CurrentViva HealthPolicy IC-0663

Carvykti (ciltacabtagene autoleucel) — prior authorization for relapsed/refractory multiple myeloma

Prior authorization policy for use of Carvykti (ciltacabtagene autoleucel) for adults with relapsed or refractory multiple myeloma and certain related plasma cell disorders; defines clinical, documentation, dosing, coding, and monitoring requirements for Viva Health coverage determinations.

Policy Summary

PayerViva Health

PolicyCarvykti (ciltacabtagene autoleucel) — prior authorization for relapsed/refractory multiple myeloma

Policy CodePolicy IC-0663

Change TypeNo material clinical changes

Effective Date04/04/2022

Next Review DateNov 4, 2025

Key ActionSubmit prior authorization with supporting clinical documentation (medical records, labs, prior therapy history, and confirmatory diagnostics) for a single treatment course; renewals are not permitted.

SourceLink

1 doseauthorization term

Q2056HCPCS

0.5-1.0 x10^6/kgdose range

>=18min age

Len-refractory or >=3 lineseligibility pathways

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Coverage Criteria for Carvykti

inv-01: Initial Approval Criteria

Covered when ALL of the following are met:

General eligibility: Patient is >=18 years of age; has not received prior CAR-T therapy; does not have an active infection or inflammatory disorder; has not received live vaccines within 6 weeks prior to lymphodepletion and will not receive live vaccines during ciltacabtagene autoleucel treatment until immune recovery; has been screened for CMV, HBV, HCV, and HIV prior to leukapheresis; prophylaxis for infection will follow institutional guidelines; used as single-agent therapy (except lymphodepleting or additional chemotherapy while awaiting manufacture); patient does not have known CNS involvement with myeloma.

Documentation required: medical records, chart notes, labs, and confirmatory diagnostics (including genetic/mutational testing when applicable) must be submitted via the prior authorization web portal or fax as part of the request.

Disease-specific eligibility (multiple myeloma): Patient has relapsed or refractory multiple myeloma AND either (1) patient has received at least one prior line of therapy that included a proteasome inhibitor and an immunomodulatory agent and is refractory to lenalidomide, OR (2) patient has received at least three prior lines of therapy.

Regimen may also be used for certain plasma cell disorders (POEMS, MIDD, MGRS) per policy note.

inv-02: Renewal

Renewal Criteria

Renewal: Authorization is not renewable; initial prior authorization is valid for a single treatment course (one therapeutic dose) and renewals are not permitted. Duration of authorization must not be exceeded as defined in Section I.

Requests for additional treatment courses beyond the one authorized single infusion will not be approved.

Known central nervous system involvement with myeloma is an exclusion to authorization. This policy requires that the patient does not have known central nervous system (CNS) involvement with myeloma as a condition of prior authorization for Carvykti.

Prior authorization is issued for a single treatment course (one dose) only. Requests for additional treatment courses beyond the one authorized single infusion (renewals) are not permitted and will not be authorized.

Component	dosing / timing	notes
Lymphodepleting chemotherapy	Cyclophosphamide 300 mg/m2 IV daily + fludarabine 30 mg/m2 IV daily for 3 days	Administered prior to CAR-T infusion as the conditioning regimen
Carvykti (ciltacabtagene autoleucel) single infusion	Infuse 2–4 days after completion of lymphodepleting chemotherapy	Infusion may be delayed up to 14 days for serious adverse reactions (eg, clinically significant active infection, cardiac or pulmonary toxicity, active GVHD)
Dose range	0.5–1.0 ×10^6 CAR-positive viable T cells/kg (recommended)	Maximum single-infusion cell count: 1 ×10^8 CAR-positive viable T cells

Coding and Billing Codes

Covered HCPCS CodesHCPCSCovered

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

NDCNDC

57894-0111-xx

Carvykti suspension for intravenous infusion single-dose bags/cassettes (NDC prefix)

Covered ICD-10 Diagnosis CodesICD-10Covered

C90.00	Multiple myeloma not having achieved remission
C90.02	Multiple myeloma, in relapse
C90.10	Plasma cell leukemia not having achieved remission
C90.12	Plasma cell leukemia in relapse
C90.20	Extramedullary plasmacytoma not having achieved remission
C90.22	Extramedullary plasmacytoma in relapse
C90.30	Solitary plasmacytoma not having achieved remission
C90.32	Solitary plasmacytoma in relapse
Z85.79	Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues

inv-08: Maximum single-infusion cell count

Maximum single-infusion cell countMaximum dose 1 x 10^8 CAR-positive viable T cells per single infusion

Recommended per‑kg dose range0.5–1.0 x 10^6 CAR-positive viable T cells/kg

Dose contextRecommended dose range applies to a single infusion following lymphodepleting chemotherapy

Provider Requirements and Submission Instructions

Prior Authorization

Single-course prior authorization

Prior authorization is required and will be issued for a single treatment course (one dose) only. Prior authorization validity will be provided initially for one treatment course (1 dose). Renewals are not permitted.

Initial: prior authorization valid for one treatment course (one dose).
Renewal: prior authorizations may NOT be renewed.

Prior Authorization

Prior therapy requirements

Patient must have relapsed or refractory disease and meet the regimen-specific prior therapy requirements. Either the patient has received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent and is refractory to lenalidomide, OR the patient has received at least three prior lines of therapy.

At least one prior line including a proteasome inhibitor (e.g., bortezomib) and an immunomodulatory agent (e.g., lenalidomide, thalidomide) and refractory to lenalidomide; OR
At least three prior lines of therapy.

Documentation Required

Required supporting documentation

Submit supporting clinical documentation including diagnosis, prior therapy history, laboratory results, and genetic/mutational testing when applicable. Documentation (medical records, chart notes, labs, and confirmatory diagnostics) must be provided at the time of the authorization request and will be reviewed as part of the evaluation.

Provide documentation related to diagnosis, step therapy, and clinical markers (e.g., genetic and mutational testing) supporting initiation when applicable.
Provide documentation via direct upload through the PA web portal or by fax.

Documentation Required

Documentation submission required

Failure to submit the required supporting clinical documentation (medical records, chart notes, laboratory results, and confirmatory diagnostics) may result in denial of the request due to inability to establish medical necessity. Records will be reviewed at the time of submission; ensure all relevant documentation is included with the request.

Required documents include: diagnosis, prior therapy history, lab results, screening for CMV/HBV/HCV/HIV when applicable, and genetic/mutational testing.
If records are not submitted, the request may be denied for lack of sufficient information to determine medical necessity.

Background and Therapeutic Context

Carvykti (ciltacabtagene autoleucel) is an autologous BCMA-directed CAR-T cell therapy for relapsed or refractory multiple myeloma. Treatment involves leukapheresis to collect the patient’s cells, manufacturing of autologous CAR‑T cells, lymphodepleting chemotherapy, and a single intravenous infusion of the product. Patients require pre-collection infection screening (including CMV, HBV, HCV, and HIV) and intensive post-infusion monitoring for cytokine release syndrome (CRS) and neurologic toxicities; supporting clinical documentation (medical records, labs, and confirmatory diagnostics) must be submitted with the prior authorization request.