CurrentMass General Brigham Health PlanPolicy 032

Medical Policy Kymriah (tisagenlecleucel)

Defines prior authorization, medical necessity criteria, facility requirements, documentation, and billing codes for Kymriah (tisagenlecleucel) across Commercial, Qualified Health Plans, Mass General Brigham ACO, Senior Care Options, Medicare Advantage, One Care, and MassHealth variations.

Policy Summary

PayerMass General Brigham Health Plan

PolicyMedical Policy Kymriah (tisagenlecleucel)

Policy CodePolicy 032

Change TypeAd hoc and annual updates (clarified, revised, added)

Effective Date

Next Review Date

Key ActionPrior authorization is required for Kymriah; follow the listed payer-specific prior authorization processes and submit required clinical documentation.

SourceLink

POLICY UPDATE CHANGES

Added variation for One Care and SCO members and updated prior authorization table (Effective January 2026).

MassHealth variation updated to include new prior authorization process (April 2025).

Clarified FDA-approved indication and Medicare variation; added summary of evidence (March 2025).

Added MassHealth variation (September 2024).

Codes updated (February 2025).

Added indication for follicular lymphoma and removed requirement for CD19 testing (February 2024).

3FDA-approved indications listed

1Authorized treatment courses

Key facility/patient criteria items

Coverage Summary

Scope summary: Defines prior authorization, medical necessity criteria, facility requirements, documentation, and billing codes for Kymriah (tisagenlecleucel) across Commercial, Qualified Health Plans, Mass General Brigham ACO, Senior Care Options, Medicare Advantage, One Care, and MassHealth variations.

Policy overview: Kymriah (tisagenlecleucel) is an autologous CD19-directed CAR‑T cell therapy with 3 FDA‑approved indications (pediatric/young adult B‑cell precursor ALL; adult relapsed/refractory large B‑cell lymphoma after ≥2 lines; adult relapsed/refractory follicular lymphoma after ≥2 lines) and coverage is provided with criteria requiring prior authorization and facility REMS compliance. The policy authorizes a single treatment course (additional courses considered experimental/investigational).

Key items

FDA-approved indicationsPatients up to 25 years with B‑cell precursor ALL refractory or in second or later relapse; adult relapsed/refractory large B‑cell lymphoma after ≥2 lines of systemic therapy (includes DLBCL, high‑grade B‑cell lymphoma, DLBCL arising from FL); adult relapsed/refractory follicular lymphoma after ≥2 lines of systemic therapy (accelerated approval)

Authorized treatment coursesSingle treatment course; additional courses considered experimental/investigational

Key facility/patient criteria itemsFacility must be enrolled in Kymriah REMS; tocilizumab available on site; prescribing hematologist/oncologist with CAR‑T expertise; patient meets disease‑specific criteria (e.g., age and prior lines for ALL or lymphoma); no prior FDA‑approved CD19‑directed therapy

Policy statusCURRENT

Policy number032

Scope summaryDefines prior authorization, medical necessity criteria, facility requirements, documentation, and billing codes for Kymriah (tisagenlecleucel) across Commercial, Qualified Health Plans, Mass General Brigham ACO, Senior Care Options, Medicare Advantage, One Care, and MassHealth variations.

Medical Necessity Criteria

Pediatric/Young Adult ALL (patients < 26 years)

Authorization for a single treatment may be granted when ALL of the following criteria are met:

ALL of the following

One of the following
- The member has Philadelphia chromosome positive ALL and has failed two tyrosine kinase inhibitors
- The member has Philadelphia chromosome negative ALL
The patient has stable and adequate kidney, liver, pulmonary, and cardiac function as determined by the treating oncologist or hematologist
The member has not received FDA approved CD19-directed therapy (e.g., Tecartus, Kymriah) prior

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Prior authorization is required for Kymriah. Commercial and Qualified Health Plan requests are managed by Prime Therapeutics (follow Prime Therapeutics Kymriah policy). Mass General Brigham ACO members require prior authorization via the MassHealth Drug Utilization Review Program (see MassHealth Table 75). Senior Care Options (SCO) members also require authorization. Medicare Advantage, One Care, and some Medicare plan variations use CMS guidance and may follow different review pathways; One Care and SCO members use CMS guidance and MassHealth/plan-specific processes when CMS guidance is not available.

Commercial and Qualified Health Plans: prior authorization managed by Prime Therapeutics
Mass General Brigham ACO: prior authorization managed by MassHealth Drug Utilization Review Program (see Table 75)
Senior Care Options (SCO): prior authorization required
One Care and Medicare Advantage: medical necessity determinations follow CMS guidance; when CMS guidance is absent, MassHealth or plan policy criteria apply

Coding

Informational codes related to CAR-T procedures and productCPT/HCPCS/mixed

38225	Chimeric antigen receptor T-cell (CAR-T) therapy; harvesting 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 preparation of CAR-T cells for administration
38228	Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous
Q2042	Tisagenlecleucel, up to 600 million CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose

Background, Evidence & Definitions

Kymriah indications: Kymriah is indicated for (1) patients up to 25 years with B‑cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse; (2) adult patients with relapsed or refractory large B‑cell lymphoma after two or more lines of systemic therapy (including DLBCL not otherwise specified, high‑grade B‑cell lymphoma, and DLBCL arising from follicular lymphoma); and (3) adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy (accelerated approval). Kymriah is not indicated for primary central nervous system lymphoma.

Alignment with FDA label and guidance: The policy criteria reflect the FDA‑approved indications and exclusion for primary CNS lymphoma and specify authorization of a single treatment course, consistent with the product labeling and clinical trial inclusion criteria.

Alignment with CMS NCD 110.24 and Medicare variation: For Medicare Advantage, One Care, and SCO members, the plan uses CMS guidance including NCD 110.24 as the basis for medical necessity determinations; when NCDs/LCDs lack specificity, the policy applies additional criteria to ensure consistent review.

Alignment with NCCN and evidence: The policy references NCCN guidance for ALL and B‑cell lymphomas and bases coverage criteria on pivotal trials (ELIANA, JULIET, ELARA) and the summarized clinical evidence supporting tisa‑cel use in the listed indications.

MassHealth variation: Prior authorization requests for Mass General Brigham ACO members are managed by the MassHealth Drug Utilization Review Program and criteria for Kymriah are found in Table 75: T‑Cell Immunotherapies (MassHealth variation and prior authorization process referenced).

Facility and documentation requirements: The policy requires facility enrollment in the Kymriah REMS, tocilizumab available on site for CRS management, prescribing by a CAR‑T experienced hematologist/oncologist, and submission of required clinical documentation (prior therapies, refractory disease, and documentation of CD19 testing where applicable).

Medicare Determinations

Name	NCD Number	Effective Date	Type
Chimeric Antigen Receptor (CAR) T-cell Therapy	110.24	2021-09-20	NCD

Revision History

January 2026clarifiedLatest

Ad hoc review: Updated prior authorization table and added variation for One Care and SCO members. Detail: Ad hoc review updated prior authorization table and added variation for One Care and SCO members.

April 2025revised

Ad hoc review: MassHealth variation updated to include new prior authorization process. Detail: MassHealth variation references Table 75: T-Cell Immunotherapies for prior authorization.

March 2025clarified

Policy Summary

PayerMass General Brigham Health Plan

PolicyMedical Policy Kymriah (tisagenlecleucel)

Policy CodePolicy 032

Change TypeAd hoc and annual updates (clarified, revised, added)

Effective Date

Next Review Date

Key ActionPrior authorization is required for Kymriah; follow the listed payer-specific prior authorization processes and submit required clinical documentation.

SourceLink

On This Page

Adult Large B-cell Lymphomas and Follicular Lymphoma (patients >= 18 years)

Authorization for a single treatment may be granted when ALL of the following criteria are met:

ALL of the following

The disease is refractory or relapsed after two or more lines of systemic therapy
The member has not received any prior FDA approved CD19-directed therapy (e.g., Kymriah or Yescarta)
The member does not have primary central nervous system lymphoma

Facility Criteria (applies to all authorized use)

All of the following facility criteria must be met:

ALL of the following

The healthcare facility that dispenses and administers Kymriah must be enrolled and comply with the Kymriah Risk Evaluation and Mitigation Strategy (REMS)
The healthcare facility must have tocilizumab available on site for management of Cytokine Release Syndrome
Kymriah is prescribed by a hematologist or oncologist with demonstrated expertise in CAR-T therapy

Documentation Required

Required clinical documentation

Required clinical documentation must be submitted with prior authorization requests. Required items include confirmation of CD19 protein on tumor B-cells (note: policy history shows CD19 testing requirement was removed in February 2024, but the required documentation section still lists it), documentation of refractory disease or prior lines of therapy, and specific documentation of two prior lines of therapy for DLBCL. Exceptions for use after prior FDA‑approved CD19‑directed therapies or for non‑FDA approved CD19 therapies will be reviewed on a case-by-case basis with detailed medical review.

Testing/analysis confirming CD19 protein on the surface of the B-cell (policy note: requirement removed in Feb 2024 per change history)
Documentation of refractory disease or prior lines of therapy for ALL
Documentation of two prior lines of systemic therapy for DLBCL
Exceptions for non‑FDA approved CD19 therapies reviewed individually with detailed medical review

Documentation Required

Facility REMS and on-site medication requirement

Facility enrollment in the Kymriah REMS is required and must be documented. The facility must have tocilizumab available on site for management of cytokine release syndrome. Kymriah must be prescribed by a hematologist or oncologist with demonstrated expertise in CAR‑T therapy.

Facility must be enrolled in and comply with the Kymriah REMS
Tocilizumab must be available on site for CRS management
Prescribing clinician must be a hematologist or oncologist with demonstrated CAR‑T expertise

Billing Rule

Single treatment course

Coverage is limited to a single treatment course. Additional courses of Kymriah are considered experimental/investigational and require separate review prior to authorization.

Single treatment course authorized
Further courses considered experimental/investigational and need separate review

Study/Label	Key Findings
ELIANA	81% ORR; median event-free survival 24 months; 3-year relapse-free survival 52%
JULIET	52% ORR; 65% relapse-free survival at 12 months among responders
ELARA	86% ORR; 57% PFS and 88% OS at 24 months

Definitions:

• Primary central nervous system lymphoma: A lymphoma primarily involving the central nervous system; patients with this diagnosis are excluded from coverage per policy.

• REMS (Risk Evaluation and Mitigation Strategy): The Kymriah REMS is a manufacturer‑specific program; facility enrollment and compliance are required to dispense and administer the product.

Ad hoc review: Clarified FDA-approved indication and Medicare variation; added summary of evidence and updated references. Detail: References updated and summary of evidence added.

September 2024added

Ad hoc update: Added MassHealth variation. Detail: MassHealth Drug List Table 75 referenced.

February 2025revised

Annual review: Codes updated. Detail: Procedure and HCPCS codes listed for informational purposes.

February 2024revised

Annual review: Added indication for follicular lymphoma and removed requirement for CD19 testing. Detail: Policy text shows removal of CD19 testing in February 2024, though required documentation section still lists CD19 testing.