CurrentCignaPolicy IP0414

Carvykti (ciltacabtagene autoleucel) coverage

Defines Cigna coverage criteria, dosing, coding, and requirements for Carvykti (BCMA-directed autologous CAR-T) for treatment of relapsed or refractory multiple myeloma in adults; applies to Cigna-administered health benefit plans and providers submitting claims/authorizations.

Policy Summary

PayerCigna

PolicyCarvykti (ciltacabtagene autoleucel) coverage

Policy CodePolicy IP0414

Change TypeMaterial revisions to prior-therapy pathways, single-dose confirmation, and coding updates

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization using the listed HCPCS/CPT/Q codes and document that the patient meets all medical necessity criteria including prior therapies and lenalidomide-refractory status when applicable.

SourceLink

POLICY UPDATE CHANGES

Documentation of an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 was removed.

Requirement that patient does not have central nervous system involvement with myeloma was removed.

Requirement that patient does not have presence or history of plasma cell leukemia was removed.

Repeat administration of ciltacabtagene autoleucel (Carvykti) was removed from Conditions Not Covered and moved to medical necessity criteria to state approval for a single dose.

Changed prior-therapy requirement so receiving four or more lines of systemic therapy is now an option rather than a strict requirement; added alternative option for approval after one or more prior lines including immunomodulatory agent and proteasome inhibitor and refractory to lenalidomide.

CPT codes 38225, 38226, 38227, 38228 were added and deleted HCPCS/CPT codes 0537T–0540T noted as deleted effective 12/31/2024.

single doseapproved administration frequency

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 and Medical Necessity Criteria

Initial Therapy — Carvykti is considered medically necessary when ALL of the following are met:

Carvykti is considered medically necessary when ALL of the following are met:

Medical necessity for Carvykti: Approve a single dose if the patient meets ALL of the following (A, B, C, D, and E)

A. Age: Patient is ≥ 18 years of age

B. Prior therapy pathways: Patient meets ONE of the following (i or ii):

Immunomodulatory agents and proteasome inhibitors examples are listed in notes.

B.i (a): Patient has received one or more lines of systemic therapy, including one therapy from BOTH: (1) an immunomodulatory agent AND (2) a proteasome inhibitor

Immunomodulatory agents include thalidomide, lenalidomide, pomalidomide; proteasome inhibitors include bortezomib, carfilzomib, ixazomib.

B.i (b): Patient is refractory to lenalidomide

B.ii: Patient has received at least three prior lines of therapy

C. Lymphodepletion: Patient has received or plans to receive lymphodepleting chemotherapy prior to infusion of Carvykti

D. CAR-T Naive: Patient has not been previously treated with chimeric antigen receptor (CAR-T) therapy

Examples of CAR-T therapies are provided in policy.

E. Prescriber: Medication is prescribed by or in consultation with an oncologist

Dose and Administration — Dose and frequency when medically necessary

Dose and frequency when medically necessary:

Dose: Up to 1 x 10^8 CAR-T cells administered IV as a single dose

Recommended weight-based dosing is 0.5 to 1.0 x 10^6 CAR-T cells/kg, maximum 1 x 10^8.

Administrative change: Repeat administration of ciltacabtagene autoleucel (Carvykti) is no longer listed under Conditions Not Covered and is now addressed in the medical necessity criteria. The policy explicitly states approval for a single dose, and repeat dosing is not approved as routine. This administrative alignment moves the repeat-administration restriction into the main coverage criteria to clarify that only one therapeutic dose is authorized under the policy.

Claims and reimbursement: Services billed for conditions or diagnoses not covered under this policy (and not supported by covered diagnosis or procedure codes) will be denied as not covered. Providers must submit claims using the most appropriate covered diagnosis and procedure codes as of the date of service; submissions that lack the covered codes specified in the policy are subject to denial.

Billing Codes and Dose Display

Covered CPT/HCPCS/Q CodesmixedCovered

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.
0537T	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. (Code deleted 12/31/2024)
0538T	Chimeric antigen receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for transportation (eg, cryopreservation, storage). (Code deleted 12/31/2024)
0539T	Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preparation of CAR-T cells for administration. (Code deleted 12/31/2024)
0540T	Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous. (Code deleted 12/31/2024)
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.

Dose

Weight‑based dosing0.5 to 1.0 x 10^6 CAR‑T cells per kg of body weight

Maximum single doseMaximum 1 x 10^8 CAR‑T cells per infusion

FrequencySingle intravenous infusion (one therapeutic dose)

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for Carvykti (ciltacabtagene autoleucel). Claims submitted without an approved prior authorization or without covered diagnosis/procedure codes will be denied. Use the most appropriate and current codes as of the date of service; legacy codes deleted 12/31/2024 should not be submitted for reimbursement.

Prior authorization required before service.
Do not submit deleted HCPCS/CPT codes (0537T–0540T were deleted 12/31/2024).
Acceptable procedure codes include 38225, 38226, 38227, 38228 and Q2056 where applicable.

Documentation Required

Required Documentation

Providers must document that the patient meets all medical necessity criteria in the policy prior to authorization and billing. Documentation must include age, diagnosis of multiple myeloma, prior lines of therapy, lenalidomide-refractory status when applicable, planned lymphodepleting chemotherapy, absence of prior CAR-T treatment, and that the prescribing clinician is or consulted an oncologist.

Clinical Background

Background: Carvykti (ciltacabtagene autoleucel) is a BCMA-directed, genetically modified autologous CAR-T cell immunotherapy indicated for relapsed or refractory multiple myeloma in adults after prior therapy. The treatment is administered as a single intravenous infusion following planned lymphodepleting chemotherapy and carries serious risks (for example, cytokine release syndrome and neurotoxicity). It is available only under a restricted distribution/REMS program and requires specialized administration and monitoring.

Definitions and Drug Name

ciltacabtagene autoleucel (Carvykti)

Generic nameciltacabtagene autoleucel

Brand nameCarvykti

Mechanism / classBCMA‑directed genetically modified autologous CAR‑T cell immunotherapy

Indication summaryTreatment of relapsed or refractory multiple myeloma in adults after at least one prior line including a proteasome inhibitor and an immunomodulatory agent, refractory to lenalidomide (alternative pathway: ≥3 prior therapies)

Distribution restrictionAvailable only through the Carvykti REMS (restricted program)

Initial Authorization Criteria

Initial Therapy — Initial authorization criteria (detailed tree)

Initial authorization criteria

Initial authorization: See coverage criteria set: age ≥18; prior therapy pathway met (either lenalidomide-refractory after immunomodulatory agent + proteasome inhibitor or ≥3 prior lines); lymphodepleting chemotherapy planned/received; CAR-T naive; prescribed by or in consultation with an oncologist.

Continuation and Repeat Dosing

Continuation Therapy — Continuation/Repeat dosing criteria including single-dose restriction

Continuation/Repeat dosing

Repeat dosing: Policy specifies approval for a single dose; repeat administration is not approved as routine and repeat administration requirement was moved into medical necessity to state single-dose approval.

Step Therapy / Sequencing Notes

Step	Policy statement	Notes / guideline preference
1	No formal step-therapy sequence is required; approval is based on meeting the specified prior-line therapy history (either lenalidomide‑refractory after prior immunomodulatory agent + proteasome inhibitor OR receipt of ≥3 prior lines of systemic therapy).	NCCN lists Carvykti as a 'Preferred Regimen' for patients who are lenalidomide‑refractory after receiving an immunomodulatory agent and a proteasome inhibitor, and also for patients with ≥3 prior therapies.

Site of Care Considerations

Note

Site of care — clinically appropriate setting

Site of care should be reasonable and clinically appropriate and supported by evidence‑based literature; the policy does not restrict Carvykti to a single setting such as an exclusive infusion center.

Select a site of care based on clinical appropriateness, patient needs, and evidence‑based guidance.