Chimeric Antigen Receptor (CAR) T‑cell Therapy
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Clinical guideline governing medical necessity, indications, and eligibility for CAR T‑cell therapies as applied to members in Ohio; addresses FDA‑approved agents, universal eligibility/contraindications, and disease‑specific sections (partial document).
No material clinical or coverage changes in this revision.
Coverage Criteria and Indications
Universal Minimum Eligibility Requirements
Eligibility evaluation should consider ALL of the following patient factors (expert panel ASTCT):
From ASTCT expert panel recommendation; used for eligibility evaluation
Universal Contraindications
The following are contraindications to CAR T‑cell therapy regardless of product:
Listed as universal contraindications in guideline
Acute Lymphoblastic Leukemia (Adults) — example criteria
Covered when ALL of the following clinical trial‑based or guideline conditions are met (example content provided for adult relapsed/refractory B‑precursor ALL with Tecartus/KTE‑X19):
Derived from ZUMA‑3 inclusion criteria and NCCN guidance
Trial eligibility parameter
Reflects trial enrollment characteristics
Descriptive of trial regimen; lymphodepletion must be documented
Brexucabtagene autoleucel (Tecartus) — Adults with B-cell precursor ALL
Covered when ALL of the following are met for adult patients (≥18 years):
Standard ZUMA‑3 lymphodepletion described in policy; documentation required
Obecabtagene autoleucel (Aucatzyl) — Adults with B-cell precursor ALL
Covered when ALL of the following are met for adult patients (≥18 years):
Per Aucatzyl (Aucatzyl) labeling and trial criteria
Tisagenlecleucel (Kymriah) — Pediatric/Young Adult B-cell precursor ALL
Covered when ALL of the following are met:
Per ELIANA/ELIANA‑like trial and Kymriah labeling
Idecabtagene vicleucel (Abecma) — Multiple myeloma
Covered when consistent with NCCN category 1 recommendation for previously treated multiple myeloma after required prior therapies:
Aligned with KarMMa study population and updated approvals
Idecabtagene vicleucel (Abecma) — Initial therapy criteria
Covered when ALL of the following are met:
From KarMMa/KarMMa‑3 trial eligibility and policy criteria
Ciltacabtagene autoleucel (Carvykti) — Initial therapy criteria
Covered when ALL of the following are met:
From CARTITUDE trials and updated approvals
Lisocabtagene maraleucel (Breyanzi) — Initial therapy for CLL/SLL
Covered when ALL of the following are met:
From TRANSCEND CLL 004 and policy criteria
Axicabtagene ciloleucel (Yescarta) — Covered when ALL of the following are met
Covered when ALL of the following are met
Axicabtagene ciloleucel general criteria
- Age: Member is 18 years of age or older
- Diagnoses: Member diagnosed with relapsed/refractory B‑cell lymphoma including specified histologies (e.g., DLBCL, primary mediastinal LBCL, high‑grade B‑cell lymphoma, DLBCL arising from follicular lymphoma, AIDS‑related B‑cell lymphoma, various MALT and marginal zone lymphomas, post‑transplant lymphoproliferative disorder, primary CNS lymphoma among others)
See product section for full list
- Prior therapy: Member received prior treatment with two or more chemoimmunotherapy regimens that included at least one anthracycline or anthracenedione‑based regimen, unless contraindicated, and has disease progression following last regimen OR disease refractory/relapse ≤12 months after first‑line chemoimmunotherapy
- Lymphodepletion: Member has received or will receive adequate standard lymphodepleting chemotherapy (e.g., cyclophosphamide 500 mg/m2 + fludarabine 30 mg/m2 on days −5 to −3 or equivalent regimen) prior to infusion
- Prior CAR T: Member has not received prior CAR T‑cell therapy
- Allogeneic HSCT: If prior allogeneic HSCT, member does not currently have active GVHD
Tisagenlecleucel (Kymriah) — Covered when ALL of the following are met
Covered when ALL of the following are met
Tisagenlecleucel general criteria
- Age: Member is 18 years of age or older
- Diagnoses: Member diagnosed with relapsed/refractory B‑cell lymphoma including listed histologies (DLBCL, AIDS‑related B‑cell lymphoma, high‑grade B‑cell lymphoma, transformed indolent lymphomas, HHV‑8 positive DLBCL, large B‑cell lymphoma, post‑transplant lymphoproliferative disorder)
See chunk 71 for full list
- Prior therapy: Member has received two or more lines of systemic therapy (for certain transformed/secondary DLBCL additional anthracycline exposure required unless contraindicated)
- Lymphodepletion options: Member has received or will receive lymphodepleting chemotherapy within two weeks preceding infusion: standard fludarabine 25 mg/m2 IV daily ×3 + cyclophosphamide 250 mg/m2 IV daily ×3 OR bendamustine 90 mg/m2 IV daily ×2 if unable to receive cyclophosphamide
- Exceptions: For follicular lymphoma lymphodepleting chemotherapy may be omitted if WBC ≤ 1 × 10^9/L within one week prior to infusionWBC ≤ 1 x 10^9/L
- Prior CAR T: Member has not received prior CAR T‑cell therapy
- Allogeneic HSCT: If prior allogeneic HSCT, member does not currently have active GVHD
Kymriah (tisagenlecleucel) — Follicular lymphoma
Tisagenlecleucel (Kymriah) — follicular lymphoma covered when ALL of the following are met
From tisagenlecleucel FL labeling and ELARA trial criteria
Breyanzi (lisocabtagene maraleucel) — Relapsed/Refractory B-cell lymphoma
Lisocabtagene maraleucel (Breyanzi) — covered when ALL of the following are met
From TRANSCEND criteria
Yescarta (axicabtagene ciloleucel) — Follicular lymphoma
Axicabtagene ciloleucel (Yescarta) — follicular lymphoma covered when ALL of the following are met
From Yescarta labeling and updated approvals
Breyanzi — Relapsed/Refractory Follicular Lymphoma
Breyanzi (lisocabtagene maraleucel) — follicular lymphoma (relapsed/refractory): Covered when ALL of the following are met
From TRANSCEND FL cohort and labeling
Kymriah — Relapsed/Refractory Follicular Lymphoma
Kymriah (tisagenlecleucel) — follicular lymphoma (relapsed/refractory): Covered when ALL of the following are met
From ELARA trial and product labeling
Tecartus — Relapsed/Refractory Mantle Cell Lymphoma
Tecartus (brexucabtagene autoleucel) — mantle cell lymphoma: Covered when ALL of the following are met
From ZUMA‑2 eligibility and payer criteria
Breyanzi — MCL and MZL
Breyanzi — mantle cell lymphoma and marginal zone lymphoma: Covered when ALL of the following are met
From TRANSCEND‑MCL cohort criteria
From TRANSCEND FL‑MZL cohort data and labeling
Medically Necessary — Lisocabtagene maraleucel for relapsed/refractory marginal zone lymphoma
Covered when ALL of the following are met:
Matches trial populations
Document lymphodepletion per policy
Not covered / Unproven
Listed explicitly as non‑covered in policy
Solid tumors are explicitly listed among the universal contraindications to CAR T‑cell therapy in this guideline and therefore are considered excluded from coverage under the CAR T policy. This reflects the current evidence base and trial populations, which have focused on hematologic malignancies rather than solid organ tumors.
Prior receipt of any CAR T‑cell therapy is an exclusion for coverage of the listed products. The policy requires that members requesting an initial CAR T product have not received prior CAR T‑cell therapy, and the document also states that second CAR T infusions (retreatment) are considered unproven and not covered due to insufficient published evidence.
Active central nervous system (CNS) involvement by disease and active graft‑versus‑host disease (GVHD) after prior allogeneic HSCT are listed as explicit exclusions. Product‑specific sections require absence of CNS myeloma or CNS lymphoma and confirm that members with prior allogeneic HSCT must not have active GVHD at the time of consideration.
Trial populations used to define eligibility frequently excluded patients with specific organ dysfunction or performance limits. Examples called out in the document include creatinine clearance ≤ 30 mL/min, ALT > 5× upper limit of normal, reduced left ventricular ejection fraction (e.g., LVEF thresholds such as <40–50% reported across trials), and higher ECOG scores (many trials excluded ECOG ≥2). These product‑specific trial exclusions inform the policy’s coverage decisions where noted.
Primary central nervous system lymphoma is repeatedly identified as an exclusion for the listed CAR T products, and the requirement that the member has not received prior CAR T‑cell therapy is reiterated across product sections as an exclusion to initial treatment authorization.
The ELARA trial for tisagenlecleucel (Kymriah) excluded patients with histologic transformation, follicular lymphoma grade 3B, prior anti‑CD19 therapy, or prior allogeneic HSCT. These trial exclusions are reflected in the policy language that requires absence of those features when applying Kymriah criteria.
Second infusions of CAR T therapy are considered not covered. Trial exclusion thresholds commonly cited (and used to guide noncoverage decisions) include laboratory and cardiac cutoffs such as creatinine clearance ≤ 30 mL/min, ALT > 5× ULN, and reduced LVEF (trial‑specific cutoffs noted), which were grounds for exclusion in pivotal studies.
Several document sections included in the source are administrative (review and approval history, version notes) or appendices and do not themselves state explicit coverage criteria; they serve as historical records rather than policy decision logic.
Indications outside the hematologic malignancies addressed in this guideline — including autoimmune diseases and solid tumors — are considered investigational until sufficient published evidence establishes efficacy and safety for those uses.
The policy treats absence of required lymphodepleting chemotherapy or failure to document specified pre‑infusion testing (for example, bone marrow blast count within defined time windows) as conditions that may render a request not medically necessary. These operational requirements function as prerequisites rather than optional considerations.
Prior Authorization, Documentation and Denial Triggers
Ohio prior authorization and review pathway
Prior authorization activities for CAR T-cell therapy requests in Ohio must follow the Ohio Department of Medicaid Managed Care Provider Agreements; reimbursement is contingent on review and recommendation by the Ohio Hematopoietic Transplant and Cellular Therapy Consortium as described in the policy.
Prior authorization must demonstrate product-specific medical necessity
Prior authorization is required for CAR T-cell products and must document that the member meets product-specific medical necessity criteria including disease status, prior therapies, intended lymphodepleting regimen, absence of prior CAR T therapy, and GVHD/CNS exclusions where applicable.
- Confirm indication and product-specific eligibility (age, diagnosis/subtype, prior therapies).
- Document planned lymphodepleting chemotherapy and absence of active GVHD if prior allo-HSCT.
- Confirm no prior CAR T-cell therapy and absence of CNS involvement when required.
Prior authorization requirements for idecabtagene vicleucel (Abecma)
For idecabtagene vicleucel (Abecma), prior authorization must include documentation that the member is ≥18, has received ≥2 prior lines including an IMiD, a proteasome inhibitor, and an anti‑CD38 antibody, was refractory to the last regimen per IMWG, will receive standard lymphodepleting chemotherapy (cyclophosphamide 300 mg/m2 + fludarabine 30 mg/m2 daily x3), and has no CNS myeloma or active GVHD.
Prior authorization requirements for ciltacabtagene autoleucel (Carvykti)
For ciltacabtagene autoleucel (Carvykti), prior authorization must document member is ≥18, has received at least 1 prior line including a proteasome inhibitor and an IMiD and is lenalidomide‑refractory, was refractory to the last regimen, will receive standard lymphodepletion (cyclophosphamide 300 mg/m2 + fludarabine 30 mg/m2 daily x3), has not had prior CAR T, and has no CNS involvement or active GVHD.
Prior authorization requirements for lisocabtagene maraleucel (Breyanzi)
For lisocabtagene maraleucel (Breyanzi), prior authorization must document member is ≥18, has had treatment failure on at least two prior lines including a BTK inhibitor and a BCL‑2 inhibitor (venetoclax), ECOG ≤2, will receive lymphodepleting chemotherapy (fludarabine 30 mg/m2/day + cyclophosphamide 300 mg/m2/day IV x3), and has not received prior CAR T therapy.
Core prior authorization documentation elements
Prior authorization requests for any CAR T product must document the indication, prior systemic therapies with regimens/dates, ECOG performance status, planned lymphodepletion regimen (drug names/doses/schedule), and confirm no prior CAR T-cell treatment.
Confirm product‑specific eligibility at prior authorization
Prior authorization must confirm the member meets FDA‑label or study‑based medical necessity criteria for the requested CAR T product, including age, diagnosis/subtype, required number/type of prior therapies, lymphodepletion plan, and absence of active GVHD after allogeneic HSCT when specified.
Prior authorization required to confirm label/study criteria
Prior authorization is required to confirm the member meets FDA‑label or study-based medical necessity criteria for the specific CAR T product, with documentation of age, diagnosis/subtype, prior therapies, no prior CAR T therapy, planned lymphodepletion, and GVHD status after allo-HSCT as applicable.
Prior authorization requirements for Breyanzi in MZL
For marginal zone lymphoma treated with lisocabtagene maraleucel, prior authorization must document the member is ≥18, has relapsed/refractory disease after ≥2 systemic therapies (including anti‑CD20 + alkylator) or relapsed after HSCT, will receive fludarabine 30 mg/m2/day + cyclophosphamide 300 mg/m2/day IV x3 for lymphodepletion, and has not had prior CAR T-cell therapy.
Prior authorization not specified in these excerpts
These document excerpts do not contain additional, explicit prior authorization workflow or billing code instructions; consult the full policy and payer resources for operational details.
Facility certification and product safety labeling
Facility certification and product safety labeling: facilities offering CAR T therapies should be FACT IEC certified or obtaining certification; product risks are conveyed via product labeling and boxed warnings following REMS elimination.
Prior therapy documentation required for coverage
Coverage decisions require documentation of specified prior lines of therapy or prior allo‑SCT per the indication; verify and list prior regimens and dates in the authorization request.
Step therapy and bridging considerations (informational)
Step‑therapy and bridging guidance: policy references prior standard regimens and permits bridging therapy between leukapheresis and lymphodepletion as used in trials; selection should reflect standard oncologic practice and may require PET reconfirmation.
- Bridging therapy permitted in TRANSCEND, CARTITUDE and TRANSFORM contexts and may require disease reassessment prior to lymphodepletion.
- No mandatory step‑therapy algorithm is specified in these excerpts.
Prior lines requirement summary
Summary of prior lines requirements: most product sections require members to have received commonly ≥2 prior systemic therapies or meet product‑specific refractory criteria; include prior regimens and dates in the authorization.
Step therapy considerations: liso‑cel vs standard salvage ± HSCT (TRANSFORM)
For liso‑cel in second‑line settings, consider authorization context versus HSCT pathways; trial TRANSFORM compared liso‑cel to standard salvage chemoimmunotherapy followed by autologous HSCT in responders and allowed one cycle of bridging therapy.
Step therapy prerequisites for Tecartus in MCL
Tecartus (brexucabtagene autoleucel) prerequisites for MCL must be documented: prior anthracycline‑ or bendamustine‑containing chemotherapy, anti‑CD20 therapy, and a BTK inhibitor prior to authorization.
Two or more prior systemic therapies commonly required
For some indications, prior therapies requirement is that the member has received two or more prior systemic therapies (including anti‑CD20 and an alkylating agent) or relapsed after HSCT; document prior regimen details in the request.
Facility certification and REMS/labeling note
Document that the treating facility is FACT IEC certified or pursuing certification and note that product labeling (boxed warnings) communicates risks after REMS elimination.
Bone marrow blast count within 7 days required for Aucatzyl
For Aucatzyl (obecabtagene autoleucel) and related ALL sections, documentation of a bone marrow blast count performed within 7 days prior to lymphodepletion is required and must be included with the authorization.
Lymphodepletion regimen documentation required
Authorization must include planned lymphodepletion details: specify drug names, doses and timing (e.g., fludarabine and cyclophosphamide regimens per product sections) in the prior authorization submission.
Document absence of active GVHD after allo‑HSCT
If the member had prior allogeneic HSCT, document the absence of active graft‑versus‑host disease (GVHD) as required for eligibility and prior authorization.
Required documentation for ide‑cel (Abecma)
For ide‑cel authorization include documentation of prior lines and refractoriness to last regimen per IMWG criteria, planned or given lymphodepleting chemotherapy, and absence of CNS involvement or active GVHD.
Required documentation for cilta‑cel (Carvykti)
For cilta‑cel authorization include documentation of lenalidomide‑refractory status, prior therapies received, planned lymphodepleting chemotherapy, confirmation of no prior CAR T therapy, and absence of CNS involvement or active GVHD.
Required documentation for liso‑cel (Breyanzi)
For liso‑cel authorization include documentation of at least two prior lines (including BTK inhibitor and venetoclax) with treatment failure, ECOG performance status, planned lymphodepleting chemotherapy (fludarabine 30 mg/m2/day + cyclophosphamide 300 mg/m2/day x3), and no prior CAR T therapy.
Documentation checklist: diagnosis, prior regimens, ECOG, lymphodepletion, prior CAR T
Ensure the authorization request documents diagnosis subtype, prior systemic regimens and dates, ECOG performance status, planned lymphodepleting chemotherapy regimen (drug names/doses/timing), and absence of prior CAR T therapy; if prior allo‑HSCT, document no active GVHD.
Required clinical documentation: relapse timing, HSCT/GVHD history, ECOG, lymphodepletion plan
Provide clinical documentation of prior systemic therapy regimens, timing of relapse (e.g., relapse within 12 months or POD24), prior HSCT history and current GVHD status, ECOG performance status, and plan for standard lymphodepleting chemotherapy as part of the authorization package.
Additional FL follow‑up documentation when progression <2 years (POD24)
For follicular lymphoma cases, additional follow‑up documentation may be requested when progression occurred < 2 years after initial chemoimmunotherapy (POD24) to describe follow‑up prior to progression and justify CAR T therapy.
Clinical documentation required to support authorization
Authorization documentation should support prior lines of therapy, absence of prior CAR T, member age, eligibility for lymphodepleting chemotherapy, and absence of active GVHD after allogeneic HSCT where applicable.
Documentation to support prior therapies, age, and lymphodepletion eligibility
Clinical documentation must support prior lines of therapy, absence of prior CAR T therapy, member age, and eligibility for lymphodepleting chemotherapy (including planned regimen and timing) for authorization decisions.
Version and approval history (no workflow detail in excerpts)
This section of the source contains version and approval history and does not specify additional documentation or prior authorization workflow details in these excerpts.
Ohio application and review requirements for unproven/limited services
Requests for services considered unproven or subject to coverage/quantity limits will be evaluated for medical necessity using Ohio Administrative Code Rule 5160-1-01 and review by the Ohio Hematopoietic Transplant and Cellular Therapy Consortium, which may affect authorization decisions.
Prior CAR T‑cell therapy exclusion and denial risk
Prior CAR T‑cell therapy is an exclusion for authorization; requests may be denied when the member has received prior CAR T-cell therapy unless the request meets specific, evidence‑supported retreatment criteria (second infusions are considered unproven).
Denial risk: missing lymphodepletion or bone marrow testing
Denial risk exists if required lymphodepleting chemotherapy was not given or if required pre‑infusion bone marrow testing (e.g., blast count within specified timeframe for Aucatzyl) was not performed and documented.
Denial triggers for idecabtagene vicleucel (Abecma)
Failure to meet idecabtagene vicleucel eligibility (age ≥18, required prior lines including IMiD/PI/anti‑CD38, refractory to last regimen, planned lymphodepletion, no CNS myeloma or active GVHD) may result in denial of coverage.
Denial triggers for ciltacabtagene autoleucel (Carvykti)
Failure to meet ciltacabtagene autoleucel eligibility (age ≥18, lenalidomide‑refractory after required prior therapies, planned lymphodepletion, no prior CAR T, no CNS involvement, no active GVHD) may result in denial.
Denial triggers for lisocabtagene maraleucel (Breyanzi)
Failure to meet lisocabtagene maraleucel eligibility (age ≥18, prior BTK and BCL‑2 inhibitor exposure and failure, ECOG ≤2, planned lymphodepletion, no prior CAR T therapy) may result in noncoverage or denial.
Denial risk for prior CAR T history
Requests may be denied if the member has received prior CAR T-cell therapy; ensure prior‑therapy history is clearly documented and absence of prior CAR T is confirmed.
Denial risk: insufficient prior therapy documentation
Requests may be denied if required prior lines of therapy (e.g., two or more chemoimmunotherapy regimens including an anthracycline when indicated) are not documented in the authorization request.
Lymphodepletion documentation requirement for Breyanzi to avoid denial
Failure to document planned lymphodepleting chemotherapy for Breyanzi (fludarabine 30 mg/m2/day + cyclophosphamide 300 mg/m2/day IV x3) prior to infusion may trigger denial.
Denial risk: prior therapy exposure required for Yescarta in FL
For Yescarta in follicular lymphoma, failure to document prior exposure to an anti‑CD20 antibody plus an alkylating agent or insufficient prior lines of therapy may trigger denial.
General eligibility denial triggers for Breyanzi
General Breyanzi eligibility denial risks: requests may be denied if the member is <18, has received prior CAR T therapy, or has active GVHD after prior allogeneic HSCT for indications requiring absence of active GVHD.
Denial risk: lymphodepletion timing and regimen adherence
Denial risk exists if lymphodepleting chemotherapy is not administered per specified timing/doses (e.g., within two weeks prior to Kymriah infusion or per product‑specific schedules); document any allowed alternatives (e.g., bendamustine for Kymriah) when used.
Second CAR T infusion considered unproven (non‑covered)
Second CAR T‑cell infusions (retreatment) are considered unproven and are not covered; authorization for a second infusion is expected to be denied absent adequate published evidence.
No additional denial triggers in review history excerpts
No explicit denial triggers are listed in the appendix/review history excerpts; operational denial reasons are captured in the product‑specific sections above.
Lymphodepleting Chemotherapy and Regimens
| Protocol | Lymphodepletion (drugs & schedule) | CAR T infusion (dose / timing) |
|---|---|---|
| ZUMA-3 (KTE‑X19) | Fludarabine 25 mg/m2 IV on days -4, -3, and -2; Cyclophosphamide 900 mg/m2 IV on day -2 | Single infusion of KTE‑X19 at 1 × 10^6 CAR T cells/kg following conditioning |
| Product | Lymphodepletion regimen (drugs & schedule) |
|---|---|
| Tecartus (brexucabtagene autoleucel) | Fludarabine 25 mg/m2 IV on days -4, -3, -2; Cyclophosphamide 90 mg/m2 IV on day -2 before infusion |
| Aucatzyl (obecabtagene autoleucel) | Fludarabine 30 mg/m2 IV daily ×4 and Cyclophosphamide 500 mg/m2 IV daily ×2 starting with first fludarabine dose before infusion |
| Kymriah (tisagenlecleucel) | Standard options per FDA label: Fludarabine 25 mg/m2 IV daily ×3 + Cyclophosphamide 250 mg/m2 IV daily ×3 starting with first fludarabine dose; alternate: Bendamustine 90 mg/m2 IV daily ×2 for patients unable to receive cyclophosphamide; regimen given within two weeks preceding infusion |
| Regimen | Dose & Schedule |
|---|---|
| Fludarabine + Cyclophosphamide (common regimen) | Fludarabine 30 mg/m2 IV daily ×3 plus Cyclophosphamide 300 mg/m2 IV daily ×3 administered prior to CAR T infusion |
| Product | Coverage requirement regarding lymphodepletion |
|---|---|
| Axicabtagene ciloleucel (Yescarta) | Member has received or will receive adequate standard lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2 IV and fludarabine 30 mg/m2 IV on days -5 to -3 or therapeutically equivalent regimen) as a condition of coverage |
| Tisagenlecleucel (Kymriah) | Member has received or will receive lymphodepleting chemotherapy within two weeks preceding infusion using standard FDA‑label regimens (e.g., fludarabine+cyclophosphamide or bendamustine alternative) as a condition of coverage |
| Lisocabtagene maraleucel (Breyanzi) | Member will receive lymphodepleting chemotherapy before infusion: fludarabine 30 mg/m2/day IV and cyclophosphamide 300 mg/m2/day IV for 3 days as a condition of coverage |
| Context | Comparator / Intervention |
|---|---|
| TRANSFORM trial setting | Lisocabtagene maraleucel (liso‑cel) infusion versus standard salvage chemoimmunotherapy (R‑DHAP, R‑ICE, or R‑GDP) followed by high‑dose therapy and autologous HSCT in responders |
| Product / Setting | Lymphodepletion regimen (dose & schedule) |
|---|---|
| Breyanzi (lisocabtagene maraleucel) | Fludarabine 30 mg/m2/day IV and Cyclophosphamide 300 mg/m2/day IV for 3 days prior to infusion |
| Yescarta (axicabtagene ciloleucel) | Cyclophosphamide 500 mg/m2 IV and Fludarabine 30 mg/m2 IV on days -5 to -3 prior to infusion (standard described) |
| Regimen option | Specification / Notes |
|---|---|
| Fludarabine 25–30 mg/m2 IV daily ×3 + Cyclophosphamide 250–500 or 300–500 mg/m2 IV daily ×3 | Various product-specific dose specifications accepted (examples include fludarabine 25–30 mg/m2 ×3 with varying cyclophosphamide dosing); bendamustine 90 mg/m2 IV ×2 is an alternative per Kymriah label for patients unable to receive cyclophosphamide; Breyanzi and other products specify exact regimens in their sections |
| Preparatory regimen | Dose & Schedule |
|---|---|
| Fludarabine + Cyclophosphamide (Breyanzi / common preparatory regimen) | Fludarabine 30 mg/m2/day IV and Cyclophosphamide 300 mg/m2/day IV for 3 days prior to CAR T infusion |
Coding, Biomarker and Eligibility Metrics
| Fludarabine 30 mg/m2 IV x3 days | Lymphodepleting chemotherapy regimen component (fludarabine) specified as standard prior to infusion. |
| Cyclophosphamide 300 mg/m2 IV x3 days | Lymphodepleting chemotherapy regimen component (cyclophosphamide) specified as standard prior to infusion. |
| fludarabine 30 mg/m2/day + cyclophosphamide 300 mg/m2/day x3 | Lymphodepleting regimen specified for lisocabtagene maraleucel (Breyanzi). |
| cyclophosphamide 500 mg/m2 and fludarabine 30 mg/m2 on days -5 to -3 | Lymphodepleting regimen specified as the standard for axicabtagene ciloleucel (Yescarta). |
| Fludarabine 25 mg/m2 IV daily x3 + Cyclophosphamide 250 mg/m2 IV daily x3 | Standard lymphodepleting regimen per tisagenlecleucel (Kymriah) FDA label option. |
| Bendamustine 90 mg/m2 IV daily x2 | Alternate lymphodepleting option per tisagenlecleucel (Kymriah) label for patients unable to receive cyclophosphamide. |
Line-of-Therapy Rules and Trial Context
inv-106: mixed
Mixed indications — line‑of‑therapy considerations drawn from product approvals and trial populations:
Summarizes product labeling statements
inv-107: salvage
Salvage setting summarized from trial and label populations:
Derived from adult ALL and myeloma trial descriptions
inv-108: second-line or later
Second‑line or later contexts described in trial populations:
Trial populations inform product‑specific line requirements
inv-109: earlier relapse (first relapse)
Earlier relapse (first relapse) contexts where CAR T was studied:
Indicates potential earlier‑line use per trial data
inv-110: relapsed/refractory (later lines)
Relapsed/refractory later‑line contexts (CLL/SLL examples):
Informs liso‑cel criteria
inv-111: third-line or later / second-line in refractory disease per trial
Third‑line or later and selected second‑line refractory contexts from trials and labels:
Combines trial contexts informing 2L/3L use
inv-112: first-line | second-line | salvage
Combined line‑of‑therapy options described across indications:
Summary of guideline and trial contexts
inv-113: second-line | subsequent
Second‑line and subsequent therapy descriptions used to define eligibility:
Reflects product‑specific prior therapy requirements
inv-114: salvage
Salvage contexts from TRANSCEND and related cohorts:
Matches trial inclusion and policy criteria
Definitions and Background
CAR T‑cell therapy uses autologous T cells engineered to express chimeric antigen receptors directed at tumor cell surface proteins. Treatment requires leukapheresis, centralized manufacturing, and reinfusion after lymphodepleting chemotherapy; manufacturing can take several weeks. Major toxicities include cytokine release syndrome (CRS) and immune effector cell‑associated neurotoxicity syndrome (ICANS), which are managed with supportive care, IL‑6 antagonists (e.g., tocilizumab) and steroids. Facilities providing CAR T are expected to meet Immune Effector Cell (IEC) standards (FACT) as described in the policy.
Biomarker and Molecular Eligibility
Policy History and Versioning
Portions of the document labeled as appendices or version history contain review dates, approval notes, and versioning details but do not include explicit medical necessity criteria or clinical decision rules; they document the guideline’s update pathway and approvals.
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