ModifiedPremera BluecrossPolicy 8.01.66

Chimeric Antigen Receptor Therapy for Multiple Myeloma

Defines medical necessity, documentation, coding, and REMS-related facility requirements for the use of idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Carvykti) in adults with relapsed or refractory multiple myeloma.

Policy Summary

PayerPremera Bluecross

PolicyChimeric Antigen Receptor Therapy for Multiple Myeloma

Policy CodePolicy 8.01.66

Change TypeMaterial coverage updates and clarifications

Effective DateMar 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation showing age ≥18, diagnosis of multiple myeloma, required prior therapies (agent-specific), adequate organ/bone marrow function, and intent for single-dose CAR T infusion per FDA labeling.

SourceLink

POLICY UPDATE CHANGES

Clarified that Abecma or Carvykti may be approved as a one-time infusion and repeat treatment is considered investigational.

Updated Abecma coverage criteria to include treatment of certain adults who have tried two therapies and Carvykti coverage criteria to include treatment of certain adults who have tried one prior therapy and lenalidomide.

Updated Abecma coverage criteria to include treatment of certain adults with multiple myeloma who have tried two therapies.

Updated Carvykti coverage criteria to include treatment of certain adults with multiple myeloma who have tried one prior therapy and prior lenalidomide.

2CAR T agents named

18+Minimum age (years)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

inv-01: Abecma (idecabtagene vicleucel) — Initial therapy

Covered when ALL of the following are met (agent‑specific):

Abecma (idecabtagene vicleucel) coverage: Individual is aged 18 years or older at time of infusion AND has a documented diagnosis of multiple myeloma AND has relapsed or refractory disease after 2 or more lines of therapy, including an immunomodulatory agent; a proteasome inhibitor; and an anti‑CD38 monoclonal antibody AND has adequate organ and bone marrow function as determined by the treating oncologist or hematologist AND does not have active infection(s) or inflammatory disorders AND has not received prior chimeric antigen receptor T-cell therapy or any other gene therapyage >= 18

Agent-specific prior therapy requirement: >=2 prior lines including specified classes.

inv-02: Carvykti (ciltacabtagene autoleucel) — Initial therapy

Covered when ALL of the following are met (agent‑specific):

Carvykti (ciltacabtagene autoleucel) coverage: Individual is aged 18 years or older at time of infusion AND has a documented diagnosis of multiple myeloma AND has relapsed or refractory disease after 1 or more prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent AND disease is refractory to lenalidomide AND has adequate organ and bone marrow function as determined by the treating oncologist or hematologist AND does not have active infection(s) or inflammatory disorders AND has not received prior chimeric antigen receptor T-cell therapy or any other gene therapyage >= 18; lenalidomide-refractory status required

Agent-specific prior therapy requirement: >=1 prior line including PI and IMiD and lenalidomide-refractory.

inv-03: General drug rules — other coverage rules (operational and exclusions)

Other coverage rules:

Dose and product labeling: Medications must be used per FDA dosing and administration prescribing informationfollow FDA prescribing information

All other uses are investigational.

Repeat treatment (re-treatment) with Abecma or Carvykti is considered investigationalno re-treatment coverage

Initial authorization may be up to 12 months for non-formulary exception reviews as stated.

inv-04: Initial CAR T-cell therapy coverage

Covered when ALL of the following are met (per FDA approval and policy updates):

FDA-approved indication (original): Adult with relapsed or refractory multiple myeloma after 4 or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti‑CD38 monoclonal antibody (FDA approvals for idecabtagene vicleucel and ciltacabtagene autoleucel).4+ prior lines

KarMMa and CARTITUDE evidence support improvement in net health outcome.

Policy-updated earlier-line coverage: Per 2024 policy update and NCCN v1.2025, idecabtagene vicleucel may be covered for certain adults after two prior lines and ciltacabtagene autoleucel may be covered for certain adults after one prior line including lenalidomide; specific patient-level criteria required to justify earlier use.1-2 prior lines (selected patients)

Refer to full policy for exact patient selection criteria.

Treatment administration:

inv-05: Product-specific prior therapy coverage

Policy coverage updated to adjust eligible prior therapy exposure for specific CAR T products

Product-specific prior therapy criteria: Abecma may be covered for certain adults with multiple myeloma who have tried two therapies; Carvykti may be covered for certain adults who have tried one prior therapy including prior lenalidomide.prior therapy counts specified per product

Full, detailed medical necessity criteria and other conditions are in other policy sections.

All uses of Abecma (idecabtagene vicleucel) and Carvykti (ciltacabtagene autoleucel) that are not described in this policy are considered investigational. The policy specifies that the medications must be used in accordance with the product's FDA dosage and administration prescribing information; any indication or clinical scenario not listed in the coverage criteria should be treated as investigational and will not meet medical necessity under this policy.

Repeat dosing or re-treatment with Abecma or Carvykti is considered investigational and is not covered by this policy. The 2024 policy clarification states these products may be approved as a one-time infusion, and requests for dose administration beyond the initial approved infusion should be evaluated as investigational and will not meet routine coverage criteria.

Operationally, initial authorizations for these agents must follow the FDA labeling and prescribing information; non-formulary exception reviews for the drugs listed may be approved for up to 12 months, but repeated administrations outside the one-time infusion framework are not supported by this policy.

Requests for repeat CAR T‑cell treatment (additional full CAR T infusions) are considered investigational and excluded from coverage unless explicitly specified otherwise. The policy history and updates reiterate that therapy is intended as a single therapeutic infusion per FDA prescribing and that multiple full re-infusions are not supported by the policy.

Providers seeking authorization should document that the request is for an initial, single infusion per FDA labeling; any request for a subsequent CAR T infusion will typically require investigational review and is not routinely approved.

Repeat treatment of Abecma or Carvykti is explicitly considered investigational (not medically necessary) under this policy. The policy language notes that re‑treatment is investigational and that use must conform to FDA dosing and administration.

When submitting requests, include documentation that this is a one-time infusion per the product label; absence of such documentation or requests for repeat infusions should be processed as investigational and are not expected to meet coverage criteria.

Policy clarification in 2024 specifies that re-treatment or repeat infusion with Abecma or Carvykti is considered investigational / not medically necessary. The update clarifies that these therapies may be approved as a single infusion and that subsequent full re-infusions do not meet the policy's coverage criteria.

Requests for repeat infusions of Abecma or Carvykti are considered investigational and not medically necessary under this policy. The policy's history documents that the intended use is a single therapeutic infusion per FDA labeling; repeat administrations are not covered absent a specific, documented exception.

From an operational perspective, prior authorization submissions should clearly indicate whether the request is for the initial single infusion. Any request indicating prior CAR T infusion or proposing repeat CAR T administration should be referred for investigational review and are likely to be denied.

Coding and Dosing

Covered CPT CodesCPTCovered

0540T

Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous.

Covered HCPCS CodesHCPCSCovered

Q2055	Idecabtagene vicleucel, up to 460 million autologous B-cell maturation antigen (BCMA) directed CAR-positive T cells, including leukapheresis and dose preparation procedures, per therapeutic dose (use to report: Abecma).
Q2056	Ciltacabtagene autoleucel, up to 100 million autologous B-cell maturation antigen (BCMA) directed CAR-positive T cells, including leukapheresis and dose preparation procedures; per therapeutic dose (use to report: Carvykti).

Coverage-related billing codesmixed

not listed in excerpt

No specific CPT/HCPCS/ICD-10 codes included in this document portion

Policy-related procedure/coding historymixed

C9081	HCPCS code added (historical coding updates)
Q2055	HCPCS code added (historical coding updates)
Q2056	HCPCS code added (historical coding updates)
0540T	CPT code added (coding update March 2024)
0537T	CPT status B code (removed from policy)
0538T	CPT status B code (removed from policy)
0539T	CPT status B code (removed from policy)

inv-16: Abecma dose — 300 to 460 x 10^6 CAR-positive viable T cells

Abecma (idecabtagene vicleucel) dose range300 to 460 x 10^6 CAR-positive viable T cells (intravenous)

Dose unitsCAR-positive viable T cells (absolute cell count)

Administration routeIntravenous infusion per FDA prescribing information

inv-17: Carvykti dose — 0.5 to 1.0 x 10^6 CAR-positive viable T cells/kg (max 1 x10^8)

Carvykti (ciltacabtagene autoleucel) dose range0.5 to 1.0 x 10^6 CAR-positive viable T cells/kg

Maximum per infusion

Provider Actions and Documentation

Prior Authorization

Prior Authorization and Billing/Coding Notes

Prior authorization is required for Abecma (idecabtagene vicleucel) and Carvykti (ciltacabtagene autoleucel). Requests must meet the policy's medical necessity criteria (age ≥18, documented diagnosis of multiple myeloma, relapsed/refractory status, required prior therapies, adequate organ and bone marrow function, absence of active infection/inflammatory disorder, and REMS/facility participation). Providers must follow the FDA-approved dosing and administration in the product prescribing information. Non-formulary exception review authorizations for the drugs listed in this policy may be approved for up to 12 months. Note: Certain CPT codes previously designated as status B were removed from this policy; a separate payment policy addresses status B codes.

Prior authorization required
Follow FDA dosing/administration and REMS/facility requirements
Non-formulary exception approvals may be up to 12 months
Status B CPT codes removed; payment policy addresses those codes separately

Step Therapy

Prior Therapies Requirement

Background

Multiple myeloma is a plasma cell malignancy characterized by abnormal plasma cell proliferation and end‑organ manifestations (CRAB: hypercalcemia, renal insufficiency, anemia, bone lesions). Autologous BCMA‑directed CAR T‑cell therapies — specifically Abecma (idecabtagene vicleucel) and Carvykti (ciltacabtagene autoleucel) — target BCMA on malignant plasma cells and are indicated for relapsed or refractory disease in adults under defined prior‑therapy criteria.

Regulatory approvals originally supported use after 4 or more prior lines of therapy; the policy was updated in 2024 to clarify that these products are generally administered as a one-time infusion and to expand eligibility in selected patients (Abecma for some adults after 2 prior therapies; Carvykti for some adults after 1 prior therapy including prior lenalidomide). Providers must follow FDA prescribing information and document prior therapies and intent for single‑dose administration when requesting authorization.

Definitions

inv-33: Relapsed multiple myeloma definition

Relapsed multiple myeloma definitionDevelopment of new or enlarging plasmacytomas or bone lesions, hypercalcemia, decreased hemoglobin, rise in creatinine, or other progression per IMWG criteria (clinical relapse/per progression), identified by laboratory or imaging evidence

Diagnostic criteria sourceUses the 2016 IMWG response criteria and routine monitoring (rise in M-protein, free light chains, or new lesions)

Clinical triggers for treatmentTherapy indicated with clinical relapse, extramedullary disease, or rapid rise in paraproteins rather than all laboratory progressions

inv-34: Refractory multiple myeloma definition

Refractory multiple myeloma definitionDocumented progressive disease during or within 60 days of completing the last anti-myeloma regimen (per KarMMa and CARTITUDE-1 and consistent with IMWG definitions)

Line of Therapy Context

inv-37: salvage — 1 top-level node (salvage context)

Salvage therapy context: Line of therapy: salvage — criteria reference relapsed or refractory disease after prior lines of therapy and consideration for CAR T-cell therapy per agent-specific requirements.

See agent-specific criteria for exact prior-line counts and refractory status.

inv-38: salvage — 1 top-level node (alternate reference)

Salvage therapy context: Line of therapy: salvage — prior therapy classes include immunomodulatory agents, proteasome inhibitors, and anti‑CD38 monoclonal antibodies; agent-specific prior-line requirements determine eligibility.

Supports documentation of prior classes and lines of therapy.

inv-39: salvage — 2 top-level nodes (FDA vs updated policy lines)

Covered Regimens

Product	FDA dose range	Coverage status
Idecabtagene vicleucel (Abecma)	300 to 460 x 10^6 CAR-positive viable T cells (intravenous)	Covered when agent-specific criteria met per policy
Ciltacabtagene autoleucel (Carvykti)	0.5 to 1.0 x 10^6 CAR-positive viable T cells/kg (maximum 1 x 10^8 per single infusion)	Covered when agent-specific criteria met per policy

Agent class / example agents	Representative agents
Monoclonal antibodies	Daratumumab, elotuzumab, isatuximab
Proteasome inhibitors	Bortezomib, carfilzomib, ixazomib
Immunomodulatory drugs (IMiDs)	Lenalidomide, pomalidomide, thalidomide
Other systemic agents	Alkylators, anthracyclines, panobinostat, selinexor, corticosteroids

Product	Prior therapy requirement (policy-specific)	Coverage status / notes
Idecabtagene vicleucel (Abecma)	Relapsed or refractory multiple myeloma after 2 or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti‑CD38 monoclonal antibody; policy updated to allow certain adults after two prior therapies per 2024 update	Covered when criteria met; one-time infusion per FDA labeling (repeat treatment investigational)
Ciltacabtagene autoleucel (Carvykti)	Relapsed or refractory multiple myeloma after 1 or more prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent; disease must be refractory to lenalidomide; policy updated to allow certain adults after one prior therapy with prior lenalidomide	Covered when criteria met; one-time infusion per FDA labeling (repeat treatment investigational)

Policy Summary

PayerPremera Bluecross

PolicyChimeric Antigen Receptor Therapy for Multiple Myeloma

Policy CodePolicy 8.01.66

Change TypeMaterial coverage updates and clarifications

Effective DateMar 1, 2025

Next Review Date

SourceLink

On This Page

inv-18: Prior lines of therapy (FDA and updated policy) — FDA 4+ prior lines; policy updated for earlier-line in some cases

Original FDA indication (lines of therapy)Relapsed or refractory multiple myeloma after 4 or more prior lines of therapy (including an IMiD, a proteasome inhibitor, and an anti‑CD38 antibody)

Policy-updated earlier-line allowancesPolicy updated (2024) to allow idecabtagene vicleucel for certain adults after 2 prior therapies and ciltacabtagene autoleucel for certain adults after 1 prior therapy with prior lenalidomide; specific patient-level criteria apply

Practical implicationRefer to product-specific criteria in policy to determine eligibility when prior lines are fewer than FDA-labeled 4+

Coverage requires documentation that the individual has relapsed or refractory multiple myeloma after the specified number and types of prior therapies. For Abecma: relapsed/refractory disease after 2 or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody (policy updated to allow approval in certain adults after two therapies where specified). For Carvykti: relapsed/refractory disease after 1 or more prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent, with disease refractory to lenalidomide (policy updated to allow approval in certain adults after one prior therapy and lenalidomide prior). Historically FDA approvals were for patients with 4 or more prior lines, and NCCN guidance supports earlier use in selected patients.

Documentation Required

Required Clinical Documentation

Medical records submitted for prior authorization must document age (≥18 years), diagnosis of multiple myeloma, the relapsed or refractory status and the specific prior regimens/classes received (including IMiD, PI, anti‑CD38 antibody and lenalidomide status where relevant), adequate organ and bone marrow function as determined by the treating oncologist/hematologist, and absence of active infections or inflammatory disorders. Documentation should also indicate that the member has not received prior CAR T‑cell or other gene therapy and that the treating facility participates in required REMS programs when applicable.

Document age ≥18 and confirmed multiple myeloma diagnosis
Document prior lines and specific agents/classes (IMiD, PI, anti‑CD38; lenalidomide refractory status for Carvykti)
Document relapsed/refractory status and refractory-to-class evidence as applicable
Document adequate organ and marrow function and absence of active infection/inflammatory disorder
Document no prior CAR T or other gene therapy and REMS/facility participation

Denial Risk

Denial Triggers and Investigational Limits

Requests that do not meet required prior-therapy criteria, involve patients younger than 18, are for non‑myeloma diagnoses, lack documentation of adequate organ/bone marrow function or evidence of refractory disease to required classes, or propose repeat CAR T infusions beyond the one-time infusion described in prescribing information may be denied as not medically necessary or investigational. Use outside FDA‑approved indications or failure to follow FDA dosing/REMS requirements can also be a basis for denial.

Denial triggers: age <18, non-myeloma diagnosis
Denial triggers: unmet prior therapy/class requirements or lack of refractory evidence
Denial triggers: inadequate organ/marrow function or active infection/inflammatory disorder
Denial triggers: repeat CAR T infusions (considered investigational) or non‑adherence to FDA dosing/REMS

inv-35: Triple-class refractory / heavily pretreated — patients refractory to IMiD, PI, anti-CD38

Triple-class refractory / heavily pretreatedPatients who have received and are refractory to an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti‑CD38 monoclonal antibody

Clinical consequenceHeavily pretreated, triple-class refractory patients have poor outcomes to subsequent therapies with limited median overall and progression-free survival

Examples of agentsIMiDs (lenalidomide, pomalidomide), PIs (bortezomib, carfilzomib), anti‑CD38 antibodies (daratumumab, isatuximab)

inv-40: salvage — 2 top-level nodes (product-specific eligibility changes)

Product-specific salvage eligibility: Abecma: eligible for certain adults after two prior therapies; Carvykti: eligible for certain adults after one prior therapy including lenalidomide, per 2024 policy updates.>=2 (Abecma) or >=1 with lenalidomide (Carvykti)

Details and patient-level selection criteria are in the main policy sections.

Administration and re-treatment: Intended as a one-time infusion per FDA labeling; repeat CAR T-cell treatment is considered investigational and not covered.single infusion

Operational clarification from 2024 updates.