Pharmacy Prior Authorization Criteria

Tecelra (afamitresgene autoleucel) - PA, NF

Indications for Prior Authorization

Tecelra (afamitresgene autoleucel)

• For diagnosis of Synovial sarcoma
  Indicated 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 as determined by FDA-approved or cleared companion diagnostic devices. This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Criteria

Tecelra

Prior Authorization

Length of Approval: 1 Time Authorization in Lifetime
For diagnosis of Synovial Sarcoma

• Diagnosis of synovial sarcoma
AND
• Disease is one of the following:
• Unresectable
• Metastatic
AND
• Both of the following:
• Patient is HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P positive
AND
• Patient does not have HLA-A*02:05P in either allele
AND
• Presence of MAGE-A4 antigen as detected by a U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Patient has received prior therapy with one of the following:
• An anthracycline (e.g. doxorubicin)
• Ifosfamide
AND
• Patient is 16 years of age or older
AND
• Patient has never received Tecelra treatment in their lifetime

Tecelra

Non Formulary

Length of Approval: 1 Time Authorization in Lifetime
For diagnosis of Synovial Sarcoma

• Submission of medical records (e.g., chart notes) confirming diagnosis of synovial sarcoma
AND
• Disease is one of the following:
• Unresectable
• Metastatic
AND
• Submission of medical records (e.g., chart notes) confirming both of the following:
• Patient is HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P positive
AND
• Patient does not have HLA-A*02:05P in either allele
AND
• Submission of medical records (e.g., chart notes) confirming presence of MAGE-A4 antigen as detected by a U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming patient has received prior therapy with one of the following:
• An anthracycline (e.g. doxorubicin)
• Ifosfamide
AND
• Patient is 16 years of age or older
AND
• Patient has never received Tecelra treatment in their lifetime

P & T Revisions

2024-10-02

References

1. Tecelra Prescribing Information. Adaptimmune LLC, Philadelphia, PA 19112. August 2024
2. Afamitresgene autoleucel for advanced synovial sarcoma and myxoid round cell liposarcoma (SPEARHEAD-1): an international, open-label, phase 2 trial D'Angelo, Sandra P et al. The Lancet, Volume 403, Issue 10435, 1460 - 1471

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Revision History

• 2024-10-02: New program

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