Viva Health Tecartus Coverage Prior Auth

Coverage Criteria — Tecartus (brexucabtagene autoleucel)

Initial Approval Criteria

Covered when ALL of the following general and disease-specific criteria are met

General eligibility: Patient is ≥18 years of age; no clinically significant active systemic infection or inflammatory disorder; prophylaxis for infection will be followed per local guidelines; no live vaccines within 6 weeks prior to lymphodepleting chemotherapy and none during brexucabtagene autoleucel treatment until immune recovery; screened for HBV, HCV, and HIV prior to leukapheresis; product used as a single agent (except lymphodepleting or additional chemotherapy while awaiting manufacture); ECOG performance status 0-1; no prior CAR‑T cell therapy.

Documentation of diagnosis, step therapy, and relevant clinical markers required; submit medical records via PA portal or fax

Mantle Cell Lymphoma specific: Relapsed or refractory mantle cell lymphoma AND used as subsequent therapy after prior covalent BTKi therapy AND one of the following: no response or progressive disease following second‑line therapy with covalent BTKi or other continuous regimens; OR partial response, no response, or progressive disease following second‑line fixed‑duration regimens; OR relapsed/progressive disease in second or greater relapse.

B‑cell Precursor ALL specific: Relapsed or refractory B‑cell precursor acute lymphoblastic leukemia AND either no prior anti‑CD19 therapy OR prior anti‑CD19 therapy with rebiopsy confirming CD19‑positive disease; AND if Philadelphia chromosome (Ph)‑positive, prior therapy has included a TKI (bosutinib, dasatinib, imatinib, nilotinib, or ponatinib).

NCCN recommendations may apply to AYA patients 15–39 years

Coverage is limited to autologous use and intravenous administration of Tecartus. Tecartus is manufactured from the patient’s own peripheral blood mononuclear cells obtained by leukapheresis; therefore, confirm availability of the product prior to initiating lymphodepleting chemotherapy. Verify that the patient’s identity matches the identifiers on the Tecartus cassette before infusion to ensure correct product handling and identity confirmation.

The policy information above is intended for non‑Medicare coverage determinations. Medicare Part B coverage for outpatient drugs is governed by the Medicare Benefit Policy Manual (Pub. 100‑2), Chapter 15, §50, and may be subject to applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs). Providers may search the CMS Coverage Database for relevant NCD/LCD/LCA guidance at: https://www.cms.gov/medicare-coverage-database/search.aspx.

Requests that do not meet the general eligibility requirements are not eligible for coverage. Examples include patients younger than 18 years, an Eastern Cooperative Oncology Group performance status > 1 (ECOG ≥2), presence of a clinically significant active systemic infection or inflammatory disorder, or receipt of prior CAR‑T cell therapy. Failure to meet the disease‑specific sequencing or biomarker requirements (for example, absence of prior covalent BTKi exposure where required for mantle cell lymphoma, or lack of CD19 positivity when previously treated with anti‑CD19 therapy in ALL) also renders the request not medically necessary.

Regimen / Indication	Lymphodepleting chemotherapy (schedule)	Tecartus target dose and maximum	Premedication / steroid guidance
Mantle cell lymphoma	Cyclophosphamide 500 mg/m2 IV and fludarabine 30 mg/m2 IV on days -5, -4, and -3 before Tecartus infusion	Target: 2 × 10^6 CAR-positive viable T cells/kg; maximum 2 × 10^8 CAR-positive viable T cells (for patients ≥100 kg)	Premedicate with acetaminophen and an H1-antihistamine; avoid prophylactic systemic corticosteroids
B‑cell precursor acute lymphoblastic leukemia (ALL)	Fludarabine 25 mg/m2 IV on days -4, -3, and -2; cyclophosphamide 900 mg/m2 IV on day -2 before Tecartus infusion	Target: 1 × 10^6 CAR-positive viable T cells/kg; maximum 1 × 10^8 CAR-positive viable T cells (for patients ≥100 kg)	Premedicate with acetaminophen and an H1-antihistamine; avoid prophylactic systemic corticosteroids

Coding — HCPCS, NDC, Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

Q2053

Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose; 1 billable unit = 200 million autologous anti-cd19 car positive viable t cells

NDCsNDC

71287-0219-xx	Tecartus suspension for intravenous infusion (MCL); 1 infusion bag (~68 mL)
71287-0220-xx	Tecartus suspension for intravenous infusion (ALL); 1 infusion bag (~68 mL)

Covered Diagnosis Codes (Appendix 1)ICD-10Covered

C83.10	Mantle cell lymphoma, unspecified site
C83.11	Mantle cell lymphoma, lymph nodes of head, face and neck
C83.12	Mantle cell lymphoma, intrathoracic lymph nodes
C83.13	Mantle cell lymphoma, intra-abdominal lymph nodes
C83.14	Mantle cell lymphoma, lymph nodes of axilla and upper limb
C83.15	Mantle cell lymphoma, lymph nodes of inguinal region and lower limb
C83.16	Mantle cell lymphoma, intrapelvic lymph nodes
C83.17	Mantle cell lymphoma, spleen
C83.18	Mantle cell lymphoma, lymph nodes of multiple sites
C83.19	Mantle cell lymphoma, extranodal and solid organ sites

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Dose targets and maxima — per indication

Mantle cell lymphoma — target dose2 x 10^6 CAR+ viable T cells per kg body weight

Mantle cell lymphoma — maximum per patientMaximum 2 x 10^8 CAR+ viable T cells (for patients ≥100 kg)

B‑cell precursor ALL — target dose1 x 10^6 CAR+ viable T cells per kg body weight

B‑cell precursor ALL — maximum per patientMaximum 1 x 10^8 CAR+ viable T cells (for patients ≥100 kg)

Billing unit equivalenceHCPCS Q2053: 1 billable unit = up to 200 million (2 x 10^8) CAR+ viable T cells

Provider Actions — Authorization, Documentation, and Billing Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorization will be provided for one treatment course (one dose) and may NOT be renewed.

Initial authorization: one treatment course (1 dose)
Renewal: not renewable

Documentation Required

Documentation Submission Required

Submission of supporting clinical documentation (including but not limited to medical records, chart notes, lab results, and confirmatory diagnostics) related to the medical necessity criteria is REQUIRED on all requests for authorizations. Records will be reviewed at the time of submission as part of the evaluation of this request. Provide documentation related to diagnosis, step therapy, and clinical markers (e.g., genetic and mutational testing) when applicable via direct upload through the PA web portal or by fax. Failure to submit the required medical records may result in denial of the request due to inability to establish medical necessity.

Line of Therapy — Indication-specific sequencing

second-line or later

Mantle cell lymphoma sequencing: Used as subsequent therapy after prior covalent BTKi therapy with specified failure scenarios (see policy): no response or progressive disease following second‑line therapy with covalent BTKi or other continuous regimens; OR partial response/no response/progressive disease following second‑line fixed‑duration regimens; OR relapsed/progressive disease in second or greater relapse.

Covered as later‑line therapy following covalent BTKi

salvage

ALL sequencing (salvage): Relapsed or refractory B‑cell precursor ALL in the salvage setting when either no prior anti‑CD19 therapy has been given OR prior anti‑CD19 therapy was given but rebiopsy confirms CD19‑positive disease; if Ph‑positive, prior therapy must have included a TKI (bosutinib, dasatinib, imatinib, nilotinib, or ponatinib).

Biomarker and Diagnostic Requirements

CD19 — biomarker requirement

RequirementCD19 positivity is required if the patient previously received other anti‑CD19 therapy; rebiopsy must confirm CD19‑positive disease.

ContextApplies to relapsed or refractory B‑cell precursor ALL when prior anti‑CD19 therapy was given (examples: blinatumomab, tafasitamab, loncastuximab tesirine).

DocumentationRebiopsy results demonstrating CD19 expression must be submitted to support eligibility.

Philadelphia chromosome (Ph) — biomarker requirement

RequirementIf disease is Philadelphia chromosome (Ph)‑positive, previous therapy must have included a tyrosine kinase inhibitor (bosutinib, dasatinib, imatinib, nilotinib, or ponatinib).

ScopeThis Ph‑positive TKI requirement applies within the B‑cell precursor ALL coverage criteria for relapsed/refractory disease.

Definitions and Treatment Course Notes

Treatment course / Tecartus preparation

Treatment course componentsOne treatment course consists of lymphodepleting chemotherapy followed by a single infusion of Tecartus prepared from the patient’s leukapheresis product.

Mantle cell lymphoma lymphodepletionCyclophosphamide 500 mg/m2 and fludarabine 30 mg/m2 IV on days -5, -4, -3 before infusion.

ALL lymphodepletionFludarabine 25 mg/m2 IV on days -4, -3, -2 and cyclophosphamide 900 mg/m2 IV on day -2 before infusion.

Product preparation notesTecartus is prepared from the patient’s peripheral blood mononuclear cells obtained by leukapheresis; confirm product availability and patient identity prior to starting lymphodepletion.

Post‑infusion monitoring

Monitoring frequency

Background — Therapy Overview

Tecartus (brexucabtagene autoleucel) is an autologous anti‑CD19 CAR T‑cell therapy prepared from the patient’s leukapheresed peripheral blood mononuclear cells and administered as a single intravenous infusion following lymphodepleting chemotherapy. One treatment course consists of lymphodepletion followed by a single Tecartus infusion; because the product is patient‑specific, providers must confirm product availability and verify patient identity prior to starting lymphodepletion.

Revision History & References

Medicare Part B beneficiaries are subject to Medicare rules and any applicable NCDs, LCDs, or LCAs. Coverage and documentation requirements for outpatient drugs are described in the Medicare Benefit Policy Manual (Pub. 100‑2), Chapter 15, §50; noncompliance with applicable NCD/LCD/LCA requirements can affect coverage decisions. Providers should consult the CMS Coverage Database (https://www.cms.gov/medicare-coverage-database/search.aspx) and follow any local coverage guidance when submitting claims or prior authorization requests for Medicare members.

OpenPayer

Tecartus (brexucabtagene autoleucel) therapy coverage