the human MAGE-A4. Autologous T cells transduced with MAGE-A4-c1032 LV express the affinity-enhanced TCR on the cell surface. The TCR recognizes an HLA-A*02 restricted MAGE-A4 peptide. MAGE-A4 is an intracellular cancer-testis antigen that has restricted expression in normal tissues and is expressed in synovial sarcoma. TECELRA was approved by the U.S. Food and Drug Administration (FDA) on August 1, 2024 for the treatment of adults with unresectable or metastatic SyS 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 as determined by FDA-approved or cleared companion diagnostic devices. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Synovial sarcoma (SyS) is a rare, aggressive soft tissue sarcoma that can occur in many parts of the body but most commonly develops in the extremities. Each year, SyS affects about 1000 people in the United States. Treatment of SyS typically involves surgery to remove the tumor and may also include radiotherapy or chemotherapy if the tumor is larger, returns after being removed, or has spread beyond its original location.
The infusion of Afamitresgene Autoleucel (Tecelra) is considered medically necessary 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.
Afamitresgene autoleucel (Tecelra) meets the definition of medical necessity when ALL of the following are met:
1. The individual is diagnosed with unresectable or metastatic (stage IV) synovial sarcoma (SyS).
2. The individual disease is HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive – laboratory documentation must be provided.
3.The individual’s tumor expresses the melanoma-associated antigen A4 (MAGE-A4) antigen as determined by FDA-approved or cleared companion diagnostic devices – laboratory documentation must be provided.
4.The individual’s disease has progressed following at least one prior systemic chemotherapy – documentation from the medical record must be provided.
5. The individual will receive a lymphodepleting regimen of cyclophosphamide and fludarabine prior to infusion of afamitresgene autoleucel.
6. The individual will be 18 years of age or older at the time of the treatment infusion.
7. The individual has been assessed and has stable and adequate organ function (kidney, liver, pulmonary and cardiac function) and bone marrow function with no significant deterioration expected within 4 weeks as determined by the treating oncologist/hematologist.
8. Afamitresgene autoleucel will not be administered if the individual has an uncontrolled systemic infection at the time of planned treatment initiation.
9. The individual has NOT previously received tumor-derived autologous T cell immunotherapy (including afamitresgene autoleucel) in their lifetime for the treatment of SyS.
10. The healthcare facility where afamitresgene autoleucel will be administered is a Tecelra Authorized Treatment Center.
11. Dose does not exceed 10 x 109 MAGE-A4 T cell receptor (TCR) positive T cells.
12. The administration of afamitresgene autoleucel will not exceed one single IV infusion NOTE: One of more infusion bags may be required to complete the single infusion.
Approval duration: 3 months to allow for one-time infusion of therapy.
TECELRA is:
• A cell suspension for intravenous infusion.
• Provided in one or more infusion bag(s) containing 2.68 x 109 to 10 x 109 MAGE-A4 TCR positive T cells.
FDA-approved
Dose Adjustments
BlueCard/National Account Issues
State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration-approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.
Based on benefits or contract language, Afamitresgene Autoleucel (Tecelra) may be considered either a pharmacy or a medical benefit.
Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.
None.
As a subsequent line of therapy for advanced/metastatic diseasein certain circumstances: HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen(synovial sarcomas only).
No Interqual Criteria Applicable.
There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.
| Codes | Number | Description |
|---|---|---|
| HCPCs | Q2057 | Afamitresgene autoleucel, including leukapheresis and dose preparation procedures, per therapeutic dose |
| ICD 10 - CM | C38.0-38.8 | Malignant neoplasm of heart, mediastinum and pleura |
| C48.1-48.8 | Malignant neoplasm of retroperitoneum and peritoneum | |
| C49.0-49.9 | Malignant neoplasm of connective and soft tissue |
| Date | Action | Description |
|---|---|---|
| 9/22/2025 | MDC creation | Medical Drug Criteria approved at the September 2025 Pharmacy Criteria Meetting. |