CurrentEmblemHealthPolicy N/A

Kymriah (tisagenlecleucel) CAR-T therapy coverage — Medicare Advantage

Medicare Advantage medical policy governing prior authorization, coverage criteria, dosing, and restrictions for Kymriah (tisagenlecleucel) for specified B-cell malignancies for EmblemHealth Medicare Advantage members.

Policy Summary

PayerEmblemHealth

PolicyKymriah (tisagenlecleucel) CAR-T therapy coverage — Medicare Advantage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 25, 2025

Next Review DateN/A

Key ActionSubmit prior authorization; approval is granted for members meeting policy criteria with a 6-month approval duration to prepare and administer one dose.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsapproval duration to allow preparation and administration of 1 dose

≤25 / ≥18age ranges referenced for ALL and lymphoma indications

singleapproval limited to a single dose per indication

6.0 x 10^8maximum lymphoma CAR-positive viable T cell dose

REMSrestricted program due to boxed warnings

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Coverage Criteria for Kymriah (tisagenlecleucel)

inv-01: Acute Lymphoblastic Leukemia (ALL) - Initial Coverage Criteria

Covered when ALL of the following are met

Acute Lymphoblastic Leukemia, B-Cell Precursor: Approve a single dose if A, B, C, and D are met

IC-COMP referenced indications and criteria

A: The patient is < 26 years of age

IC-COMP

B: Patient meets one of: i) disease refractory or in second or later relapse; OR ii) minimal residual disease positive after consolidation therapy; OR iii) Philadelphia chromosome-positive with (a) less than complete response; OR (b) tyrosine kinase inhibitor intolerant or refractory disease; OR (c) relapse post-hematopoietic stem cell transplantation

IC-COMP

C: The patient received or plans to receive lymphodepleting chemotherapy prior to Kymriah infusion

IC-COMP

D: The patient has not been previously treated with CAR-T therapy

IC-COMP

Dosing: For patients ≤ 50 kg: up to 5.0 x 10^6 CAR-positive viable T cells/kg IV; for patients > 50 kg: up to 2.5 x 10^8 CAR-positive viable T cells IV

inv-02: B-Cell Lymphoma - Initial Coverage Criteria

Covered when ALL of the following are met

B-Cell Lymphoma: Approve a single dose if A, B, C, and D are met

IC-COMP

A: Patient is ≥ 18 years of age

IC-COMP

B: Patient meets ONE of: i) BOTH a) follicular lymphoma AND b) relapsed/refractory after two or more lines of systemic therapy; OR ii) BOTH a) diagnosis is one of the listed B-cell lymphoma subtypes (large B-cell lymphoma; diffuse large B-cell lymphoma; high-grade B-cell lymphoma; DLBCL arising from indolent lymphoma; HIV-related B-cell lymphoma; HIV-related plasmablastic lymphoma; HHV8-positive DLBCL; primary effusion lymphoma; post-transplant lymphoproliferative disorders B-cell type) AND b) medication is used for either (1) disease relapsed or refractory after two or more lines of systemic therapy OR (2) disease relapse >12 months after first-line therapy and partial response to second-line therapy

IC-COMP

Kymriah has a Limitation of Use: it is not indicated for treatment of patients with primary central nervous system lymphoma. This statement is based on the product’s approved indications and explicitly restricts use for primary CNS lymphoma.

Coverage is not recommended for requests that fall outside the policy’s listed Recommended Authorization Criteria. Authorization criteria are the basis for approval and will be updated as new published data become available; requests outside those criteria may be denied.

Example prior systemic regimen
R-CHOP (rituximab product, cyclophosphamide, doxorubicin, vincristine, prednisone)
Dose-adjusted EPOCH + rituximab (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin)
CHOP + obinutuzumab/rituximab
CVP + rituximab
Lenalidomide + rituximab
DHA + platinum ± rituximab (dexamethasone, cytarabine + carboplatin/cisplatin/oxaliplatin ± rituximab)

Coding and Test Requirements

Referenced coding listsmixed

no explicit HCPCS/ICD-10 codes listed

Policy references HCPCS and ICD-10 lists in companion articles but does not enumerate specific codes in this document.

inv-06: WBC prior to infusion — <= 1 x 10^9 /L within 1 week prior to infusion

WBC threshold<= 1 x 10^9 /L within 1 week prior to Kymriah infusion

ContextAcceptable alternative to planned lymphodepleting chemotherapy for B-cell lymphoma eligibility (meets criterion C.i/ii)

ApplicabilityReferenced specifically under B-Cell Lymphoma initial coverage criteria

Provider Actions, Authorization, and Handling

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage of Kymriah; approval is recommended for members who meet the policy's Criteria and Dosing. The approval duration is 6 months to allow time to prepare and administer one dose of therapy.

Step Therapy

Prior systemic therapy requirement

For follicular lymphoma and the listed large B‑cell lymphoma diagnoses, Kymriah is indicated only after two or more lines of systemic therapy (or the specific relapse/response scenarios listed in the criteria) — prior lines of systemic therapy are required before approval.

Follicular lymphoma: relapsed/refractory after two or more lines of systemic therapy (chunk 10).
Other listed B‑cell lymphoma subtypes: relapsed/refractory after two or more lines of systemic therapy, or relapse >12 months after first‑line therapy with partial response to second‑line therapy (chunk 10, 11).

Background

Kymriah (tisagenlecleucel) is an autologous CD19-directed CAR-T cell therapy supplied as a frozen suspension of genetically modified autologous T cells labeled for the specific recipient. It is indicated for selected relapsed or refractory B-cell malignancies including pediatric/young adult B-cell precursor acute lymphoblastic leukemia and adult follicular and large B-cell lymphomas, and requires specialized handling (stored in the vapor phase of liquid nitrogen and thawed prior to infusion).

Definitions and Key Terms

inv-12: REMS — Risk Evaluation and Mitigation Strategy; restricted program required for Kymriah due to boxed warnings for CRS, neurotoxicity

DefinitionRisk Evaluation and Mitigation Strategy (REMS) — restricted program required for Kymriah due to boxed warnings for cytokine release syndrome, neurological toxicities, and secondary hematologic malignancies

Program nameKymriah REMS

Implication for providersKymriah is available only through REMS-participating providers and infusion centers meeting REMS requirements

inv-13: Lymphodepleting chemotherapy — chemotherapy given prior to CAR-T infusion; required or planned prior to Kymriah infusion for several indications per policy criteria

DefinitionLymphodepleting chemotherapy — chemotherapy given prior to CAR‑T infusion; required or planned prior to Kymriah infusion for several indications per policy criteria

Line of Therapy Requirements

inv-14: second-line_or_later

Prior therapy for follicular lymphoma: Relapsed or refractory after two or more lines of systemic therapy

IC-COMP

Prior therapy for other large B-cell lymphoma: Relapsed or refractory after two or more lines of systemic therapy; OR relapse >12 months after first-line therapy with partial response to second-line therapy

IC-COMP

Examples of Prior Systemic Regimens

Examples include
R-CHOP (rituximab product, cyclophosphamide, doxorubicin, vincristine, prednisone)
Dose-adjusted EPOCH + rituximab (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin)
CHOP + obinutuzumab/rituximab
CVP + rituximab
Lenalidomide + rituximab
DHA + platinum ± rituximab (dexamethasone, cytarabine + carboplatin/cisplatin/oxaliplatin ± rituximab)

Revision History

2025-03-25policy_revisionLatest

Policy revision updating B-Cell Lymphoma options for approval and moving multiple lymphoma subtypes into new approval options (commercial policy update).

2025-03-11policy_revision

Formatting and notation updates; no clinical criteria changes noted in review cycle.

2025-01-06policy_review

Policy reviewed with no criteria changes reported.

Policy Summary

PayerEmblemHealth

PolicyKymriah (tisagenlecleucel) CAR-T therapy coverage — Medicare Advantage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 25, 2025

Next Review DateN/A

Key ActionSubmit prior authorization; approval is granted for members meeting policy criteria with a 6-month approval duration to prepare and administer one dose.

SourceLink

On This Page

C: Patient received or plans to receive lymphodepleting chemotherapy prior to Kymriah infusion; OR patient's white blood cell count is ≤ 1 x 10^9 /L within 1 week prior to infusion<= 1 x 10^9 /L within 1 week prior to infusion

D: The patient has not been previously treated with CAR-T therapy

IC-COMP

Dosing: Dose up to 6.0 x 10^8 CAR-positive viable T cells IV

Documentation Required

REMS and product handling

Providers must ensure REMS program requirements and boxed‑warning monitoring are met; Kymriah is available only through the Kymriah REMS. The product is supplied frozen, shipped in a liquid nitrogen Dewar, must be stored in the vapor phase of liquid nitrogen (≤ −120°C) in a temperature‑monitored system, and thawed prior to infusion.

Kymriah has a Boxed Warning for cytokine release syndrome, neurological toxicities, and secondary hematologic malignancies and is available only through the Kymriah REMS (chunk 3).
Product handling: frozen suspension shipped in a liquid nitrogen Dewar; store in vapor phase liquid nitrogen (≤ −120°C) in a temperature‑monitored system; thaw prior to infusion (chunk 1).

Denial Risk

Out‑of‑criteria denials

Coverage is not recommended for requests that fall outside the Recommended Authorization Criteria; such out‑of‑criteria requests may be denied.

Role in criteriaSpecified as part of criterion C for both ALL and B‑cell lymphoma initial coverage (patient received or plans to receive lymphodepleting chemotherapy)

Examples contextListed as an option in B‑Cell Lymphoma criterion C alongside a qualifying WBC threshold

inv-15: Philadelphia chromosome / BCR::ABL1 — biomarker requirement information (item referenced under BIOMARKER REQUIREMENTS)

BiomarkerPhiladelphia chromosome / BCR::ABL1

When requiredReferenced in ALL criteria where Philadelphia chromosome-positive disease is eligible under specific subcriteria (less than complete response; TKI intolerant or refractory; relapse post‑hematopoietic stem cell transplant)

Guideline supportNCCN guidance cites Kymriah as an option in Philadelphia chromosome–positive B‑cell ALL in selected refractory/relapsed scenarios

2024-04-22policy_revision

B-Cell Lymphoma: changed wording (follicular to indolent in one option) and removed diffuse large B-cell lymphoma arising from nodal marginal zone lymphoma.

2023-07-26policy_revision

Added approval duration of 6 months to policy statement to allow preparation and administration of one dose; other history entries recorded earlier policy changes.

2019-10-09policy_creation

New Medicare Advantage medical policy established (initial policy effective date).