CurrentMass General Brigham Health PlanPolicy 061

Carvykti (ciltacabtagene autoleucel) coverage

Defines prior authorization, medical necessity criteria, and coverage variations for Carvykti (ciltacabtagene autoleucel) for Mass General Brigham Health Plan members across commercial, ACO, Medicare Advantage, One Care, and SCO products.

Policy Summary

PayerMass General Brigham Health Plan

PolicyCarvykti (ciltacabtagene autoleucel) coverage

Policy CodePolicy 061

Change TypeCriteria and authorization updates

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit documentation of prior lines of therapy, REMS enrollment, organ function, and ECOG performance status.

SourceLink

POLICY UPDATE CHANGES

Added variation and authorization processes for One Care and SCO members.

Updated prior authorization table and clarified Medicare variation.

Updated criteria to align with NCCN guidance and FDA label including lenalidomide-refractory indication following 1-3 prior lines.

Single courseauthorized duration of therapy

ECOG 0-2performance status required

≥4 lines or lenalidomide‑refractoryFDA-approved indications

Q2056HCPCS code

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Coverage Criteria for Carvykti (ciltacabtagene autoleucel)

Initial Approval Criteria

Covered when ALL of the following are met for a single treatment course:

FDA indication options: Member meets EITHER: (1) relapsed or refractory multiple myeloma after four or more prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody; OR (2) relapsed or refractory multiple myeloma after at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent, and is refractory to lenalidomide.

Aligns with FDA-approved indications and CARTITUDE-4 expansion

Additional required conditions: Patient has not received prior FDA‑approved BCMA‑directed CAR‑T; will receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine) prior to infusion; stable and adequate renal, hepatic, pulmonary, and cardiac function as determined by treating physician; no clinically significant active infectious or inflammatory disorders; no active graft‑versus‑host disease; ECOG performance status 0‑2 (performance status >2 may be considered case‑by‑case); treating facility and providers are enrolled in and compliant with the Carvykti REMS; tocilizumab is available on site for CRS management.

All conditions required

Additional courses of Carvykti beyond a single authorized treatment course are considered experimental/investigational. The policy authorizes a single treatment course and explicitly states that repeat dosing is not covered under the standard authorization criteria.

The listed procedure and product codes are provided for informational purposes only; inclusion of a code does not constitute or imply coverage. Codes included in the policy (for example, 38225, 38226, 38227, 38228, and Q2056) should not be interpreted as standalone coverage statements.

Regimen	Indication / timing	Notes
Cyclophosphamide plus fludarabine	Lymphodepleting chemotherapy prior to infusion of Carvykti (required for initial authorization)	Administered prior to CAR‑T cell infusion as part of conditioning; facility must be REMS‑enrolled and have tocilizumab available for CRS management

Coding and Procedure Codes

Informational CAR-T and product 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

ECOG performance status — initial approval criteria

Required ECOG rangeECOG performance status 0–2

Consideration for ECOG >2Performance status above 2 may be considered on a case‑by‑case basis

Age requirementPatient is ≥18 years of age at time of authorization

Documentation requiredDocumentation of ECOG performance status must be submitted with prior authorization request

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Carvykti across product lines. Prior authorization requests must include all required documentation; incomplete requests may be denied.

Applies to Commercial, Qualified Health Plans, Mass General Brigham ACO, Medicare Advantage, One Care, and Senior Care Options (SCO).
Prior authorization for Commercial and QHP members is managed by Prime Therapeutics — see Prime Therapeutics policy.
Mass General Brigham ACO prior auth is managed by the MassHealth Drug Utilization Review Program (see MassHealth variation).

Documentation Required

Provider Documentation to Submit

Submit the following documentation with the prior authorization request to avoid processing delays or denials.

Documentation of prior lines of therapy (showing prior use of proteasome inhibitor, immunomodulatory agent, anti-CD38 monoclonal antibody, or documentation of lenalidomide-refractory status as applicable).

Line of Therapy Criteria

Salvage — Line‑of‑Therapy Criteria

FDA-indicated lines: Either: (A) after four or more prior lines including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody; OR (B) lenalidomide‑refractory after at least 1 prior line including a proteasome inhibitor and an immunomodulatory agent.

Reflects FDA label and CARTITUDE‑4 evidence

Biomarker and Target Requirements

BCMA — BCMA-directed therapy requirement / biomarker note

Therapy targetBCMA-directed (B‑cell maturation antigen) therapy

Prior BCMA CAR‑T exclusionPatient must not have received prior FDA‑approved BCMA‑directed CAR‑T therapy

Biomarker testingPolicy does not require prior measurement of BCMA expression for coverage

Therapy implicationCarvykti is a BCMA‑directed CAR‑T; coverage aligns with BCMA‑targeted indication(s)

Definitions

Definition — Carvykti (ciltacabtagene autoleucel)

Product definitionCarvykti (ciltacabtagene autoleucel) is a genetically modified autologous T cell immunotherapy that targets B‑cell maturation antigen (BCMA).

Therapy classBCMA‑directed autologous CAR‑T cell therapy

Indication contextIndicated for adult patients with relapsed or refractory multiple myeloma per FDA‑approved criteria

Administration settingSingle treatment course with lymphodepleting chemotherapy prior to infusion

Background

Carvykti (ciltacabtagene autoleucel) is a BCMA-directed, autologous chimeric antigen receptor T‑cell (CAR‑T) therapy used for relapsed or refractory multiple myeloma. Clinical use per this policy is limited to a single treatment course under the specified criteria; lymphodepleting chemotherapy with cyclophosphamide and fludarabine is required prior to infusion, and treating facilities must be enrolled in and compliant with the Carvykti REMS. The policy also notes supportive-service requirements such as on‑site availability of tocilizumab for management of cytokine release syndrome. Codes related to CAR‑T processes and the product are included for informational purposes only.