Criteria for Prior Authorization: Chimeric Antigen Receptor T‑Cell (CAR‑T) Therapy Agents
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Defines prior authorization requirements for chimeric antigen receptor T-cell (CAR‑T) therapies for KDHE members, including agent-specific indications, age, dosing limits, and approval duration; applies to providers seeking PA for listed CAR‑T agents.
No material clinical or coverage changes in this revision.
Coverage Criteria and Agent‑Specific Requirements
Initial Therapy / Agent‑specific coverage criteria
Covered when ALL of the following are met:
Reauthorization is not permitted. Approval for CAR‑T therapy is limited to one infusion per lifetime. The length of prior authorization for an approved request is 3 months.
Patients who have previously received any CAR T‑cell therapy are not eligible for approval under these criteria. Requests for therapy will require documentation demonstrating the patient has not received prior CAR T‑cell treatment.
Agent Dosing and Indications (Table 1)
| Agent | FDA‑approved indication(s) (examples) | Age | Dosing limits (per infusion) |
|---|---|---|---|
| Axicabtagene ciloleucel (Yescarta®) | |||
| Treatment of r/r large B‑cell lymphoma (including DLBCL NOS, primary mediastinal LBCL, high‑grade B‑cell lymphoma and DLBCL arising from FL); treatment of r/r follicular lymphoma; treatment of r/r mantle cell lymphoma; treatment of r/r B‑ALL | |||
| ≥ 18 years | |||
| 2 x 10^6 CAR‑positive viable T cells/kg (or a maximum of 2 x 10^8 CAR‑positive viable T cells for patients ≥ 100 kg) |
Listed Agents, Codes, and Dosing Limits
| Axicabtagene ciloleucel | Yescarta® — agent listed for PA |
| Brexucabtagene autoleucel | Tecartus® — agent listed for PA |
| Ciltacabtagene autoleucel | Carvykti® — agent listed for PA |
| Idecabtagene vicleucel | Abecma® — agent listed for PA |
| Lisocabtagene maraleucel | Breyanzi® — agent listed for PA |
| Obecabtagene autoleucel | Aucatzyl® — agent listed for PA |
| Tisagenlecleucel | Kymriah® — agent listed for PA |
Prior Authorization, Documentation, and Denial Triggers
Prior authorization required; single infusion lifetime
Prior authorization is required for all listed CAR‑T agents and dose forms. Length of approval is 3 months and approval is limited to one infusion per lifetime; reauthorization is not permitted.
Confirm age and dosing per Table 1
The PA must confirm the patient meets the FDA‑approved age, indication, and dosing limits shown in Table 1 for the requested agent (per‑agent dosing limits and age indications are listed in Table 1).
Prior therapy requirements — relapsed/refractory despite required therapies
Document that the patient has relapsed or refractory disease and has received the agent‑specific prior lines and types of systemic therapy required for the indication (examples in Table 1 include ≥2 prior lines for many B‑cell indications, inclusion of BTKi and BCL‑2i for CLL/SLL, and IMiD/PI requirements for multiple myeloma).
Required clinical documentation
Provide clinical documentation of the requested indication, patient age (and weight if applicable), and prior lines of therapy including specific prior treatments (for example: TKIs, BTKi, BCL‑2i, IMiD, PI, anti‑CD38) to demonstrate the patient meets agent‑specific prerequisites and Table 1 dosing limits.
Triggers for denial
Requests will be denied if the submission does not meet the listed indication, FDA‑approved age or weight, required prior therapies, or if the requested dose exceeds the dosing limits in Table 1; requests for patients who received prior CAR T‑cell therapy will also be denied.
Prior Lines and Eligibility
Line of Therapy Requirements
See Table 1 and agent-specific text for exact prior-line counts and class requirements.
Abbreviations and Terms
Background and Scope
Chimeric antigen receptor T‑cell (CAR‑T) therapies are cellular immunotherapies approved for various relapsed or refractory hematologic malignancies, including B‑cell leukemias, B‑cell lymphomas, mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, and multiple myeloma. Coverage under these criteria requires that treatment match the FDA‑approved indication, age, and dosing limits and that therapy be prescribed by or in consultation with an oncologist or hematologist.
Prior authorization is required for all listed CAR‑T agents and dose forms. Approval duration is 3 months and is limited to one infusion per lifetime; reauthorization is not permitted. Providers must confirm agent‑specific age and dosing limits and meet the documented prior‑therapy requirements described in Table 1 and the criteria text.
Policy Revision History
Policy last revised and consolidated CAR‑T prior authorization criteria, including agent list, Table 1 dosing limits, and approval terms (length of approval 3 months; one infusion per lifetime).
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