CurrentCareSourcePolicy N/A

Carvykti (ciltacabtagene autoleucel) medical coverage

Defines prior authorization and medical necessity criteria for Carvykti (ciltacabtagene autoleucel) as a medical benefit for treatment of relapsed or refractory multiple myeloma in adults.

Policy Summary

PayerCareSource

PolicyCarvykti (ciltacabtagene autoleucel) medical coverage

Policy CodePolicy N/A

Change TypeRevised coverage criteria and references

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent, and confirm REMS enrollment before Carvykti administration.

SourceLink

POLICY UPDATE CHANGES

Updated references and changed prior lines of therapy requirement wording from 'at least 3 prior lines of therapy' to 'at least 1 prior line of therapy' consistent with labeling.

Effective date set to 07/01/2025 and revised date 12/09/2024 recorded.

18+Minimum member age for coverage

Prior authAuthorization status

ECOG 0-1Performance status required

0.5-1.0 x10^6/kgAllowed dose range

1 x10^8Dose maximum

3 moInitial approval period

Medical Necessity Criteria for Carvykti (ciltacabtagene autoleucel)

Initial authorization — Multiple myeloma

Covered when ALL of the following are met:

ALL of the following

Member is at least 18 years of age
Member has a diagnosis of relapsed or refractory multiple myeloma
Healthcare facility/provider has enrolled in the Carvykti REMS program
Prior therapy requirements
- Member's disease has progressed after receiving at least 1 line of therapy

Policy Summary

PayerCareSource

PolicyCarvykti (ciltacabtagene autoleucel) medical coverage

Policy CodePolicy N/A

Change TypeRevised coverage criteria and references

Effective DateJul 1, 2025

Next Review DateN/A

SourceLink

On This Page

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Prior therapy included a proteasome inhibitor

Prior therapy included an immunomodulatory agent

Member is refractory to lenalidomide

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Dosage within allowed limits: 0.5 - 1.0 x 10^6 CAR-positive viable T cells per kg of body weight0.5 - 1.0 x 10^6 CAR-positive viable T cells per kg of body weight

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

Authorization period

When initial criteria are met:

ALL of the following

Medication will be approved for 3 months

Reauthorization

Reauthorization rules

ALL of the following

Carvykti will not be reauthorized (no criteria provided for continuation)

Not medically necessary / Exclusions

Not covered when any of the following apply:

ANY of the following

Treatment of conditions not listed in this document (off-label indications)

Actions Required of Providers

Prior Authorization

Prior authorization required

Prior authorization is required for Carvykti; approval is granted for 3 months when initial criteria are met.

Documentation Required

REMS enrollment

Healthcare facility/provider must be enrolled in the Carvykti REMS program prior to administration.

Documentation Required

Prior therapy documentation

Provider must document prior lines of therapy demonstrating at least 1 prior line including a proteasome inhibitor and an immunomodulatory agent, and that the member is refractory to lenalidomide.

Document at least 1 prior line of therapy that included a proteasome inhibitor and an immunomodulatory agent.
Document that the member is refractory to lenalidomide.

Denial Risk

Off-label use not covered

Carvykti is considered not medically necessary for indications not listed in the policy and will be denied if used off-label without following the Off-Label policy.

Procedure and Diagnosis Codes

Procedure/HCPCS/CPT/ICD-10 codesmixed

No codes listed

Clinical Thresholds and Limits

Coverage thresholds

Minimum age>= 18 years

ECOG performance status0 or 1

Dose range0.5 - 1.0 x10^6 CAR-positive viable T cells/kg

Maximum single infusion dose1 x10^8 CAR-positive viable T cells

Clinical Background

Carvykti (ciltacabtagene autoleucel) is a BCMA-directed autologous CAR T-cell therapy approved for adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and who are refractory to lenalidomide. (See prescribing information for full labeling.)

The therapy involves harvesting the patient’s own T cells, genetically modifying them ex vivo to express a chimeric antigen receptor that recognizes B-cell maturation antigen (BCMA) on malignant plasma cells, and reinfusing the re-engineered cells back into the patient to target and kill myeloma cells.

Administration of Carvykti requires prior authorization and must be provided at a healthcare facility/provider enrolled in the Carvykti REMS program. Dosing is weight-based; the allowed range is 0.5–1.0 x 10^6 CAR-positive viable T cells per kg with a maximum single infusion dose of 1 x 10^8 CAR-positive viable T cells.

Defined Terms

Definitions

REMSRisk Evaluation and Mitigation Strategy program specific to Carvykti requiring enrollment of healthcare facilities/providers.

ECOGEastern Cooperative Oncology Group performance status, a measure of functional status.

Policy Updates

2024-12-09Material revisionLatest

Updated references and changed prior lines of therapy requirement wording from 'at least 3 prior lines of therapy' to 'at least 1 prior line of therapy' consistent with labeling.

2025-07-01Administrative effective date

Policy effective date set to 07/01/2025; revised date recorded as 12/09/2024.