Last Review Date: 09/05/2024

Date of Origin: 09/05/2024

Dates Reviewed: 09/2024

1. Length of Authorization

Coverage will be provided for one treatment course (1 dose) and may not be renewed.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• A single dose of Tecelra containing a minimum of 2.68 x 10⁹ to a maximum of 10 x 10⁹ of viable cells suspended in one or more patient-specific infusion bags

2. Max Units (per dose and over time) [HCPCS Unit]:

• A single dose of Tecelra containing a minimum of 2.68 x 10⁹ to a maximum of 10 x 10⁹ of viable cells suspended in one or more patient-specific infusion bags

3. Initial Approval Criteria ¹

Coverage is provided for the following conditions:

• Patient is at least 18 years of age; AND
• Patient does not have HLA-A*02:05P in either allele (i.e., heterozygous or homozygous); AND
• Patient has not received systemic corticosteroids for at least 14 days prior to leukapheresis and lymphodepletion; AND
• Patient has not received a prior allogeneic stem cell transplant (or has, but is without evidence of residual donor cells present), and is a candidate for autologous stem cell transplantation (e.g., adequate renal and hepatic function); AND
• Patient does not have a history of hypersensitivity to dimethyl sulfoxide (DMSO); AND
• Patient does not have symptomatic brain metastases including leptomeningeal disease; AND
• Patient does not have a left ventricular ejection fraction (LVEF) less than 50%; AND
• Patient does not have a clinically significant active systemic infection; AND

• Patient is screened and found to be negative for Epstein-Barr Virus (EBV), Cytomegalovirus (CMV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and any other infectious agents, if clinically indicated; AND
• Patient is HIV negative as confirmed by a negative HIV test prior to mobilization (Note: Patients who have received Tecelra are likely to test false-positive on some commercial HIV nucleic acid tests for HIV due to the lentiviral vector used to make Tecelra having limited, short spans of genetic material which is identical to HIV); AND
• Patient will be monitored for secondary malignancies periodically after treatment; AND

Synovial Sarcoma † Ф ^1-5

• Patient has a diagnosis of unresectable or metastatic synovial sarcoma; AND
• Patient expresses the MAGE-A4 tumor antigen; AND
• Patient is HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, and HLA-A*02:06P allele positive; AND
• Used as subsequent therapy after prior treatment with doxorubicin or ifosfamide

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria

Coverage cannot be renewed.

5. Dosage/Administration

6. Billing Code/Availability Information

HCPCS Code:

• J9999 – Not otherwise classified, antineoplastic drug
• C9399 – Unclassified drugs or biologicals (Hospital Outpatient Use Only)

NDC(s):

• Tecelra contains 2.68 x 10⁹ to 10 x 10⁹ MAGE-A4 TCR positive T-cells suspended in 1 or mor patient-specific infusion bag(s): 83205-0001-xx

7. References

1. Tecelra [package insert]. Philadelphia, PA; Adaptimmune, LLC; August 2024. Accessed August 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) afamitresgene autoleucel . National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed August 2024.

3. Lee DW, Santomasso BD, Locke FL, et al. ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells. Biol Blood Marrow Transplant 2019; 25: 625-638.
4. Sandra P. D'Angelo et al., SPEARHEAD-1: A phase 2 trial of afamitresgene autoleucel (Formerly ADP-A2M4) in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma. JCO 39, 11504-11504(2021). DOI:10.1200/JCO.2021.39.15_suppl.11504

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A

Medical Necessity Criteria

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