Currentculinary health fundPolicy N/A

Oncology (Injectable - CAR-T) - Kymriah Utilization Management Medical Policy

Defines prior authorization criteria, dosing, prescriber requirements, and indications for medical-benefit coverage of Kymriah (tisagenlecleucel) for pediatric/young adult B-cell precursor ALL and adult B-cell lymphomas including large B-cell and follicular lymphoma per FDA/NCCN-aligned criteria. Also states non-recommended circumstances and REMS/safety considerations.

Policy Summary

Payerculinary health fund

PolicyOncology (Injectable - CAR-T) - Kymriah Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeAnnual revision with material updates to B-cell lymphoma indications

Effective Date

Next Review DateMar 5, 2025

Key ActionPrior Authorization is recommended; approve eligible patients for a single dose for up to 6 months to allow preparation and administration.

POLICY UPDATE CHANGES

Primary effusion lymphoma was added as an additional option for approval in B-cell lymphoma.

Acquired immune deficiency syndrome (AIDS)-related B-cell lymphoma terminology changed to human immunodeficiency virus (HIV)-related B-cell lymphoma.

Follicular lymphoma moved to an option for approval if used for relapsed or refractory disease after two or more lines of systemic therapy.

2Primary FDA-approved disease groups (ALL; B-cell lymphoma)

6+B-cell lymphoma diagnoses eligible (examples listed)

Dose per patient (single dose approval)

Coverage Summary

This policy covers Kymriah (tisagenlecleucel), a CD19-directed autologous CAR-T therapy for FDA‑approved indications in pediatric/young adult B‑cell precursor acute lymphoblastic leukemia (ALL) and for adult B‑cell lymphomas. For ALL the age threshold is < 26 years (patients ≤25 years per PI); for B‑cell lymphoma the age threshold is ≥ 18 years.

Kymriah is approved as a single dose (prior authorization and a 6‑month approval window are used to allow preparation and administration of one dose). It is distributed as a frozen infusion bag that requires liquid nitrogen vapor‑phase storage and must be thawed prior to infusion. Because of serious toxicities, Kymriah is available only through the Kymriah REMS program.

Kymriah Key Thresholds

Age for ALL indication< 26 years

Age for B-cell lymphoma indication≥ 18 years

White blood cell count≤ 1 x 10^9 /L within 1 week prior to infusion

Dose (patients ≤ 50 kg)up to 5.0 x 10^6 CAR-positive viable T cells per kg IV

Dose (patients > 50 kg)up to 2.5 x 10^8 CAR-positive viable T cells IV

Dose (B-cell lymphoma dosing statement)up to 6.0 x 10^8 CAR-positive viable T cells IV

Medical Necessity / Approval Criteria

B-Cell Lymphoma (FDA-approved)

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

ALL of the following

Patient is ≥ 18 years of age
ONE of
- Option i (Follicular lymphoma)
  - Patient has follicular lymphoma
  - Medication is used for relapsed or refractory disease after two or more lines of systemic therapy
    Examples of systemic therapy: CHOP + obinutuzumab or rituximab products, CVP + rituximab products, lenalidomide + rituximab products

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization recommended

Prior authorization is recommended for medical benefit coverage of Kymriah. Approval is recommended for patients who meet the policy Criteria and Dosing. Approval duration is 6 months to allow time to prepare and administer a single dose. Kymriah is supplied frozen in a labeled infusion bag, shipped in a liquid nitrogen Dewar, stored in vapor-phase liquid nitrogen (≤ -120°C), and should be thawed prior to infusion; single-dose preparation and handling must be planned during the authorization period.

Documentation Required

Specialist prescriber requirement

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

Coding

No specific procedure/drug/billing codes listed in policy bodymixed

No codes listed

Background & Evidence

Kymriah is a CD19‑directed genetically modified autologous T‑cell immunotherapy (CAR‑T) supplied as a frozen suspension in infusion bag(s) labeled for the specific recipient. It is shipped to the cell laboratory in a liquid nitrogen Dewar and must be stored in the vapor phase of liquid nitrogen (≤ −120°C) and thawed prior to infusion.

Because of a Boxed Warning for cytokine release syndrome (CRS), neurologic toxicities, and secondary hematologic malignancies, Kymriah is available only through a restricted program under the Kymriah REMS, and facilities must have specialized monitoring and skills to manage these risks.

Evidence sources cited include the FDA Prescribing Information: Kymriah intravenous infusion [prescribing information], Novartis Oncology; December 2024.

Guideline support is provided by NCCN guidance for ALL and B‑cell lymphomas (NCCN versions cited, 2024–2025).

Definitions

CAR‑T therapy: Chimeric antigen receptor T‑cell therapy; examples listed include Kymriah, Breyanzi, Tecartus, Yescarta, Abecma, Carvykti.

Revision History

03/05/2025ChangeLatest

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, and post-transplant lymphoproliferative disease moved to new options for approval. Added approval pathways for relapsed/refractory after two or more lines or relapse >12 months with partial response to second-line therapy. (Material)

03/05/2025Change

Follicular lymphoma moved to an option for approval if used for relapsed or refractory disease after two or more lines of systemic therapy; added note with examples of systemic therapy. (Material)

03/29/2023

Policy Summary

Payerculinary health fund

PolicyOncology (Injectable - CAR-T) - Kymriah Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeAnnual revision with material updates to B-cell lymphoma indications

Effective Date

Next Review DateMar 5, 2025

Key ActionPrior Authorization is recommended; approve eligible patients for a single dose for up to 6 months to allow preparation and administration.

On This Page

Option ii (Other B-cell lymphoma diagnoses)

Patient has ONE of the following diagnoses: Large B-cell lymphoma; Diffuse large B-cell lymphoma; Diffuse large B-cell lymphoma arising from indolent lymphoma; High-grade B-cell lymphoma; Human immunodeficiency virus (HIV)-related B-cell lymphoma; HIV-related plasmablastic lymphoma; Human Herpes Virus 8-positive diffuse large B-cell lymphoma; Primary effusion lymphoma; Post-transplant lymphoproliferative disorders, B-cell type
ONE of the following disease situations
- Disease that is relapsed or refractory after two or more lines of systemic therapy
  Examples of systemic therapy: R-CHOP, dose-adjusted EPOCH + rituximab, DHA + platinum ± rituximab
- Disease relapse > 12 months after first-line therapy and partial response to second-line therapy
  Examples of systemic therapy: R-CHOP, dose-adjusted EPOCH + rituximab, RCDOP

ONE of

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

Patient has not been previously treated with chimeric antigen receptor T-cell (CAR-T) therapy

Examples of CAR-T therapies listed: Kymriah, Breyanzi, Tecartus, Yescarta, Abecma, Carvykti

Kymriah is prescribed by or in consultation with an oncologist

Documentation Required

Lymphodepleting chemotherapy or WBC requirement

Document that the patient received or plans to receive lymphodepleting chemotherapy prior to Kymriah infusion OR that the patient’s white blood cell count is ≤ 1 x 10^9 /L within 1 week prior to infusion for B‑cell lymphoma patients.

Denial Risk

Prior CAR-T therapy exclusion

Prior treatment with any CAR‑T therapy is exclusionary. Claims may be denied or not approved if the patient has previously received CAR‑T therapy.

Documentation Required

REMS program and safety monitoring

Kymriah is available only through a REMS program and has Boxed Warnings for cytokine release syndrome, neurologic toxicities, and secondary hematologic malignancies. Provide evidence of REMS enrollment/compliance and that the treating facility has the capability to monitor and manage these boxed‑warning toxicities and possesses the specialized skills required for CAR‑T therapy care.

Primary effusion lymphoma was added as an additional option for approval. (Material)

03/29/2023Change

Acquired immune deficiency syndrome (AIDS)-related B-cell lymphoma terminology changed to human immunodeficiency virus (HIV)-related B-cell lymphoma. (Material)