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    OpenPayerPolicy UpdatesHematology/OncologyEmpire Bluecross Abecma Coverage & Prior Auth | Op…
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    CurrentEmpire BluecrossPolicy 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 adult patients with relapsed or refractory multiple myeloma; intended for use by providers and utilization management staff at Empire Bluecross.

    Policy Summary
    PayerEmpire Bluecross
    PolicyAbecma (idecabtagene vicleucel) — Clinical Coverage Criteria
    Policy CodePolicy CC-0195
    Change TypeReviewed
    Effective Date12/22/2025
    Last ReviewNov 14, 2025
    Next Review DateN/A
    Key ActionSubmit prior authorization with supporting clinical documentation including diagnosis, prior therapy history, ANC and platelet counts, ECOG status, and confirmation this is a single administration and no prior CAR T/BCMA therapy.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    ≥18
    min age
    ≥2 linesprior therapies
    0-1ECOG
    ANC ≥1000; Plt ≥50kbone marrow
    Single administration onlydosing

    Coverage Criteria for Abecma (idecabtagene vicleucel)

    Initial Therapy — Covered when ALL of the following are met

    Covered when ALL of the following are met

    Patient 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)

    (Label, NCCN 2A)

    Clinical status and labs: ECOG performance status 0-1; adequate bone marrow reserve defined as ANC ≥ 1000 cells/uL and platelet count ≥ 50,000 cells/uLECOG 0-1; ANC ≥ 1000; Platelets ≥ 50,000
    Prior therapy and treatment limitations: Has not received prior CAR T-cell or BCMA-targeted therapy; therapy intended as a one-time single administration

    Policy aligned with FDA label requiring prior exposure to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody

    Contraindications / Not approved

    Not approved for any of the following (any one applies 12 not approved)

    Exclusion 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 measurable disease; use in combination with other chemotherapy agents (excluding lymphodepleting chemotherapy) or with other CAR T-cell immunotherapy; active GVHD; history of CAR T-cell or other genetically modified T-cell therapy; significant cardiac disease (NYHA III/IV CHF, MI/CABG within 6 months, clinically significant ventricular arrhythmia, unexplained syncope, severe nonischemic cardiomyopathy); left ventricular ejection fraction (LVEF) < 45% (scan within 8 weeks of leukapheresis); active hepatitis B or C, HIV positive, or other active uncontrolled infection; and any situation where the above criteria are not met

    Based on Protocol for Munshi NC et al 2021 and policy exclusions

    Abecma is not appropriate in several specific situations. Requests will not be approved for repeat administration. It is contraindicated for individuals with an active presence or history of central nervous system (CNS) involvement with myeloma, for those with the presence or history of plasma cell leukemia, and for patients who have solitary plasmacytomas or non‑secretory myeloma without measurable disease.

    Use of Abecma in combination with other systemic anti‑cancer therapies is not allowed except for the institution of standard lymphodepleting chemotherapy prior to infusion. Concurrent use with another CAR T‑cell immunotherapy (for example, Breyanzi, Carvykti, Kymriah, Tecartus, Yescarta) is not permitted. Prior history of another genetically modified T‑cell therapy or prior CAR T‑cell therapy also excludes approval.

    Other exclusionary conditions include patients with active graft versus host disease (GVHD), significant cardiac disease (for example, NYHA class III/IV heart failure, recent myocardial infarction or CABG within 6 months, clinically significant ventricular arrhythmia, unexplained syncope, or severe nonischemic cardiomyopathy), a measured left ventricular ejection fraction (LVEF) < 45% (with scan performed within 8 weeks of leukapheresis), and those with active hepatitis B or C, HIV positive status, or other active, uncontrolled infection.

    When the coverage criteria above are not met, Abecma is considered not medically necessary. This includes use for indications other than relapsed or refractory multiple myeloma as defined in the policy and any situation meeting the listed exclusionary conditions.

    Providers should ensure all required eligibility criteria are documented prior to authorization submission because absence of the specified criteria (for example prior CAR T/BCMA therapy, inadequate bone marrow reserve, ECOG >1, or active/uncontrolled infections) is a common basis for denial as not medically necessary.

    RegimenAdministration detailsCoverage status
    Idecabtagene vicleucel (Abecma) single administration
    One-time autologous BCMA‑directed CAR T-cell infusion given as a single therapeutic dose following appropriate lymphodepleting chemotherapy per product labeling
    Covered with criteria

    Line of Therapy Requirements

    Third-line (Line of Therapy)

    Label-based prior therapy: Patient has 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>=2 prior lines

    FDA-approved indication

    Coding and Clinical Thresholds

    Covered CPT CodesCPT
    38225Chimeric 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]
    38226Chimeric antigen receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for transportation (eg, cryopreservation, storage) [Abecma]
    38227Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preparation of CAR-T cells for administration [Abecma]
    38228Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous [Abecma]
    Covered HCPCS CodesHCPCS
    Q2055Idecabtagene 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
    XW033K7Introduction of idecabtagene vicleucel immunotherapy into peripheral vein, percutaneous approach, new technology group [Abecma]
    XW043K7Introduction of idecabtagene vicleucel immunotherapy into central vein, percutaneous approach, new technology group [Abecma]
    Relevant ICD-10 Diagnosis CodesICD-10
    C90.00Multiple myeloma not having achieved remission
    C90.02Multiple myeloma in relapse
    Z51.12Encounter for antineoplastic immunotherapy
    Z85.79Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues
    inv-09: Absolute neutrophil count (ANC) — required threshold
    Required ANCAbsolute neutrophil count (ANC) ≥ 1000 cells/µL
    Context in criteriaPart of adequate bone marrow reserve required for eligibility
    Related exclusion riskRequests may be denied if bone marrow reserve criteria (including ANC) are not met
    inv-10: Platelet count — required threshold
    Required platelet countPlatelet count ≥ 50,000 cells/µL
    Context in criteriaPart of adequate bone marrow reserve required for eligibility

    Provider Actions, Authorization & Documentation

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for Abecma (idecabtagene vicleucel). Requests must include supporting clinical documentation and should cite applicable billing codes. Submit requests to the payer's prior authorization department before service. Failure to obtain prior authorization may result in claim denial or delay.

    • Required HCPCS: Q2055 - Idecabtagene vicleucel, up to 510 million autologous BCMA-directed CAR-positive T cells, per therapeutic dose
    • Relevant CPT codes: 38225, 38226, 38227, 38228 (CAR-T harvesting, preparation/transport, receipt/preparation for administration, and administration)
    Step Therapy

    Prior Therapy Requirement

    Per the FDA label and coverage criteria, the individual must have prior exposure to an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody. Documentation of prior lines of therapy should clearly list agents, dates, and responses to therapy.

    • Document prior exposure to: an IMiD (e.g., lenalidomide, pomalidomide), a proteasome inhibitor (e.g., bortezomib, carfilzomib), and an anti-CD38 mAb (e.g., daratumumab)

    Background

    Abecma (idecabtagene vicleucel) is an autologous B‑cell maturation antigen (BCMA)‑directed chimeric antigen receptor (CAR) T‑cell therapy indicated for adult patients with relapsed or refractory multiple myeloma after prior therapies. The treatment involves harvesting the patient’s own T cells, genetic modification to target BCMA on malignant plasma cells, and a single infusion of the manufactured CAR T product following appropriate lymphodepleting chemotherapy.

    Because of the mechanism of action and safety profile, use is restricted to a one‑time, single administration and is contraindicated in patients who have previously received CAR T‑cell or other BCMA‑targeted therapies or who meet the exclusionary conditions listed in this policy.

    Definitions

    inv-17: ECOG — ECOG Performance Status definition
    ECOG scale summaryECOG performance status 0–4: 0 = fully active; 1 = restricted in strenuous activity but ambulatory; 2 = ambulatory and capable of self‑care >50% of waking hours; 3 = limited self‑care; 4 = completely disabled; 5 = dead
    Policy required scoresEligibility requires ECOG performance status 0–1
    Role in decision-makingECOG used to assess functional status and determine appropriateness of CAR T therapy
    inv-18: Autologous cells — definition
    DefinitionAutologous cells: cells harvested from the individual's own cells
    Relevance to therapyAbecma is an autologous BCMA‑directed CAR T‑cell therapy using the patient’s own T cells

    Revision History

    2025-10-27reviewed

    Document reviewed; no substantive changes (coding reviewed).

    2025-11-14last_reviewedLatest

    Policy last reviewed (document lists Last Review Date 11/14/2025).

    Policy Summary
    PayerEmpire Bluecross
    PolicyAbecma (idecabtagene vicleucel) — Clinical Coverage Criteria
    Policy CodePolicy CC-0195
    Change TypeReviewed
    Effective Date12/22/2025
    Last ReviewNov 14, 2025
    Next Review DateN/A
    Key ActionSubmit prior authorization with supporting clinical documentation including diagnosis, prior therapy history, ANC and platelet counts, ECOG status, and confirmation this is a single administration and no prior CAR T/BCMA therapy.
    SourceLink
    On This Page
    Coverage Criteria for Abecma (idecabtagene vicleucel)Line of Therapy RequirementsCoding and Clinical ThresholdsProvider Actions, Authorization & DocumentationBackgroundDefinitionsRevision History
    Related exclusion riskRequests may be denied if bone marrow reserve criteria (including platelets) are not met
    inv-11: Left ventricular ejection fraction (LVEF) — exclusionary threshold and timing
    Exclusionary LVEF thresholdLeft ventricular ejection fraction (LVEF) < 45% is exclusionary
    Timing requirementLVEF assessment must be from a scan performed within 8 weeks of leukapheresis
    Related cardiac exclusionsOther significant cardiac disease (NYHA III/IV, recent MI/CABG within 6 months, severe nonischemic cardiomyopathy) also excluded
  1. Indicate number of prior lines of therapy (FDA label requires ≥ 2 prior lines)
    2. Documentation Required

    Required Clinical Documentation

    Provide the following clinical documentation with the prior authorization request: age, diagnosis of relapsed or refractory multiple myeloma, ECOG performance status (0–1), complete prior therapy history including specific agents and dates, documentation of no prior BCMA-targeted therapy or prior CAR T-cell therapy, baseline laboratory values (ANC, platelet count), cardiac assessment including LVEF within 8 weeks if available, history of allogeneic transplant and absence of active GVHD if applicable, and infection/HIV/hepatitis status.

    • ANC ≥ 1000 cells/µL and platelet count ≥ 50,000 cells/µL required
    • ECOG 0–1 documented
    • No prior CAR T-cell or BCMA-targeted therapy
    • LVEF ≥ 45% (scan within 8 weeks of leukapheresis preferred)
    • No active hepatitis B or C, HIV positive status, or uncontrolled infection
    Denial Risk

    Common Triggers for Denial

    Common reasons requests may be denied include active hepatitis B or C, HIV positivity, uncontrolled active infection, LVEF < 45%, active graft versus host disease, prior BCMA-targeted therapy or prior CAR T-cell therapy, repeat administration, or use in combination with other CAR T-cell products.

    • Active hepatitis B or C, HIV positive, or other uncontrolled infection
    • LVEF < 45%
    • Active GVHD or history of CNS involvement with myeloma
    • Prior BCMA-targeted therapy or prior CAR T-cell therapy
    • Request for repeat administration or combined use with other CAR T-cell therapies
    Implication for prior transplantPrior allogeneic transplant is separately addressed; autologous refers specifically to self‑derived cells rather than donor cells