CurrentBlue Cross Blue Shield - WisconsinPolicy CC-0195

Abecma (idecabtagene vicleucel) — Clinical Coverage Criteria

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Clinical coverage criteria for Abecma (idecabtagene vicleucel), an autologous BCMA-directed CAR T-cell therapy, for adults with relapsed or refractory multiple myeloma; intended for use by providers and prior authorization reviewers.

Policy Summary

PayerBlue Cross Blue Shield - Wisconsin

PolicyAbecma (idecabtagene vicleucel) — Clinical Coverage Criteria

Policy CodePolicy CC-0195

Change TypeNo material change

Effective DateDec 22, 2025

Last ReviewNov 14, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation confirming age ≥18, relapsed/refractory multiple myeloma after ≥2 prior lines including IMiD, PI, and anti‑CD38, adequate marrow reserve (ANC ≥1000, platelets ≥50,000), ECOG 0–1, and no prior CAR T or BCMA‑targeted therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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CurrentBlue Cross Blue Shield - WisconsinPolicy CC-0195

Abecma (idecabtagene vicleucel) — Clinical Coverage Criteria

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Policy Summary

PayerBlue Cross Blue Shield - Wisconsin

PolicyAbecma (idecabtagene vicleucel) — Clinical Coverage Criteria

Policy CodePolicy CC-0195

Change TypeNo material change

Effective DateDec 22, 2025

Last ReviewNov 14, 2025

Next Review Date

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Coverage Criteria for Abecma (idecabtagene vicleucel)

inv-01: Initial Therapy / Approval Criteria

Requests for Abecma may be approved when ALL of the following criteria are met:

Primary eligibility: Individual is 18 years of age or older; diagnosis of relapsed or refractory multiple myeloma; if history of allogeneic stem cell transplant, no current signs of active graft-versus-host disease (GVHD); absolute neutrophil count (ANC) ≥ 1000 cells/uL; platelet count ≥ 50,000 cells/uL; Eastern Cooperative Oncology Group (ECOG) performance status 0–1; no prior CAR T-cell or BCMA-targeted therapy; therapy is a one-time, single administration.ANC ≥ 1000 cells/uL; Platelets ≥ 50,000 cells/uL; ECOG 0–1; LVEF per policy if applicable

Per FDA label and NCCN 2A; documentation of prior therapies and baseline labs required

inv-02: May Not Be Approved / Exclusion Criteria

Therapy may not be approved for any of the following conditions (selection from protocol/criteria):

Contraindications / Exclusionary conditions: Repeat administration; active presence or history of central nervous system involvement with myeloma; presence or history of plasma cell leukemia; solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease; use in combination with other chemotherapy agents (except lymphodepleting chemotherapy prior to infusion); use in combination with another CAR T-cell immunotherapy; active GVHD; prior genetically modified T-cell therapy.n/a

Protocol Munshi NC et al. 2021 referenced

Abecma may not be approved for certain exclusionary conditions. Key exclusions include repeat administration; active presence or history of central nervous system (CNS) involvement with myeloma; presence or history of plasma cell leukemia; solitary plasmacytomas or non‑secretory myeloma without measurable disease; use in combination with other chemotherapy agents (except for permitted lymphodepleting chemotherapy prior to infusion); and use in combination with another CAR T‑cell immunotherapy.

Use of Abecma is allowed only when the specified eligibility elements are met. These include: the individual is an adult (per policy elsewhere), has relapsed or refractory multiple myeloma, demonstrates adequate marrow reserve with ANC ≥ 1000 cells/uL and platelets ≥ 50,000 cells/uL, has ECOG performance status 0–1, has not received prior CAR T‑cell or BCMA‑targeted therapy, and the therapy is provided as a one‑time, single administration. Use when any of these criteria are not met is considered not medically necessary.

Regimen	Description	Coverage
Idecabtagene vicleucel (Abecma) single therapeutic dose following lymphodepleting chemotherapy	Autologous BCMA-directed CAR T-cell therapy administered as a single, one-time therapeutic dose after receipt of lymphodepleting chemotherapy prior to infusion.	Covered with criteria

Coding and Clinical Thresholds

Covered CPT CodesCPTCovered

38225	Chimeric antigen receptor T-cell (CAR-T) therapy; harvesting of blood-derived T lymphocytes for development of genetically modified autologous CAR-T cells, per day [Abecma]
38226	Chimeric antigen receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for transportation (eg, cryopreservation, storage) [Abecma]
38227	Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preparation of CAR-T cells for administration [Abecma]
38228	Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous [Abecma]

HCPCSHCPCSCovered

Q2055

Idecabtagene vicleucel, up to 510 million autologous B-cell maturation antigen (BCMA) directed CAR-positive T cells, including leukapheresis and dose preparation procedures, per therapeutic dose

ICD-10-PCS Procedure CodesICD-10

XW033K7	Introduction of idecabtagene vicleucel immunotherapy into peripheral vein, percutaneous approach, new technology group [Abecma]
XW043K7	Introduction of idecabtagene vicleucel immunotherapy into central vein, percutaneous approach, new technology group [Abecma]

ICD-10 Diagnosis CodesICD-10Covered

C90.00	Multiple myeloma not having achieved remission
C90.02	Multiple myeloma in relapse
Z51.12	Encounter for antineoplastic immunotherapy
Z85.79	Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues

inv-09: Absolute neutrophil count (ANC) — clinical threshold

ANC requirementAbsolute neutrophil count (ANC) ≥ 1000 cells/µL

ContextANC is part of adequate bone marrow reserve required for eligibility

Measurement timingBaseline ANC must be documented prior to therapy/leukapheresis per policy

inv-10: Platelet count — clinical threshold

Platelet requirementPlatelet count ≥ 50,000 cells/µL

ContextPlatelet count is part of adequate bone marrow reserve required for eligibility

Prior Authorization, Documentation, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization required. Requests will be reviewed for medical necessity and coverage when all policy criteria are met.

Prior authorization required for Abecma (idecabtagene vicleucel).
Requests considered when criteria are met: age ≥18, diagnosis of relapsed or refractory multiple myeloma, adequate marrow reserve, ECOG 0–1, no prior CAR T-cell or BCMA-targeted therapy, one-time single administration.

Step Therapy

Step therapy / Prior Regimen Expectations

Policy requires prior exposure to key drug classes and documentation of prior regimens before authorization; no multi-step therapeutic sequencing beyond these prior exposure requirements is mandated.

Requirement that patient previously received an immunomodulatory agent, a proteasome inhibitor, and an anti‑CD38 monoclonal antibody (per FDA label).

Line of Therapy Requirements

inv-19: third-line or later

FDA label setting: Treatment for adults with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti‑CD38 monoclonal antibody.prior therapies per label

FDA‑approved indication

Biomarker Requirements

inv-20: BCMA — biomarker note

Biomarker targetB-cell maturation antigen (BCMA) — target of idecabtagene vicleucel (Abecma)

RoleTherapy binds BCMA on malignant plasma cells to induce tumor cell death

RequirementBCMA is the therapeutic target; presence of BCMA expression supports mechanism of action

Background

Abecma (idecabtagene vicleucel) is an autologous BCMA‑directed CAR T‑cell therapy intended as a single therapeutic dose for adults with relapsed or refractory multiple myeloma who meet eligibility criteria. Serious toxicities and exclusion considerations are outlined in the criteria and include requirements for marrow reserve, cardiac function, and absence of active infections or prior genetically modified T‑cell therapy. Examples of conditions that preclude approval include active graft‑versus‑host disease, prior CAR T or other genetically modified T‑cell therapy, LVEF < 45% (when assessed within 8 weeks of leukapheresis), recent significant cardiac events (e.g., NYHA class III/IV heart failure or recent MI/CABG), and active hepatitis B/C, HIV, or other uncontrolled infection.

Definitions

inv-17: Autologous cells — Harvested from the individual's own cells.

DefinitionAutologous cells: Harvested from the individual's own cells.

ContrastDistinguishes from allogeneic cells which are harvested from a histocompatible donor

RelevanceAbecma is an autologous CAR T-cell therapy using the individual's T cells for manufacturing

inv-18: ECOG Performance Status — Scale to assess disease impact on daily living (0 = fully active to 5 = dead).

Scale descriptionECOG Performance Status: 0 = fully active to 5 = dead

Clinical useUsed to assess disease impact on daily living and determine eligibility (policy requires ECOG 0–1)