CurrentExecutive Office of Health and Human ServicesPolicy N/A

Coverage Criteria — KYMRIAH® (tisagenlecleucel) and YESCARTA™ (axicabtagene ciloleucel)

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Medicaid FFS coverage criteria, limitations, and facility requirements for FDA-approved CAR-T therapies KYMRIAH® (tisagenlecleucel) and YESCARTA™ (axicabtagene ciloleucel). Applies to members seeking those therapies under the Executive Office of Health & Human Services Medicaid FFS program.

Policy Summary

PayerExecutive Office of Health and Human Services

PolicyCoverage Criteria — KYMRIAH® (tisagenlecleucel) and YESCARTA™ (axicabtagene ciloleucel)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization documenting diagnosis, age, prior lines of therapy or relapse, absence of prior gene/CAR‑T therapy, and REMS‑certified treating facility.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA-approved CAR-T products addressed

≤25KYMRIAH pediatric ALL age threshold

≥2Minimum prior lines required

Required

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CurrentExecutive Office of Health and Human ServicesPolicy N/A

Coverage Criteria — KYMRIAH® (tisagenlecleucel) and YESCARTA™ (axicabtagene ciloleucel)

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Sign up for all Executive Office of Health and Human Services policy alerts

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Policy Summary

PayerExecutive Office of Health and Human Services

PolicyCoverage Criteria — KYMRIAH® (tisagenlecleucel) and YESCARTA™ (axicabtagene ciloleucel)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization documenting diagnosis, age, prior lines of therapy or relapse, absence of prior gene/CAR‑T therapy, and REMS‑certified treating facility.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA-approved CAR-T products addressed

≤25KYMRIAH pediatric ALL age threshold

≥2Minimum prior lines required

Required

Coverage Criteria for KYMRIAH® and YESCARTA™

KYMRIAH (tisagenlecleucel) - Covered Indications and Eligibility

Covered when ALL of the following groups/conditions are met as specified below:

KYMRIAH_indications

KYMRIAH_pediatric_ALL_failure: Member age 25 years or younger AND diagnosis of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) AND has failed at least two lines of treatment
KYMRIAH_pediatric_ALL_relapse: Member age 25 years or younger AND diagnosis of B-cell precursor acute lymphoblastic leukemia (ALL) AND is experiencing a second or later relapse after a minimum of two lines of treatment
KYMRIAH_adult_LBCL: Member age 18 years or older AND diagnosis of CD19-positive large B-cell lymphoma AND has failed at least two lines of systemic therapy AND is experiencing a biopsy-proven relapse after a minimum of two lines of systemic therapy

KYMRIAH_general_eligibility: All of the following must be met: member has not previously had gene therapy; no primary central nervous system (CNS) lymphoma; adequate bone marrow, cardiac, pulmonary and other organ function to tolerate the procedure; if history of allogeneic stem cell transplantation, no evidence of graft vs host disease; treating facility is certified under the KYMRIAH REMS program

YESCARTA (axicabtagene ciloleucel) - Covered Indications and Eligibility

Covered when the following criteria are met:

YESCARTA_indication: Member is age 18 years or older AND diagnosis of CD19-positive large cell lymphoma (including diffuse large cell lymphoma) AND either has failed at least two lines of therapy OR has biopsy-proven relapse after at least two lines of therapy

YESCARTA_general_eligibility: All of the following must be met: no prior therapy with YESCARTA or other gene therapy; no evidence of primary central nervous system (CNS) lymphoma; adequate bone marrow, cardiac, pulmonary and other organ function to tolerate the procedure; if prior allogeneic stem cell transplantation, no indication of graft vs host disease; treating facility must be certified under the YESCARTA REMS program

Coverage is not authorized for members with any of the following exclusionary or disqualifying clinical conditions: pregnancy; currently receiving immunosuppressive therapy for an autoimmune disorder; an untreated underlying immune disorder; presence of an additional active or metastatic malignancy outside the scope of this policy; or a history of prior CAR‑T therapy. These conditions will generally result in denial of coverage for KYMRIAH® or YESCARTA™ under this policy.

In addition to indication-specific eligibility, members must meet general clinical and facility requirements: no evidence of primary central nervous system (CNS) lymphoma; adequate bone marrow, cardiac, pulmonary, and other organ function to tolerate therapy; if there is a history of allogeneic stem cell transplantation, there must be no evidence of graft‑versus‑host disease; and the treating facility must be REMS‑certified for the product being administered. Documentation of these conditions should be provided with prior authorization requests.

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization required

Obtain prior authorization before CAR‑T therapy is provided. The PA must document that the member meets the listed indication criteria (age and diagnosis), meets the required prior‑therapy or relapse criteria per indication, has not previously received gene/CAR‑T therapy, and that the treating facility is REMS‑certified.

Step Therapy

Prior therapy requirement (≥2 lines)

Document failure of at least two prior lines of systemic therapy or a biopsy‑proven relapse after a minimum of two lines of therapy when required by the indication (e.g., KYMRIAH pediatric/adult LBCL and YESCARTA LBCL).

KYMRIAH: failed at least two lines of treatment (pediatric ALL) or biopsy‑proven relapse after ≥2 lines; adult LBCL: failed ≥2 lines and biopsy‑proven relapse after ≥2 lines.
YESCARTA: failed at least two lines of therapy or biopsy‑proven relapse after ≥2 lines.

Line of Therapy Requirements

Second-line or Later Therapy Requirement

prior_lines_requirement: Failure of at least two prior lines of therapy OR biopsy-proven relapse after a minimum of two lines of therapy as specified per indication>=2 prior lines

Biomarker and Diagnostic Requirements

CD19 — biomarker requirement

Required biomarkerCD19 positive status is required for the listed indications (B-cell precursor ALL and large B‑cell lymphoma)

RoleTarget antigen for KYMRIAH® and YESCARTA™ CAR‑T therapies

Required documentationMedical record must document CD19-positive disease for eligibility

Definitions

CD19-positive B-cell precursor ALL — definition

DefinitionCD19‑positive B‑cell precursor acute lymphoblastic leukemia (ALL)

Age eligibility (KYMRIAH)Member age 25 years or younger for KYMRIAH pediatric ALL indications

Therapy requirementHas failed at least two lines of treatment OR is experiencing a second or later relapse after a minimum of two lines of treatment

CD19-positive large B-cell lymphoma (LBCL) — definition

DefinitionCD19‑positive large B‑cell lymphoma, including diffuse large B‑cell lymphoma

Age eligibilityMember age 18 years or older for KYMRIAH adult LBCL and YESCARTA indications

Background on CAR-T Therapies

KYMRIAH® (tisagenlecleucel) and YESCARTA™ (axicabtagene ciloleucel) are FDA‑approved autologous CAR‑T cell therapies that target the CD19 antigen on B‑cell malignancies. These products are indicated for specific populations with CD19‑positive B‑cell precursor acute lymphoblastic leukemia (ALL) and CD19‑positive large B‑cell lymphoma (including diffuse large B‑cell lymphoma), with coverage conditioned on meeting age, diagnosis, prior‑therapy, organ function, and facility certification requirements.

Both therapies require administration at centers certified under their respective REMS programs and appropriate clinical assessment to confirm adequate organ function and absence of contraindications (for example, primary CNS lymphoma or active uncontrolled comorbidity). Prior authorization must demonstrate the member meets the listed indication criteria and eligibility requirements before coverage is approved.