CurrentCentenePolicy CP.PHAR.678

Afamitresgene Autoleucel (Tecelra) (PDF)

This Centene clinical policy defines medical necessity criteria, exclusions, dosing limits, prior authorization routing, coding, and administration details for afamitresgene autoleucel (Tecelra) for adults with unresectable or metastatic synovial sarcoma.

Policy Summary

PayerCentene

PolicyAfamitresgene Autoleucel (Tecelra) (PDF)

Policy CodePolicy CP.PHAR.678

Change TypeRevised coding and criteria

Effective DateAug 1, 2024

Next Review Date

Key ActionProviders must submit prior authorization via PDAC UM Review and include documentation (office notes, lab results) showing HLA-A*02.P positivity, FDA-approved/cleared MAGE-A4 diagnostic results, prior systemic chemotherapy, and absence of prior allogenic HSCT or prior gene therapy.

SourceLink

POLICY UPDATE CHANGES

Criteria updated per FDA labeling: clarified 'unresectable and metastatic' synovial sarcoma and removed MRCLS; age revised to ≥ 18 years; added exclusion for HLA-A*02:05P; revised MAGE-A4 testing requirement to FDA-approved/cleared diagnostic device; revised prior therapy requirement to ≥1 prior systemic chemotherapy; prior gene therapy language updated.

HCPCS code Q2057 added and J3590/C9399 removed for coding of Tecelra.

Prior authorization reviews redirected to Precision Drug Action Committee (PDAC) Utilization Management Review.

4Q 2025 annual review: no significant changes; references reviewed and updated.

1Covered Indication (FDA)

Lifetime infusion limit

10 x 10^9Max dose (cells)

Q2057HCPCS product code

Coverage Summary

Coverage stance: covered_with_criteria for afamitresgene autoleucel (Tecelra). Scope: This policy defines medical necessity criteria, exclusions, dosing limits, prior authorization routing, coding, and administration details for afamitresgene autoleucel (Tecelra) for adults with unresectable or metastatic synovial sarcoma. FDA-approved indication: Tecelra is indicated for the treatment of adults ≥ 18 years with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02.P positive (one of HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P), and whose tumor expresses the MAGE-A4 antigen as determined by an FDA-approved or cleared companion diagnostic device. Approval status: this indication was approved under accelerated approval based on overall response rate and duration of response; continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Tecelra key thresholds and stats

Maximum single dose10 x 10^9 MAGE-A4 TCR positive T-cells

Minimum prior systemic therapy>= 1 prior systemic chemotherapy

Age>= 18 years

Covered IndicationAdults with unresectable or metastatic synovial sarcoma whose tumors express MAGE-A4 and are HLA-A*02.P positive

Lifetime infusion limit1 (one time infusion per lifetime)

Max dose (cells)10 x 10^9

HCPCS product codeQ2057

Initial Therapy Criteria - Synovial Sarcoma

Initial Approval Criteria - Synovial Sarcoma (must meet all)

Tecelra is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of unresectable or metastatic synovial sarcoma
Prescriber: Prescribed by or in consultation with an oncologist
Age >= 18 years>= 18 years
Member HLA-A*02.P positive (one of)

Continuation / Repeat Dosing

Continuation/Repeat Dosing

Continuation criteria

Continued therapy will not be authorized because Tecelra is indicated to be dosed one time only

Approval duration: Not applicable

Diagnoses / Indications Not Authorized

Diagnoses/Indications Not Authorized

Coverage is NOT authorized for

Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents

Applicable Codes

HCPCS - Product code (informational)HCPCS

Q2057

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

Removed/replaced HCPCS/J-codes (historical)HCPCS

J3590	Unclassified biologics (removed from policy coding list)
C9399	Unclassified drugs or biologicals (removed from policy coding list)

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization via PDAC UM Review

Require PDAC Utilization Management Review. Providers must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria.

Documentation Required

HLA and diagnostic documentation required

Document member HLA-A*02.P allele positivity (one of: HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, HLA-A*02:06P). Document MAGE-A4 antigen expression as determined by an FDA‑approved or cleared companion diagnostic device. Document receipt of ≥ 1 prior systemic chemotherapy. Document absence of prior allogenic hematopoietic stem cell transplant and absence of prior gene therapy.

Clinical Evidence

Evidence basis: Accelerated approval was granted based on overall response rate and duration of response, with the SPEARHEAD-1 trial referenced as the supporting clinical study. The policy notes that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Background & Definitions

Background: Afamitresgene autoleucel (Tecelra) is a MAGE-A4-directed genetically modified autologous T-cell immunotherapy developed to target tumors expressing MAGE-A4. Tecelra is FDA-approved for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy and who are HLA-A*02.P positive (specified alleles) with tumors expressing MAGE-A4 as determined by FDA-approved or cleared companion diagnostic devices. The approval was granted under accelerated approval, and continued approval may depend on confirmatory trials such as SPEARHEAD-1.

MAGE-A4: Melanoma-associated antigen A4.

TCR: T cell receptor.

HLA P-group: HLA alleles that share the same protein sequence in the peptide binding domain (for example, the policy denotes alleles as A*02:01P, etc.).

Revision History

04.09.24 / 08.27.24criteria_updated

Criteria updated per FDA labeling: clarified 'unresectable and metastatic' synovial sarcoma and removed MRCLS; revised age to ≥ 18 years; added exclusion that member is not heterozygous or homozygous for HLA-A*02:05P; changed MAGE-A4 testing from immunohistochemistry to determination by an FDA‑approved or cleared diagnostic device; revised prior therapy requirement to ≥ 1 prior systemic chemotherapy; prior gene therapy language updated to 'member has not received prior gene therapy'; Appendix B and Section V updated; references reviewed and updated.

05.24 (P&T approval noted in log)policy_initialization

Policy created pre-emptively and P&T approval recorded alongside criteria updates reflecting FDA labeling (see 04.09.24/08.27.24 revisions).

02.13.25

Policy Summary

PayerCentene

PolicyAfamitresgene Autoleucel (Tecelra) (PDF)

Policy CodePolicy CP.PHAR.678

Change TypeRevised coding and criteria

Effective DateAug 1, 2024

Next Review Date

SourceLink

On This Page

Exclusion: Member is not heterozygous or homozygous for HLA-A*02:05P

Contraindication per policy/Appendix C

Diagnostic: Documentation of MAGE-A4 antigen expression as determined by an FDA-approved or cleared companion diagnostic device

Prior therapy: Member has received >= 1 prior systemic chemotherapy (see Appendix B for examples)>= 1 prior systemic chemotherapy

Prior transplant: Member has not received prior allogenic hematopoietic stem cell transplant

Prior gene therapy: Member has not received prior gene therapy

Dose limit: Dose does not exceed a single dose of 10 x 10^9 MAGE-A4 TCR positive T-cellsMaximum single dose = 10 x 10^9

One time infusion per lifetime

Initial Approval - Other diagnoses/indications

Requests for uses outside the synovial sarcoma criteria

ANY of the following

Recent label change: If drug label changed within last 6 months and policy not updated, follow formulary/no-coverage or non-formulary policies for relevant line of business (CP.CPA.190, HIM.PA.33, CP.PMN.255 or HIM.PA.103, CP.PMN.16 as applicable)
Off-label reference: If requested use is not listed under section III and above does not apply, refer to off-label use policy for relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Billing Rule

Single lifetime infusion limit

Only the initial treatment dose is covered; subsequent doses will not be covered (one time infusion per lifetime).

Q2057

Denial Risk

Contraindication for HLA-A*02:05P

Claims will not meet medical necessity if the member is heterozygous or homozygous for HLA-A*02:05P; patients with HLA-A*02:05 should not be treated with Tecelra.

Billing Rule

Dose limit enforcement

Dose must not exceed 10 x 10^9 MAGE-A4 TCR positive T-cells per infusion. Requests exceeding this maximum single dose will not meet criteria.

Q2057

Coding implications updated: HCPCS product code Q2057 added and prior unclassified codes J3590 and C9399 removed for coding of Tecelra.

07.09.25 / 4Q2025 annual reviewadministrative_review

4Q 2025 annual review: no significant changes; references reviewed and updated.

11.04.25language_update

Updated language under Policy/Criteria to effectively redirect prior authorization reviews to Precision Drug Action Committee (PDAC) Utilization Management Review.

11.25 (P&T Approval Date)policy_review_pandtLatest

P&T review recorded (11.25) with updated language redirecting prior authorization reviews to PDAC UM Review; policy last reviewed and remains current. (Material changes previously noted in 04.09.24/08.27.24 and 02.13.25 coding update.)