ModifiedBaylor Scott & White Health PlanPolicy 278

Axicabtagene ciloleucel (Yescarta®) coverage

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This policy governs prior authorization and medical-necessity review for axicabtagene ciloleucel (Yescarta) administered to eligible members. Coverage is limited to specified lymphoma indications and clinical criteria, with repeat treatment and all other indications considered experimental and investigational.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyAxicabtagene ciloleucel (Yescarta®) coverage

Policy CodePolicy 278

Change TypeModified

Effective DateOct 1, 2026

Last ReviewSep 24, 2026

Next Review DateSep 24, 2027

Key ActionPrior authorization is required for axicabtagene ciloleucel (Yescarta).

SourceLink

POLICY UPDATE CHANGES

Indication-specific criteria were added for primary central nervous system lymphoma and pediatric primary mediastinal large B-cell lymphoma.

The policy updated its diagnosis and procedure codes.

Primary CNS lymphoma was removed from the universal exclusion criteria and replaced with CNS involvement language.

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ModifiedBaylor Scott & White Health PlanPolicy 278

Axicabtagene ciloleucel (Yescarta®) coverage

Customize your policy alerts

Sign up for Baylor Scott & White Health Plan Policy 278 alerts

Get alerted when Policy 278 changes without checking for updates manually.

Monitor payer policy activity

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Policy Summary

PayerBaylor Scott & White Health Plan

PolicyAxicabtagene ciloleucel (Yescarta®) coverage

Policy CodePolicy 278

Change TypeModified

Effective DateOct 1, 2026

Last ReviewSep 24, 2026

Next Review DateSep 24, 2027

Key ActionPrior authorization is required for axicabtagene ciloleucel (Yescarta).

SourceLink

POLICY UPDATE CHANGES

Indication-specific criteria were added for primary central nervous system lymphoma and pediatric primary mediastinal large B-cell lymphoma.

The policy updated its diagnosis and procedure codes.

Primary CNS lymphoma was removed from the universal exclusion criteria and replaced with CNS involvement language.

RequiredPrior authorization

18+Minimum member age

ECOG 0-1Required performance status

1Lifetime Yescarta treatments

4Covered lymphoma indications

Medical Necessity Coverage Criteria

Universal Criteria

Covered when ALL universal criteria are met:

Universal criteria

Member is 18 years or older.
Axicabtagene is prescribed by or provided in consultation with a board-certified hematologist or oncologist.
Axicabtagene will be dosed and administered according to FDA-approved labeling.
Axicabtagene will be used as monotherapy.
Member has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.ECOG 0-1
Member has been assessed by a hematologist/oncologist to be an appropriate candidate for apheresis.
Documentation of CD-19 tumor expression is available.CD-19-positive disease
Member has had no prior treatment with CAR T-cell immunotherapy.
If the member has received prior anti-CD19 therapy, repeat biopsy indicates CD-19-positive disease.
Member does not have active hepatitis B, active hepatitis C, HIV infection, or uncontrolled infection.
Member has not undergone allogeneic hematopoietic stem-cell transplantation during the 84 days preceding leukapheresis.No allogeneic transplant within 84 days before leukapheresis

Large B-Cell Lymphoma

Covered for large B-cell lymphoma when ALL universal and indication-specific criteria are met:

Large B-cell lymphoma

All universal criteria are met.
Member has large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, or diffuse large B-cell lymphoma arising from follicular lymphoma for which the member has received chemotherapy.
Qualifying prior-treatment pathway
- First-line failure or early relapse
  - ONE of
    Disease is refractory to first-line chemoimmunotherapy, meaning partial response, no response, or progression.

Follicular Lymphoma

Covered for follicular lymphoma when ALL universal and indication-specific criteria are met:

Follicular lymphoma

All universal criteria are met.
Member has a diagnosis of follicular lymphoma.
Member has relapsed or refractory disease, defined as progressive disease or stable disease relapsing within 12 months.Relapse within 12 months
Member received two or more prior lines of systemic therapy containing both an anti-CD20 monoclonal antibody and an alkylating agent.At least 2 prior systemic therapy lines

Primary Central Nervous System Lymphoma

Covered for primary central nervous system lymphoma when ALL universal and indication-specific criteria are met:

Primary central nervous system lymphoma

All universal criteria are met.
Member has relapsed or refractory primary central nervous system lymphoma.
Member has received at least one prior high-dose methotrexate-containing regimen.At least 1 prior high-dose methotrexate-containing regimen

Pediatric PMBCL

Covered for pediatric primary mediastinal large B-cell lymphoma when ALL applicable criteria are met:

Pediatric primary mediastinal large B-cell lymphoma

Member meets all universal criteria apart from the standard age requirement.
Age and treatment pathway
- Member is 18 years of age or younger.Age <=18 years
- Member is younger than 39 years and is being treated under the pediatric NCCN PMBCL pathway.Age <39 years under pediatric NCCN PMBCL pathway
Member has relapsed or refractory primary mediastinal large B-cell lymphoma.

Relapsed or Refractory PCNSL

For relapsed or refractory primary central nervous system lymphoma:

NCCN treatment option

Member has relapsed or refractory primary central nervous system lymphoma.
Axicabtagene is being considered as an NCCN Category 2A treatment option.NCCN Category 2A

Pediatric PMBCL: Treatment Pathways and CAR-T Options

For pediatric primary mediastinal large B-cell lymphoma, clinical trial enrollment is preferred and the following treatment pathways are described:

Pediatric PMBCL treatment pathway

For first-line therapy, NCCN options include dose-adjusted EPOCH-R, RCHOP with or without radiation therapy, or LMB modified group B/C chemotherapy plus rituximab.
For relapsed or refractory disease, second-line cross-resistant chemoimmunotherapy followed by autologous hematopoietic cell transplantation is recommended.
CAR-T treatment setting
- Patient achieves a partial response to second-line therapy; axicabtagene or lisocabtagene may be considered.Partial response to second-line therapy
- Patient achieves less than a partial response to second-line therapy; clinical trial or best supportive care is recommended.

Coverage requires that the member not have active hepatitis B (HBsAg-positive), active hepatitis C, HIV infection, or an uncontrolled infection. The member must also not have undergone allogeneic hematopoietic stem-cell transplantation within the 84 days before leukapheresis.

Only one axicabtagene ciloleucel treatment per lifetime is considered medically necessary. Repeat administration is considered experimental and investigational because the effectiveness of repeat treatment has not been established.

Axicabtagene ciloleucel for indications other than the lymphoma pathways addressed by this policy is considered experimental and investigational because the effectiveness of treatment for those indications has not been established.

Billing and 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 CodeHCPCS

Q2041

Axicabtagene ciloleucel, up to 200 million autologous anti-CD19 CAR positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose

Diagnosis CodesICD-10

C83.30-C83.39	Diffuse large B-cell lymphoma
C83.390	Primary central nervous system lymphoma
C85.20-C85.29	Mediastinal (thymic) large B-cell lymphoma
C85.80-C85.89	Other specified types of non-Hodgkin lymphoma

Authorization, Documentation, and Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for all axicabtagene ciloleucel (Yescarta®) requests. BSWHP will review the submitted documentation for medical necessity before treatment is authorized.

Note

Clinical Review and Program References

All requests are reviewed by a clinical pharmacist and medical director. Confirm the member’s plan-specific coverage requirements and applicable program guidance before submission.

For commercial coverage, review the applicable Evidence of Coverage (EOC) or Summary Plan Description (SPD).
For Medicare plans, refer to Medicare NCD 110.24, Chimeric Antigen Receptor (CAR) T-cell Therapy.
For Medicaid plans, confirm coverage under the Texas Medicaid Provider Procedures Manual (TMHP/TMPPM); Texas Mandate HB154 applies to Medicaid plans.

Therapy Overview

Axicabtagene ciloleucel is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell immunotherapy. The patient's peripheral blood cells are collected by leukapheresis and used to prepare genetically modified T cells that recognize and eliminate CD19-expressing cells. The therapy is administered as a patient-specific cellular treatment after the member has been assessed as an appropriate candidate for apheresis.

Clinical and Disease Definitions

Large B-cell lymphoma terminology

Diffuse large B-cell lymphoma not otherwise specifiedIncluded within large B-cell lymphoma (LBCL).

Primary mediastinal large B-cell lymphomaIncluded within LBCL.

High-grade B-cell lymphomaIncluded within LBCL.

Diffuse large B-cell lymphoma arising from follicular lymphomaIncluded when the member has received chemotherapy.

Relapsed or refractory disease

Refractory diseasePartial response, no response, or progression after first-line chemoimmunotherapy.

Early relapsed disease

Required Treatment Line and Disease Setting

Second-Line Therapy: Large B-Cell Lymphoma

Axicabtagene qualifies as second-line therapy for large B-cell lymphoma when ONE of the following treatment settings applies:

ONE of

First-line refractory disease or early relapse
- ONE of
  - Disease is refractory to first-line chemoimmunotherapy, meaning partial response, no response, or progression.
  - Disease relapsed from complete remission within 12 months of first-line chemoimmunotherapy.Relapse within 12 months
Multiple prior systemic lines

Required Tumor Biomarkers

CD-19 requirement

Applies toAll axicabtagene requests.

Required findingCD-19 tumor expression must be documented.

Disease statusThe tumor must be CD-19-positive.

Repeat CD-19 confirmation

When requiredWhen the member has received prior anti-CD19 therapy, such as tafasitamab or loncastuximab.

Required testA repeat biopsy is required.

Required resultThe repeat biopsy must indicate CD-19-positive disease.

Covered Treatment Regimens

Indication	Regimen	Coverage
All covered indications	Axicabtagene ciloleucel monotherapy, dosed and administered according to FDA-approved labeling	Covered

Indication	Regimen	Coverage
Repeat treatment	Repeat axicabtagene ciloleucel administration	Not covered; experimental and investigational

Indication	Regimen	Coverage
Relapsed or refractory pediatric or adult primary mediastinal large B-cell lymphoma with a partial response to second-line therapy	Axicabtagene ciloleucel or lisocabtagene maraleucel CAR-T therapy	Covered

Treatment setting	Regimen	Coverage
First-line pediatric primary mediastinal large B-cell lymphoma	Dose-adjusted EPOCH-R; RCHOP with or without radiation therapy; or LMB modified group B/C chemotherapy plus rituximab	NCCN-listed option

Treatment setting	Regimen	Coverage
Relapsed or refractory pediatric or adult primary mediastinal large B-cell lymphoma	Cross-resistant chemoimmunotherapy followed by autologous hematopoietic cell transplantation	Recommended second-line option

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyAxicabtagene ciloleucel (Yescarta®) coverage

Policy CodePolicy 278

Change TypeModified

Effective DateOct 1, 2026

Last ReviewSep 24, 2026

Next Review DateSep 24, 2027

Key ActionPrior authorization is required for axicabtagene ciloleucel (Yescarta).

SourceLink

On This Page

Disease relapsed from complete remission within 12 months of first-line chemoimmunotherapy.Relapse within 12 months

Multiple prior systemic lines with relapsed or refractory disease

Member received two or more lines of systemic therapy containing both an anthracycline chemotherapy regimen and an anti-CD20 monoclonal antibody, unless the tumor is CD-20 negative.At least 2 systemic therapy lines
ONE of
- Progressive disease or stable disease relapsed within 6 months.Relapse within 6 months
- Disease progression or recurrence occurred within 12 months after prior autologous stem-cell transplantation.Progression or recurrence within 12 months after ASCT
- When salvage therapy is given after autologous stem-cell transplantation, the member had no response to or relapsed after the last line of therapy.

If diffuse large B-cell lymphoma arose from follicular lymphoma, the member received an anthracycline-based regimen unless contraindicated.

Member has received two or more prior chemoimmunotherapy regimens.At least 2 prior chemoimmunotherapy regimens

Axicabtagene will be used as consolidation or additional therapy following partial response to chemoimmunotherapy.Partial response required

CAR-T therapy is not identified as an option in this response setting.

Documentation Required

Clinical Criteria Documentation

Submit documentation demonstrating that all universal criteria and the applicable indication-specific criteria are satisfied. Include clinical records supporting the diagnosis, treatment history, disease status, prior regimens, and planned Yescarta® administration.

Universal criteria: member is at least 18 years old, except where the specified PMBCL exception applies; treatment is prescribed by or performed in consultation with a board-certified hematologist or oncologist; dosing and administration follow FDA-approved labeling; and Yescarta® is used as monotherapy.
Document ECOG performance status of 0 or 1, appropriateness for apheresis, CD-19 tumor expression, no prior CAR-T-cell immunotherapy, and repeat-biopsy CD-19 positivity when prior anti-CD19 therapy was used.
Document absence of active hepatitis B, active hepatitis C, HIV infection, uncontrolled infection, and allogeneic hematopoietic stem-cell transplantation within 84 days before leukapheresis.
For LBCL, document the qualifying diagnosis and refractory or relapsed disease, including required prior chemoimmunotherapy, anthracycline and anti-CD20 therapy, and applicable post-ASCT disease history.
For FL, document follicular lymphoma, relapsed or refractory disease, and at least two prior systemic therapy lines containing an anti-CD20 monoclonal antibody and an alkylating agent.
For PCNSL, document relapsed or refractory primary CNS lymphoma and at least one prior high-dose methotrexate-containing regimen.
For PMBCL, document the applicable age exception or pediatric NCCN PMBCL pathway, relapsed or refractory disease, at least two prior chemoimmunotherapy regimens, and use as consolidation/additional therapy following partial response.

Documentation Required

Eligibility and Biomarker Documentation

Document candidacy for leukapheresis and the required biomarker and treatment history before requesting authorization.

Hematologist/oncologist assessment that the member is an appropriate candidate for apheresis.
Pathology or other clinical documentation confirming CD-19 tumor expression.
If prior anti-CD19 therapy was received, submit a repeat biopsy showing CD-19-positive disease.
Confirm that the member has not previously received CAR-T-cell immunotherapy, including lisocabtagene or tisagenlecleucel.

Denial Risk

Failure to Meet Clinical Criteria

Requests may be denied when required clinical criteria are not met or when an exclusion applies. In particular, BSWHP requires ECOG performance status of 0 or 1 and CD-19-positive disease when the policy requires confirmation after prior anti-CD19 therapy.

No documented CD-19 tumor expression, or no CD-19-positive repeat biopsy after prior anti-CD19 therapy, does not meet the applicable criteria.
An ECOG performance status outside 0 or 1 does not meet the universal criteria.
Active hepatitis B or C, HIV infection, uncontrolled infection, or allogeneic hematopoietic stem-cell transplantation within 84 days before leukapheresis are exclusionary.

Denial Risk

Repeat Treatment Excluded

BSWHP considers only one Yescarta® treatment per lifetime medically necessary. Repeat administration is considered experimental and investigational because effectiveness has not been established.

Denial Risk

Other Indications Not Covered

BSWHP considers Yescarta® for indications other than those addressed by the policy criteria to be experimental and investigational because effectiveness has not been established.

Billing Rule

Codes Do Not Establish Coverage

Applicable diagnosis and procedure codes may support claim processing, but codes alone do not establish coverage or guarantee reimbursement. The patient must satisfy all policy criteria and applicable plan requirements.

The policy notes that an inclusive diagnosis-code list may not be presented because of the wide range of applicable codes and potential code changes.
Submit clinical documentation with any applicable codes; code inclusion does not override the medical-necessity criteria.

Relapse from complete remission within 12 months of first-line chemoimmunotherapy.

Relapsed or refractory disease after multiple systemic linesFor the LBCL multiple-line pathway, progressive disease or stable disease relapsing within 6 months, progression or recurrence within 12 months after autologous stem-cell transplant, or no response to or relapse after the last post-transplant salvage therapy.

Follicular lymphoma disease statusProgressive disease or stable disease relapsing within 12 months.

CAR T-cell therapy

Therapy typeGenetically modified autologous T-cell immunotherapy.

Targeting mechanismUses a chimeric antigen receptor to identify and eliminate CD19-expressing cells.

Cell sourcePrepared from the patient's peripheral blood cells obtained by leukapheresis.

Primary central nervous system lymphoma

Disease classificationA rare and aggressive extranodal non-Hodgkin lymphoma.

Sites of involvementArises within the brain, spinal cord, cerebrospinal fluid, or leptomeninges.

Most common histologyMost cases are diffuse large B-cell lymphoma.

Primary mediastinal large B-cell lymphoma

Typical presentationUsually presents as a bulky mediastinal mass.

Primary anatomical siteThe anterior mediastinum.

Possible local extensionMay spread to adjacent structures, including the chest wall, pleura, pericardium, and lung.

Other disease distributionExtrathoracic spread to the kidney or liver may occur; central nervous system and bone marrow involvement are generally rare.

Member received two or more lines of systemic therapy containing both an anthracycline chemotherapy regimen and an anti-CD20 monoclonal antibody, unless the tumor is CD-20 negative.At least 2 systemic therapy lines

Relapsed or refractory disease defined as ONE of

Progressive disease or stable disease relapsed within 6 months.Relapse within 6 months
Disease progression or recurrence occurred within 12 months after prior autologous stem-cell transplantation.Within 12 months after ASCT
When salvage therapy is given after autologous stem-cell transplantation, the member had no response to or relapsed after the last line of therapy.

Salvage Therapy: Follicular Lymphoma

Salvage therapy is supported when ALL of the following are met:

Follicular lymphoma salvage setting

Member has relapsed or refractory follicular lymphoma, defined as progressive disease or stable disease relapsing within 12 months.Relapse within 12 months
Member received two or more prior lines of systemic therapy containing both an anti-CD20 monoclonal antibody and an alkylating agent.At least 2 prior systemic therapy lines

Salvage Therapy: Primary CNS Lymphoma

Salvage therapy is supported when ALL of the following are met:

Primary CNS lymphoma salvage setting

Member has relapsed or refractory primary central nervous system lymphoma.
Member has received at least one prior high-dose methotrexate-containing regimen.At least 1 prior regimen

Salvage Therapy: Pediatric PMBCL

Salvage therapy for pediatric PMBCL is supported when ALL of the following are met:

Pediatric PMBCL salvage setting

Member meets all universal criteria apart from the standard age requirement and is either 18 years or younger or younger than 39 years under the pediatric NCCN PMBCL pathway.Age <=18 years OR age <39 years under pediatric NCCN PMBCL pathway
Member has relapsed or refractory primary mediastinal large B-cell lymphoma.
Member has received two or more prior chemoimmunotherapy regimens.At least 2 prior regimens
Axicabtagene will be used as consolidation or additional therapy following partial response to chemoimmunotherapy.Partial response required

Salvage Therapy: Relapsed or Refractory PCNSL

Salvage therapy for relapsed or refractory primary CNS lymphoma:

Relapsed or refractory PCNSL treatment setting

Member has relapsed or refractory primary central nervous system lymphoma.
Axicabtagene is identified as an NCCN Category 2A treatment option.NCCN Category 2A

Second-Line Therapy: PMBCL

Second-line therapy for PMBCL supports CAR-T treatment when ALL of the following are met:

PMBCL second-line response setting

Member has relapsed or refractory primary mediastinal large B-cell lymphoma.
Member has received second-line therapy.
Member has achieved a partial response to second-line therapy.Partial response to second-line therapy
CAR-T option
- Axicabtagene may be used.
- Lisocabtagene may be used.

CD-20 treatment history

Applies toThe LBCL pathway requiring two or more lines of systemic therapy.

Treatment requirementPrior systemic therapy must include an anti-CD20 monoclonal antibody, unless the tumor is CD-20 negative.

ExceptionAnti-CD20 therapy is not required when the tumor is CD-20 negative.