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    OpenPayerPolicy UpdatesHematology/OncologyEmpire Bluecross Abecma CAR-T Coverage Update | Op…
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    CurrentEmpire BluecrossPolicy CC-0195

    Abecma (idecabtagene vicleucel) CAR-T for multiple myeloma — Clinical coverage criteria and coding

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    Clinical coverage criteria and coding for Abecma (idecabtagene vicleucel), an autologous BCMA-directed CAR T-cell therapy for adults with relapsed or refractory multiple myeloma; applies to authorization decisions for Empire Bluecross members and treating providers.

    Policy Summary
    PayerEmpire Bluecross
    PolicyAbecma (idecabtagene vicleucel) CAR-T for multiple myeloma
    Policy CodePolicy CC-0195
    Change TypeCoding update and clarification
    Effective DateDec 23, 2024
    Last ReviewNov 15, 2024
    Next Review Date
    Key ActionObtain prior authorization documenting age ≥18, diagnosis of relapsed/refractory multiple myeloma, ECOG 0-1, adequate marrow reserve (platelets ≥50,000; ANC ≥1000), no active GVHD if prior allogeneic transplant, and that therapy is intended as a one-time administration.
    SourceLink
    POLICY UPDATE CHANGES

    Coding update: Removed CPT codes 0537T, 0538T, 0539T, 0540T and added CPT codes 38225, 38226, 38227, 38228.

    Clarified requirement that individuals with prior allogeneic stem cell transplant must have no current signs of active graft-versus-host disease (GVHD).

    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
    ECOG 0-1performance status
    ANC ≥1000; Plt ≥50khematologic thresholds
    singleadministration
    RequiresREMS

    Coverage Criteria for Abecma (idecabtagene vicleucel)

    Initial Therapy

    Covered when ALL of the following are met:

    Eligibility: Individual is 18 years of age or older; diagnosis of relapsed or refractory multiple myeloma; indicated after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody (per FDA label); no current signs of active graft-versus-host disease (GVHD) if there is a history of allogeneic stem cell transplant; intended as a one-time, single administration; no prior CAR T-cell or BCMA-targeted therapy.>=18 years; >=2 prior lines

    Per FDA label and NCCN 2A

    Functional and marrow reserve: ECOG performance status 0-1; platelet count >=50,000 cells/µL; absolute neutrophil count (ANC) >=1000 cells/µL.ECOG 0-1; platelets >=50,000 cells/µL; ANC >=1000 cells/µL

    Laboratory values should be current per clinical practice

    Abecma is not approved for repeat administration. Other explicit exclusions include presence or history of plasma cell leukemia; active presence or history of central nervous system (CNS) involvement with myeloma; and solitary plasmacytomas or non-secretory myeloma without measurable disease.

    Additional exclusions include use in individuals with active graft-versus-host disease (GVHD); a history of prior CAR T-cell or other genetically modified T-cell therapy; certain recent or serious cardiac conditions (for example NYHA class III–IV heart failure, recent myocardial infarction or CABG within 6 months, or clinically significant ventricular dysfunction/arrhythmia); active hepatitis B or C, HIV, or other uncontrolled infections; and a left ventricular ejection fraction (LVEF) <45% (with LVEF assessment within 8 weeks of leukapheresis where indicated).

    Abecma should not be used in combination with other CAR T-cell immunotherapies (for example Breyanzi, Carvykti, Kymriah, Tecartus, Yescarta) or with other chemotherapy agents except when those agents are part of a lymphodepleting chemotherapy regimen prior to infusion.

    The policy specifies that Abecma is intended as a one-time, single administration and therefore repeat dosing is not approvable. Use in patients without measurable disease (such as solitary plasmacytoma or non-secretory myeloma without other evidence of measurable disease) is also considered not medically necessary.

    Coding and Administrative Codes

    Covered CPT CodesCPTCovered
    38225Chimeric antigen receptor T-cell (CAR-T) therapy; harvesting of blood-derived T lymphocytes for development of genetically modified autologous CAR-T cells, per [Abecma] day.
    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 HCPCSHCPCSCovered
    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].
    ICD-10 Diagnosis CodesICD-10
    C90.00Multiple myeloma not having achieved remission.
    C90.02Multiple myeloma in relapse.
    Z51.12Encounter for antineoplastic immunotherapy.
    285.79Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues.
    inv-08: Platelet count — minimum threshold
    Minimum platelet count>= 50,000 cells/µL
    Measurement timingTest should be current per clinical practice (documented for authorization)
    Context for useRequired as part of adequate bone marrow reserve for Abecma eligibility
    inv-09: Absolute neutrophil count (ANC) — minimum threshold
    Minimum ANC>= 1000 cells/µL
    Measurement timingTest should be current per clinical practice (documented for authorization)

    Provider Actions, Authorization & Documentation

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for Abecma (idecabtagene vicleucel). Requests must document that the member meets FDA‑labeled criteria for use in 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), and that therapy is planned as a one‑time, single administration. Coordinate REMS program enrollment and ensure treatment facility participation in the REMS.

    • Prior authorization required before scheduling leukapheresis/collection
    • REMS program enrollment required for prescriber and treatment facility
    • One-time, single administration use only
    Documentation Required

    Required Documentation for Authorization

    Submit documentation that supports each eligibility criterion below. Include copies of prior therapy records (regimens and dates), recent laboratory tests, and relevant consult notes. Failure to provide complete documentation may delay or result in denial of coverage.

    Line-of-Therapy Requirement

    third-line_or_later

    Line-of-therapy requirement: Indicated for adult patients 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 (per FDA label).>=2 prior lines

    NCCN referenced (2A)

    Background

    Abecma (idecabtagene vicleucel) is an autologous, B-cell maturation antigen (BCMA)–directed chimeric antigen receptor (CAR) T-cell therapy approved for adults with relapsed or refractory multiple myeloma after prior therapy. The product uses the patient’s own T cells engineered to target BCMA on malignant plasma cells, with the intent of a single administration. Notable safety considerations include boxed warnings for cytokine release syndrome and neurologic toxicity and restricted availability through a REMS program.

    Definitions

    inv-16: ECOG performance status — definition and required ECOG 0-1 for approval
    ECOG scale definitionA performance status scale where 0 = fully active and 4 = completely disabled (used to assess daily living impact)
    Required score for approvalECOG 0-1
    Context for authorizationECOG 0-1 is required as part of functional and marrow reserve criteria for Abecma eligibility
    Policy Summary
    PayerEmpire Bluecross
    PolicyAbecma (idecabtagene vicleucel) CAR-T for multiple myeloma
    Policy CodePolicy CC-0195
    Change TypeCoding update and clarification
    Effective DateDec 23, 2024
    Last ReviewNov 15, 2024
    Next Review Date
    Key ActionObtain prior authorization documenting age ≥18, diagnosis of relapsed/refractory multiple myeloma, ECOG 0-1, adequate marrow reserve (platelets ≥50,000; ANC ≥1000), no active GVHD if prior allogeneic transplant, and that therapy is intended as a one-time administration.
    SourceLink
    On This Page
    Coverage Criteria for Abecma (idecabtagene vicleucel)Coding and Administrative CodesProvider Actions, Authorization & DocumentationLine-of-Therapy RequirementBackgroundDefinitions
    Context for useRequired as part of adequate bone marrow reserve for Abecma eligibility
    inv-10: Left ventricular ejection fraction (LVEF) — required threshold and timing
    Minimum LVEF>= 45%
    Timing of scanEjection fraction assessment must be performed within 8 weeks of leukapheresis
    Denial triggerLVEF <45% is listed among common denial triggers for Abecma
    • Member age (>= 18 years) and identification
    • Diagnosis of relapsed or refractory multiple myeloma with evidence of measurable disease
    • History of prior lines of therapy listing agents/classes (must include IMiD, proteasome inhibitor, and anti‑CD38 monoclonal antibody) with dates and responses
    • Statement that patient has not received prior CAR T‑cell or BCMA‑targeted therapy
    • If prior allogeneic SCT: documentation showing no active graft‑versus‑host disease (GVHD)
    • ECOG performance status (0–1) documented by treating clinician
    • Recent labs within 4 weeks prior to authorization request: CBC with platelets, ANC, comprehensive metabolic panel, liver function tests; specific marrow reserve thresholds: platelets >= 50,000/µL and ANC >= 1000/µL
    • Cardiac assessment including LVEF (performed within 8 weeks of leukapheresis)
    • Infection testing results (HBV, HCV, HIV) and documentation of absence of active uncontrolled infection
    • Planned treatment intent (one‑time CAR‑T infusion) and confirmation of REMS site participation
    Note

    Line of Therapy Requirement

    Abecma is indicated only after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti‑CD38 monoclonal antibody. Requests must clearly list prior lines of systemic therapy and demonstrate inadequate response or progression after these therapies.

    • Document each prior line (agents, combination regimens, start/stop dates, best response)
    • If clinical trial or alternative sequencing used, provide rationale and supporting records