CurrentEmblemHealthPolicy N/A

Carvykti (ciltacabtagene autoleucel) — Coverage Criteria for Multiple Myeloma (CAR-T)

Defines prior authorization and medical necessity criteria for coverage of Carvykti (ciltacabtagene autoleucel) for adults with relapsed or refractory multiple myeloma under EmblemHealth Medicare Advantage Medical lines of business.

Policy Summary

PayerEmblemHealth

PolicyCarvykti (ciltacabtagene autoleucel) — Coverage Criteria for Multiple Myeloma (CAR-T)

Policy CodePolicy N/A

Change TypeRevised criteriaclarified dosing

Effective Date03/25/2025

Next Review Date

Key ActionObtain prior authorization with documentation of diagnosis, prior therapies (including lenalidomide-refractory status if applicable), and plan for lymphodepleting chemotherapy to approve a single Carvykti infusion.

SourceLink

POLICY UPDATE CHANGES

Multiple Myeloma criteria: removed requirement for ≥4 lines of systemic therapy and added option of ≥3 lines of therapy as an approval pathway; retained alternative pathway of ≥1 line including a proteasome inhibitor and an immunomodulatory agent with lenalidomide-refractory status.

Approval is for a single dose (up to 1 x 10^8 CAR-T cells) and prior authorization is recommended to allow time to prepare and administer one dose.

Policy incorporates relevant NCDs/LCDs and CMS compendia and notes internal criteria designators (IC-COMP, IC-L, IC-ISGP, IC-EC).

single doseapproved administration per patient

0.5–1.0 x10^6/kgrecommended dosing

Boxed Warningserious safety risks

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Recommended Authorization Criteria

Coverage of Carvykti is not recommended for circumstances that are not listed in the Recommended Authorization Criteria. Requests that do not meet the stated authorization criteria may be denied.

The policy does not provide additional explicit not medically necessary statements beyond the generic exclusion: situations outside the Recommended Authorization Criteria are not recommended for coverage.

Regimens and Administration

Regimen	Indication / Prior therapy requirements	Dose / Administration
Carvykti (ciltacabtagene autoleucel) single IV infusion	Relapsed or refractory multiple myeloma in adults (≥18 years) who meet ONE of the following prior‑therapy pathways: (i) received one or more lines of systemic therapy including an immunomodulatory agent and a proteasome inhibitor AND is refractory to lenalidomide; OR (ii) received at least three prior lines of systemic therapy. Patient must have received or plan to receive lymphodepleting chemotherapy prior to infusion, and must not have prior CAR‑T therapy.	Approve a single dose: up to 1 x 10^8 CAR‑T cells administered as a single intravenous infusion.

Billing and Coding

Referenced billing codesmixed

Not enumerated in policy

Policy references HCPCS and ICD-10 code lists in companion articles and applicable NCDs/LCDs but does not list specific codes in this document.

CAR-T dose maximum

Maximum per infusionMaximum 1 x 10^8 CAR-T cells per single intravenous infusion

Recommended dosing rangeSingle infusion of 0.5–1.0 x 10^6 CAR‑T cells/kg (per prescribing information)

Approved administrations per patientSingle dose

Provider Requirements and Authorization Process

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage of Carvykti; approval should allow adequate time to prepare and administer one dose of therapy.

Step Therapy

Prior therapy requirements

Patient must have received prior systemic therapy and meet ONE of the following pathways: (a) received one or more lines of systemic therapy including an immunomodulatory agent and a proteasome inhibitor AND be refractory to lenalidomide; OR (b) received at least three prior lines of therapy.

Documentation Required

Required clinical documentation

Authorized Lines of Therapy

second-line | later

Line options: Either (a) at least one prior line including a proteasome inhibitor and an immunomodulatory agent with lenalidomide-refractory disease, OR (b) at least three prior lines of systemic therapy

IC-COMP; policy history documents replacement of prior ≥4-line requirement

Biomarker and Diagnostic Requirements

BCMA

Biomarker targetBCMA (B‑cell maturation antigen) — required target for BCMA‑directed therapy

Role in eligibilityCarvykti is a BCMA‑directed therapy; presence of BCMA as the therapy target is implied in indication and coverage criteria

Clinical contextIndicated for relapsed or refractory multiple myeloma in adults after specified prior therapies

Drug and Program Definitions

Carvykti (definition)

Generic nameCiltacabtagene autoleucel

DescriptionA BCMA‑directed genetically modified autologous T‑cell immunotherapy for relapsed or refractory multiple myeloma in adults

Indication summaryFor patients with relapsed or refractory multiple myeloma after prior therapy (including specified prior agents/lines)

REMS

REMS requirementCarvykti is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (Carvykti REMS)

Reason for REMSRequired because of severe potential adverse events including cytokine release syndrome, neurotoxicity (ICANS), parkinsonism, Guillain‑Barre, and other serious toxicities

Background and Indication

Carvykti (ciltacabtagene autoleucel) is an autologous, BCMA-directed genetically modified T‑cell (CAR‑T) immunotherapy indicated for adults with relapsed or refractory multiple myeloma after prior therapy. It is supplied as a single intravenous infusion product and carries significant safety risks, including cytokine release syndrome, immune effector cell‑associated neurotoxicity syndrome, parkinsonism, and Guillain‑Barré‑like syndromes; a Risk Evaluation and Mitigation Strategy (REMS) is required for its use.

Policy Revision History

2025-03-25criteria_revisionLatest

Multiple Myeloma criteria revised to remove the previous ≥4‑line requirement and add an option for approval after ≥3 lines of systemic therapy (commercial policy alignment).

2024-04-19criteria_revision

Multiple Myeloma criteria changed to make ≥4 lines of systemic therapy an option and added an alternative pathway of one or more prior lines including an immunomodulatory agent and a proteasome inhibitor with lenalidomide‑refractory disease.

2022-03-10policy_creation