CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Abecma (idecabtagene vicleucel)

Policy governs medical-benefit coverage, clinical criteria, exclusions, and prior authorization/continuation rules for Abecma (idecabtagene vicleucel) for treatment of multiple myeloma across Commercial, Exchange, and Medicaid lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAbecma (idecabtagene vicleucel)

Policy CodePolicy N/A

Change TypeClarified (administrative committee/approval dates)

Effective DateMay 31, 2024

Next Review Date

Key ActionDocument prior therapies and measurable disease per lab thresholds and ensure medication use is supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature when requesting authorization.

SourceLink

POLICY UPDATE CHANGES

Committee review dates and approval dates listed through 05/08/24; effective date listed as May 31, 2024.

1Covered Indications (Multiple Myeloma)

7Named Exclusion Criteria

3Measurable Disease Lab Thresholds

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Policy governs medical-benefit coverage, clinical criteria, exclusions, and prior authorization/continuation rules for Abecma (idecabtagene vicleucel) for treatment of multiple myeloma across Commercial, Exchange, and Medicaid lines of business. Short summary: Abecma is a CAR T‑cell therapy for relapsed/refractory multiple myeloma. Coverage follows FDA labeling and CMS-recognized compendia (and may also rely on NCCN/ASCO or acceptable peer‑reviewed literature). Approval requires evidence of measurable disease and documentation of prior lines of therapy (at least two prior lines including an immunomodulatory agent, a proteasome inhibitor, and an anti‑CD38 monoclonal antibody).

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Initial Therapy Criteria (Indications — Medically Necessary)

Indications - Multiple Myeloma (Medically Necessary)

Abecma may be used when ALL of the following are met:

ALL of the following

Member is an adult with relapsed/refractory multiple myeloma
Member has received two or more prior lines of therapy including an immunomodulatory agent (e.g., lenalidomide, thalidomide, pomalidomide)
Member has received a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib)
Member has received an anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab)

Key Thresholds / Limits

Serum M-protein>= 1.0 g/dL

Urine M-protein>= 200 mg/24 h

Serum involved free light chain (FLC)>= 10 mg/dL (100 mg/L) with abnormal FLC ratio

Single dose CAR-positive T cell limit<= 460 x 10^6 CAR-positive T cells

Continuation Therapy Criteria

Continuation Therapy

Continuation requests for a not-approvable medication shall be exempt from this policy when ALL of the following are met:

ALL of the following

The member has not experienced disease progression on the requested medication
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization
Additional medication(s) are not being added to the continuation request

Denial Risk

Continuation exemption conditions

Continuation requests are exempt only when ALL of the following are met: the member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; and additional medication(s) are not being added to the continuation request. Failure to meet all conditions risks denial.

No disease progression on the requested medication
Requested medication used within the last year without >30-day lapse of active authorization
No additional medication(s) are being added to the continuation request

Provider Actions

Prior Authorization

Prior authorization & clinical support required

Medication use must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature. Evolent (UM) processes medication requests and may deem medications not authorized as not reimbursable.

Acceptable sources: FDA approved product labeling
CMS-recognized compendia
NCCN or ASCO clinical guidelines
Acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements

Documentation Required

Document prior therapies and measurable disease

Provider must document prior therapies (immunomodulatory agent, proteasome inhibitor, anti-CD38 antibody) and evidence of measurable disease meeting the specified lab thresholds; document that dosing and administration do not exceed single-dose and duration limits.

Required prior therapy classes: immunomodulatory agent (e.g., lenalidomide, thalidomide, pomalidomide); proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib); anti‑CD38 monoclonal antibody (e.g., daratumumab, isatuximab)
Measurable disease lab thresholds: Serum M-protein >= 1.0 g/dL; Urine M-protein >= 200 mg/24 h; involved serum free light chain (FLC) >= 10 mg/dL (100 mg/L) with abnormal FLC ratio
Dosing/duration limits to document: one-time administration only; single dose <= 460 x 10^6 CAR-positive T cells

Denial Risk

Continuation request denial risk

Continuation requests are exempt only if all specified continuation conditions are met; failure to meet all conditions risks denial.

Clinical Evidence

KarMMa Trial; Ide-cel vs standard regimensKey randomized/registrational trials referenced in policy (KarMMa; Ide-cel vs standard regimens)

Abecma prescribing information, 2024Prescribing information referenced for dosing, labelling, and administration details

Key evidence referenced includes the KarMMa trial (Munshi et al., NEJM 2021) and the Ide‑cel vs standard regimens trial (Rodriguez‑Otero et al., NEJM 2023), as well as earlier anti‑BCMA CAR T reports. The policy also cites the Abecma prescribing information (Celgene Corporation, 2024). Coverage decisions follow FDA labeling and CMS‑recognized compendia (and may use NCCN/ASCO guidance or acceptable peer‑reviewed literature).

Background & Definitions

Abecma (idecabtagene vicleucel) is a CAR T‑cell therapy indicated for adult patients with relapsed or refractory multiple myeloma. Coverage is aligned with FDA labeling and CMS‑recognized compendia (with consideration of NCCN/ASCO or acceptable peer‑reviewed literature). Approval requires documented measurable disease (laboratory thresholds defined in the policy) and prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti‑CD38 monoclonal antibody.

Measurable diseaseAny of: Serum M-protein >= 1.0 g/dL; Urine M-protein >= 200 mg/24 h; involved serum free light chain >= 10 mg/dL (100 mg/L) with abnormal FLC ratio

Revision History

05/12/21clarified

Committee review noted (part of ongoing reviews leading to policy approval); no specific clinical policy changes.

11/15/21clarified

Committee review noted; no specific clinical policy changes.

02/09/22clarified

Committee review noted; no specific clinical policy changes.

04/13/22clarified

Committee review noted; no specific clinical policy changes.

05/11/22clarified

Committee approval date listed; no specific clinical policy changes.

02/08/23clarified

Committee approval date listed; no specific clinical policy changes.

02/14/24clarified

Committee approval date listed; no specific clinical policy changes.

05/08/24clarifiedLatest

Most recent committee approval date listed; no specific clinical policy changes. Policy effective date listed as May 31, 2024.

2024-05-31clarifiedLatest

Policy effective date (May 31, 2024) noted; no material clinical policy changes associated with this update.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAbecma (idecabtagene vicleucel)

Policy CodePolicy N/A

Change TypeClarified (administrative committee/approval dates)

Effective DateMay 31, 2024

Next Review Date

SourceLink

On This Page

OpenPayer

Abecma (idecabtagene vicleucel)

Coverage Summary

Initial Therapy Criteria (Indications — Medically Necessary)

Continuation Therapy Criteria

Exclusions / Not Medically Necessary

Applicable Codes

Provider Actions

Clinical Evidence

Background & Definitions

Revision History