CurrentBlue Cross Blue Shield - IowaPolicy 05.04.74

Idecabtagene vicleucel (Abecma) — Coverage Criteria and Prior Authorization

Policy governs prior authorization, coverage criteria, dosing limits, and billing for Abecma (idecabtagene vicleucel) in adult members with relapsed or refractory multiple myeloma; applies to Wellmark/Blue Cross and Blue Shield members subject to contract benefits.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyIdecabtagene vicleucel (Abecma) — Coverage Criteria and Prior Authorization

Policy CodePolicy 05.04.74

Change TypeNo material changes

Effective DateMay 19, 2024

Next Review Date2025-08

Key ActionObtain prior authorization and submit documentation of prior therapies and clinical status for a 3-month authorization when all criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

onetreatment per lifetime allowed

3 moinitial authorization period

>=18minimum patient age (yrs)

Q2055billing code

Coverage Criteria for Idecabtagene vicleucel (Abecma)

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inv-01: Initial Approval Criteria

Covered when ALL of the following are met for authorization of 3 months:

Main criteria set: Member is >=18 years with relapsed or refractory multiple myeloma; has received at least two prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody; has not received a prior course of the requested medication or any other CAR T-cell therapy directed at any target; ECOG performance status 0-2; adequate and stable renal, hepatic, pulmonary, and cardiac function; no history or presence of clinically relevant central nervous system (CNS) pathology; no clinically significant active infection; no active graft-versus-host disease; no active inflammatory disorder.

Authorization period: 3 months; approvals limited to one lifetime treatment.

Previous receipt of idecabtagene vicleucel (Abecma) or any other chimeric antigen receptor (CAR) T-cell therapy directed at any target excludes approval for an additional course of therapy. The policy limits authorization to one treatment per lifetime, and a prior course of the requested medication or another CAR T-cell therapy is a disqualifying criterion.

Therapy is considered not appropriate when the member has any of the following active clinical conditions: clinically significant active infection, clinically relevant central nervous system (CNS) pathology, active graft-versus-host disease, or an active inflammatory disorder. These exclusions must be absent at the time of assessment for authorization.

Regimen	Coverage	Notes
Idecabtagene vicleucel (Abecma) — single treatment course
One treatment per lifetime
Dosing per FDA label; approvals subject to dosing limits in accordance with FDA labeling and accepted compendia

Procedures, Dosing, and Billing Codes

Procedures and Billing CodesHCPCSCovered

Q2055

Idecabtagene vicleucel, up to 460 million autologous B-cell maturation antigen (BCMA) directed CAR-positive cells, including leukapheresis and dose preparation procedures, per therapeutic dose.

Cell dose

Maximum per therapeutic doseUp to 460 million CAR-positive cells (autologous BCMA-directed)

IncludesLeukapheresis and dose preparation procedures included in the Q2055 descriptor

Billing codeHCPCS Q2055 corresponds to idecabtagene vicleucel up to 460 million cells

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit documentation of prior therapies and the member’s current clinical status. Authorization period: up to 3 months.

Prior authorization required before initiating therapy
Authorization period: 3 months

Prior Authorization

Prior Therapy and Clinical Criteria

The member must have received at least two prior lines of therapy that include an immunomodulatory agent, a proteasome inhibitor, and an anti‑CD38 monoclonal antibody. The member must not have received a prior course of the requested medication or any prior CAR T‑cell therapy directed at any target. Additional clinical requirements include adequate and stable renal, hepatic, pulmonary, and cardiac function; ECOG performance status 0–2; no clinically relevant CNS pathology; no clinically significant active infection; no active graft‑versus‑host disease; and no active inflammatory disorder.

At least two prior lines of therapy including: an immunomodulatory agent; a proteasome inhibitor; an anti‑CD38 monoclonal antibody
No prior course of the requested medication or prior CAR T‑cell therapy directed at any target
Adequate and stable kidney, liver, pulmonary, and cardiac function
ECOG performance status 0–2
No clinically relevant CNS pathology
No clinically significant active infection
No active graft‑versus‑host disease
No active inflammatory disorder

Documentation Required

Required Documentation to Initiate Review

Submit chart notes, relevant medical records, and/or claims history that document prior lines of therapy and current clinical status. Include dates and regimen details for prior treatments, documentation of organ function tests, ECOG performance status, infection status, and any imaging or neurologic evaluations relevant to CNS pathology.

Chart notes and medical records documenting prior therapies (dates, regimens)
Claims history supporting prior lines of therapy
Documentation of renal, hepatic, pulmonary, and cardiac function (lab results, imaging, consult notes)
ECOG performance status documentation
Documentation of infection status and treatment
Neurologic evaluation or imaging to rule out clinically relevant CNS pathology

Denial Risk

Denial Triggers for Unmet Clinical Criteria

Denial may be issued if the member does not meet ALL required clinical criteria. Common denial triggers include insufficient prior lines of therapy or missing required drug classes, prior receipt of CAR T‑cell therapy or the requested agent, inadequate or unstable organ function, ECOG >2, active or uncontrolled infections, presence of clinically relevant CNS pathology, active graft‑versus‑host disease, or active inflammatory disorders. Missing or incomplete documentation of prior therapies or clinical status may also result in denial.

Insufficient number of prior therapy lines or missing required drug classes
Prior CAR T‑cell therapy or prior course of the requested medication
Inadequate or unstable kidney, liver, pulmonary, or cardiac function
ECOG performance status greater than 2
Active or uncontrolled infection
Clinically relevant CNS pathology
Active graft‑versus‑host disease
Active inflammatory disorder
Incomplete or missing documentation of prior therapies or clinical status

Key Definitions and Terms

Abecma / idecabtagene vicleucel

Generic nameIdecabtagene vicleucel (Abecma)

Mechanism/targetBCMA-directed chimeric antigen receptor (CAR) T‑cell therapy

Indication summaryTreatment of 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

ECOG performance status

Required ECOG score for initial approvalECOG performance status 0–2

Purpose of requirementDemonstrates adequate functional status to receive CAR T‑cell therapy

Assessment timingECOG should be documented at time of prior authorization/assessment

Required Line(s) of Therapy

inv-13: third-line_or_later

Line of therapy: Indicated for patients after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.>=2 prior lines

This requirement is part of initial eligibility prior to consideration of CAR T-cell therapy.

Covered Regimens and Dosing Limits

Product	Coverage	Dosing/Limitations
Idecabtagene vicleucel (Abecma)
One treatment per lifetime
Dosing per FDA label; approvals may be subject to dosing limits in accordance with FDA-approved labeling and accepted compendia

Background

Abecma (idecabtagene vicleucel) is a B-cell maturation antigen (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 monoclonal antibody. Authorization may be granted for members 18 years of age and older for a single-course treatment, subject to clinical criteria including ECOG performance status 0–2 and adequate and stable renal, hepatic, pulmonary, and cardiac function; approvals are limited to an initial authorization period of 3 months.