CurrentCentenePolicy CP PHAR.533

Ciltacabtagene Autoleucel (Carvykti) Clinical Policy

Defines medical necessity and coverage criteria for Carvykti for adults with relapsed or refractory multiple myeloma and related authorization rules for Centene lines of business.

Policy Summary

PayerCentene

PolicyCiltacabtagene Autoleucel (Carvykti) Clinical Policy

Policy CodePolicy CP PHAR.533

Change TypeNo material changes

Effective DateFeb 28, 2022

Next Review DateN/A

Key ActionObtain prior authorization with documentation that all approval criteria are met for a single-dose CAR-T administration.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 dosesingle authorized CAR-T dose per member

>=1required prior lines of therapy

>=18member age requirement

Q2056HCPCS code

0.5-1 x10^6/kgTypical dose range

CRS/Neuro

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Coverage Criteria

Initial Therapy (Multiple Myeloma)

Covered when ALL of the following are met:

Initial approval criteria: Diagnosis of relapsed or refractory multiple myeloma; prescribed by or in consultation with an oncologist or hematologist; age >= 18 years; measurable disease within the last 30 days evidenced by at least one of: serum M-protein >= 0.5 g/dL, urine M-protein >= 200 mg/24 h, or involved serum free light chain >= 10 mg/dL with abnormal ratio; member is lenalidomide-refractory (disease progression within 60 days of completing lenalidomide therapy) OR has progressive disease per IMWG criteria assessed within 60 days following the last dose of the last antimyeloma regimen; member has received at least one prior line of therapy that included BOTH a proteasome inhibitor and an immunomodulatory drug; member does not have active or history of central nervous system (CNS) involvement (e.g., seizure, cerebrovascular ischemia) or clinical signs of meningeal involvement of multiple myeloma; member has not previously received anti-BCMA targeted therapy (e.g., belantamab mafodotin, teclistamab) and has not previously received CAR T-cell immunotherapy; Carvykti is not prescribed concurrently with other CAR T-cell immunotherapy; dose does not exceed 1 x 10^8 CAR-positive viable T cells.

Approval duration: 3 months (one dose only). Tocilizumab up to 4 doses of 800 mg allowed if requested.

Coverage criteria (partial)

Covered when policy-specific criteria are met per clinical trials and FDA labeling (partial criteria present in this document fragment):

Eligibility overview: Patient has relapsed or refractory multiple myeloma meeting CARTITUDE/FDA labeling criteria; documentation of measurable disease or progressive disease per IMWG criteria is required; policy reflects therapy-line requirements that have been revised over time (historically 2-4 prior lines, updated to allow use after at least one prior line per labeling changes).see IMWG criteria

Full node details found in other sections of the complete policy.

Dosing limits: Dose administered within specified dosing range (0.5-1 x10^6 CAR-positive viable T cells/kg) and not exceeding the maximum of 1 x10^8 CAR-positive viable T cells.0.5-1 x10^6 cells/kg; max 1 x10^8 cells

Per dosing and product information.

Safety considerations: Candidate must be counseled and monitored for boxed warnings including cytokine release syndrome (CRS), neurologic toxicities/ICANS, hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), prolonged/recurrent cytopenias, and risk of secondary hematologic malignancies; appropriate monitoring and management plans (including tocilizumab availability) must be in place.

Coverage is NOT authorized for members with active or a history of central nervous system (CNS) involvement related to multiple myeloma (for example, seizure or cerebrovascular ischemia) or who exhibit clinical signs of meningeal involvement of multiple myeloma.

There are no absolute contraindications reported in the policy appendices; however, the product carries boxed warnings for serious toxicities that must be considered prior to administration.

Requests for uses not listed in this policy or for drugs that are non‑formulary should be routed per the applicable no‑coverage/non‑formulary or off‑label use policies for the member's line of business (for example, CP.CPA.190, HIM.PA.33, CP PMN.255, or CP.PMN.53 as applicable).

Inclusion or exclusion of billing/coding entries in this clinical policy does not guarantee coverage; claims must follow professional coding guidance and may be denied if documentation or coding does not support medical necessity.

Initial Therapy (Multiple Myeloma)

Initial therapy (Multiple Myeloma)

Initial approval criteria for Carvykti in multiple myeloma

Initial therapy nodes: See Initial Therapy (Multiple Myeloma) criteria: relapsed/refractory MM; prescribed by or in consultation with an oncologist/hematologist; age >=18; measurable disease within 30 days; lenalidomide-refractory or progressive disease per IMWG within 60 days; at least one prior line including both a proteasome inhibitor and an immunomodulatory drug; no prior anti-BCMA targeted therapy or prior CAR T-cell therapy; not concurrent with other CAR T-cell immunotherapy; dose limit 1 x 10^8 CAR-positive viable T cells.

Approval duration: 3 months (one dose only). Tocilizumab up to 4 doses of 800 mg may be requested.

Initial therapy eligibility (partial)

Initial eligibility relates to prior lines of therapy and refractory status:

Prior therapy requirement (historical and current notes): Policy criteria and labeling have evolved: criteria previously required 2-4 prior lines of therapy (with other historical restrictions); updated labeling and policy revisions permit use after at least one prior line of therapy and include definitions for lenalidomide-refractory per CARTITUDE-4/IMWG (progression on or within 60 days of last lenalidomide dose).

Continuation Therapy

Continued therapy

Continuation therapy rules

Continuation: Continued therapy will not be authorized because Carvykti is indicated to be dosed one time only.

Continuation therapy definitions

Continuation/maintenance context as used in trials:

Line of therapy grouping: In CARTITUDE trials, induction with or without hematopoietic stem cell transplant and with or without maintenance therapy was considered a single line of therapy; a new line starts when planned therapy is modified for progression, relapse, or toxicity, or when observation is interrupted by need for further treatment.N/A

Per CARTITUDE-1 trial definition in Appendix D.

Provider Actions & Administrative Rules

Prior Authorization

Prior Authorization Required — Single-Dose Approval

Prior authorization is required. Approval is issued as a single-dose authorization (one therapeutic dose). Provider must request prior authorization before administration and documentation must support dosing and product details.

Approval duration: single-dose authorization (one therapeutic dose); prior authorization required
Dose limit: does not exceed 1 x 10^8 CAR-positive viable T cells per FDA labeling

Documentation Required

Required Documentation

Provider must submit documentation (e.g., office chart notes, lab results, imaging, pathology, operative reports, and other clinical information) that supports the member meets all approval criteria, including prior lines of therapy, measurable disease, dosing calculations, and any requested tocilizumab doses.

Include records showing prior lines of therapy and dates, response and refractory status (lenalidomide refractory when required per trial definitions)

Coding and Billing

Covered HCPCS CodeHCPCS

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

inv-08: Dose range

Typical dosing range0.5 to 1 x 10^6 chimeric CAR-positive viable T cells per kg

Maximum total doseDo not exceed 1 x 10^8 chimeric CAR-positive viable T cells

Dosing unitCells documented as CAR-positive viable T cells per kg with a specified maximum

Quantity Limits

inv-28: ciltacabtagene autoleucel (Carvykti)

Authorized doses per member1 dose (single therapeutic course)

Administration formatSingle-dose unit infusion — frozen suspension labeled for the specific recipient

Approval durationApproval duration covers one dose (single administration)

inv-29: tocilizumab (Actemra)

Quantity limitUp to 4 doses of tocilizumab (Actemra) may be requested

Per-dose maximumUp to 800 mg per dose

Indication for use

Site of Care Requirements

Note

Administer only where CRS and neurotoxicity can be managed (hospital outpatient)

Administration must occur in a hospital outpatient setting with facilities and monitoring capable of managing cytokine release syndrome, neurologic toxicities (ICANS), and other severe adverse events described in boxed warnings.

Boxed warnings include CRS, neurologic toxicities, HLH/MAS, prolonged or recurrent cytopenias, and secondary hematologic malignancies.
Ensure capability for intensive monitoring and management of these events prior to scheduling administration.

Definitions

inv-18: BCMA — definition (B-cell maturation antigen)

DefinitionB-cell maturation antigen

AbbreviationBCMA

RelevanceTarget antigen for BCMA-directed CAR-T cell therapies such as ciltacabtagene autoleucel

inv-19: CRS — cytokine release syndrome

DefinitionCytokine release syndrome

AbbreviationCRS

Clinical importanceListed among boxed warnings for CAR-T therapies; requires monitoring and management

Step Therapy / Prior Treatment Documentation

Requirement	Details
Documentation of prior lines of therapy	Provider must submit documentation of all prior lines of antimyeloma therapy; policy references CARTITUDE/CARTITUDE‑4 definitions for grouping lines of therapy and historical updates to required number of prior lines (policy revisions reflect changes from 2–4 lines to allowance after ≥1 prior line per FDA labeling).
Evidence of response or refractoriness per IMWG/CARTITUDE definitions	Documentation must state whether disease progression or refractoriness meets IMWG or CARTITUDE trial definitions (eg, lenalidomide‑refractory defined as progression on or within 60 days of completing lenalidomide therapy in CARTITUDE‑4); measurable disease or progressive disease per IMWG criteria must be documented.
Prior therapy components required	Member must have received prior therapy that included a proteasome inhibitor and an immunomodulatory drug (policy examples in Appendix B); prior anti‑BCMA targeted therapy or prior CAR‑T therapy excludes eligibility.
Source and supporting documentation	Include office/clinic notes, treatment records, and laboratory or imaging evidence demonstrating prior regimens, dates, and objective response/progression assessments consistent with IMWG or CARTITUDE definitions.

Background

Ciltacabtagene autoleucel (Carvykti) is a BCMA‑directed CAR‑T cell therapy indicated for adults with relapsed or refractory multiple myeloma who have received prior therapy. It is provided as a single‑dose, autologous CAR‑T infusion and is associated with serious risks including cytokine release syndrome (CRS) and neurologic toxicities (immune effector cell‑associated neurotoxicity syndrome, ICANS) that require specialized monitoring and management.

Policy Summary

PayerCentene

PolicyCiltacabtagene Autoleucel (Carvykti) Clinical Policy

Policy CodePolicy CP PHAR.533

Change TypeNo material changes

Effective DateFeb 28, 2022

Next Review DateN/A

Key ActionObtain prior authorization with documentation that all approval criteria are met for a single-dose CAR-T administration.

SourceLink

On This Page

Boxed warnings and monitoring guidance per prescribing information and policy appendices.

see policy effective criteria

Specific current numeric requirement and historical changes documented in policy history.

Include product labeling/lot and infusion bag documentation for the autologous single-dose product

If tocilizumab is requested, document indication and requested number/dose (up to 4 doses, up to 800 mg each as applicable)

Documentation Required

Product & Dosing Documentation

Carvykti is a single-dose autologous CAR-T product supplied as a frozen, labeled infusion bag sized for the specific recipient. Providers must document product identity, date of manufacture/receipt, and the administered dose (cells/kg and total CAR-positive viable T cells).

Product: single-dose frozen suspension of genetically modified autologous T-cells labeled for the specific recipient
Document: lot/unit identifier, infusion bag labeling, administered total cell dose and cells/kg calculation

Note

Formulary / Non‑Formulary Routing

Follow the applicable formulary, non‑formulary, and off‑label use policies for the member's line of business when the requested use is not listed in this policy. Refer to the relevant policies for commercial, marketplace, and Medicaid.

Commercial formulary/no-coverage: CP.CPA.190
Health Insurance Marketplace: HIM.PA.33 or HIM.PA.103 as applicable
Medicaid: CP.PMN.255 or CP.PMN.16 and CP.PMN.53 for off-label guidance

Step Therapy

Therapy‑Line Requirements

Therapy-line requirements must be documented. For approvals per CARTITUDE trials and updated labeling, document number of prior lines of therapy and lenalidomide refractory status when applicable. Induction with or without hematopoietic stem cell transplant, consolidation and maintenance therapy may be considered a single line of therapy per policy notes.

Document count and dates of prior lines of systemic therapy and whether therapies were part of the same line (e.g., transplant/consolidation/maintenance)
Document lenalidomide refractory status when trial-defined criteria apply (progression on or within 60 days of last lenalidomide)

Denial Risk

CNS Involvement Exclusion

Members with active or prior central nervous system (CNS) involvement are excluded from coverage under this policy. Do not approve if member has active or history of CNS involvement (e.g., seizure disorder, cerebrovascular ischemia) or clinical signs of meningeal involvement of multiple myeloma.

Exclude if history of seizures, cerebrovascular ischemia, or meningeal disease involvement consistent with policy language

Billing Rule

Coding May Affect Coverage

Coding inclusion here is informational and does not guarantee coverage. Providers must reference the most up‑to‑date professional coding guidance prior to claim submission. Note that HCPCS Q2056 for ciltacabtagene autoleucel is included and may require authorization when billed.

HCPCS Q2056: Ciltacabtagene autoleucel, up to 100 million autologous BCMA‑directed CAR‑positive T cells, including leukapheresis and dose prep — prior authorization may be required when billed with Q2056
Inclusion/exclusion of codes in this policy is informational only; final billing guidance should follow professional coding sources

Permitted as supportive therapy for management of cytokine release syndrome when requested

inv-30: Ciltacabtagene autoleucel — single therapeutic dose per labeled product (single-dose unit)

Therapeutic unitSingle therapeutic dose per labeled product (single-dose unit)

Product formFrozen suspension of genetically modified autologous T-cells labeled for the specific recipient

Dosing documentationDose documented as cells/kg with specified maximum (see dosing limits)

inv-20: ICANS — immune effector cell-associated neurotoxicity syndrome

DefinitionImmune effector cell-associated neurotoxicity syndrome

AbbreviationICANS

Clinical importanceNeurologic toxicity listed in boxed warnings for CAR-T therapies and requires monitoring

inv-21: Line of therapy (CARTITUDE definition) — definition of a line of therapy

DefinitionOne or more cycles of a planned treatment program; induction, transplant, and maintenance may be considered a single line

Line-change criteriaA new line begins when planned therapy is modified for progression, relapse, or toxicity, or observation is interrupted by need for further treatment

Trial contextCARTITUDE-1 considered induction +/- transplant and maintenance as a single line of therapy

inv-22: Lenalidomide-refractory (CARTITUDE-4 definition) — definition of lenalidomide-refractory

DefinitionLenalidomide-refractory: failure to achieve at least a minimal response or disease progression on or within 60 days of completing lenalidomide therapy

Maintenance dosing noteProgression on or within 60 days of last lenalidomide dose given as maintenance meets the criterion

Trial applicationCARTITUDE-4 required lenalidomide-refractory status per IMWG consensus guidelines for enrollment