CurrentCareSourcePolicy N/A

PHARMACY POLICY STATEMENT Arkansas PASSE

Defines prior authorization medical necessity criteria, dosing/quantity limit, and reauthorization stance for Abecma (idecabtagene vicleucel) as a medical benefit for adults with relapsed or refractory multiple myeloma under CareSource Arkansas PASSE. Applies to initial authorization and states that reauthorization is not permitted.

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Arkansas PASSE

Policy CodePolicy N/A

Change TypeRevised (12/06/2024) — indication and criteria updates

Effective DateJul 1, 2025

Next Review Date

Key ActionPrior authorization is required for Abecma under the medical benefit; initial approval is for 3 months when documented criteria are met.

SourceLink

POLICY UPDATE CHANGES

Updated indication and clinical criteria (12/06/2024) — aligns policy with updated label and NCCN guidance.

Added performance status requirement (05/20/2022).

New policy created (04/22/2021).

1Covered Indication (Multiple Myeloma)

300-460 MAllowed CAR-positive T cell dose per infusion

>=2Required prior lines of therapy

ECOG 0-1Performance status requirement

Coverage Summary & Stance

Abecma (idecabtagene vicleucel) is covered with medical necessity criteria for adults (age ≥ 18 years) with relapsed or refractory multiple myeloma under CareSource Arkansas PASSE. Coverage is allowed when members meet the policy’s specified criteria — including diagnosis of RRMM, enrollment of the treating facility/provider in the Abecma REMS program, prior disease after ≥ 2 prior lines of therapy that include an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, ECOG performance status of 0 or 1, required infectious disease screening, and the dosing/quantity limit of a single infusion of 300 to 460 x 10^6 CAR-positive T cells. Effective date: 2025-07-01; Last review: 2024-12-06.

Policy Thresholds

Age>= 18 years

Prior lines of therapy>= 2 prior lines including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody

ECOG performance status0 or 1

Dosage/quantity limitSingle infusion of 300 to 460 x 10^6 CAR-positive T cells

Reauthorization permittedNo

Initial Authorization Criteria

Prior Authorization

Prior authorization required

Prior authorization is required for Abecma (idecabtagene vicleucel) under the medical benefit. If all initial authorization criteria are met, initial approval will be granted for 3 months.

Documentation Required

Document prior therapies and REMS enrollment

Document the following at time of request: member age (≥18 years); diagnosis of relapsed or refractory multiple myeloma (RRMM); treating facility/provider enrollment in the Abecma REMS program; details of at least 2 prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody; ECOG performance status 0–1; and screening for cytomegalovirus (CMV), hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV).

Member age (≥18 years)

Reauthorization / Continuation Therapy

Denial Risk

Reauthorization prohibited

Reauthorization for continued Abecma therapy will not be approved; claims for continued therapy/reauthorization are considered not medically necessary.

Not Medically Necessary / Exclusions

Applicable Codes

Relevant drug productNDCCovered

No codes listed

Procedure / billing (CAR-T infusion)CPT|HCPCS

No codes listed

Provider Actions & Operational Requirements

Operational requirements: the treating facility/provider must be enrolled in the Abecma REMS program prior to administration; required screening for CMV, HBV, HCV, and HIV may be completed before infusion or will be completed per policy; and dosing is limited to a single infusion within the allowed range of 300 to 460 x 10^6 CAR-positive T cells with prior authorization and a single 3-month approval period if criteria are met.

Documentation Required

REMS enrollment required before infusion

The treating facility/provider must be enrolled in the Abecma REMS program prior to infusion; document REMS enrollment as part of the authorization request.

Clinical Evidence & References

300-460 MAllowed CAR-positive T cell dose per infusion

>=2Required prior lines of therapy (including immunomodulatory agent, proteasome inhibitor, and anti-CD38 mAb)

ECOG 0-1Performance status requirement

Evidence summary: the policy references the Abecma package insert (2024), NCCN Multiple Myeloma guidance, and key clinical trials including Munshi NC et al. and the NEJM report (Rodriguez-Otero et al.). The policy states it aligns with the product label and NCCN guidance and cites these sources in support of indications, prior therapy requirements, dosing limits, and safety monitoring.

Background & Definitions

Background: Abecma (idecabtagene vicleucel) is a BCMA-targeted CAR-T cell therapy that uses a patient’s harvested and genetically modified T cells to target B-cell maturation antigen in relapsed or refractory multiple myeloma. The policy aligns coverage with the product label and NCCN guidance and establishes REMS enrollment for the treating facility/provider, required infectious disease screening (CMV, HBV, HCV, HIV), an ECOG performance status requirement (0–1), specified prior therapy requirements (≥2 prior lines including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody), and dosing/quantity limits consistent with the label.

Term	Definition
RRMM	Relapsed or refractory multiple myeloma
REMS	Risk Evaluation and Mitigation Strategy; treating facility/provider must be enrolled in the Abecma REMS program
ECOG	Eastern Cooperative Oncology Group performance status

Revision History

12/06/2024material revisionLatest

Updated indication from 4 prior lines of therapy to 2 prior lines of therapy; removed exclusions of prior HSCT or gene therapy; updated dosing; changed screening language to 'has been or will be screened' and added CMV to screening.

05/20/2022administrative change

Added ECOG performance status requirement to be consistent with other CAR-T policies.

04/22/2021initial creation

Initial policy creation for Abecma.