213 Form

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Medical Policy Engineered T-Cell Therapy for Synovial Sarcoma (Tecelra®) Table of Contents
• Policy: Commercial • Policy History • Endnotes
• Policy: Medicare • Information Pertaining to All Policies • Forms • Coding Information • References

Policy Number: 213 BCBSA Reference Number: None Related Policies Engineered T-Cell Therapy for Synovial Sarcoma (Tecelra®)– Prior Authorization Request Form, #222 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity

Prior Authorization Information ☒ Prior Authorization ☐ Step Therapy ☐ Quality Care Dosing

Pharmacy Operations: Tel: 1-800-366-7778 Fax: 1-800-583-6289 Policy last updated 3/19/2025 Pharmacy (Rx) or Medical (MED) benefit coverage ☐ Rx ☒ MED To request for coverage: Providers may call, fax, or mail the attached form (Authorization Manager) to the address below.
Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043

Individual Consideration: Policy for requests that do not meet clinical criteria of this policy, see section labeled Individual Consideration
Policy applies to Commercial Members:
• Managed Care (HMO and POS),
• PPO and Indemnity • MEDEX
• Managed Major Medical
• Comprehensive Managed Major Medical
• Managed Blue for Seniors

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Please refer to the chart below for the formulary and step status of the medications affected by this policy.

Standard Formulary

Drug

Formulary Status Tecelra (afamitresgene autoleucel) Medical benefit; PA required NOTE: If approved, the Prior Authorization will be granted for three (3) months as a one (1) time treatment. Policy Coverage for Tecelra® (afamitresgene) may be considered medically necessary when used for the treatment of adults with unresectable or metastatic synovial sarcoma when all of the following criteria are met:

1. Individual is at least 18 years of age
2. Diagnosis of synovial sarcoma that is: a. Unresectable OR b. Metastatic OR c. Refractory to most recent treatment OR d. Progressed after most recent treatment
3. Members’ tissues and cells express one of the following HLA markers: a. -A02:01P,
   b. -A02:02P,
   c. -A02:03P,
   d. -A02:06P
4. Tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared Companion Diagnostic
5. ECOG performance scale of 0 or 1
6. No history of CNS metastases
7. No active or serious infections
8. Cardiac ejection fractions ≥ 50%

9. No prior treatment with any engineered autologous T-cell product directed at any target (including any CAR-T or tumor-infiltrating lymphocytes)

   Repeat treatment with Tecelra is considering investigational. Any use of Tecelra not meeting criteria 1-9 above is considered investigational for any indication.

   Prior Authorization Information
   Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
   Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

   Outpatient Commercial Managed Care (HMO and POS) Prior authorization is required
   Commercial PPO and Indemnity Prior authorization is required

   Requesting Prior Authorization Using Authorization Manager

3 Providers will need to use Authorization Manager to submit initial authorization requests for services. Authorization Manager, available 24/7, is the quickest way to review authorization requirements, request authorizations, submit clinical documentation, check existing case status, and view/print the decision letter. For commercial members, the requests must meet medical policy guidelines.
To ensure the request is processed accurately and quickly:
• Enter the facility’s NPI or provider ID for where services are being performed.
• Enter the appropriate surgeon’s NPI or provider ID as the servicing provider, not the billing group.

Authorization Manager Resources
• Refer to our Authorization Manager page for tips, guides, and video demonstrations.

Complete Prior Authorization Request Form for Tecelra (afamitresgene autoleucel) for Synovial Sarcoma (#213) using Authorization Manager.

For out of network providers: Requests should still be faxed to 888-973-0726. CPT Codes / HCPCS Codes / ICD-9 Codes The following codes are included below for informational purposes. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable. CPT Codes There is no specific CPT code for this service.

HCPCS Codes HCPCS codes: Code Description Q2057 Afamitresgene autoleucel, including leukapheresis and dose preparation procedures, per therapeutic dose (Tecelra) C9399 Unclassified drug or biologic J3590 Unclassified biologic J3490 Unclassified drugs J9999 Not otherwise classified, antineoplastic

Individual Consideration Our medical policies are written for most people with a given condition. Each policy is based on peer reviewed clinical evidence. We also take into consideration the needs of atypical patient populations and diagnoses.
If the coverage criteria outlined is unlikely to be clinically effective for the prescribed purpose, the health care provider may request an exception to cover the requested medication based on an individual’s unique clinical circumstances. This is also referred to as “individual consideration” or an “exception request.”
Some reasons why you may need us to make an exception include: therapeutic contraindications; history of adverse effects; expected to be ineffective or likely to cause harm (physical, mental, or adverse reaction).

4 To facilitate a thorough and prompt review of an exception request, we encourage the provider to include additional supporting clinical documentation with their request. This may include: • Clinical notes or supporting clinical statements. • The name and strength of formulary alternatives tried and failed (if alternatives were tried) and specifics regarding the treatment failure, if applicable. • Clinical literature from reputable peer reviewed journals. • References from nationally recognized and approved drug compendia such as American Hospital Formulary Service® Drug Information (AHFS-DI), Lexi-Drug, Clinical Pharmacology, Micromedex or Drugdex®; and • References from consensus documents and/or nationally sanctioned guidelines.

Providers may call, fax or mail relevant clinical information, including clinical references for individual patient consideration, to:

Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
Phone: 1-800-366-7778 Fax: 1-800-583-6289 Policy History
Date Action 6/2025 Implement new policy for Tecelra. References

1. Tecelra ® [Product Information]. Philadelphia, PA. Adaptimmune, LLC.; August 2024.