CurrentViva HealthPolicy N/A

Tecelra (afamitresgene autoleucel) — Coverage Criteria

Prior authorization and medical necessity criteria for Tecelra (afamitresgene autoleucel) for treatment of unresectable or advanced/metastatic synovial sarcoma, including eligibility, dosing, coding, and required documentation for Viva Health members.

Policy Summary

PayerViva Health

PolicyTecelra (afamitresgene autoleucel) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateOct 2, 2025

Key ActionSubmit required clinical documentation via the prior authorization portal or fax; prior authorization is valid for one treatment course (one dose) and will not be renewed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 doseauthorization provided for one treatment course (no renewals)

1 unitHCPCS billing unit per therapeutic dose

≥18minimum patient age for eligibility

LVEF ≥50%left ventricular ejection fraction requirement

2.68–10 x10^9recommended single IV dose range

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Coverage Criteria for Tecelra (afamitresgene autoleucel)

Initial Therapy

Covered when ALL of the following are met:

Age: Patient is at least 18 years of age

HLA exclusion: Patient does not have HLA-A*02:05P in either allele (i.e., heterozygous or homozygous)

Steroid washout: Patient has not received systemic corticosteroids for at least 14 days prior to leukapheresis and lymphodepletion

Allogeneic SCT: Patient has not received a prior allogeneic stem cell transplant (or has, but is without evidence of residual donor cells), and is a candidate for autologous stem cell transplantation (e.g., adequate renal and hepatic function)

DMSO hypersensitivity: Patient does not have a history of hypersensitivity to dimethyl sulfoxide (DMSO)

CNS disease: Patient does not have symptomatic brain metastases including leptomeningeal disease

Cardiac function: Patient does not have a left ventricular ejection fraction (LVEF) less than 50%LVEF >= 50%

Active infection: Patient does not have a clinically significant active systemic infection

Infectious disease screening: Patient is screened and found negative for EBV, CMV, HBV, HCV and other infectious agents as clinically indicated; patient is HIV negative prior to mobilization

Note: patients who have received Tecelra may test false-positive on some commercial HIV nucleic acid tests due to the lentiviral vector

Secondary malignancy monitoring: Patient will be monitored for secondary malignancies periodically after treatment

Diagnosis: Patient has a diagnosis of unresectable or advanced/metastatic synovial sarcoma

Tumor antigen: Tumor expresses the MAGE-A4 tumor antigen

HLA positive alleles: Patient is HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P allele positive

Line of therapy: Used as subsequent therapy for synovial sarcoma

Coverage is limited to patients who meet specific safety and disease criteria. Exclusions include patients with symptomatic brain metastases including leptomeningeal disease, those with a left ventricular ejection fraction (LVEF) < 50%, and patients with a clinically significant active systemic infection. Additional exclusions and safety requirements include a history of hypersensitivity to dimethyl sulfoxide (DMSO), presence of the HLA-A*02:05P allele, and failure to meet required infectious-disease screening (negative EBV, CMV, HBV, HCV and other agents as indicated; HIV negative prior to mobilization). Patients who receive Tecelra must be monitored periodically for secondary malignancies after treatment.

Prior authorization is required and is valid for a single treatment course only. Additional doses beyond one treatment course are not authorized and prior authorization validity will not be renewed for further dosing.

Coding and Billing

Covered HCPCS CodesHCPCSCovered

Q2057

Afamitresgene autoleucel, including leukapheresis and dose preparation procedures, per therapeutic dose

NDCNDC

83205-0001-xx

Tecelra NDC (2.68 x10^9 to 10 x10^9 MAGE-A4 TCR positive T-cells)

Covered Diagnosis CodesICD-10Covered

C47.0	Malignant neoplasm of peripheral nerves of head, face and neck
C47.10	Malignant neoplasm of peripheral nerves of unspecified upper limb, including shoulder
C47.11	Malignant neoplasm of peripheral nerves of right upper limb, including shoulder
C47.12	Malignant neoplasm of peripheral nerves of left upper limb, including shoulder
C47.20	Malignant neoplasm of peripheral nerves of unspecified lower limb, including hip
C47.21	Malignant neoplasm of peripheral nerves of right lower limb, including hip
C47.22	Malignant neoplasm of peripheral nerves of left lower limb, including hip
C47.3	Malignant neoplasm of peripheral nerves of thorax
C47.4	Malignant neoplasm of peripheral nerves of abdomen
C47.5	Malignant neoplasm of peripheral nerves of pelvis

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inv-07: Dose range — single infusion of MAGE-A4 T cells

Dose (single IV infusion)2.68 x 10^9 to 10 x 10^9 MAGE-A4 TCR positive T cells

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and, when approved, is valid for one treatment course (one dose). Prior authorization may not be renewed.

Initial authorization: 1 treatment course (1 dose)
Renewal: Not permitted

Step Therapy

Line of Therapy Requirement

Tecelra is indicated for use as subsequent therapy for unresectable or advanced/metastatic synovial sarcoma. Providers must document that the patient has a diagnosis of unresectable or advanced/metastatic synovial sarcoma and that tumor MAGE-A4 expression and appropriate HLA-A*02 allele positivity have been confirmed.

Diagnosis: unresectable or advanced/metastatic synovial sarcoma
Tumor expresses MAGE-A4
HLA allele positive: HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P
Therapy line: used as subsequent therapy

Preparation and Administration

Regimen	Lymphodepleting chemotherapy (timing & doses)	Tecelra infusion dose (single IV)
Single IV infusion regimen for unresectable or advanced/metastatic synovial sarcoma; Tecelra is provided as a single dose for infusion in one or more infusion bag(s). Verify number of bags prior to preparation.	Fludarabine 30 mg/m2/day IV for 4 days (Day -7 to Day -4) AND Cyclophosphamide 600 mg/m2/day IV for 3 days (Day -7 to Day -5). Plan for Tecelra to arrive prior to beginning lymphodepleting chemotherapy.	Recommended dose range: 2.68 x 10^9 to 10 x 10^9 MAGE-A4 TCR positive T cells administered as a single intravenous infusion; do not use a leukodepleting filter.

Definitions and Regimen Terms

inv-13: Lymphodepleting chemotherapy regimen definition

Lymphodepleting chemotherapy regimenFludarabine 30 mg/m2/day IV for 4 days (Day -7 to -4); Cyclophosphamide 600 mg/m2/day IV for 3 days (Day -7 to -5)

inv-14: MAGE-A4 positive tumor — definition

MAGE-A4 positive tumor definitionTumor antigen expression of MAGE-A4 required on tumor testing prior to therapy

Testing requirementDocumented tumor testing demonstrating MAGE-A4 expression must be submitted with authorization request

Indication tie-inRequired for eligibility for Tecelra in unresectable or advanced/metastatic synovial sarcoma

Line of Therapy Specification

Subsequent

Subsequent therapy: Used as subsequent therapy for synovial sarcoma

Biomarker and HLA Requirements

inv-16: MAGE-A4 — tumor expression requirement

MAGE-A4 biomarker requirementTumor must express MAGE-A4 prior to therapy

PurposeRequired for patient eligibility for Tecelra administration

DocumentationSubmit tumor testing results with prior authorization request

inv-17: HLA-A*02 alleles — required positive and negative allele specifications

HLA-A*02 allele positive (acceptable)HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, HLA-A*02:06P

HLA-A*02 allele negative (exclusion)HLA-A*02:05P must be absent in either allele (heterozygous or homozygous)

Background

Afamitresgene autoleucel (Tecelra) is an autologous, MAGE-A4–directed T‑cell receptor (TCR) therapy administered as a single intravenous infusion following lymphodepleting chemotherapy. Eligibility requires tumor expression of MAGE-A4 and specific HLA allele status, and patients must complete required infectious screening and safety assessments prior to mobilization and infusion.

Revision History

2025-10-02policy_reviewLatest

Policy last reviewed on 10/02/2025; dates reviewed include 09/2024, 12/2024, and 10/2025.

2024-09-05policy_origin

Policy date of origin recorded as 09/05/2024.

2024-08reference_update

Tecelra package insert (Adaptimmune, LLC; August 2024) cited as a reference supporting clinical information.