Kymriah - OpenPayer

Coverage Summary

Scope: Cigna medical-benefit coverage policy for Kymriah (tisagenlecleucel) CAR-T therapy that defines prior authorization requirement, covered FDA-approved indications (B-cell precursor ALL in patients < 26 years and specified B-cell lymphoma indications in adults ≥ 18 years), clinical criteria, dosing, coding, and program requirements for coverage.

Coverage stance: Covered with criteria for the FDA-approved indications described above; prior authorization is required and approval duration is 6 months to allow preparation and administration of one dose.

Authorized indications: Kymriah is covered for all FDA-approved indications listed in the policy: B-cell precursor acute lymphoblastic leukemia in patients ≤ 25 years (pediatric/young adult ALL indications) and the specified relapsed/refractory adult B-cell lymphoma indications (including follicular lymphoma for relapsed/refractory disease after ≥2 lines, large B-cell lymphoma/DLBCL and specified subtypes) when policy criteria are met.

Program and safety requirements: Kymriah carries boxed warnings for cytokine release syndrome, neurologic toxicities, and secondary hematologic malignancies and is available only through the Kymriah REMS program; treatment must be prescribed by or in consultation with an oncologist and meet the policy’s clinical and coding requirements.

Initial Therapy Criteria — FDA-Approved Indications

Acute Lymphoblastic Leukemia (B-cell precursor ALL) - FDA-Approved Indication

Approve a single dose if the patient meets ALL of the following (A, B, C, D, and E):

ALL of the following

Patient is < 26 years of age< 26 years
ONE of
- Patient has disease that is refractory, or in second or later relapse
- Patient is minimal residual disease positive after consolidation therapy
- Patient is Philadelphia chromosome-positive and has experienced ONE of the following
  - Less than complete response
  - Tyrosine kinase inhibitor intolerant or refractory disease

B-Cell Lymphoma - FDA-Approved Indication

Approve a single dose if the patient meets ALL of the following (A, B, C, D, and E):

Dosing - ALL and B-cell lymphoma

Approve one of the following dosing regimens:

ANY of the following

ALL (≤ 50 kg): For ALL: dose up to 5.0 x 10^6 CAR-positive viable T cells per kg intravenously for patients ≤ 50 kg≤ 50 kg: up to 5.0 x 10^6 CAR-positive viable T cells/kg
ALL (> 50 kg): For ALL: dose up to 2.5 x 10^8 CAR-positive viable T cells intravenously for patients > 50 kg> 50 kg: up to 2.5 x 10^8 CAR-positive viable T cells
B-cell lymphoma: For B-cell lymphoma: dose up to 6.0 x 10^8 CAR-positive viable T cells administered intravenouslyup to 6.0 x 10^8 CAR-positive viable T cells

Not Medically Necessary

Kymriah for any other use is considered not medically necessary.

Any use not meeting the above FDA-approved indication criteria or dosing

Provider Actions & Billing

Prior Authorization

Prior Authorization Required

Prior Authorization is required for medical benefit coverage of Kymriah. Approval duration is 6 months to allow preparation and administration of one dose. Affected codes include Q2042 and CPT codes 38225–38228.

Q2042
38225
38226
38227
38228

Documentation Required

Specialist Prescriber Requirement

Kymriah must be prescribed by or in consultation with a physician who specializes in the condition being treated (oncologist).

Applicable Codes

Considered Medically Necessary / Covered HCPCS/CPTmixedCovered

Q2042	Tisagenlecleucel, up to 600 million CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose
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 (eg, cryopreservation, storage)
38227	Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preparation of CAR cells for administration
38228	Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous

Clinical Evidence & References

Evidence sources cited in the policy include NCCN guideline references for ALL (adult and pediatric) and B-cell lymphoma (versions cited include 2024/2025 NCCN versions) and the Novartis Kymriah prescribing information (May 2022).

Specifically referenced materials in the brief: NCCN guideline references (ALL adult/pediatric and B-cell lymphoma, 2024/2025 versions) and the Prescribing information (Novartis Kymriah PI, May 2022).

Background & Definitions

Background: Kymriah is an autologous CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy supplied as a frozen suspension of genetically modified autologous T cells for infusion; it is indicated for B-cell precursor ALL in patients ≤ 25 years and for specified relapsed/refractory B-cell lymphomas in adults when policy criteria are met.

Safety boxed warnings: The product carries Boxed Warnings for cytokine release syndrome, neurologic toxicities, and secondary hematologic malignancies, and because of these risks Kymriah is available only through a restricted REMS program (Kymriah REMS).

Program and operational details: The policy requires prior authorization for medical-benefit coverage, specifies dosing and administration requirements (including lymphodepleting chemotherapy or WBC thresholds where applicable), and lists applicable procedure and HCPCS/CPT codes for CAR-T therapy (for example, 38225–38228 and Q2042 ).

Definitions/example therapies: The policy defines CAR-T therapies and provides examples including Kymriah and other CAR-T products (for example, Breyanzi, Tecartus, Yescarta, Abecma, and Carvykti).

Revision History

2024-07-01removed

Removed prior exclusion: 'Individual is not being treated for primary central nervous system lymphoma.'

2024-07-01removed

Removed ECOG performance status requirement of 0-1 from criteria.

2024-07-01revised

Expanded B-cell lymphoma approval options: moved follicular lymphoma to an approval option when used for relapsed/refractory disease after two or more lines of systemic therapy; added multiple lymphoma subtype options (large B-cell lymphoma, DLBCL, DLBCL arising from indolent lymphoma, high-grade B-cell lymphoma, HIV-related B-cell lymphoma, HHV8-positive DLBCL, primary effusion lymphoma, posttransplant lymphoproliferative disorders) and added HIV-related plasmablastic lymphoma as a new option for approval; added examples of systemic therapy.