CurrentMass General Brigham Health PlanPolicy 01

Medical Policy Abecma

Defines authorization, medical necessity criteria, documentation requirements, coding information, and plan variations for Abecma (ide-cel) for treatment of relapsed/refractory multiple myeloma in adults across Mass General Brigham Health Plan lines of business, including Medicare, MassHealth (ACO), One Care and SCO variations.

Policy Summary

PayerMass General Brigham Health Plan

PolicyMedical Policy Abecma

Policy CodePolicy 01

Change TypeAd hoc & annual updates

Effective DateSep 1, 2021

Next Review Date

Key ActionPrior authorization is required and providers must submit confirmed diagnosis, supporting lab results, and documentation of prior lines of therapy; include facility capability (tocilizumab onsite) when required.

SourceLink

POLICY UPDATE CHANGES

January 2026 ad hoc update: Updated prior authorization table and added variation for One Care and SCO members; changed policy number.

September 2025 ad hoc update: Removed REMS requirement based on new package insert; fixed typos; updated code disclaimer and references.

April 2025 ad hoc update: MassHealth variation updated to include new authorization process.

March 2025 ad hoc update: Summary of evidence added and references updated.

February 2025 annual update: Code update and criteria updated per current NCCN guidelines.

February 2023 annual update: Added Medicare Advantage to table and added Medicare variation language.

1Approved Indication(s)

18+Age requirement (years)

>=2Prior systemic therapy lines required

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Coverage Summary

Abecma (idecabtagene vicleucel) is an autologous BCMA-directed CAR-T therapy approved for adult patients with relapsed or refractory multiple myeloma after two or more lines of systemic therapy. The policy aligns authorization criteria with the pivotal KarMMa trials and NCCN guidance and requires documentation of prior lines of therapy and confirmed diagnosis. Common severe toxicities observed in trials include myelosuppression and cytokine release syndrome (CRS), and facilities must have tocilizumab available on site for CRS management. Plan- and line-of-business specific variations are described: prior authorization for Commercial and Qualified Health Plans is managed by Prime Therapeutics; Mass General Brigham ACO prior authorization is managed by the MassHealth Drug Utilization Review Program with MassHealth criteria (Table 75); Medicare/One Care/SCO follow CMS guidance (NCD 110.24) and MassHealth guidance as applicable, and the prior authorization table and One Care/SCO variations were updated in January 2026.

Key Policy Facts

Approved Indication(s)Adult patients with relapsed or refractory multiple myeloma after two or more lines of systemic therapy (including immunomodulatory agent, proteasome inhibitor, and anti‑CD38 monoclonal antibody)

Age requirement (years)18+

Prior systemic therapy lines required>=2

Treatment courses coveredSingle treatment course (additional courses considered experimental/investigational)

Policy statusCURRENT

Effective date2021-09-01 (policy effective) ; Implementation/Effective notes include Jan 2026 ad hoc update

Last review2026-01-01

Authorization / Medical Necessity Criteria

Abecma (idecabtagene vicleucel): a BCMA-directed genetically modified autologous T cell immunotherapy (CAR-T) for relapsed or refractory multiple myeloma in adults after two or more lines of systemic therapy.

Coding

Informational codes (inclusion does not imply coverage)mixed

Q2055	Idecabtagene vicleucel, up to 460 million autologous anti-BCMA CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose
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
38226	Chimeric antigen receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for transportation (eg, cryopreservation, storage)
38227	Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preparation of CAR-T cells for administration
38228	Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration autologous

Not payable for Mass General Brigham ACOCPTNot Covered

38225
38226
38227
38228

Code disclaimer: Informational billing codes listed in the policy (for example 38225, 38226, 38227, 38228, Q2055) are provided for reference only; inclusion does not constitute or imply coverage. Note that the policy underwent code and disclaimer updates (including a September 2025 update) — providers should confirm applicable line-of-business billing and prior authorization rules before submitting claims.

Provider Actions / Authorization Workflow

Prior Authorization

Prior authorization required

Prior authorization is required for Abecma. Commercial and Qualified Health Plan members: prior authorization is managed by Prime Therapeutics. Mass General Brigham ACO members: prior authorization is managed by the MassHealth Drug Utilization Review Program. One Care and Senior Care Options (SCO) follow CMS/MassHealth guidance as noted.

Documentation Required

Submit clinical documentation

Submit clinical documentation to support medical necessity, including a confirmed diagnosis with supporting laboratory results and documentation of prior lines of therapy.

Documentation Required

Facility requirement for CRS management

Facility must have tocilizumab available on site for management of Cytokine Release Syndrome. Include evidence of facility capability in authorization documentation when required.

Background & Evidence

Abecma is an autologous BCMA-directed CAR-T therapy approved for adult patients with relapsed or refractory multiple myeloma after two or more lines of systemic therapy (including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody). Authorization criteria align with the inclusion criteria of the pivotal KarMMa trials and NCCN guidance. Trial safety data report frequent high-grade toxicities, most notably myelosuppression and cytokine release syndrome (CRS), and the policy requires facility capability for CRS management (tocilizumab on site) as part of authorization.

Evidence Highlights

KarMMa (phase 2) response rate73% overall response rate; median PFS 8.8 months

KarMMa-3 (phase 3) PFSMedian PFS 13.3 months with ide-cel vs 4.4 months with standard regimens

Overall survivalNo improvement in OS reported in updated analysis; interpretation confounded by 56% crossover

Medicare Determinations

Name	Number	Effective Date	Type
Chimeric Antigen Receptor (CAR) T-cell Therapy	110.24	2021-09-20	NCD

Revision History

2023-02annual update

February 2023 annual update: Added Medicare Advantage to the authorization table and added Medicare variation language; references updated.

2025-02annual update

February 2025 annual update: Code update and criteria updated per current NCCN guidelines; references updated.

2025-03ad hoc update

March 2025 ad hoc update: Summary of evidence added and references updated.