CurrentBaylor Scott & White Health PlanPolicy 298

Ciltacabtagene autoleucel (Carvykti) coverage

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This prior authorization policy governs coverage of ciltacabtagene autoleucel (Carvykti), a BCMA-directed CAR-T therapy, for eligible adults with relapsed or refractory multiple myeloma. Documentation must demonstrate that all medical necessity, prior-treatment, safety, dosing, and specialist requirements are met.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyCiltacabtagene autoleucel (Carvykti) coverage

Policy CodePolicy 298

Change TypeRevision

Effective DateAug 1, 2026

Last ReviewJun 25, 2026

Next Review DateJun 25, 2027

Key ActionSubmit prior authorization documentation showing that all policy criteria are met.

SourceLink

POLICY UPDATE CHANGES

Criteria 1 through 4 were updated to align with standard language, and monotherapy use was added as a requirement.

Examples of immunomodulatory agents, proteasome inhibitors, and BCMA-targeted therapies were added.

Cardiac conditions, LVEF, and cumulative corticosteroid dose exclusion criteria were removed.

REMS criteria were removed.

CPT, HCPCS, and ICD-10 code sections were updated.

≥18 years

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CurrentBaylor Scott & White Health PlanPolicy 298

Ciltacabtagene autoleucel (Carvykti) coverage

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Sign up for baylor_scott_and_white_health_plan Policy 298 alerts

Get alerted when Policy 298 changes without checking for updates manually.

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Policy Summary

PayerBaylor Scott & White Health Plan

PolicyCiltacabtagene autoleucel (Carvykti) coverage

Policy CodePolicy 298

Change TypeRevision

Effective DateAug 1, 2026

Last ReviewJun 25, 2026

Next Review DateJun 25, 2027

Key ActionSubmit prior authorization documentation showing that all policy criteria are met.

SourceLink

POLICY UPDATE CHANGES

Criteria 1 through 4 were updated to align with standard language, and monotherapy use was added as a requirement.

Examples of immunomodulatory agents, proteasome inhibitors, and BCMA-targeted therapies were added.

Cardiac conditions, LVEF, and cumulative corticosteroid dose exclusion criteria were removed.

REMS criteria were removed.

CPT, HCPCS, and ICD-10 code sections were updated.

≥18 years

ECOG 0-1Performance status

1 treatmentLifetime treatment limit

≥1 prior linePrior therapy requirement

98%Reported response rate

Coverage Criteria

Initial medically necessary therapy

Covered when ALL of the following are met:

All medical necessity requirements

Member and treatment requirements
- Diagnosis and age: Member has relapsed or refractory multiple myeloma and is at least 18 years of age.
- Prescribing and administration: Ciltacabtagene is prescribed by or in consultation with a board-certified hematologist or oncologist, is dosed and administered according to FDA-approved labeling, and is used as monotherapy.
- Clinical status and organ function: Member has an Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 1 and adequate bone marrow, renal, hepatic, and cardiac function.ECOG 0-1
Apheresis and prior treatment requirements
- Apheresis candidacy: Member has been assessed by a hematologist/oncologist to be an appropriate candidate for apheresis.
- Qualifying prior therapy: Member has lenalidomide-refractory multiple myeloma and has received one or more prior lines of therapy containing both one immunomodulatory agent and one proteasome inhibitor.At least 1 prior line; 1 immunomodulatory agent and 1 proteasome inhibitor
  Examples of immunomodulatory agents include lenalidomide, pomalidomide, and thalidomide. Examples of proteasome inhibitors include bortezomib, carfilzomib, and ixazomib.
No prohibited prior therapies or exclusionary conditions
- Prior therapy history: Member has not previously been treated with CAR-T cell therapy and has not received prior B-cell maturation antigen (BCMA)-targeted therapy, such as teclistamab or elranatamab.
- Clinical exclusions: Member does not have an active infection, including hepatitis B, hepatitis C, or HIV infection; an inflammatory disorder; a history of allogeneic stem cell transplant within 6 months before apheresis; a history of autologous stem cell transplant within or equal to 12 weeks before apheresis; known active or prior central nervous system (CNS) involvement of multiple myeloma; or clinical signs of meningeal involvement of multiple myeloma.

Repeat treatment and other indications

Ciltacabtagene autoleucel is not medically necessary under this policy in either of the following situations:

Any noncovered use

Repeat administration: Ciltacabtagene autoleucel is administered more than once during the member's lifetime.One treatment per lifetime
Repeat administration is considered experimental and investigational because the effectiveness of this strategy has not been established.
Other indications: Ciltacabtagene autoleucel is used for an indication other than relapsed or refractory multiple myeloma meeting the policy criteria.
Treatment for other indications is considered experimental and investigational because the effectiveness of this strategy has not been established.

Coverage requires that the member has no prior CAR-T cell therapy and no prior BCMA-targeted therapy, including therapies such as teclistamab or elranatamab. The member must also have no active infection, including hepatitis B, hepatitis C, or HIV infection; inflammatory disorder; allogeneic stem cell transplant within 6 months before apheresis; autologous stem cell transplant within or equal to 12 weeks before apheresis; or known active or prior central nervous system involvement or clinical signs of meningeal involvement from multiple myeloma.

Repeat administration of ciltacabtagene autoleucel beyond one treatment per lifetime is considered experimental and investigational because the effectiveness of repeat treatment has not been established.

Ciltacabtagene autoleucel used for indications other than policy-covered relapsed or refractory multiple myeloma is considered experimental and investigational because the effectiveness of such use has not been established.

Coding

CPT CodesCPT

38225	Chimeric antigen receptor T-cell (CAR-T) therapy; harvest 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 (e.g., cryopreservation, storage)
38227	Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preservation of CAR-T cells for administration
38228	Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous

HCPCS CodesHCPCS

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

ICD-10 CodesICD-10

C90.00	Multiple myeloma not having achieved remission
C90.01	Multiple myeloma in remission
C90.02	Multiple myeloma in relapse
Z51.12	Encounter for antineoplastic

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit the request with documentation demonstrating that all applicable medical-necessity criteria are met; requests are reviewed by a clinical pharmacist and medical director.

Step Therapy

Required Prior Treatment Classes

Document that the member has lenalidomide-refractory multiple myeloma and has received one or more prior lines of therapy containing both required treatment classes.

At least one immunomodulatory agent, such as lenalidomide, pomalidomide, or thalidomide.
At least one proteasome inhibitor, such as bortezomib, carfilzomib, or ixazomib.

Background

Ciltacabtagene autoleucel is a BCMA-directed autologous CAR-T therapy. The member’s T cells are collected, genetically modified to recognize malignant plasma cells, and reinfused as a targeted antitumor treatment. The policy applies to adults with relapsed or refractory multiple myeloma who are lenalidomide-refractory and have received prior therapy that includes an immunomodulatory agent and a proteasome inhibitor. Because CAR-T treatment may cause cytokine release syndrome, neurologic toxicities, cytopenias, infections, and delayed neurologic events, administration requires specialized monitoring and multidisciplinary care.

Definitions

Chimeric antigen receptor (CAR) T-cell therapy

DefinitionAn autologous immunotherapy in which a patient’s T cells are collected, genetically modified to target cancer cells, and reinfused to produce a targeted antitumor response.

Cell sourceThe therapy uses the patient’s own T cells.

Primary useCAR T-cell therapies are primarily used to treat hematologic malignancies.

Multiple myeloma

DefinitionMultiple myeloma is a cancer of plasma cells in the bone marrow.

Disease featureThe disease leads to production of abnormal proteins.

Potential consequence

Initial Therapy Criteria

Initial ciltacabtagene therapy

Ciltacabtagene autoleucel may be medically necessary for initial treatment when ALL of the following criteria are met:

Initial ciltacabtagene therapy criteria: Member is at least 18 years of age and has relapsed or refractory, lenalidomide-refractory multiple myeloma; has received one or more prior lines of therapy containing one immunomodulatory agent and one proteasome inhibitor; has ECOG performance status between 0 and 1; has adequate bone marrow, renal, hepatic, and cardiac function; is an appropriate candidate for apheresis; receives ciltacabtagene according to FDA-approved labeling as monotherapy; and has no prior CAR-T therapy, prior BCMA-targeted therapy, or exclusionary clinical condition.Age ≥18; ECOG 0-1; at least 1 prior line; 1 immunomodulatory agent plus 1 proteasome inhibitor

Ciltacabtagene must be prescribed by or in consultation with a board-certified hematologist or oncologist. Exclusionary conditions include active infection, inflammatory disorder, recent allogeneic or autologous stem cell transplant, and active or prior CNS or meningeal multiple myeloma involvement.

Step Therapy

Step	Prior therapy requirement	Refractory criterion
1	One or more prior lines of therapy must include one immunomodulatory agent (for example, lenalidomide, pomalidomide, or thalidomide) and one proteasome inhibitor (for example, bortezomib, carfilzomib, or ixazomib).	Multiple myeloma must be refractory to lenalidomide.

Quantity Limits

Ciltacabtagene autoleucel (Carvykti)

Lifetime limitOne treatment per lifetime.

Repeat administrationRepeat administration beyond one treatment per lifetime is considered experimental and investigational.

RationaleThe effectiveness of repeat administration has not been established.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyCiltacabtagene autoleucel (Carvykti) coverage

Policy CodePolicy 298

Change TypeRevision

Effective DateAug 1, 2026

Last ReviewJun 25, 2026

Next Review DateJun 25, 2027

Key ActionSubmit prior authorization documentation showing that all policy criteria are met.

SourceLink

On This Page

Documentation Required

Required Clinical Documentation

Submit clinical documentation demonstrating that all medical-necessity criteria are satisfied for ciltacabtagene autoleucel (Carvykti).

Relapsed or refractory multiple myeloma and age 18 years or older.
Prescription by or consultation with a board-certified hematologist or oncologist.
FDA-label-consistent dosing and administration as monotherapy.
ECOG performance status of 0 or 1.
Adequate bone marrow, renal, hepatic, and cardiac function.

Denial Risk

Treatment and Safety History

Document the member’s treatment and safety history before requesting therapy. Prior CAR-T cell therapy or prior BCMA-targeted therapy disqualifies the request, and the listed safety exclusions must be absent.

The member must not have previously received CAR-T cell therapy.
The member must not have received prior BCMA-targeted therapy, such as teclistamab or elranatamab.
The member must have no active infection, inflammatory disorder, or disqualifying transplant history or CNS involvement.

Documentation Required

Specialist and Apheresis Documentation

Document that ciltacabtagene is prescribed by or used in consultation with a board-certified hematologist or oncologist and that the member has been assessed by a hematologist/oncologist as an appropriate candidate for apheresis.

Include specialist involvement in the treatment plan.
Include the hematology/oncology assessment supporting apheresis eligibility.

Denial Risk

Failure to Meet Medical Necessity Criteria

Requests may be denied when the member does not meet the covered diagnosis, age, prior-treatment, administration, performance-status, organ-function, or treatment-center eligibility requirements.

Covered diagnosis is relapsed or refractory multiple myeloma; the member must be at least 18 years old.
Therapy must be prescribed or supervised as required, administered according to FDA-approved labeling, and used as monotherapy.
The member must have ECOG 0–1, adequate bone marrow, renal, hepatic, and cardiac function, and eligibility for apheresis.
The member must have lenalidomide-refractory disease and prior therapy containing an immunomodulatory agent and a proteasome inhibitor.

Denial Risk

Exclusionary Clinical Conditions

The request may be denied if any listed exclusionary clinical condition is present.

Active infection, including hepatitis B, hepatitis C, or HIV infection.
Inflammatory disorder.
Allogeneic stem cell transplant within 6 months before apheresis.
Autologous stem cell transplant 12 weeks or less before apheresis.
Known active or prior central nervous system involvement, or clinical signs of meningeal involvement, from multiple myeloma.

Denial Risk

Repeat Lifetime Treatment

Only one lifetime treatment with ciltacabtagene autoleucel (Carvykti) is considered medically necessary. Repeat administration is considered experimental and investigational because its effectiveness has not been established.

Do not submit requests for treatment beyond one administration during the member’s lifetime.

Denial Risk

Uncovered Indication

Ciltacabtagene autoleucel is covered only for the specified relapsed or refractory multiple myeloma indication when all criteria are met. Treatment for other indications is considered experimental and investigational because effectiveness has not been established.

Requests for indications outside covered relapsed or refractory multiple myeloma may be denied.

Multiple myeloma can cause organ damage.

B-cell maturation antigen (BCMA)

DefinitionB-cell maturation antigen (BCMA) is a cell-surface target of ciltacabtagene autoleucel.

Therapeutic relationshipCiltacabtagene autoleucel is a BCMA-directed CAR T-cell therapy.

Targeted disease cellsThe therapy targets malignant plasma cells.