CurrentMass General Brigham Health PlanPolicy 061

Medical Policy Carvykti (ciltacabtagene autoleucel)

Defines medical necessity, prior authorization, and coverage criteria for Carvykti (ciltacabtagene autoleucel) for treatment of adult patients with relapsed or refractory multiple myeloma across Mass General Brigham Health Plan product variations.

Policy Summary

PayerMass General Brigham Health Plan

PolicyMedical Policy Carvykti (ciltacabtagene autoleucel)

Policy CodePolicy 061

Change TypeClarified eligibility and updated prior authorization variations

Effective DateJul 1, 2022

Next Review Date

Key ActionSubmit prior authorization with documentation of prior lines of therapy and REMS certification/enrollment; facility must have tocilizumab available for CRS management.

SourceLink

POLICY UPDATE CHANGES

Clarified hierarchy of criteria in One Care and SCO variation and updated FDA indications, eligibility criteria, and references as of March 2026.

Updated prior authorization table and added variation for One Care and SCO members.

single courseauthorized duration

≥1minimum prior lines

Q2056,38225-28billing codes

CARTITUDE trialskey evidence

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Coverage Criteria for Carvykti (ciltacabtagene autoleucel)

Initial Approval

Covered when ALL of the following are met:

Initial Approval Criteria: Patient is ≥18 years old; diagnosis of relapsed or refractory multiple myeloma after at least 1 prior line of therapy that included a proteasome inhibitor and an immunomodulatory agent, and refractory to lenalidomide.

Initial Approval Criteria: No prior receipt of any FDA‑approved BCMA‑directed CAR‑T cell therapy.

Initial Approval Criteria: No clinically significant active infectious or inflammatory disorders.

Initial Approval Criteria: No active graft‑versus‑host disease.

The treating facility must have tocilizumab available on site for management of cytokine release syndrome.

Authorization and Duration: Single treatment course only; additional courses are considered experimental/investigational and are not authorized.

Providers must document prior lines of therapy and confirm provider/patient REMS certification/enrollment.

Authorization is limited to patients who do not have conditions that would meaningfully increase the risk of harm or interfere with expected benefit. Specifically, requests will not be approved for members with clinically significant active infectious or inflammatory disorders or with active graft versus host disease. Additionally, members who have previously received any FDA‑approved BCMA‑directed CAR‑T cell therapy are excluded from authorization. Facilities administering therapy must have tocilizumab available on site for management of cytokine release syndrome, and providers must submit documentation of prior lines of therapy and provider/patient REMS certification/enrollment as required.

Only a single treatment course of Carvykti (ciltacabtagene autoleucel) is authorized under this policy. Additional courses of Carvykti beyond a single treatment course are considered experimental/investigational and are not medically necessary.

Covered Treatment Regimens

Regimen	Description	Authorized course	Coverage status
Autologous BCMA-directed CAR-T cell therapy (ciltacabtagene autoleucel; cilta‑cel)	Single infusion of cilta‑cel administered after lymphodepletion conditioning. Cilta‑cel is a BCMA‑directed, genetically modified autologous T‑cell immunotherapy for adult patients with relapsed or refractory multiple myeloma; pivotal trials (CARTITUDE‑1; CARTITUDE‑4) used a single infusion given 5–7 days after lymphodepletion and demonstrated high response rates and durable outcomes.	Single treatment course (one therapeutic dose/infusion)	Covered with criteria — authorization granted when patient meets initial approval criteria (adult with relapsed/refractory MM after ≥1 prior line including a proteasome inhibitor and an immunomodulatory agent, lenalidomide‑refractory, no prior FDA‑approved BCMA‑directed CAR‑T, and no clinically significant active infection/inflammatory disorder or active GVHD).

Line of Therapy / Salvage Use

Salvage (Line of Therapy)

Line of therapy per indications: FDA indication and evidence support use in patients with relapsed or refractory multiple myeloma after at least 1 prior line of therapy (including a proteasome inhibitor and an immunomodulatory agent) and who are lenalidomide‑refractory; CARTITUDE‑4 provides evidence for use in lenalidomide‑refractory disease following 1–3 prior lines of therapy, and guidelines also include use after ≥3 prior lines in certain contexts.

Provider Actions and Prior Authorization

Prior Authorization

Prior authorization required — product-specific submission routing

Prior authorization is required for Carvykti for Medicare Advantage, Mass General Brigham ACO, One Care/SCO, and Commercial/Qualified Health Plan members. Submission pathways vary by product line: Medicare Advantage requests follow CMS guidance (NCD/LCDs) and are reviewed per Mass General Brigham policy when CMS guidance lacks specificity; Mass General Brigham ACO requests must be submitted to the MassHealth Drug Utilization Review Program; Commercial and Qualified Health Plan requests are managed by Prime Therapeutics.

Medicare Advantage: review follows CMS NCD 110.24 and related Medicare manuals; Mass General Brigham policy applied when CMS guidance is not specific. [[citation only in metadata]]
Mass General Brigham ACO: submit prior authorization requests to the MassHealth Drug Utilization Review Program.
Commercial/Qualified Health Plans: prior authorization managed by Prime Therapeutics.

Step Therapy

Step therapy / treatment sequence — single authorized course

Authorization is limited to a single treatment course of Carvykti; additional courses beyond a single treatment course are considered experimental/investigational and are not authorized.

Informational Billing and Procedure Codes

Informational codesmixed

38225	Chimeric antigen receptor T-cell (CAR-T) therapy; harvesting of blood-derived T lymphocytes for development of genetically modified autologous CAR-T cells, per day.
38226	Chimeric antigen receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for transportation (eg, cryopreservation, storage).
38227	Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preparation of CAR-T cells for administration.
38228	Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous.
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

Definitions

Carvykti (ciltacabtagene autoleucel) — definition and mechanism

Generic nameCiltacabtagene autoleucel (brand name: Carvykti)

Therapy typeAutologous, BCMA-directed genetically modified T‑cell immunotherapy (CAR‑T)

Mechanism of actionPatient T cells are genetically modified to express a chimeric antigen receptor targeting B‑cell maturation antigen (BCMA) on myeloma cells, enabling immune‑mediated recognition and killing of BCMA‑expressing plasma cells.

Indicated populationAdult patients with relapsed or refractory multiple myeloma who have received ≥1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent and are refractory to lenalidomide.

Course authorizedSingle treatment course (single autologous CAR‑T infusion) per policy; additional courses considered experimental/investigational.

Background

Carvykti (ciltacabtagene autoleucel) is an autologous, B‑cell maturation antigen (BCMA)‑directed chimeric antigen receptor T‑cell (CAR‑T) therapy that genetically modifies a patient’s T cells to target BCMA‑expressing plasma cells in multiple myeloma. The FDA‑approved indication covers adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent and who are refractory to lenalidomide. Carvykti is administered as a single cilta‑cel infusion after lymphodepletion in appropriately selected patients.