CurrentBlue Cross Blue Shield - MassachusettsPolicy N/A

Afamitresgene autoleucel (Tecelra) — coverage criteria for unresectable or metastatic synovial sarcoma

Prior authorization and medical necessity documentation requirements for use of afamitresgene autoleucel (Tecelra) for unresectable or metastatic synovial sarcoma; applies to providers requesting coverage for Blue Cross Blue Shield of Massachusetts members.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyCoverage criteria for afamitresgene autoleucel (Tecelra) for unresectable or metastatic synovial sarcoma

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionRequest prior authorization via Authorization Manager (or fax for out-of-network) and submit required clinical documentation using the Complete Prior Authorization Request Form for Engineered T‑Cell Therapy for Synovial Sarcoma (Tecelra).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum patient age required

ECOG 0-1Performance status required

No prior engineered T‑cell productPrior therapy exclusion

HLA-A*02:01/02:02/02:03/02:06Required HLA markers

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Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial criteria: Patient is at least 18 years of age; diagnosis of synovial sarcoma that is unresectable OR metastatic OR refractory to most recent treatment OR progressed after most recent treatment; member tissue expresses one of the specified HLA‑A*02 alleles (A*02:01, A*02:02, A*02:03, A*02:06); tumor expresses MAGE‑A4 antigen as determined by an FDA‑approved or cleared companion diagnostic; ECOG performance status of 0 or 1; no history of CNS metastases; no active or serious infections; left ventricular ejection fraction >= 50%; no prior treatment with any engineered autologous T‑cell product directed at any target (including CAR‑T or tumor‑infiltrating lymphocytes).ECOG 0-1; LVEF >=50%

Criteria correspond to checklist fields on the prior authorization form.

Prior treatment with any engineered autologous T‑cell product directed at any target is an exclusion. This includes prior receipt of any autologous engineered T‑cell therapies such as CAR‑T products or tumor‑infiltrating lymphocyte (TIL) therapies.

Additional exclusion and limit criteria include: the member must express one of the specified HLA‑A*02 alleles (A*02:01, A*02:02, A*02:03, or A*02:06); the tumor must express MAGE‑A4 as determined by an FDA‑approved or cleared companion diagnostic; performance status must be ECOG 0 or 1; there must be no history of CNS metastases; there must be no active or serious infections; and cardiac function must meet the threshold of left ventricular ejection fraction ≥50%.

Prior Authorization & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for engineered T‑cell therapy. Submit initial authorization requests using Authorization Manager (available 24/7) — this is the quickest way to review requirements, request authorizations, submit clinical documentation, check case status, and view/print the decision letter. For out-of-network providers, requests may be faxed to 888-973-0726. Enter the appropriate surgeon's NPI or provider ID as the servicing provider (not the billing group) and the facility's NPI or provider ID where services are performed.

Authorization Manager available 24/7
Out-of-network fax: 888-973-0726

Note

Prior Engineered T‑cell Therapy Exclusion

Document that the patient has no history of prior treatment with any engineered autologous T‑cell product directed at any target (including CAR‑T or tumor‑infiltrating lymphocytes).

Billing and Coding

HCPCS / unclassified codes listedHCPCS

kc9399	Afamitresgene autoleucel, including leukapheresis and dose preparation procedures, per therapeutic dose (Tecelra)
03590	Unclassified drug or biologic therapeutic dose
03490	Unclassified biologic
09999	Not otherwise classified, antineoplastic

inv-05: Performance status — ECOG 0-1

Performance statusECOG 0 or 1

Source requirementDocumented ECOG performance scale of 0 or 1 is required for eligibility

Related exclusionECOG >1 does not meet medical necessity criteria

Biomarker and HLA Requirements

inv-14: MAGE-A4 — Positive per FDA‑approved or cleared companion diagnostic.

BiomarkerMAGE-A4 positive

Test requirementTumor expresses the MAGE-A4 antigen as determined by an FDA‑approved or cleared companion diagnostic

Role in eligibilityRequired to determine eligibility for afamitresgene autoleucel (Tecelra)

inv-15: HLA-A*02 alleles — One of A*02:01, A*02:02, A*02:03, A*02:06 required.

Required HLA allelesOne of HLA-A*02:01, A*02:02, A*02:03, A*02:06

Tissue requirementMember tissues and cells must express one of the specified HLA markers

Key Definitions and Indications

inv-11: Indication — Unresectable or metastatic synovial sarcoma.

IndicationUnresectable or metastatic synovial sarcoma

Disease states includedAlso includes refractory to most recent treatment or progressed after most recent treatment as part of synovial sarcoma disease state

Age requirementPatient must be at least 18 years of age to meet criteria

inv-12: MAGE‑A4 positive — Presence of tumor MAGE‑A4 antigen as determined by an FDA‑approved or cleared companion diagnostic.

DefinitionPresence of tumor MAGE‑A4 antigen as determined by an FDA‑approved or cleared companion diagnostic

DocumentationCompanion diagnostic result must be documented on the prior authorization request

Line of Therapy

Disease state: Unresectable OR Metastatic OR Refractory to most recent treatment OR Progressed after most recent treatment

Covered Regimens and Products

Regimen	Indication	Coverage status	Relevant codes
Afamitresgene autoleucel (engineered autologous T-cell therapy)	Unresectable or metastatic synovial sarcoma meeting medical necessity criteria (see policy): patient ≥18 years; tumor MAGE‑A4 positive by FDA‑approved/cleared companion diagnostic; member tissue expresses one of HLA‑A02 alleles (A02:01, A02:02, A02:03, A*02:06); ECOG 0–1; no CNS metastases; LVEF ≥50%; no active serious infections; no prior engineered autologous T‑cell product directed at any target.	Covered	HCPCS: kc9399; unclassified codes: 03590, 03490, 09999

Background

Afamitresgene autoleucel (Tecelra) is described as an engineered autologous T‑cell therapy directed at MAGE‑A4 for the treatment of unresectable or metastatic synovial sarcoma. Patient selection requires demonstration of tumor MAGE‑A4 expression by an FDA‑approved or cleared companion diagnostic and presence of one of the specified HLA‑A*02 alleles; candidates typically have good performance status and no CNS metastases or active serious infections.