CurrentEmblemHealthPolicy 3183

Tecelra (afamitresgene autoleucel) coverage for synovial sarcoma

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Defines coverage, prior authorization, coding, indications, contraindications, and exclusions for Tecelra (afamitresgene autoleucel) for EmblemHealth members; applies to network ordering providers and multiple lines of business.

Policy Summary

PayerEmblemHealth

PolicyTecelra (afamitresgene autoleucel) coverage for synovial sarcoma

Policy CodePolicy 3183

Change TypeTemplate conversion and content updates

Effective DateSep 1, 2025

Last ReviewSep 1, 2025

Next Review Date

Key ActionObtain prior authorization from Evolent for Tecelra; requests not authorized by Evolent may be deemed not reimbursable.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaces UM ONC_1507 Tecelra.

1primary HCPCS code listed (Q2057)

adultpatient population specified

10 x 10^9single dose T cell limit

Commercial, Exchange, Medicaidlines of business

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CurrentEmblemHealthPolicy 3183

Tecelra (afamitresgene autoleucel) coverage for synovial sarcoma

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Sign up for EmblemHealth Policy 3183 alerts

Get alerted when Policy 3183 changes without checking for updates manually.

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Policy Summary

PayerEmblemHealth

PolicyTecelra (afamitresgene autoleucel) coverage for synovial sarcoma

Policy CodePolicy 3183

Change TypeTemplate conversion and content updates

Effective DateSep 1, 2025

Last ReviewSep 1, 2025

Next Review Date

Key ActionObtain prior authorization from Evolent for Tecelra; requests not authorized by Evolent may be deemed not reimbursable.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaces UM ONC_1507 Tecelra.

1primary HCPCS code listed (Q2057)

adultpatient population specified

10 x 10^9single dose T cell limit

Commercial, Exchange, Medicaidlines of business

Coverage Criteria for Tecelra (afamitresgene autoleucel)

Primary coverage criteria for Tecelra

Coverage is allowed when ALL of the following criteria are met:

ALL of the following

Adult member with unresectable or metastatic synovial sarcoma
source: indication
Member has received prior chemotherapy for synovial sarcoma
source: indication
Member is HLA-A*02:01, -A*02:02, -A*02:03, or -A*02:06 positive
HLA requirement
Tumor is MAGE-A4 antigen positive as determined by an FDA‑approved or cleared companion diagnostic
companion diagnostic requirement
Member is NOT heterozygous or homozygous for HLA-A*02:05 (contraindication)
contraindication
No disease progression while taking Tecelra
exclusion
No concurrent use with other anticancer therapies
exclusion
Requested dosing does not exceed a single dose limit of 10 x 10^9 MAGE-A4 TCR positive T cells
quantity limit / exclusion
Provider and site can manage boxed‑warning risks: immediate evaluation and access to medications and resuscitative equipment for cytokine release syndrome (CRS)
boxed warning / site of care

Initial Therapy Criteria

Continuation Therapy Criteria and Exceptions

Documentation Required

Continuation authorization exception

Continuation requests for a previously authorized medication are exempt from the Evolent authorization requirements if all of the following are met: no disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of active authorization; and no additional medications are being added to the continuation request.

Member has not experienced disease progression on the requested medication
Medication used within the last year without >30 day lapse of active authorization
No additional medications added to the continuation request

Coding — HCPCS and Billing Codes

HCPCSHCPCSCovered

Q2057

Afamitresgene autoleucel, including leukapheresis and dose preparation procedures, per therapeutic dose

Provider Actions and Prior Authorization

Prior Authorization

Prior authorization requirement — Evolent processing required

Evolent is responsible for processing all medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Quantity Limits

Tecelra (afamitresgene autoleucel) — Quantity limits

Single-dose cell limit10 x 10^9 MAGE-A4 TCR positive T cells (exclusion if dosing exceeds this limit)

Unitper therapeutic course (cells)

Applicable drugTecelra (afamitresgene autoleucel)

Related exclusionInvestigational or off-label use not supported by sufficient evidence is excluded

Evidence standard for exceptionsUse must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or qualifying peer-reviewed literature

Site of Care Requirements

Note

Hospital outpatient — manage CRS and hospitalize if needed

At the first sign of cytokine release syndrome (CRS) during outpatient administration, immediately evaluate the patient for hospitalization and ensure administrators have immediate access to medications and resuscitative equipment to manage CRS.

CRS may be severe or life‑threatening in patients receiving afamitresgene autoleucel
Ensure immediate availability of medications and resuscitative equipment during administration
Hospitalization should be instituted at first sign of CRS

Definitions and Accepted Evidence

Accepted evidence

Accepted evidence sourcesFDA-approved product labeling; CMS-recognized compendia; NCCN or ASCO clinical guidelines; qualifying peer-reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15

Prior authorization processingEvolent is responsible for processing all medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and not reimbursable

Insufficient evidence examplesCase reports and meeting abstracts without full peer-reviewed publication generally lack adequate supportive clinical evidence

Evidence considerationsAssess whether patient and cancer characteristics, treatment regimens, and clinically meaningful outcomes are adequately represented in the published evidence

Study design noteNon-randomized trials with substantial subjects may support accepted uses; randomized designs may not always be required depending on context