ModifiedBaylor Scott & White Health PlanPolicy 279

Tisagenlecleucel (Kymriah®) — Medical Coverage Policy

Medical necessity and prior authorization criteria for use of tisagenlecleucel (Kymriah®) across pediatric B-cell precursor ALL and adult B-cell lymphomas for members of Baylor Scott & White Health Plan.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyTisagenlecleucel (Kymriah®) — Medical Coverage Policy

Policy CodePolicy 279

Change TypeOperational clarifications and criteria updates

Effective Date11/1/2025

Next Review Date9/8/2026

Key ActionObtain prior authorization and submit documentation demonstrating all required clinical criteria including board-certified hematologist/oncologist involvement, dosing per FDA labeling, monotherapy use, apheresis candidacy, and CD19 tumor expression.

SourceLink

POLICY UPDATE CHANGES

Updated beginning note to align with standard language and updated prescriber, age, dosing/administration, monotherapy, and apheresis language to align with standard language; removed REMS program requirement and some universal exclusion criteria.

Added examples of anti-CD19 therapies and clarified no prior CAR T-cell therapy requirement formatting.

Specified only one lifetime treatment with tisagenlecleucel is considered medically necessary; repeat administration is experimental/investigational.

1treatment per lifetime considered medically necessary

≤25age limit for B-ALL

≥18

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age requirement for B-cell lymphoma

Prior authadministrative requirement

Policy 279document identifier

Coverage and Medical Necessity Criteria

inv-01: Universal criteria

Covered when ALL universal criteria are met:

Universal Criteria: 1) Tisagenlecleucel is prescribed by or in consultation with a board-certified hematologist or oncologist; 2) Tisagenlecleucel will be dosed and administered according to FDA-approved labeling; 3) Tisagenlecleucel will be used as monotherapy; 4) Member has been assessed by a hematologist/oncologist to be an appropriate candidate for apheresis; 5) Member has documentation of CD19 tumor expression; 6) Member has had no prior treatment with CAR T-cell immunotherapy (e.g., axicabtagene, brexucabtagene, liscabtagene, obecabtagene); 7) If the member has received prior anti-CD19 therapy (e.g., tafasitamab, loncastuximab, blinatumomab), the member's repeat biopsy indicates CD19-positive disease; 8) Member does NOT have any of the following: a) Active hepatitis B (HBs AG-positive), active hepatitis C, HIV infection, or uncontrolled infection; b) Active CNS malignancy involvement with presence of lymphoblasts (WBC ≥ 5 cells/mcL in cerebrospinal fluid).

Universal criteria apply to all requests

inv-02: B-cell precursor Acute Lymphoblastic Leukemia (B-ALL) criteria

B-cell precursor ALL specific — Covered when ALL of the following are met:

B-ALL Criteria: 1) Member meets all universal criteria; 2) Member is 25 years or younger; 3) Karnofsky or Lansky performance score ≥ 50% or ECOG performance score 0-3; 4) Diagnosis of B-cell precursor acute lymphoblastic leukemia (B-ALL); 5) For Ph-negative disease: a) Primary refractory (no complete response after 2 cycles of standard chemotherapy) or chemorefractory (no complete response after 1 cycle of standard chemotherapy for relapsed disease), OR b) Second or greater bone marrow relapse; 6) For Ph-positive disease: a) Contraindication, intolerance, or failure of two prior lines of tyrosine kinase inhibitor (TKI) therapy (e.g., imatinib, dasatinib, ponatinib), OR b) Any bone marrow relapse after allogeneic stem cell transplant.

Indication aligns with FDA‑labeled pediatric/young adult B‑ALL use

inv-03: B-cell lymphoma criteria

B-cell lymphoma specific — Covered when ALL of the following are met:

B-cell Lymphoma Criteria: 1) Member meets all universal criteria; 2) Member is 18 years or older; 3) ECOG performance status 0-1; 4) Diagnosis is one of: a) Diffuse large B-cell lymphoma (DLBCL) not otherwise specified; b) High-grade B-cell lymphoma; c) DLBCL arising from follicular lymphoma; d) Follicular lymphoma (FL); 5) Tisagenlecleucel will be used as third-line or subsequent therapy (i.e., after two or more prior lines of systemic therapy).

Only one lifetime treatment is considered medically necessary; repeat administration is experimental/investigational.

BSWHP considers repeat administration of tisagenlecleucel (Kymriah®) to be experimental and investigational because effectiveness of repeat dosing has not been established. Tisagenlecleucel is covered only when all applicable policy criteria are met for the specified indications and dosing is consistent with FDA labeling and the policy's universal criteria.

No additional explicit exclusions beyond those stated in the universal criteria and disease‑specific sections are provided in the referenced material. The policy notes that the Medical Coverage Policy Committee will continue to review evidence and may modify exclusions if new data emerge.

Repeat administration of tisagenlecleucel (Kymriah®) is considered not medically necessary and experimental and investigational; only one lifetime treatment with tisagenlecleucel is specified as medically necessary in this policy because the benefit of repeat treatment has not been established.

The provided text contains no additional statements designating other services or indications as not medically necessary. The policy indicates ongoing evidence surveillance and potential future updates based on emerging literature.

Approved Regimens and Dosing

Regimen	Indication	Coverage status
Single-dose tisagenlecleucel infusion per FDA labeling (monotherapy)
Pediatric B-cell precursor acute lymphoblastic leukemia (B-ALL) that is refractory or in second or later relapse; patients up to 25 years of age
Covered

Regimen	Indication / approval note	Coverage status
Tisagenlecleucel (Kymriah®)
Adult relapsed or refractory follicular lymphoma after two or more lines of systemic therapy — accelerated approval based on response rate; continued approval may be contingent on confirmatory trials
Covered

Billing and Diagnosis Codes

CPT CodesCPT

36511

Therapeutic apheresis; for white blood cells.

HCPCS CodesHCPCS

Q2042	Kymriah (Tisagenlecleucel)
S2107	Adoptive immunotherapy i.e., development of specific antitumor reactivity (e.g., tumor-infiltrating lymphocyte therapy) per course of treatment.

ICD-10 Codes (may apply)ICD-10

C83.30 - C83.39	Diffuse large B-cell lymphoma
C85.20 - C85.29	Primary mediastinal large B-cell lymphoma
C91.00 - C91.02	Acute lymphoblastic leukemia

ICD10 Not coveredICD-10Not Covered

D47.Z1

Post-transplant lymphoproliferative disorder

Performance status requirements (Karnofsky/Lansky or ECOG) for indications

B-ALL performance requirementKarnofsky or Lansky ≥50% OR ECOG 0–3 for members ≤25 years with B-cell precursor ALL

B-cell lymphoma performance requirementECOG performance status 0–1 for adult members (≥18 years) with B-cell lymphoma

Assessment sourcePerformance status must be documented by treating hematologist/oncologist as part of eligibility evaluation

Authorization, Documentation, and Provider Requirements

Note

Policy identification and prior authorization note

Policy Number: 279 — MEDICAL COVERAGE POLICY for Tisagenlecleucel (Kymriah®). No explicit prior authorization steps beyond the plan's general prior authorization requirement are specified here; please review the member's Evidence of Coverage (EOC) or Summary Plan Description (SPD) for plan-specific prior authorization procedures and any Medicare/Medicaid routing (Medicare NCD 110.24; Texas Medicaid TMPPM and HB154 where applicable).

Denial Risk

Denial triggers for failing universal criteria

Denial may be issued if universal criteria are not met or required documentation is missing. Common operational denial triggers include: prescriber is not a board-certified hematologist or oncologist (or lack of documentation of consultation), dosing or administration not per FDA labeling, absence of documentation of CD19 tumor expression, prior CAR T-cell therapy, lack of assessment for apheresis candidacy, active uncontrolled infection or excluded comorbidities, or missing performance status/line-of-therapy documentation.

Prescriber not board-certified hematologist/oncologist or missing consultation note
Dosing/administration not per FDA labeling or not documented

Required Line(s) of Therapy for Coverage

inv-24: third-line_or_subsequent

Tisagenlecleucel is covered when used as third-line or subsequent therapy per the following:

Third-line or subsequent therapy: Tisagenlecleucel will be used as third-line or subsequent therapy for adult relapsed/refractory large B-cell lymphomas and for follicular lymphoma after two or more lines of systemic therapy.

Applies to eligible adult B‑cell lymphoma indications; aligns with FDA labeled adult lymphoma indications

inv-25: second-line_or_subsequent

Tisagenlecleucel is covered when used as second-line or subsequent therapy per the following:

Second-line or subsequent therapy: Indicated for patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse (i.e., second-line or subsequent therapy).

Applies to pediatric/young adult B-ALL indication consistent with FDA labeling

Tumor Biomarker and Pathology Requirements

CD19 — documented tumor expression; if prior anti-CD19 therapy given, repeat biopsy must indicate CD19 positive disease

Required biomarkerDocumented tumor expression of CD19 is required for all requests

Prior anti-CD19 therapyIf prior anti-CD19 therapy (e.g., tafasitamab, loncastuximab, blinatumomab) was given, a repeat biopsy must show CD19-positive disease

Documentation responsibilityCD19 expression must be documented in the patient record and submitted with prior authorization request

Definitions and Drug Description

Tisagenlecleucel (Kymriah®) — CD19-directed genetically modified autologous T-cell immunotherapy key attributes

Therapy typeCD19-directed genetically modified autologous T-cell immunotherapy (tisagenlecleucel, Kymriah®)

CAR designCAR includes a murine single-chain antibody fragment targeting CD19 fused to intracellular signaling domains from 4-1BB (CD137) and CD3 zeta

Indications summaryIndicated for pediatric B-cell precursor ALL (≤25 yrs) refractory or second/later relapse and certain adult relapsed/refractory large B-cell lymphomas and follicular lymphoma after ≥2 lines

CAR T-cell therapy / tisagenlecleucel — general definition and referenced trials

DefinitionCAR T-cell therapy: autologous T cells genetically modified to express a chimeric antigen receptor (CAR) targeting CD19 to identify and eliminate CD19-expressing malignant cells

Background

Tisagenlecleucel (Kymriah®) is an autologous, genetically modified CD19‑directed chimeric antigen receptor (CAR) T‑cell therapy produced from a patient’s leukapheresis product. The therapy reprograms the patient’s T cells to target CD19‑expressing malignant B cells and is administered as a single‑dose infusion per FDA labeling for indicated B‑cell malignancies.

Policy Revision History

2025-09-08policy_updatedLatest

Updated beginning note, age requirement, prescriber requirement, removed REMS requirement, clarified dosing/administration, monotherapy and apheresis language, added examples of anti-CD19 therapies, revised universal exclusion criteria and lifetime treatment language, and updated background and citations.

2024-10-14formatting_update

Reformatted policy with Universal and Specific criteria and aligned universal exclusion criteria across CAR-T therapies.

2023-10-26reviewed

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyTisagenlecleucel (Kymriah®) — Medical Coverage Policy

Policy CodePolicy 279

Change TypeOperational clarifications and criteria updates

Effective Date11/1/2025

Next Review Date9/8/2026

SourceLink

On This Page

Missing proof of CD19 tumor expression or repeat biopsy when prior anti‑CD19 therapy received

Evidence of prior CAR T-cell therapy (makes request ineligible)

Missing documentation of apheresis assessment or performance status

Active uncontrolled infections or excluded CNS involvement noted without appropriate documentation

Note

Authorization / denial trigger note

This policy does not list specific automated authorization/denial triggers (e.g., system flags or time-based approvals). Determinations are expected to be made based on submitted clinical documentation against the policy criteria.

Prior Authorization

Prior lines of therapy requirements

Prior lines of therapy requirements are explicit in the disease-specific criteria: for B-cell precursor ALL (Ph-negative) members must have primary refractory or second-or-greater marrow relapse after standard chemotherapy as defined; for Ph-positive ALL members must have contraindication/intolerance/failure of two prior TKIs or relapse after allogeneic SCT; for B‑cell lymphoma indications, tisagenlecleucel is considered only as third-line or subsequent therapy. Documentation of prior therapies and responses (including number of lines, agents, and reasons for discontinuation) must be provided.

B-ALL (Ph-negative): primary refractory after ≥2 cycles or chemorefractory after 1 cycle for relapsed disease, or second+ marrow relapse
B-ALL (Ph-positive): failed/intolerant to two TKIs or marrow relapse after allogeneic SCT
B-cell lymphoma: therapy line = third-line or later; only one lifetime administration allowed

Step Therapy

Step therapy

No step therapy requirements are specified in this policy — there is no mandated step or trial of alternative agents listed prior to consideration beyond the disease-specific prior-line thresholds noted above.

Documentation Required

Required documentation to support requests

Required documentation should accompany requests to demonstrate all applicable criteria are met: board-certified hematologist/oncologist prescribing or documented consultation, dosing per FDA labeling, documentation of CD19 expression (including repeat biopsy if prior anti‑CD19 therapy), assessment for apheresis candidacy, prior therapy history with dates and outcomes, performance status, and absence of exclusionary infections or CNS findings.

Board-certified hematologist/oncologist prescribing or documented consultation note
Dosing and administration plan per FDA labeling
CD19 tumor expression report (or repeat biopsy if prior anti‑CD19 therapy)
Apheresis candidacy assessment
Complete prior therapy history including agents, number of lines, and response
Performance status (Karnofsky/Lansky or ECOG)
Documentation ruling out active hepatitis B/C, HIV, uncontrolled infection, or CNS leukemic blast criteria

MechanismCAR transmits activation signals after binding CD19, promoting T-cell expansion, activation, target cell elimination, and persistence

Key clinical trials/referencesReferenced trials and reviews include ELIANA, JULIET, ELARA and multiple foundational CAR T–cell publications informing clinical use and policy formation

Applied new layout and format to the policy.

2022-12-01criteria_added

Added additional follicular lymphoma criteria.

2022-10-27updated

Removed language referencing CMS LCD since NCD applies and removed Texas Mandate HB1584 language from main policy section; minor formatting updates.

2022-06-23updated

Added National Coverage Determination (NCD) information.

2021-07-22updated

Added clinician reviewer criteria.

2021-05-27updated

Added apheresis criteria and reformatted criteria; removed Oncology Analytics line.

2021-04-22updated

Added Medicaid instructions.

2020-11-19updated

Added criteria for prescriber, dosing and administration.

2020-10-22created

Policy created (new policy).