ModifiedCentenePolicy CP.PHAR.481

Idecabtagene vicleucel (Abecma) for relapsed/refractory multiple myeloma

Defines Centene's medical necessity and prior authorization requirements for a single-dose administration of idecabtagene vicleucel (Abecma) in adults with relapsed or refractory multiple myeloma who meet specified clinical criteria.

Policy Summary

PayerCentene

PolicyIdecabtagene vicleucel (Abecma) for relapsed/refractory multiple myeloma

Policy CodePolicy CP.PHAR.481

Change TypeIndication expansioncoding and operational updates

Effective DateMar 26, 2021

Next Review Date

Key ActionSubmit prior authorization to PDAC with documentation showing ≥2 prior lines of therapy and dosing details (single IV infusion, target 300–510 x10^6 CAR+ T cells, max 510 x10^6).

SourceLink

POLICY UPDATE CHANGES

Updated criteria to reflect indication expansion for earlier use after two or more prior lines of therapy.

Revised HCPCS Q2055 description to specify up to 510 million CAR-positive T cells (previously 460 million).

Added IMWG response criteria clarifications regarding the 25% increase applying to FLC levels and bone marrow plasma cell percentage.

Redirected prior authorization reviews to the Precision Drug Action Committee (PDAC) Utilization Management Review.

≥2Required prior lines of therapy

300-510Target dose range

510

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Coverage Criteria for Idecabtagene Vicleucel (Abecma)

Initial Therapy (Multiple Myeloma)

Covered when ALL of the following are met for initial approval (Multiple Myeloma):

Initial Approval - Multiple Myeloma: 1. Diagnosis of relapsed or refractory multiple myeloma; 2. Prescribed by or in consultation with an oncologist or hematologist; 3. Age ≥ 18 years; 4. One of the following assessed per timeframe: (a) Measurable disease within the last 30 days defined by at least one of: serum M-protein ≥ 0.5 g/dL; urine M-protein ≥ 200 mg/24 h; or involved serum free light chain (FLC) ≥ 10 mg/dL with an abnormal serum FLC ratio; OR (b) Progressive disease per IMWG response criteria assessed within 60 days following the last dose of the last antimyeloma regimen; 5. Member has received ≥ 2 prior lines of therapy that include all of: (a) one immunomodulatory agent, (b) one proteasome inhibitor, and (c) one anti‑CD38 antibody; 6. No known CNS involvement with myeloma or history/presence of clinically relevant CNS pathology; 7. No prior treatment with anti‑BCMA targeted therapy; 8. No prior CAR T‑cell therapy; 9. Abecma is not prescribed concurrently with other CAR T‑cell immunotherapy; 10. Dose does not exceed 510 x 10^6 CAR‑positive T cells.dose ≤ 510 x10^6

Approval duration: 3 months (single dose only); up to 4 doses of tocilizumab (Actemra) may be authorized if requested, up to 800 mg per dose

Continuation Therapy

Continuation: Continued therapy will not be authorized as Abecma is indicated to be dosed one time only.

Initial therapy coverage criteria

Covered when ALL of the following are met:

Main eligibility: Member has relapsed or refractory multiple myeloma consistent with the policy and updated FDA indication (expanded to earlier use after two or more prior lines of therapy); member has documented prior therapy history per indication; measurable disease criteria or progressive disease per IMWG (see Appendix D) are met; member has not received prior anti‑BCMA targeted therapy; no known CNS involvement with myeloma or clinically relevant CNS pathology per KarMMa exclusions; dosing consistent with product labeling (single IV infusion, target 300–510 x10^6 CAR‑positive T cells, maximum 510 x10^6) and billed under HCPCS Q2055 where applicable.

Requests for uses of idecabtagene vicleucel (Abecma) outside of the FDA‑approved indication described in this policy are not authorized unless supported by the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid) or other documented evidence of efficacy and safety. Additionally, coverage excludes patients with known central nervous system (CNS) involvement or a history/presence of clinically relevant CNS pathology as specified in policy exclusions.

Patients with CNS involvement from multiple myeloma or with clinically relevant CNS pathology are excluded from coverage. The pivotal KarMMa trial excluded patients with CNS involvement, and policy language was updated (2Q 2022) to align the active CNS disease exclusion to “known CNS involvement with myeloma, or history or presence of clinically relevant CNS pathology” as described in the KarMMa study protocol.

Idecabtagene vicleucel (Abecma) is authorized as a one‑time therapy. Continued or repeat dosing will not be authorized; the product is intended for a single administration and approval duration is not applicable for ongoing dosing.

As of the 2Q 2022 policy update, prior receipt of any anti‑BCMA targeted therapy disqualifies a member from coverage under this policy. Requests for members who previously received anti‑BCMA agents are not acceptable and may be denied.

Coding and Product Dose Information

Codingmixed

No explicit CPT/HCPCS/ICD-10 codes listed in this portion of the document

Document does not provide specific billing or procedure codes in chunks 0-19

Covered HCPCS CodesHCPCSCovered

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

Measurable disease thresholds — serum/urine M-protein and involved FLC

Serum M-protein thresholdSerum M-protein ≥ 0.5 g/dL (measured within last 30 days)

Urine M-protein thresholdUrine M-protein ≥ 200 mg/24 h (measured within last 30 days)

Involved FLC thresholdInvolved free light chain (FLC) level ≥ 10 mg/dL (100 mg/L) with an abnormal serum FLC ratio (measured within last 30 days)

Product dose threshold — Maximum 510 x10^6 CAR-positive T cells

Maximum product doseMaximum 510 x10^6 CAR-positive T cells per single infusion

Target dose rangeTarget 300–510 x10^6 CAR-positive T cells (single IV infusion)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

All prior authorization requests for idecabtagene vicleucel (Abecma) must undergo Precision Drug Action Committee (PDAC) Utilization Management Review per CC.PHAR.21. Providers should route PA requests to PDAC and include all required clinical documentation to support medical necessity.

All requests require PDAC review and prior authorization
Refer to CC.PHAR.21 for PDAC process details

Denial Risk

Denial Triggers

Requests will be denied when documented exclusion criteria are present or when prior therapy exclusions apply. Common denial triggers include prior treatment with anti‑BCMA targeted therapy and known or history of clinically relevant CNS involvement with myeloma (e.g., seizures, stroke, dementia, other major CNS pathology). Non‑FDA indications lacking sufficient evidence per off‑label policies are also not authorized.

Line of Therapy Requirements

salvage

Line of therapy requirement: Patient must have 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.

salvage

Line of therapy: Member has received at least two or more prior lines of therapy per the indication expansion; prior therapy history must be documented for review.

Measurable Disease and Biomarker Thresholds

Serum/urine M-protein, free light chains (FLC) — measurable disease thresholds

Serum M-proteinSerum M-protein ≥ 0.5 g/dL (assessed within the last 30 days)

Urine M-proteinUrine M-protein ≥ 200 mg/24 h (assessed within the last 30 days)

Involved free light chain (FLC)Involved FLC ≥ 10 mg/dL (100 mg/L) with an abnormal serum FLC ratio (assessed within the last 30 days)

Therapeutic Alternatives and Product Regimen Details

Regimen / Therapeutic alternative	Notes
Bortezomib + lenalidomide + dexamethasone	Dosing regimen varies per Appendix B; may require PA and may not be formulary for all lines of business.
Bortezomib + cyclophosphamide + dexamethasone	Dosing regimen varies per Appendix B; listed as a preferred alternative prior to Abecma.
Carfilzomib + lenalidomide + dexamethasone (Kyprolis®/Revlimid®/dexamethasone)	Dosing regimen varies per Appendix B; included among recommended therapeutic alternatives.
Carfilzomib + cyclophosphamide + dexamethasone	Dosing regimen varies per Appendix B; listed as a potential alternative prior to CAR T therapy.
Daratumumab-containing regimens (e.g., daratumumab ± hyaluronidase with bortezomib/melphalan/prednisone or lenalidomide/dexamethasone)	Multiple daratumumab-based combinations listed in Appendix B; dosing varies.
Pomalidomide-based regimens (pomalidomide ± dexamethasone; pomalidomide combinations)	Pomalidomide and combinations are included in Appendix B as alternatives; dosing varies.
Ixazomib (Ninlaro®) combinations (e.g., ixazomib + lenalidomide + dexamethasone)	Listed in Appendix B; dosing regimen varies.
Panobinostat-containing regimens	Included in Appendix B as an alternative; dosing varies.
Isatuximab (Sarclisa®) combinations	Listed among Appendix B therapeutic alternatives; dosing varies.
Other regimens listed in Appendix B (e.g., bendamustine combinations, selinexor combinations, VTD-PACE, cyclophosphamide + lenalidomide + dexamethasone)	Appendix B provides an extensive list of single-agent and combination regimens that may be considered prior to Abecma; dosing and dose limits vary.

Product / Dose	Billing / Coding note
Idecabtagene vicleucel (Abecma) — single IV infusion; target dose 300–510 x10^6 CAR-positive T cells; maximum 510 x10^6.	Documentation must support dosing per labeled target and maximum; therapy is single-dose only.
	Bill product under HCPCS code 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.'

Definitions and Acronyms

BCMA — B-cell maturation antigen

DefinitionBCMA: B-cell maturation antigen

RelevanceTarget antigen for idecabtagene vicleucel (BCMA-directed CAR T-cell therapy)

Acronym sourceListed in Appendix A: Abbreviation/Acronym Key

CAR — chimeric antigen receptor

DefinitionCAR: chimeric antigen receptor

RoleEngineered receptor expressed on T cells to target tumor antigens (used in CAR T-cell therapies)

Acronym sourceListed in Appendix A: Abbreviation/Acronym Key

Background

Idecabtagene vicleucel (Abecma) is an autologous BCMA‑directed CAR T‑cell therapy indicated for adult patients with relapsed or refractory multiple myeloma after at least two prior lines of therapy that include an immunomodulatory agent, a proteasome inhibitor, and an anti‑CD38 antibody. The therapy is administered as a single IV infusion of genetically modified autologous T cells, with a target dose range of 300–510 x10^6 CAR‑positive T cells and a maximum authorized dose of 510 x10^6 CAR‑positive T cells (product billed under HCPCS Q2055). Pivotal clinical trial populations excluded patients with CNS involvement.

Policy Revision History and Material Changes

2024-06-03coding_update

Revised HCPCS Q2055 descriptor to specify up to 510 million autologous BCMA-directed CAR-positive T cells (previously 460 million).

2024-04-10indication_expansion

Updated criteria to reflect FDA indication expansion allowing use after two or more prior lines of therapy (earlier use).

2025-11-04operational_routing_changeLatest