CurrentViva Health PlanPolicy IC-0765

Tecelra (afamitresgene autoleucel) Coverage Criteria

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This policy governs prior authorization, medical necessity, dosing, administration, and billing requirements for Tecelra, an intravenous autologous T-cell therapy used for eligible patients with unresectable or advanced/metastatic synovial sarcoma.

Policy Summary

PayerViva Health Plan

PolicyTecelra (afamitresgene autoleucel) Coverage Criteria

Policy CodePolicy IC-0765

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionSubmit supporting clinical documentation with every prior authorization request.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 doseInitial authorization duration

1 unitMaximum units per dose

12 yearsMinimum member age

1.62–10 × 10^9MAGE-A4 TCR-positive cell dose

Q2057

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CurrentViva Health PlanPolicy IC-0765

Tecelra (afamitresgene autoleucel) Coverage Criteria

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Policy Summary

PayerViva Health Plan

PolicyTecelra (afamitresgene autoleucel) Coverage Criteria

Policy CodePolicy IC-0765

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionSubmit supporting clinical documentation with every prior authorization request.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 doseInitial authorization duration

1 unitMaximum units per dose

12 yearsMinimum member age

1.62–10 × 10^9MAGE-A4 TCR-positive cell dose

Q2057

Tecelra billing code

No renewalRenewal authorization

Coverage Criteria

Initial Therapy

Tecelra is covered for initial therapy when ALL of the following criteria are met. Submission of supporting clinical documentation, including medical records, chart notes, laboratory results, and confirmatory diagnostics, is required with every authorization request.

ALL of the following

Member is at least 12 years of age.
Member does not have HLA-A*02:05P in either allele (heterozygous or homozygous).
Member has not received systemic corticosteroids for at least 14 days before leukapheresis and lymphodepletion.
Member has not received a prior allogeneic stem cell transplant, or, if previously transplanted, has no evidence of residual donor cells, and is a candidate for autologous stem cell transplantation, such as having adequate renal and hepatic function.
Member does not have a history of hypersensitivity to dimethyl sulfoxide (DMSO).
Member does not have symptomatic brain metastases, including leptomeningeal disease.
Member does not have a left ventricular ejection fraction (LVEF) less than 50%.
Member does not have a clinically significant active systemic infection.
Member is screened and found negative for Epstein-Barr virus (EBV), cytomegalovirus (CMV), hepatitis B virus (HBV), hepatitis C virus (HCV), and any other infectious agents when clinically indicated.
Member is HIV negative, confirmed by a negative HIV test before mobilization.
Members who have received Tecelra may test false-positive on some commercial HIV nucleic acid tests because of limited short spans of lentiviral-vector genetic material identical to HIV.
Member will be monitored periodically for secondary malignancies after treatment.
Synovial sarcoma indication
- Member has unresectable or advanced/metastatic synovial sarcoma.
- Tumor expresses the MAGE-A4 antigen, as determined by an FDA-approved or Clinical Laboratory Improvement Amendments (CLIA)-compliant test.
  If confirmed using an immunotherapy assay, use an FDA-recognized companion diagnostic resource.
- Member is positive for one of the following HLA alleles: HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P.
- Tecelra is being used as subsequent therapy.

Renewal Criteria

Continued authorization requires that the duration of authorization has not been exceeded, as described in Section I.

Duration of authorization has not been exceeded.

Coverage is excluded when the member has HLA-A*02:05P in either allele, has received systemic corticosteroids within the 14 days before leukapheresis and lymphodepletion, or otherwise fails the required safety, transplant-candidacy, infection-screening, cardiac, or hypersensitivity criteria. Avoid prophylactic systemic corticosteroids because they may interfere with Tecelra activity.

Tecelra is not covered for indications other than unresectable or advanced/metastatic synovial sarcoma with MAGE-A4 antigen expression, an eligible HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P allele, and use as subsequent therapy.

Medical necessity cannot be established without supporting documentation of the diagnosis, required biomarkers, eligible HLA status, treatment history, safety criteria, and other required records. Supporting records may include medical records, chart notes, laboratory results, genetic or mutational testing, confirmatory diagnostics, and documentation of step therapy; records must be submitted through the prior authorization web portal or by fax. Failure to submit required records may result in denial.

Tecelra is provided as a single dose for infusion in one or more infusion bags. The recommended dose is 1.62 × 10^9 to 10 × 10^9 MAGE-A4 T-cell receptor (TCR)-positive T cells administered as a single intravenous infusion; do not use a leukodepleting filter. The maximum coverage limit is 1 billable HCPCS unit for one dose of up to 10 billion MAGE-A4 TCR-positive T cells. Administer in an inpatient hospital setting under the supervision of a physician experienced in anticancer agents, with intensive care capability and appropriate cardiopulmonary or intensive-care specialists available. Tecelra is for autologous use only; the member identity must match the identifiers on the drug cassette(s) and infusion bag(s).

Coding and Clinical Parameters

HCPCS CodeHCPCSCovered

Q2057

Afamitresgene autoleucel, including leukapheresis and dose preparation procedures, per therapeutic dose; 1 billable unit = 1 dose

NDCNDCCovered

83205-0001-xx

Tecelra contains 1.62 x 10^9 to 10 x 10^9 MAGE-A4 TCR positive T-cells suspended in 1 or more patient-specific infusion bag(s)

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

1–10 of 30

1/3

Minimum Age Requirement

Minimum ageAt least 12 years

Coverage applicationRequired for Tecelra initial authorization

DocumentationAge must be supported by clinical documentation submitted with the authorization request

Left Ventricular Ejection Fraction

Required LVEFNot less than 50%

Exclusion thresholdLVEF less than 50% is excluded

Documentation

Authorization and Submission Requirements

Prior Authorization

Initial Prior Authorization Required

Submit a prior authorization request for one treatment course consisting of one dose when the member meets the applicable coverage criteria. Authorization is valid for that single treatment course only.

Initial authorization: one treatment course (1 dose).
Tecelra dose contains up to 10 billion MAGE-A4 TCR-positive T-cells.

Denial Risk

No Renewal Authorization

Do not submit a renewal request. Prior authorization may not be renewed and is limited to the authorized one-treatment-course duration.

Authorization is limited to one treatment course and one dose.

Unsupported block type: documentation

Therapy Background

Tecelra (afamitresgene autoleucel) is an autologous, genetically modified T-cell receptor therapy for eligible patients with unresectable or advanced/metastatic synovial sarcoma. It is administered as a single intravenous infusion after lymphodepleting chemotherapy. Administration must occur in an inpatient hospital setting under the supervision of a physician experienced in anticancer therapy, with intensive-care capabilities and appropriate cardiopulmonary or intensive-care specialists available.

Policy Definitions

MAGE-A4 Antigen Expression

DefinitionTumor expression of the MAGE-A4 antigen

Qualifying testDetermined using an FDA-approved or Clinical Laboratory Improvement Amendments (CLIA)-compliant test

Coverage requirementThe member must have unresectable or advanced/metastatic synovial sarcoma with MAGE-A4 expression

Eligible HLA-A*02 Allele Status

Qualifying allelesHLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P allele positive

Excluded allele statusHLA-A*02:05P in either allele is excluded, including heterozygous or homozygous status

Coverage requirement

Initial Treatment Course

Initial authorization is provided when all policy conditions are met.

Tecelra initial authorization: The member meets all required age, HLA, corticosteroid, transplant, autologous-transplant candidacy, DMSO hypersensitivity, central nervous system disease, cardiac, infection, viral screening, HIV testing, secondary malignancy monitoring, diagnosis, MAGE-A4, eligible HLA-A*02 allele, and subsequent-therapy criteria.Age >= 12 years; LVEF >= 50%; one treatment course consisting of one dose

Supporting clinical documentation is required with every authorization request.

Continuation and Renewal

No Renewal or Continuation

Continuation is not available through renewal.

Authorization duration: The authorization duration has not been exceeded; however, prior authorization may not be renewed.One treatment course, 1 dose

No repeat or renewed course is authorized.

Treatment Sequencing

Step	Therapy requirement	Eligible indication
1	Tecelra must be used as subsequent therapy	Unresectable or advanced/metastatic synovial sarcoma with MAGE-A4 antigen expression and positivity for HLA-A02:01P, HLA-A02:02P, HLA-A02:03P, or HLA-A02:06P

Dose and Quantity Limits

Tecelra Quantity Limit

Quantity limit1 billable unit per dose

Unit definitionOne billable unit represents 1 dose

Cell limitThe dose may contain up to 10 billion MAGE-A4 TCR-positive T-cells

Tecelra Administered Dose

Dose range1.62 x 10^9 to 10 x 10^9 MAGE-A4 T cell receptor (TCR) positive T cells

Route and frequencyAdministered as a single intravenous infusion

Product presentationProvided as a single dose for infusion in one or more infusion bag(s)

Administration Setting

Note

Use the required inpatient site of care

Administer Tecelra in an inpatient hospital setting under the supervision of a physician experienced in the use of anticancer agents. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available.

Inpatient hospital setting
Physician supervision
Intensive care capability and appropriate specialists available

Policy Summary

PayerViva Health Plan

PolicyTecelra (afamitresgene autoleucel) Coverage Criteria

Policy CodePolicy IC-0765

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionSubmit supporting clinical documentation with every prior authorization request.

SourceLink

On This Page

Cardiac function must be supported in the clinical documentation

Tecelra Dose and Billing Limit

Recommended dose1.62 x 10^9 to 10 x 10^9 MAGE-A4 TCR-positive T cells

AdministrationAdministered as a single intravenous infusion

Maximum billable amount1 billable unit per dose

Documentation Required

Provide Indication-Specific Evidence

For the synovial sarcoma indication, provide evidence that all indication-specific requirements are met.

Unresectable or advanced/metastatic synovial sarcoma.
Tumor expression of MAGE-A4 antigen confirmed by an FDA-approved or CLIA-compliant test, including an immunotherapy assay when applicable.
Positive HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P allele status.
Use as subsequent therapy.

Documentation Required

Provide Safety and Eligibility Evidence

Document safety and eligibility before treatment, including required age, HLA, treatment-history, transplant, candidacy, infection, cardiac, and hypersensitivity findings.

Member is at least 12 years old and does not have HLA-A*02:05P in either allele.
No systemic corticosteroids for at least 14 days before leukapheresis and lymphodepletion.
No prior allogeneic stem cell transplant, or no residual donor cells if a transplant was received; member is a candidate for autologous stem cell transplantation with adequate renal and hepatic function.
No history of hypersensitivity to dimethyl sulfoxide (DMSO), symptomatic brain metastases including leptomeningeal disease, LVEF below 50%, or clinically significant active systemic infection.
Negative screening for EBV, CMV, HBV, HCV, and other clinically indicated infectious agents; negative HIV test before mobilization.
Plan for periodic monitoring for secondary malignancies after treatment.

Denial Risk

Missing Supporting Documentation

Incomplete supporting records may result in denial because medical necessity cannot be established under the policy.

Ensure the submission includes records, chart notes, laboratory results, confirmatory diagnostics, and documentation of diagnosis, therapy status, and required clinical markers.

Denial Risk

Safety or Eligibility Criteria Not Met

Coverage may be denied when required safety or eligibility criteria are not met or cannot be confirmed.

Age, HLA-A*02:05P exclusion, corticosteroid-free interval, transplant and autologous-transplant candidacy requirements.
Absence of DMSO hypersensitivity, symptomatic brain metastases, LVEF below 50%, and clinically significant active systemic infection.
Required negative infectious-disease and HIV testing and post-treatment secondary-malignancy monitoring plan.

Denial Risk

Indication or Biomarker Criteria Not Met

Coverage may be denied when the member does not have the covered indication or required biomarker and HLA profile.

Diagnosis is not unresectable or advanced/metastatic synovial sarcoma.
MAGE-A4 tumor expression is absent or not confirmed by an FDA-approved or CLIA-compliant test.
Member is not positive for an eligible HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P allele.
Treatment is not being used as subsequent therapy.

Denial Risk

Authorization Duration Exceeded

Requests beyond the authorized duration or for more than one treatment course are not eligible. Authorization cannot be renewed after the one-dose course.

Do not request authorization beyond one treatment course (1 dose).

Billing Rule

Do Not Exceed the Dose Unit Limit

Bill no more than one billable unit per dose. Billing beyond the one-unit limit is outside the policy dosing allowance.

Maximum: 1 HCPCS billable unit per dose.
One unit represents one dose of up to 10 billion MAGE-A4 TCR-positive T-cells.

Eligible HLA-A*02 allele positivity must be documented

Autologous Use

Use requirementTecelra is for autologous use only

MeaningThe product is administered to the member from whom the cells were collected

Administration identity checkThe member's identity must match the member identifiers on the drug cassette(s) and infusion bag(s)