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Chimeric Antigen Receptor (CAR) T-Cell Therapy
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Clinical guidelines governing indications, eligibility, FDA-approved agents, and clinical evidence for CAR T-cell therapy as applied to members in Ohio; affects providers requesting authorization and facilities providing CAR T-cell therapy.
No material clinical or coverage changes in this revision.
Coverage Criteria — Product and Universal Requirements
Universal Eligibility Requirements
Covered when ALL of the following universal minimum eligibility and administrative conditions are met:
Based on ASTCT expert panel recommendations
Indications and product-specific constraints
Covered when product-specific indication and prior‑therapy constraints are met (examples shown; see individual product sections and FDA labeling for exact prior‑therapy requirements):
Refer to individual product labeling and product sections below for exact prior therapy and line‑of‑therapy constraints.
NCCN guidance and ZUMA‑3 trial context inform criteria.
Tecartus — Initial Therapy
Tecartus (brexucabtagene autoleucel) is considered medically necessary for initial therapy when ALL of the following are met for adult patients (≥18 years):
Aucatzyl — Initial Therapy
Aucatzyl (obecabtagene autoleucel) is considered medically necessary for initial therapy when ALL of the following are met for adult patients (≥18 years):
Kymriah — Pediatric/Young Adult ALL
Kymriah (tisagenlecleucel) is considered medically necessary for pediatric/young adult B‑cell precursor ALL when ALL of the following are met:
Abecma — Initial Therapy
Abecma (idecabtagene vicleucel) is considered medically necessary for initial therapy when ALL of the following are met for adult patients (≥18 years) with active, measurable multiple myeloma:
IMWG and KarMMa/KarMMa‑3 context
Idecabtagene vicleucel (Abecma) — Initial Therapy
Covered when ALL of the following Abecma medical necessity criteria are met:
Idecabtagene vicleucel (Abecma) — Initial Therapy
(Duplicate product‑specific node for Abecma) Covered when ALL of the following criteria are met:
Duplicate criteria block as provided in source
Ciltacabtagene autoleucel (Carvykti) — Initial Therapy
Ciltacabtagene autoleucel (Carvykti) is considered medically necessary for initial therapy when ALL of the following are met for adult patients (≥18 years):
Lisocabtagene maraleucel (Breyanzi) — Initial Therapy
Lisocabtagene maraleucel (Breyanzi) is considered medically necessary for initial therapy in specified hematologic malignancies when ALL of the following are met:
Axi-cel (Yescarta) medical necessity
Axi‑cel (axicabtagene ciloleucel, Yescarta) is considered medically necessary when ALL of the following are met:
Subtypes listed in policy
Either pathway qualifies
Tisagenlecleucel (Kymriah) medical necessity
Tisagenlecleucel (Kymriah) is considered medically necessary for adult relapsed/refractory B‑cell lymphoma and for pediatric/young‑adult ALL per product‑specific criteria. When used in adult B‑cell lymphoma or FL, ALL of the following apply:
Subtypes and grade‑specific notes present in policy
Liso-cel (Breyanzi) clinical evidence summary
Lisocabtagene maraleucel (Breyanzi) — clinical evidence summary and scope:
Lisocabtagene maraleucel — LBCL coverage criteria
Lisocabtagene maraleucel (Breyanzi) — relapsed/refractory large B‑cell lymphoma (LBCL) coverage criteria:
Exact lymphodepletion regimen specified
Axicabtagene ciloleucel — FL coverage criteria
Axicabtagene ciloleucel (Yescarta) — relapsed/refractory follicular lymphoma coverage criteria:
Lymphodepletion regimen and performance status required
Lisocabtagene maraleucel — FL coverage criteria
Lisocabtagene maraleucel (Breyanzi) — relapsed/refractory follicular lymphoma coverage criteria:
Specifies lymphodepletion regimen for Breyanzi in FL
Breyanzi for follicular lymphoma (FL)
Breyanzi (lisocabtagene maraleucel) — medical necessity for follicular lymphoma (consolidated):
Kymriah for follicular lymphoma (FL grade 1-3A)
Kymriah (tisagenlecleucel) — relapsed/refractory follicular lymphoma (grade 1‑3A) medical necessity:
Tecartus for mantle cell lymphoma (MCL)
Tecartus (brexucabtagene autoleucel) — mantle cell lymphoma (MCL) medical necessity:
Breyanzi for mantle cell lymphoma (MCL)
Breyanzi (lisocabtagene maraleucel) — mantle cell lymphoma (MCL) medical necessity:
Breyanzi for marginal zone lymphoma (MZL)
Breyanzi (lisocabtagene maraleucel) — marginal zone lymphoma (MZL) medical necessity:
Non-Covered Indications
Initial therapy criteria for lisocabtagene maraleucel (Breyanzi) in marginal zone lymphoma consolidated:
Requests for CAR T‑cell therapy are subject to universal contraindications that will preclude coverage when present. Contraindications include: pregnancy; receipt of immunosuppressive therapy for autoimmune disorders; any active, uncontrolled infection; uncontrolled HIV infection until controlled by an HIV specialist; active hepatitis B or C (hematologic malignancy‑specific distinctions noted in product sections); active graft‑versus‑host disease after prior allogeneic HSCT; and solid tumors. In addition, members with relapsed or refractory disease who have previously received a CAR T‑cell therapy are excluded from coverage for subsequent CAR T treatment unless otherwise specified by product‑specific rules. These universal exclusions apply across products and are grounds for denial when present.
Product‑specific clinical eligibility must also be met (age, prior lines and classes of therapy, refractory status, lymphodepletion plan, absence of active CNS disease or active GVHD where required). Where a product’s criteria are satisfied, coverage is conditional on documentation of planned or completed standard lymphodepleting chemotherapy and lack of any universal contraindication. Requests that do not document required prior therapy exposures, planned lymphodepletion, or that meet any of the universal contraindications above may be denied.
Prior receipt of any CAR T‑cell therapy is treated as an exclusion across multiple product sections. For example, the Tecartus, Aucatzyl, Kymriah, Abecma and lisocabtagene maraleucel sections each state the member has not received prior treatment with CAR T‑cell therapy as an eligibility requirement. When prior CAR T exposure is documented and the policy or product-specific criteria prohibit repeat use, the request will be excluded from coverage.
In addition to prior CAR T exposure, product sections uniformly require absence of active graft‑versus‑host disease after prior allogeneic HSCT and completion or planned administration of the product‑specific lymphodepleting chemotherapy regimen before infusion; these conditions function as co‑requirements that, when unmet, likewise exclude authorization.
Active central nervous system (CNS) involvement, active graft‑versus‑host disease (GVHD) following allogeneic HSCT, and prior CAR T‑cell therapy are explicit exclusion triggers in the policy. The universal contraindications list identifies active GVHD after prior allogeneic HSCT and prior CAR T therapy as exclusionary; product sections (e.g., Tecartus, Aucatzyl, Kymriah, Abecma) reiterate that members must not have active GVHD and must not have received prior CAR T treatment to be eligible. Similarly, active CNS disease is disqualifying for certain products (see product‑specific sections) and will trigger noncoverage when present.
Providers must document absence of these conditions (no active CNS involvement where prohibited; no active GVHD if prior allo‑HSCT; no prior CAR T exposure when the product requires it) as part of prior authorization; failure to do so may result in denial.
Tisagenlecleucel (Kymriah) policy language explicitly excludes members with primary central nervous system lymphoma. The Kymriah section states that the member does not have primary CNS lymphoma and that prior anti‑CD19 therapy or other trial‑specified exclusions may apply in certain contexts; primary CNS lymphoma remains a stated exclusion for Kymriah in the coverage criteria.
Exclusions are aggregated across the policy and reinforced in multiple product sections: prior CAR T‑cell therapy and active GVHD after prior allogeneic HSCT are exclusionary across Tecartus, Aucatzyl, Kymriah, Abecma and other products that require no prior CAR T exposure and no active GVHD. Active CNS involvement is also excluded for products that specify its absence. These overlapping exclusions function as both universal contraindications and product‑specific disqualifiers; documentation confirming absence of these conditions is required for approval.
Kymriah trial‑derived exclusions and coverage considerations note that patients with histologic transformation, follicular lymphoma grade 3B, prior anti‑CD19 therapy, or prior allogeneic HSCT were excluded from the trial populations that inform coverage. The policy uses these trial exclusions to inform coverage language for Kymriah — specifically excluding prior anti‑CD19 therapy and certain transformed histologies from eligibility where noted.
The TRANSCEND FL‑MZL cohort applied specific trial exclusion criteria that are referenced in the policy. Exclusions included creatinine clearance ≤ 30 mL/min, alanine aminotransferase (ALT) > 5× ULN, left ventricular ejection fraction (LVEF) < 40%, transformed lymphoma, active or serious infections, active autoimmune disease requiring immunosuppression, and history of a central nervous system disorder. These limits inform safety‑related exclusions and documentation expectations for Breyanzi in the FL‑MZL setting.
Administration of a second CAR T infusion (retreatment) for relapsed or refractory disease is considered unproven across products and is specifically listed among non‑covered indications. In the absence of adequate published evidence demonstrating efficacy for second infusions, such requests are not covered and may be denied.
No explicit additional exclusions or policy‑level prohibitions are described in the referenced administrative history chunks beyond those already captured in the clinical sections above.
Several conditions listed as universal contraindications also act as noncoverage triggers: pregnancy, any active uncontrolled infection, uncontrolled HIV (until controlled), active hepatitis B/C where specified by indication, and active graft‑versus‑host disease after allogeneic HSCT. When present, these conditions preclude authorization regardless of product and should be documented in the record.
Coverage is limited to patients who meet product‑specific requirements for prior therapies, refractory status, age, lymphodepletion, and no prior CAR T exposure where specified. Requests for patients who do not meet those product‑specific prerequisites (for example, insufficient prior lines or missing required prior agents/classes, inappropriate age, omission of required lymphodepleting chemotherapy, or prior CAR T exposure when prohibited) are not covered under the policy.
The policy reiterates that retreatment with a second CAR T infusion is unproven; second infusions for relapsed/refractory disease are considered not supported by adequate published evidence and therefore are not covered.
No explicit statements titled 'not medically necessary' are provided in the referenced administrative/history chunks beyond the non‑covered indications and contraindications already summarized in the clinical criteria and exclusions sections.
Provider Requirements — Authorization, Documentation, and Denial Triggers
Prior authorization and Ohio Consortium review required
Prior authorization is required for CAR T‑cell therapy and reimbursement is contingent on review and recommendation by the Ohio Hematopoietic Transplant and Cellular Therapy Consortium; prior authorization activities must follow Ohio Administrative Code and Ohio Department of Medicaid managed care agreements.
- Reimbursement contingent on Consortium review/recommendation
- Prior authorization processed per Ohio Administrative Code and Managed Care Provider Agreements
Prior authorization must include diagnosis, prior lines, HSCT details, and prior therapy evidence
Submit a product‑specific prior authorization that documents the requested CAR T product, member diagnosis, number and types of prior systemic therapy lines, prior HSCT history, and evidence the member meets the product's labeled eligibility (including planned lymphodepletion).
- Diagnosis and disease subtype per product labeling
- Number and classes/agents of prior systemic therapies
- Details of prior HSCT and current GVHD status
- Planned lymphodepleting chemotherapy regimen per product standard
Confirm product‑specific eligibility (age, prior lines, refractory status, lymphodepletion)
Prior authorization must confirm product‑specific eligibility elements (age, prior lines/classes of therapy, refractory status, planned lymphodepletion, absence of prior CAR T, and GVHD/CNS exclusions) are met before approval.
- Age ≥18 for adult product approvals (or product-specific pediatric age when applicable)
- No prior CAR T therapy when policy prohibits repeat use
- If prior allogeneic HSCT, documentation that active GVHD is not present
- Evidence of planned or received product‑specific lymphodepleting chemotherapy
Prior authorization to confirm B‑cell lymphoma subtype, prior therapies, age, and medical necessity
For B‑cell lymphomas, prior authorization must verify the specific lymphoma subtype, the required prior therapies and that age and other medical necessity criteria are met (e.g., prior anthracycline/anti‑CD20 exposure where specified).
- Document subtype (e.g., DLBCL, FL, MCL, MZL) as listed in product criteria
- Show prior chemoimmunotherapy exposure (including anthracycline/anti‑CD20 when required)
- Confirm ECOG/performance and organ function where requested
Authorization contingent on meeting medical necessity criteria
Approval is contingent on meeting the policy's medical necessity criteria — authorization should not be granted unless documentation demonstrates all product‑specific coverage requirements are satisfied.
- Member meets age and diagnosis requirements
- Required prior lines and classes of systemic therapy documented
- Planned lymphodepleting chemotherapy per product label
Prior authorization required for CAR T therapies — product‑specific medical necessity
Prior authorization must document product‑specific medical necessity criteria (adult age ≥18, diagnosis, required prior therapies) for CAR T agents before reimbursement will be approved.
- Age ≥18 for listed adult indications
- Required prior systemic therapy lines and agent classes per product (e.g., BTKi for MCL; IMiD/PI/anti‑CD38 for MM)
- No prior CAR T therapy when prohibited by the product section
Prior authorization — Breyanzi (lisocabtagene) MZL: >=18, 2+ prior lines, and documentation
For lisocabtagene maraleucel in MZL, prior authorization must show the member is ≥18, has relapsed/refractory MZL after two or more systemic therapies, has not had prior CAR T, and will receive the specified lymphodepletion regimen.
- Age ≥18 documented
- Two or more prior systemic therapy lines documented
- Planned lymphodepletion: fludarabine 30 mg/m2/day IV + cyclophosphamide 300 mg/m2/day IV x3
- No prior CAR T documented
Prior authorization details not specified in these excerpts
This placeholder represents portions of the document where specific prior authorization details are not described in the cited excerpt; providers must rely on the product‑specific sections elsewhere in the policy.
- See product‑specific coverage sections for detailed requirements when not specified in summary excerpts
No explicit step therapy sequencing policy — follow FDA lines per product
The policy cites product labeling and FDA‑approved lines of therapy but does not prescribe an explicit step‑therapy sequencing rule; follow FDA‑labeled prior‑line requirements and the policy's product sections for sequencing.
- No formal step‑therapy algorithm specified in the policy
- Use product labeling (lines of prior systemic therapy) to determine eligibility
Prior therapy requirements — document specific prior agents/classes per indication
Coverage requires documentation of specific prior therapies depending on indication (for example, adult ALL pathways require prior systemic chemotherapy lines or allo‑SCT; MM agents require IMiD, PI and anti‑CD38 exposure; CLL/SLL requires BTKi and venetoclax where specified).
- ALL: prior systemic chemotherapy lines or prior allo‑SCT as specified
- MM (Abecma): ≥2 prior lines including IMiD, PI, and anti‑CD38
- CLL/SLL (Breyanzi): prior BTKi and BCL‑2 inhibitor (venetoclax)
Provide evidence of prior relevant systemic therapies (classes/agents) with dates
Prior authorization must include evidence (medical record) of the required prior systemic therapies — list the specific classes/agents and dates of administration to demonstrate eligibility.
- List prior agents (e.g., lenalidomide, bortezomib, daratumumab for MM)
- Provide dates and outcomes for each prior regimen
Sequencing context: document trial-based justification for second‑line CAR T use
For certain indications the policy discusses trial contexts where CAR T was compared to standard second‑line therapy; when requesting second‑line use, document how the patient aligns with trial eligibility and rationale.
- TRANSFORM and ZUMA‑7 provide trial-based context for second‑line liso‑cel and axi‑cel, respectively
- Document patient's similarity to trial populations if requesting second‑line CAR T
Line‑of‑therapy requirement — document ≥2 prior lines for Breyanzi and most indications
When requesting lisocabtagene maraleucel, prior authorization must show the member progressed after or is refractory to at least two prior lines of systemic therapy (policy limits most indications to ≥2 prior lines).
- Document count of prior systemic therapy lines (≥2)
- Include prior chemoimmunotherapy details (anthracycline and anti‑CD20 when required)
Required clinical documentation and Ohio Consortium recommendation
Prior authorization must include the Ohio Consortium review/recommendation and baseline organ function evaluation (renal, hepatic, cardiac, pulmonary), hematologic status, neurologic baseline exam, autoimmune status, and infection control per Ohio rules.
- Attach Consortium recommendation or documentation of review
- Provide baseline labs and organ function assessments (GFR/Cr, AST/ALT, bilirubin, LVEF, pulse oximetry, ANC/platelets)
- Include baseline neurologic exam and infection assessment
Aucatzyl requires bone marrow blast count within 7 days pre‑lymphodepletion
For Aucatzyl, include a bone marrow blast count performed within 7 days prior to lymphodepletion as part of the authorization package.
- Bone marrow blast count result and date (within 7 days prior to lymphodepletion)
Document planned lymphodepletion regimen per product labeling
Document the planned lymphodepleting chemotherapy regimen per product standards (exact agents and dosing are product‑specific) and state whether it will be administered prior to CAR T infusion.
- Specify regimen and schedule (e.g., fludarabine/cyclophosphamide doses and days per product labeling)
- Confirm intent to administer lymphodepletion prior to infusion
Documentation must show patient age, prior therapy history, refractory status, and lymphodepletion plan
Authorization documentation must show member age (≥18 for adult indications or product‑specific pediatric age), prior therapy history with dates and outcomes, refractory status per IMWG or product definitions, and planned or completed lymphodepletion.
- Member birthdate/age verifying eligibility
- Prior therapy list with dates and response
- Statement of refractory status per referenced criteria (e.g., IMWG)
Required documentation for lisocabtagene maraleucel (Breyanzi)
For lisocabtagene maraleucel requests, include documentation that the member is ≥18, has had two or more prior systemic therapy lines, has not had prior CAR T, and will receive the specified lymphodepletion regimen (fludarabine 30 mg/m2/day + cyclophosphamide 300 mg/m2/day x3).
- Age verification (≥18)
- Count and details of prior systemic therapies (≥2)
- No prior CAR T documented
- Planned lymphodepletion regimen: fludarabine 30 mg/m2/day IV + cyclophosphamide 300 mg/m2/day IV x3
Contraindications (if present) trigger non‑coverage — confirm absence in documentation
The policy lists universal contraindications that, if present, will result in non‑coverage; prior authorization should document absence of these (for example: pregnancy, active uncontrolled infection, uncontrolled HIV, active hepatitis B/C when relevant, active GVHD after allo‑HSCT, solid tumors, or prior CAR T exposure).
- Confirm member is not pregnant
- Confirm no active uncontrolled infection or uncontrolled HIV
- Document hepatitis B/C/CMV status where relevant
- Confirm no active GVHD if prior allo‑HSCT
- Confirm no prior CAR T therapy when policy prohibits repeat use
Tecartus excludes prior CAR T and active GVHD after allo‑HSCT
Tecartus specifically excludes prior CAR T‑cell therapy and requires that members with prior allo‑HSCT not have active GVHD; authorization will be denied if these exclusionary conditions are present.
- Do not request Tecartus for members with prior CAR T treatment
- If prior allo‑HSCT, document absence of active GVHD
Prior CAR T exposure and active GVHD are exclusionary for listed products
Prior CAR T‑cell therapy is exclusionary for several products (Aucatzyl, Kymriah, Abecma) and active GVHD after prior allogeneic HSCT is exclusionary; prior authorization must document absence of these conditions.
- Confirm no prior CAR T therapy for these products
- If prior allo‑HSCT, confirm no active GVHD
Denial risk if age, prior‑therapy, refractory status, lymphodepletion, prior CAR T, GVHD, or CNS criteria not met
Requests may be denied if the member does not meet age, prior‑therapy, refractory status, lymphodepletion, prior CAR T exposure, active GVHD, or CNS involvement criteria; ensure documentation addresses each applicable criterion.
- Verify age and diagnosis
- Document prior lines and refractory status
- Confirm planned lymphodepletion and absence of CNS disease when required
- Confirm no prior CAR T or active GVHD where excluded
Denial risk: inadequate documentation of required prior agents/lines
Failure to document required prior lines or specific agents (for example: IMiD, PI, anti‑CD38 in MM; BTKi and venetoclax in CLL) may justify denial — include agent names, dates, and response in authorization materials.
- List specific agents used (e.g., lenalidomide, bortezomib, daratumumab; ibrutinib, venetoclax)
- Provide dates of therapy and reason for discontinuation or progression
Denial risk for missing documentation of prior therapies and lymphodepletion
Requests lacking documentation that the member received the required number of prior systemic therapies (typically ≥2) or lacking confirmation of planned/administered standard lymphodepleting chemotherapy may be denied.
- Document count of prior systemic therapy lines and the component agents
- Document planned or completed lymphodepleting chemotherapy with product‑specific dosing
Denial triggers — unmet clinical criteria or missing Consortium review
If required clinical criteria are unmet (age, subtype, prior lines, refractory status) or required Consortium review is absent, the request may be denied — include all supporting clinical and administrative documentation.
- Attach Ohio Consortium review/recommendation
- Include clinical evidence showing member meets each medical necessity criterion
Second CAR T infusion considered unproven — retreatment may be denied
Second infusions (retreatment) of CAR T‑cell therapy are considered unproven and may be denied in the absence of adequate published evidence; do not expect authorization for repeat CAR T without strong supporting data.
- Second CAR T infusions regarded as unproven regardless of product or indication
- Authorization likely denied unless robust published evidence supports retreatment
Retreatment requests: second infusions considered unproven and may be denied
Requests for retreatment with a second CAR T infusion are considered unproven and may be denied absent adequate published evidence; include any trial data or rationale if retreatment is requested.
- Provide published evidence if requesting second infusion
- Describe prior response and reason for retreatment request
Authorization/denial triggers not present in these excerpts — consult full policy sections
Certain excerpts do not describe authorization or denial triggers; when citation gaps exist rely on the detailed product‑specific sections and Ohio Consortium requirements elsewhere in the policy.
- Refer to full product sections for complete authorization criteria when summary chunks lack detail
Required Lymphodepleting Chemotherapy Regimens
| Product | Lymphodepletion regimen (dosing) |
|---|---|
| Tecartus (brexucabtagene autoleucel) | |
| Fludarabine 25 mg/m2 IV on days -4, -3, -2; cyclophosphamide 90 mg/m2 IV on day -2 | |
| Aucatzyl (obecabtagene autoleucel) | |
| Fludarabine 30 mg/m2 IV daily x4 and cyclophosphamide 500 mg/m2 IV daily x2 starting with first fludarabine dose | |
| Kymriah (tisagenlecleucel) | |
| Fludarabine 30 mg/m2 IV daily x4 and cyclophosphamide 500 mg/m2 IV daily x2 within two weeks preceding infusion (per policy) | |
| Abecma (idecabtagene vicleucel) | |
| Cyclophosphamide 300 mg/m2 IV and fludarabine 30 mg/m2 IV daily for 3 days prior to infusion |
| Regimen | Description |
|---|---|
| Cyclophosphamide 300 mg/m2 IV + Fludarabine 30 mg/m2 IV daily x3 | |
| Specified in policy as a standard lymphodepleting chemotherapy regimen prior to CAR T infusion (cyclophosphamide 300 mg/m2 IV and fludarabine 30 mg/m2 IV daily for 3 days) |
| Example/regimen | Details / when used / alternate |
|---|---|
| Axi-cel (Yescarta) regimen example | |
| Fludarabine 30 mg/m2 IV + cyclophosphamide 500 mg/m2 IV on days -5, -4, -3 (conditioning used in ZUMA-1 and cited as standard for axi-cel) | |
| Tisagenlecleucel (Kymriah) regimen example | |
| Fludarabine 25 mg/m2 IV daily x3 and cyclophosphamide 250 mg/m2 IV daily x3 per FDA label; bendamustine 90 mg/m2 IV daily x2 cited as an alternate when cyclophosphamide contraindicated |
| Product | Product-specific fludarabine + cyclophosphamide dosing example |
|---|---|
| Lisocabtagene maraleucel (Breyanzi) | |
| Fludarabine 30 mg/m2/day IV and cyclophosphamide 300 mg/m2/day IV for 3 days prior to infusion (specified as standard for liso-cel/Breyanzi) | |
| Axicabtagene ciloleucel (Yescarta) | |
| Cyclophosphamide 500 mg/m2 IV and fludarabine 30 mg/m2 IV on days -5, -4, -3 (conditioning regimen cited for axi-cel) |
| Product / example | Fludarabine + cyclophosphamide dosing (policy examples) |
|---|---|
| Breyanzi (lisocabtagene maraleucel) | |
| Fludarabine 30 mg/m2 IV + cyclophosphamide 300 mg/m2 IV daily x3 (policy-specified regimen) | |
| Kymriah (tisagenlecleucel) label example | |
| Fludarabine 25 mg/m2 IV daily x3 + cyclophosphamide 250 mg/m2 IV daily x3 (FDA label standard regimens cited in policy) | |
| Tecartus (ZUMA-2 regimen example) | |
| Cyclophosphamide 500 mg/m2 IV + fludarabine 30 mg/m2 IV (used in ZUMA-2 and cited in policy as an example) |
| Regimen | Policy-specified dosing |
|---|---|
| Fludarabine 30 mg/m2/day IV + cyclophosphamide 300 mg/m2/day IV x3 | |
| Specified in the policy as an accepted lymphodepleting chemotherapy regimen to be administered prior to CAR T infusion (used for Breyanzi and other products per policy examples) |
Line-of-Therapy Groupings and Product Positioning
varied
Line‑of‑therapy distinctions (grouped by product/indication):
Refer to ZUMA‑1/ZUMA‑7 and label
ZUMA‑2/ZUMA‑3 context
Refer to product labels and NCCN
second-line | later
Second‑line and later therapy positioning (examples):
Tecartus and Aucatzyl pathways
KarMMa‑3 evidence supports criteria
varies
Variation in line‑of‑therapy requirements by product and indication (examples):
KarMMa and KarMMa‑3
CARTITUDE trial and label updates
TRANSCEND and subsequent approvals
second-line | third-line and higher
Second‑line versus third‑line and higher context (trial‑based examples):
ZUMA‑7 randomized evidence
second-line | third-line
Second‑line and third‑line considerations (liso‑cel examples):
Trial evidence informs line‑of‑therapy placement
second-line | subsequent
General guidance on sequencing and required prior agents/classes:
Refer to product sections for exact agent/class requirements
salvage
Salvage‑setting summary (example for Breyanzi/MZL):
Applies to many indications including MZL
Biomarker Requirements and Age/Coding Facts
Documentation Required for Prior Authorization
Provide evidence of prior relevant systemic therapies
Authorization requires submission of objective evidence of prior relevant systemic therapies — listing of agents/classes, number of lines, dates, and response — before coverage will be considered.
- Provide dates and outcomes for each prior line of therapy
- Specify agents and drug classes used
Include Ohio Consortium review/recommendation with authorization
Prior authorization requires review/recommendation from the Ohio Hematopoietic Transplant and Cellular Therapy Consortium as part of the authorization package submitted per Ohio Administrative Code.
- Include Consortium recommendation or documentation of Consortium evaluation
Document planned lymphodepletion regimen per product labeling
Document the planned lymphodepleting chemotherapy regimen per product standards in the prior authorization request (product sections specify exact regimens and dosing examples).
- Cite the product‑specific regimen and dosing schedule to be used
Breyanzi prior authorization documentation: age, prior lines, no prior CAR T, lymphodepletion
For lisocabtagene maraleucel (Breyanzi) prior authorization documentation must confirm age ≥18, at least two prior systemic therapy lines, no prior CAR T therapy, and planned or completed lymphodepletion per the Breyanzi regimen.
- Age confirmation (≥18)
- List of prior systemic therapies (≥2)
- Statement that no prior CAR T therapy was given
- Planned/received lymphodepletion: fludarabine 30 mg/m2/day + cyclophosphamide 300 mg/m2/day x3
Denial risk for missing prior therapy or lymphodepletion documentation
Requests missing documentation of required prior systemic therapies or the planned/received lymphodepleting chemotherapy regimen are at risk for denial.
- Ensure prior therapy lines and agents are fully documented
- Provide lymphodepletion regimen details and timing relative to infusion
Key Definitions and Toxicities
Biomarker and Test Requirements
Age and Other Quick Coding Facts
Background — CAR T Therapy Overview
CAR T‑cell therapy is an autologous adoptive T‑cell treatment that begins with leukapheresis to collect patient T cells, followed by ex vivo genetic modification and expansion of those cells, and then reinfusion of the engineered cells after a lymphodepleting chemotherapy preparative regimen. Manufacturing typically requires several weeks between apheresis and infusion. Major acute 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 corticosteroids; CAR T programs are expected to ensure appropriate monitoring and facility certification for safe delivery.
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