CurrentBlue Cross Blue Shield - MassachusettsPolicy N/A

Tecelra (afamitresgene autoleucel) coverage and prior authorization policy

Medical policy governing prior authorization and coverage criteria for Tecelra (afamitresgene autoleucel) for adult members with unresectable or metastatic synovial sarcoma under BCBS Massachusetts commercial products; affects providers requesting treatment under the medical benefit.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyTecelra (afamitresgene autoleucel) coverage and prior authorization policy

Policy CodePolicy N/A

Change TypeNew policy implemented

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed Prior Authorization Request Form for Tecelra using Authorization Manager (or fax for out-of-network) with supporting clinical documentation.

SourceLink

POLICY UPDATE CHANGES

Implement new policy for Tecelra.

3 monthsauth duration

≥18min age

ECOG 0-1performance status

>50%ejection fraction

PA requiredbenefit requirement

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Coverage Criteria for Tecelra (afamitresgene autoleucel)

Initial coverage criteria

Covered when ALL of the following are met

Tecelra initial therapy criteria: 1) Patient is at least 18 years of age; 2) Diagnosis of synovial sarcoma that is unresectable OR metastatic; 3) Disease has progressed after the most recent treatment OR is refractory to the most recent treatment; 4) Tumor expresses the MAGE-A4 antigen as determined by an FDA‑approved or cleared companion diagnostic; 5) Member's tissues/cells express an eligible HLA marker (specified HLA markers documented); 6) No history of central nervous system (CNS) metastases; 7) ECOG performance status of 0 or 1; 8) No active or serious infections; 9) Cardiac ejection fraction > 50%; 10) No prior treatment with any engineered autologous T‑cell product directed at any target (including CAR‑T or tumor‑infiltrating lymphocytes).

Repeat treatment is considered investigational; use outside these criteria is investigational.

Repeat treatment with Tecelra (afamitresgene autoleucel) is considered investigational and is not supported by this policy.

Use of Tecelra that does not meet criteria 1–9 in the coverage criteria (including age ≥18, unresectable or metastatic synovial sarcoma, disease progressed or refractory to most recent treatment, tumor MAGE‑A4 positivity by an FDA‑approved/cleared companion diagnostic, eligible HLA marker expression, no CNS metastases, ECOG 0–1, no active/serious infections, cardiac ejection fraction >50%, and no prior engineered autologous T‑cell product exposure) is considered investigational for any indication.

Initial Therapy

Initial therapy

Initial treatment coverage criteria

Initial therapy nodes: See coverage criteria: patient >= 18 years; unresectable OR metastatic synovial sarcoma; disease progressed after or refractory to most recent treatment; tumor MAGE‑A4 positive by FDA‑approved/cleared companion diagnostic; member tissues/cells express eligible HLA marker; no CNS metastases; ECOG 0‑1; no active/serious infections; cardiac ejection fraction >50%; no prior engineered autologous T‑cell product exposure.

Continuation Therapy / Repeat Treatment

Continuation therapy

Repeat treatment

Repeat treatment with Tecelra is considered investigational and is not supported by this policy.

Coding and Clinical Parameters

CPT CodesCPT

No codes listed

HCPCS / miscellaneous drug codesHCPCS

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.

inv-06: ECOG performance status

Required ECOG performance statusECOG 0 or 1

Source contextPolicy specifies ECOG performance scale of 0 or 1 as a coverage requirement

RelevancePart of initial therapy criteria required for medical necessity

inv-07: Cardiac ejection fraction

Required cardiac ejection fraction> 50%

Source contextPolicy lists ‘Cardiac ejection fractions > 50%’ as a coverage requirement

Relevance

Provider Actions, Prior Authorization & Submission

Prior Authorization

Prior Authorization Required

Prior authorization is required for services described in this policy. Providers must submit prior authorization requests for outpatient and inpatient settings as specified below.

Prior authorization required for Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity for outpatient services
Precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient

Step Therapy

Step/PA Contact / Submission

Requests for prior authorization should be submitted using Authorization Manager. Providers may also fax requests when appropriate. For commercial members, requests must meet medical policy guidelines. Enter the facility's NPI or provider ID where services will be performed and the servicing provider's NPI or provider ID (surgeon) — not the billing group.

Authorization Manager is the preferred submission method for initial authorization requests, clinical documentation, checking case status, and viewing/printing decision letters

Site of Care and Facility Billing

Billing Rule

Hospital inpatient/outpatient — PA required; facility and servicing provider NPI must be entered

When submitting authorization requests for inpatient or outpatient hospital services, enter the facility NPI or provider ID for where services will be performed and enter the servicing provider's NPI or provider ID (the appropriate surgeon/servicing provider), not the billing group.

Precertification/preauthorization is required for inpatient services.
Prior authorization is required for outpatient services for commercial members.

Definitions and Coding Notes

inv-13: Unresectable or metastatic synovial sarcoma

DefinitionSynovial sarcoma that cannot be removed surgically (unresectable) or that has spread to distant sites (metastatic).

Policy indicationTecelra covered for adults (>=18 years) with unresectable OR metastatic synovial sarcoma meeting all listed criteria

Coverage noteRepeat treatment is considered investigational; use outside listed criteria is investigational

inv-14: Tecelra coding — HCPCS Q2057 and related notes

Primary HCPCS codeQ2057 — Afamitresgene autoleucel, including leukapheresis and dose preparation procedures per therapeutic dose (Tecelra).

Related miscellaneous codesC9399 — Unclassified drug or biologic; J3590 — Unclassified biologic; J3490 — Unclassified drugs; J9999 — Not otherwise classified, antineoplastic.

Background

Tecelra (afamitresgene autoleucel) is an engineered autologous T‑cell therapy described in this policy for the treatment of adults with unresectable or metastatic synovial sarcoma whose tumors express the MAGE‑A4 antigen and who have eligible HLA markers. Coverage under this policy is contingent on meeting all listed clinical criteria, including age ≥18, disease progression or refractory status after most recent therapy, ECOG performance status 0–1, no active or serious infections, cardiac ejection fraction >50%, no history of CNS metastases, and no prior exposure to any engineered autologous T‑cell product.

Step Therapy and Pharmacy Operations

Process	Contact / Submission methods
Prior authorization and step therapy are managed through Pharmacy Operations; prior authorization is required for coverage requests under the medical benefit.	Providers may call Pharmacy Operations at 1-800-366-7778 or fax to 1-800-583-6289. Requests can also be submitted using the Prior Authorization Request Form via Authorization Manager or by fax/mail to: Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department, 25 Technology Place, Hingham, MA 02043.

Revision History

2025-06implementationLatest

Implemented new policy for Tecelra (afamitresgene autoleucel).