ModifiedAnthemPolicy CC-0271

Medical Drug Clinical Criteria — Tecelra (afamitresgene autoleucel)

Clinical coverage criteria for Tecelra (afamitresgene autoleucel) as a medical-benefit immunotherapy for adults with unresectable or metastatic synovial sarcoma, including diagnostic, biomarker, prior therapy, performance status, dosing frequency, and applicable coding for billing reference.

Policy Summary

PayerAnthem

PolicyMedical Drug Clinical Criteria — Tecelra (afamitresgene autoleucel)

Policy CodePolicy CC-0271

Change TypeCoding update (HCPCS consolidated to Q2057)annual review (no criteria change)

Effective Date10/01/2025

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, HLA-A subtype (A*02:01/02:02/02:03/02:06), tumor MAGE-A4 positivity, prior systemic chemotherapy, and ECOG 0-1 to meet approval criteria.

SourceLink

POLICY UPDATE CHANGES

03/04/2025 - Coding Update: Removed HCPCS NOC C9399, J9999, and all diagnosis pend for Tecelra. Added HCPCS Q2057 effective 4/1/25. Added ICD-10-CM C48.0-C48.8, C49.0-C49.9, Z85.831.

08/15/2025 - Annual Review: No criteria changes. Added references. Coding Reviewed: Added ICD-10-CM C47.0-C47.9.

09/09/2024 - New criteria document for Tecelra (afamitresgene autoleucel).

1Single lifetime administration allowed

≥1Prior systemic chemotherapy required

0-1ECOG performance status required

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Coverage Summary

Tecelra (afamitresgene autoleucel) is FDA indicated for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01/02:02/02:03/02:06 positive, and whose tumor expresses MAGE-A4. The recommended administration is a single intravenous infusion per lifetime with a dose range of 2.68 x 10^9 to 10 x 10^9 MAGE-A4 TCR positive T cells. Tecelra carries a black box warning for Cytokine Release Syndrome (CRS). NCCN gives a 2A recommendation for Tecelra as palliative single-agent therapy in subsequent lines for certain advanced/metastatic synovial sarcoma patients. Scope: Clinical coverage criteria for Tecelra as a medical-benefit immunotherapy for adults with unresectable or metastatic synovial sarcoma, including diagnostic, biomarker, prior therapy, performance status, dosing frequency, and applicable coding for billing reference.

Initial Therapy Criteria

Not Approved / Exclusions

Not approved / Exclusions

Requests for Tecelra (afamitresgene autoleucel) may not be approved for the following:

ANY of the following

Repeat administration
Individual is heterozygous or homozygous for HLA-A*02:05P positive
When the above criteria are not met and for all other indications

Denial Risk

Denial risk for repeat dosing or disqualifying HLA

Claims will be denied/not approved for repeat administration of Tecelra or for individuals who are heterozygous or homozygous positive for HLA-A*02:05P.

Repeat administration
HLA-A*02:05P (heterozygous or homozygous)

Applicable Codes

HCPCS (Therapeutic drug code)HCPCS

Q2057

Afamitresgene autoleucel, including leukapheresis and dose preparation procedures, per therapeutic dose [Tecelra]

Previously used/removed HCPCS (historical)HCPCS

C9399	Not otherwise classified drug/biological (historical)
J9999	Not otherwise classified, antineoplastic drugs (historical)

ICD-10-PCS (Procedure codes)ICD-10

XW03368	Introduction of Afamitresgene Autoleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 8 [Tecelra]
XW04368	Introduction of Afamitresgene Autoleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 8 [Tecelra]

ICD-10-CM Diagnosis codes (suggested/for informational purposes)ICD-10

C47.0-C47.9	Malignant neoplasm of peripheral nerves and autonomic nervous system
C48.0-C48.8	Malignant neoplasm of retroperitoneum and peritoneum
C49.0-C49.9	Malignant neoplasm of other connective and soft tissue
Z85.831	Personal history of malignant neoplasm of soft tissue

ICD-10-PCS / New Technology group (informational)ICD-10

XW03368

Introduction of Afamitresgene Autoleucel Immunotherapy into Peripheral Vein, Percutaneous Approach

Billing Rule

Single administration billing

Tecelra is administered as a single intravenous infusion per lifetime. Bill HCPCS Q2057 for the therapeutic dose and use the applicable ICD-10-PCS procedure codes for introduction of therapy when appropriate.

Q2057
XW03368
XW04368

Provider Actions & Documentation

Prior Authorization

Prior authorization required with clinical criteria

Requests must meet all clinical criteria (diagnosis, age, permitted HLA-A*02 subtypes, tumor MAGE-A4 positivity, ≥1 prior systemic chemotherapy, ECOG 0-1, single lifetime dose) to be approved. Documentation of HLA-A subtype and tumor MAGE-A4 test results and prior chemotherapy is required for prior authorization decisions.

HLA-A subtype test results (A*02:01, A*02:02, A*02:03, A*02:06)
Tumor MAGE-A4 test results (MAGE-A4 antigen positive)
Documentation of ≥1 prior systemic chemotherapy
Affected codes: Q2057, XW03368, XW04368

Documentation Required

Biomarker documentation required

Medical record documentation must include HLA-A subtype testing results showing A*02:01, A*02:02, A*02:03, or A*02:06 positivity and tumor MAGE-A4 antigen positivity.

Clinical Evidence & Key Facts

Adults with unresectable or metastatic synovial sarcoma; prior chemotherapy; HLA-A*02:01/02:02/02:03/02:06+, MAGE-A4+FDA indication

2.68e9-10e9Dose (MAGE-A4 TCR+ T cells) — single IV infusion per lifetime

NCCN 2ANCCN recommendation — palliative single-agent for subsequent lines in advanced/metastatic synovial sarcoma

Key evidence lines: FDA-approved indication specifies adults with unresectable or metastatic synovial sarcoma after prior chemotherapy who are HLA-A*02:01/02:02/02:03/02:06 positive and MAGE-A4 tumor positive. Dosing is specified as a single IV infusion per lifetime of 2.68 x 10^9 to 10 x 10^9 MAGE-A4 TCR positive T cells. NCCN assigns a 2A recommendation for palliative use as a single agent in subsequent lines for advanced/metastatic synovial sarcoma. The product includes a black box warning for Cytokine Release Syndrome (CRS).

Background & Definitions

Background (expanded): Tecelra is an autologous MAGE-A4-directed, genetically modified T-cell immunotherapy that, when activated by the TCR–peptide–HLA-A02 complex, induces T cell proliferation, cytokine release, and destruction of MAGE-A4/HLA-A02–expressing synovial sarcoma cells. It is indicated for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, meet HLA-A*02 subtyping requirements, and whose tumors express MAGE-A4. The recommended dosing range is 2.68 x 10^9 to 10 x 10^9 MAGE-A4 TCR positive T cells administered as a single intravenous infusion per lifetime. Note: Tecelra carries a black box warning for Cytokine Release Syndrome (CRS), which may be severe or life-threatening.

Term	Definition
ECOG Performance Status	Scale to assess disease impact on daily living abilities; allowed values 0 (fully active) to 5 (dead); policy requires 0-1.
Chemotherapy	Medical treatment of cancer with drugs or other chemicals.

Revision History

09/09/2024added

New criteria document for Tecelra (afamitresgene autoleucel) created; initial coding included HCPCS NOC codes C9399 and J9999 and ICD-10-PCS XW03368, XW04368.

03/04/2025material

Coding Update: Removed HCPCS NOC codes C9399 and J9999 and removed prior diagnosis pend for NOC codes; added HCPCS Q2057 effective 04/01/2025 and added ICD-10-CM codes C48.0-C48.8, C49.0-C49.9, and Z85.831.

08/15/2025revisedLatest