Kymriah (tisagenlecleucel) clinical coverage criteria
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Defines Fallon Community Health Plan's medical necessity, prior authorization, and coverage criteria for Kymriah (tisagenlecleucel) for applicable Fallon products and describes clinical context and exclusions for pediatric and adult hematologic indications.
Effective April 1, 2025, MassHealth transitioned review and management of APAD and APEC carve-out drugs, including Kymriah, to the MassHealth Drug Utilization Review (DUR) Program; prior authorizations for these drugs must be submitted to the DUR Program for dates of service on or after April 1, 2025.
The FDA eliminated the Kymriah REMS following Novartis's request, with the most recent REMS modification previously approved on August 16, 2024.
Coverage Criteria for Kymriah (tisagenlecleucel)
Pediatric and Young Adult Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia (ALL) — Initial Therapy
Covered when ALL of the following are met:
Adult Relapsed or Refractory Large B-cell Lymphoma — Initial Therapy
Covered when ALL of the following are met:
Adult Relapsed or Refractory Follicular Lymphoma — Initial Therapy (Accelerated Approval)
Covered when ALL of the following are met:
Initial therapy coverage criteria
Covered when ALL of the following are met (as supported by pivotal trial inclusion criteria and FDA label statements):
Per trial procedures and Fallon coding/authorization guidance.
Billing and Coverage Conditions
Covered when ALL of the following billing and policy conditions are met:
Requests for Kymriah (tisagenlecleucel) will be denied if the member has prior treatment with any CAR T‑cell or other gene therapy. This exclusion is absolute and applies regardless of current disease status or other eligibility criteria; include documentation of prior cellular or gene‑based systemic therapies in the prior authorization submission to allow reviewers to verify this exclusion.
Use of Kymriah for indications that are not listed in this policy is considered experimental/investigational and not medically necessary. The evidence base outside the FDA‑approved indications is limited and mainly consists of single‑arm early‑phase studies with low certainty; therefore, requests for off‑label uses should include robust comparative evidence to be considered and will generally be denied in the absence of that evidence.
Patients were excluded from the pivotal trials and are therefore not supported by the cited evidence if they have: (1) a history of prior allogeneic hematopoietic stem cell transplant (HSCT), (2) active central nervous system (CNS) involvement of disease at time of consideration, (3) primary mediastinal diffuse large B‑cell lymphoma, or (4) prior CD19‑directed therapy. Prior authorization requests must document absence of these exclusionary conditions; if any are present, the request is not supported by the pivotal trial evidence and is likely to be denied.
Not all services discussed in this policy are covered for every Fallon product or employer group. Coverage for Kymriah and associated CAR‑T services depends on the member's specific benefit plan and Evidence of Coverage; plan provisions, state mandates for fully insured plans, or federal mandates where applicable will govern if inconsistent with this policy. Providers should verify coverage with the member's benefit terms before proceeding.
Use of Kymriah (tisagenlecleucel) outside the populations and indications supported by the FDA label and the trial inclusion/exclusion criteria described in this policy is not medically necessary and will be treated as experimental/investigational. Requests for populations or clinical scenarios not reflected in the pivotal trials should include high‑quality comparative evidence; absent that, coverage is not supported.
Use of tisagenlecleucel outside the populations and indications supported by comparative or robust evidence is not covered. The published trials and systematic reviews highlight substantial uncertainty for off‑trial patient groups and outcomes; therefore, requests that fall outside trial‑specified inclusion/exclusion criteria (including prior therapy requirements, organ‑function and performance‑status thresholds, marrow reserve criteria, and absence of prior gene/CAR‑T therapy) are not supported by high‑certainty evidence and will generally be denied.
Exclusion — prior gene therapy
Requests for Kymriah will be denied if the member has prior treatment with any CAR T-cell or other gene therapy.
Failure to meet indication-specific criteria
Requests that do not meet the indication-specific enrollment and clinical criteria may be denied — including failures to meet age, diagnosis, prior-line definitions, organ function, performance status, marrow reserve, measurable disease, or other listed clinical requirements for the applicable indication.
- Age limits: pediatric/young adult ALL ≤25 years (infusion) or adult indications ≥18 years (infusion) (chunks 5–7).
- Diagnosis and disease definitions: B‑cell precursor ALL with >5% marrow blasts and confirmed CD19 expression (chunk 5); DLBCL histologic subtypes and FL Grade 1–3A as specified (chunks 6–7).
- Prior‑therapy/relapse requirements: pediatric ALL relapse/refractory definitions (chunk 5); DLBCL relapsed/refractory after ≥2 lines including rituximab and an anthracycline and failed or was ineligible for autologous HSCT (chunk 6); FL refractory/relapsed after specified systemic therapy (chunk 7).
- Organ function and performance: provider attestation of adequate kidney, liver, pulmonary and cardiac function; Karnofsky/Lansky ≥50% for pediatric ALL or ECOG 0–1 for adult lymphoma (chunks 5–7).
- Marrow reserve and labs required for adult DLBCL: ANC >1,000/mm3, ALC >300/mm3, CD3+ >150/mm3, platelets ≥50,000/mm3, hemoglobin >8.0 g/dL (chunk 6).
- Measurable disease requirements for FL: nodal >20 mm long axis or extranodal >10 mm long and short axis (chunk 7).
- No active primary CNS disease where specified (chunk 6).
- Treatment must be at a facility enrolled in the FDA REMS for Kymriah (chunks 5–7).
Coding and Billing Codes
| Q2042 | Tisagenlecleucel, up to 600 million CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
| 0871 | Cell/Gene Therapy - Cell Collection |
| 0872 | Cell/Gene Therapy - Specialized Biologic Processing and Storage - Prior to Transport |
| 0873 | Cell/Gene Therapy - Storage and Processing after Receipt of Cells from Manufacturer |
| 0874 | Cell/Gene Therapy - Infusion of Modified Cells |
| 0891 | Special Processed Drugs - FDA Approved Cell Therapy - Charges for Modified Cell Therapy |
| 38225 | Chimeric antigen receptor T-cell (CAR T) therapy; harvest 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 T cells for administration |
| 38228 | Chimeric antigen receptor T-cell (CAR T) therapy; CAR T cell administration, autologous |
| Q2042 | Tisagenlecleucel, up to 600 million CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
| Q2041 | HCPCS code referenced for inpatient CAR T (as noted with revenue code 0891) |
Provider Requirements, Prior Authorization, and Billing Actions
Prior authorization and MassHealth DUR submission
Prior authorization is required for Kymriah; for MassHealth APAD/APEC carve‑out members with dates of service on or after April 1, 2025, the PA request for Kymriah must be submitted to the MassHealth DUR Program for review prior to administration while Fallon remains responsible for the hospital encounter PA.
Prior authorization for Kymriah and CAR‑T services
Prior authorization is required for Kymriah and related CAR‑T services (including HCPCS Q2042/Q2043/Q2041 and relevant collection/preparation CPTs); PA requests must include documentation of the indication, prior therapies, and planned site/setting for administration.
- Include clinical justification and treating provider records with the PA request.
- Report the planned inpatient or outpatient setting and associated codes when requesting PA.
Coverage basis and coding requirement
Claims for CAR T‑cell therapy must report the specified revenue and HCPCS codes; Fallon follows CMS NCDs/LCDs and applicable Medicare statutes when making medical necessity determinations and may apply internal criteria when Medicare guidance is absent.
- Use required revenue and HCPCS codes on claims as described in the policy (see coding sections for mapping).
Required prior therapies
Indication‑specific prior lines of therapy or documented failures are required before Kymriah is considered medically necessary (for example, adult large B‑cell lymphoma requires relapsed or refractory disease after two or more lines of chemotherapy including rituximab and an anthracycline and failed or was ineligible for autologous HSCT).
- Document number and agents of prior systemic therapies as specified by the indication.
Evidence/trial eligibility: prior systemic therapies required
Clinical trial eligibility and FDA labeling indicate Kymriah is indicated after at least two prior systemic therapies in adult lymphoma populations, typically including an anti‑CD20 antibody and an anthracycline (or alkylator for FL), or after relapse following autologous HSCT where applicable.
- Confirm prior exposure to anti‑CD20 therapy and anthracycline (DLBCL) or anti‑CD20 and alkylator (FL) in the medical record.
Required documentation and prior authorization
Medical records from diagnosing and treating providers must be submitted to support the PA request; prior authorization by a Fallon Health Medical Director is required for Kymriah.
- Include treating provider notes, diagnostic pathology, staging/imaging, and treatment history with the PA.
Organ function and performance status attestation
Provider attestation of adequate kidney, liver, pulmonary, and cardiac function is required, and documentation of performance status must meet the policy thresholds (Karnofsky/Lansky ≥50% for pediatric ALL; ECOG 0–1 for adult lymphoma indications).
- Include explicit attestation statements and pertinent laboratory/imaging results in the record.
Document prior therapies, transplant status, lymphodepletion, bridging, and leukapheresis
Documentation must be available for prior lines of therapy, refractory status, history of prior autologous HSCT (if applicable), planned lymphodepleting regimen, any bridging therapy, and leukapheresis/manufacturing outcomes to support clinical eligibility and claims.
- Provide dates and agents for prior therapies, transplant dates and outcomes, lymphodepletion regimen plan, and leukapheresis/manufacturing reports.
Claim reporting and dates
Claims must report appropriate revenue codes (0871–0874 or 0891) and the HCPCS Q‑code for tisagenlecleucel (Q2041 for inpatient; Q2042 for outpatient) and include the correct date of CAR‑T administration on the inpatient claim when administration occurs inpatient.
- If preparation occurs outpatient but administration inpatient, inpatient should report the CAR‑T administration date and may report collection/preparation charges using revenue codes 0871–0873 or include them under 0891.
Infusion not received may affect coverage
Patients who are enrolled but do not receive infusion are not included in efficacy analyses; lack of infusion (e.g., due to progression or death) may affect coverage of the administration and should be documented.
- Document reasons for non‑infusion and any changes in clinical status in the medical record submitted with PA/claims.
Inpatient HCPCS requirement: include HCPCS Q2041 on inpatient claim
Inpatient claims for CAR T‑cell therapy must include the required HCPCS code (Q2041) along with revenue code 0891; failure to include the HCPCS code on the inpatient claim may result in claim denial or misprocessing.
- Ensure inpatient claims report revenue code 0891 and HCPCS Q2041 for CAR‑T administration as required by Fallon.
Line of Therapy and Salvage Indications
salvage — Line-of-therapy node (pediatric/ALL context)
salvage — Line-of-therapy node (adult large B-cell lymphoma context)
salvage — Line-of-therapy node (adult follicular lymphoma context)
salvage — Additional line-of-therapy node supporting trial-based eligibility
Biomarker and Test Requirements
Lymphodepletion and Bridging Regimens
| Lymphodepleting regimen | Details / dosing | Purpose / notes |
|---|---|---|
| Bendamustine | ||
| Bendamustine 90 mg/m2 IV daily × 2 days | ||
| Alternative lymphodepleting regimen used in pivotal studies and described in FDA prescribing information |
Definitions and Background
Kymriah (tisagenlecleucel) is an autologous, genetically modified CD19-directed CAR T-cell therapy approved for specific relapsed or refractory B‑cell malignancies (pediatric/young adult B-cell precursor ALL, adult relapsed/refractory large B‑cell lymphoma, and relapsed/refractory follicular lymphoma under accelerated approval). CAR T–cell therapies carry significant risks including cytokine release syndrome, neurologic toxicities, and prolonged B‑cell aplasia; tocilizumab is an FDA‑approved treatment for CAR T–induced CRS. Policy application and coverage of services are subject to plan benefit terms and any applicable state or federal mandates.
Policy Revision History
MassHealth transitioned review and management of APAD/APEC carve-out drugs (including Kymriah) to the MassHealth DUR Program; prior authorization requests for these drugs for dates of service on or after April 1, 2025 must be submitted to the DUR Program, while Fallon remains responsible for the inpatient/outpatient encounter PA.
FDA modification related to the Kymriah REMS was most recently approved on August 16, 2024; subsequent FDA action removed the REMS per manufacturer request.
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