CurrentAvMedPolicy N/A

Tecelra (afamitresgene autoleucel) medical prior authorization

Defines prior authorization clinical criteria, dosing limits, and documentation requirements for Tecelra (afamitresgene autoleucel) for members receiving the product in a medical (infusion) setting.

Policy Summary

PayerAvMed

PolicyTecelra (afamitresgene autoleucel) medical prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization with the prescribing physician signature and required documentation (pathology confirming SYT-SSX translocation, companion diagnostic for MAGE-A4, HLA-A*02 typing, HIV and infectious disease testing, and prior therapy history) to AvMed via fax at 1-877-535-1391.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum member age for coverage

1 doseAllowed single dose range (viable cells)

2.68–10 x10^9Viable cells per single dose

ExcludedPrior CAR-T therapy

Medical Necessity Criteria for Tecelra (afamitresgene autoleucel)

Overall approval requirement

All criteria must be met for approval. To support each line checked, all documentation, including lab results, diagnostics, and/or chart notes, must be provided.

ALL of the following

Member is 18 years of age or older
Provider is an oncologist and the administrating healthcare facility is trained in the management of cytokine release syndrome (CRS) and neurological toxicities
Member has NOT received prior CAR-T therapy
Member has NOT received systemic corticosteroids for at least 14 days prior to leukapheresis and lymphodepletion
No systemic corticosteroids within 14 days before leukapheresis/lymphodepletion

Policy Summary

PayerAvMed

PolicyTecelra (afamitresgene autoleucel) medical prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Allogeneic transplant status

Member has NOT received a prior allogeneic stem cell transplant
Member has received a prior allogeneic stem cell transplant but is without evidence of residual donor cells present

Member is a candidate for autologous stem cell transplantation (e.g., adequate renal and hepatic function)

Member has been screened and found to be negative for EBV, CMV, HBV, HCV, and any other infectious agents, if clinically indicated

Member is HIV negative as confirmed by a HIV test prior to mobilization

Tecelra may cause false-positive on some commercial HIV nucleic acid tests due to lentiviral vector sequences

Member does NOT have a left ventricular ejection fraction (LVEF) less than 50%>= 50%

Member does NOT have a history of hypersensitivity to dimethyl sulfoxide (DMSO)

Member does NOT have a clinically significant active systemic infection

Member does NOT have symptomatic brain metastases including leptomeningeal disease

Provider will monitor for secondary malignancies periodically after treatment

Member has a diagnosis of unresectable or metastatic synovial sarcoma confirmed by SYT-SSX (t(X;18)) translocation

Member's tumor expresses the MAGE-A4 tumor antigen as determined by an FDA-approved or cleared companion diagnostic device

Member's tumor is positive for HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P allele

Member's condition does NOT have HLA-A*02:05P in either allele (heterozygous or homozygous)

Prior systemic therapy requirement

Member has received one prior line of therapy with an anthracycline (e.g., doxorubicin) or ifosfamide
If member is intolerant or has contraindication to both anthracycline and ifosfamide, member must have received at least one systemic therapy

Key Thresholds

Minimum viable cell count per single dose2.68 x 10^9 cells

Maximum viable cell count per single dose10 x 10^9 cells

Left ventricular ejection fraction (LVEF)>= 50%

Systemic corticosteroid-free interval prior to leukapheresis/lymphodepletion>= 14 days

Relevant Billing and Coding Guidance

HCPCS/Medical drug billing codes referencedHCPCSCovered

C9399	Unclassified drugs or biologicals (used in form header)
J9999	Not otherwise classified, antineoplastic drugs (used in form header)

Administration/medical product coding guidancemixed

Single dose contains minimum 2.68 x 10^9 to maximum 10 x 10^9 viable cells in one or more patient-specific infusion bags (quantity/units guidance)

ICD-10ICD-10

Document asks for diagnosis and ICD code if applicable; no specific ICD-10 codes mandated in policy text

Prior Authorization, Documentation & Site Requirements

Prior Authorization

Submit medical prior authorization request for Tecelra

Prescribing physician must sign and submit the completed medical prior authorization request for Tecelra (C9399, J9999). Fax the signed form and all supporting documentation to 1-877-535-1391.

Include HCPCS/medical drug codes C9399 and J9999 on the form
Fax completed, signed form to 1-877-535-1391

Documentation Required

Required diagnostic and lab documentation

Provide diagnostic and laboratory documentation verifying synovial sarcoma and treatment eligibility: pathology confirming SYT‑SSX translocation, companion diagnostic demonstrating MAGE‑A4 expression, HLA‑A*02 allele typing with allowed positive alleles and explicit negative result for HLA‑A*02:05P, HIV test result prior to mobilization, and infectious disease screening as clinically indicated.

Pathology showing SYT‑SSX (t(X;18)) translocation
Companion diagnostic result confirming MAGE‑A4 expression (FDA‑approved/cleared)
HLA‑A*02 typing positive for allowed alleles (HLA‑A*02:01P, *02:02P, *02:03P, *02:06P) and negative for HLA‑A*02:05P
HIV test result prior to mobilization (patient must be HIV negative)
Screening results for EBV, CMV, HBV, HCV, and other infectious agents as clinically indicated

Documentation Required

Administration site/provider requirements

Administration must occur at a trained healthcare facility with an oncology provider and capability to manage cytokine release syndrome (CRS) and neurological toxicities. Include the administering location’s NPI or DEA number or specialty pharmacy details on the request.

Facility trained in management of CRS and neurologic toxicities
Administering provider is an oncologist
Provide administering location NPI or DEA # on the form, or indicate specialty pharmacy (Proprium Rx)

Denial Risk

Denial risk if criteria not met or documentation incomplete

All listed clinical criteria must be checked and supported by documentation; incomplete, incorrect, or illegible information may delay authorization or result in denial.

Failure to provide complete, correct, and legible information can delay authorization
Missing supporting labs, diagnostics, or chart notes may lead to denial

Prior Authorization

Urgent review process

For urgent reviews (when lack of treatment could seriously jeopardize life, health, or ability to regain function), submit the PA form and call the AvMed Pre‑Authorization Department to request expedited review.

Submit the completed form and also call AvMed Pre‑Authorization Department for urgent review requests

Clinical and Safety Context

Tecelra (afamitresgene autoleucel) is an autologous, genetically modified T‑cell (CAR‑T style) therapy that targets tumors expressing the MAGE‑A4 antigen and is indicated for unresectable or metastatic synovial sarcoma confirmed by the characteristic SYT‑SSX (t(X;18)) translocation. The single‑dose product contains a patient‑specific infusion with a viable cell range of minimum 2.68 x 10^9 to maximum 10 x 10^9 cells suspended in one or more infusion bags, and administration is performed in a medical (infusion) setting under prior authorization requirements.

Appropriate candidates must meet several prerequisites prior to leukapheresis and treatment: be aged 18 years or older; have tumor MAGE‑A4 expression confirmed by an FDA‑approved or cleared companion diagnostic; demonstrate positivity for an allowed HLA‑A*02 allele (HLA‑A*02:01P, A*02:02P, A*02:03P, or A*02:06P) and must not have the HLA‑A*02:05P allele in either copy; have a confirmed diagnosis of synovial sarcoma by SYT‑SSX translocation; have not received prior CAR‑T therapy; and meet treatment fitness criteria (including adequate renal and hepatic function and LVEF ≥ 50%). Patients must be screened and found negative for EBV, CMV, HBV, HCV and other infectious agents as clinically indicated, and must be HIV negative by test prior to mobilization (with the caveat that Tecelra may cause false‑positive results on some commercial HIV nucleic acid assays due to lentiviral vector sequences).

Providers and sites must be qualified oncology professionals and facilities trained to manage cytokine release syndrome (CRS) and neurological toxicities; known treatment risks that require monitoring include CRS, immune effector neurotoxicity (neurologic events), infectious complications, and the need for periodic surveillance for secondary malignancies following treatment.

Key Terms and Definitions

Definitions

TecelraAfamitresgene autoleucel, an autologous genetically modified T-cell therapy targeting MAGE-A4

CRSCytokine release syndrome

LeukapheresisProcedure to collect peripheral blood mononuclear cells for manufacturing of cellular therapies

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