CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Kymriah (tisagenlecleucel) prior authorization

Prior authorization form and requirements for intravenous tisagenlecleucel (Kymriah) for members of Neighborhood Health Plan of Rhode Island; intended for providers requesting initial or continuation CAR-T therapy coverage.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKymriah (tisagenlecleucel) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and submit the Kymriah prior authorization form with required clinical documentation and coding for initial or continuation requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1form

2primary indications

>=6mSCT interval

2+prior therapy lines

Coverage Criteria for Tisagenlecleucel (Kymriah)

inv-01: ALL eligibility

Covered when the submitted documentation meets the clinical checkbox criteria appropriate to the diagnosis:

Acute Lymphoblastic Leukemia (ALL): Member has diagnosis of ALL with confirmed CD19 tumor expression (demonstrated in bone marrow or peripheral blood by flow cytometry) AND member has not previously experienced treatment failure on Kymriah or Yescarta AND (member has experienced disease relapse after allogeneic stem cell transplantation (SCT) and is ≥ 6 months from transplantation at time of infusion OR member has relapsed/refractory Philadelphia chromosome–negative B-ALL progressed after 2 cycles of a standard chemotherapy regimen for initial diagnosis OR progressed after 1 cycle of standard chemotherapy for relapsed leukemia OR member has relapsed/refractory Philadelphia chromosome–positive B-ALL progressed after failure of 2 TKI-containing regimens)

Logical grouping mirrors form checkboxes; CD19 documented by flow cytometry in marrow or peripheral blood.

inv-02: B-cell lymphoma eligibility

Covered when ALL of the following are met for B-cell lymphomas:

B-cell lymphomas (including relapsed/refractory DLBCL and follicular lymphoma):

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKymriah (tisagenlecleucel) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and submit the Kymriah prior authorization form with required clinical documentation and coding for initial or continuation requests.

SourceLink

On This Page

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Member has diagnosis of B-cell lymphoma AND member has grade 1–2 relapsed or refractory follicular lymphoma or relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) AND member has experienced disease progression after two or more lines of systemic therapy (if Kymriah or Yescarta not previously given)

Form queries prior CAR-T exposure and requires prior-line documentation when no prior CAR-T.

The prior authorization form explicitly queries whether the member previously experienced treatment failure on Kymriah® or Yescarta®. Providers should document prior CAR-T exposure on the form because prior treatment with these agents is a conditional item that may affect eligibility under the submitted checkboxes. Include dates and outcomes of any prior CAR-T therapy to support the review.

The form requires confirmation of certain clinical findings to support coverage. For example, absence of a documented CD19 tumor expression (demonstrated in bone marrow or peripheral blood by flow cytometry) or missing documentation of prior lines of therapy or transplant timing may render the request ineligible. If these required confirmations are not provided, the request may not meet the checklist-based criteria and coverage could be denied or delayed.

Regimen	Indication / Eligibility (per form checkboxes)	Coverage stance
Tisagenlecleucel (Kymriah) — single CAR‑T cell infusion (intravenous)	Relapsed/refractory pediatric/young adult Acute Lymphoblastic Leukemia (ALL) with confirmed CD19 expression (documented by flow cytometry in bone marrow or peripheral blood) AND no prior treatment failure on Kymriah or Yescarta AND one of the following: relapse after allogeneic SCT and ≥ 6 months from transplant at infusion, or relapsed/refractory Ph‑negative B‑ALL progressed after 2 cycles of standard chemotherapy for initial diagnosis or after 1 cycle for relapsed leukemia, or relapsed/refractory Ph‑positive B‑ALL progressed after failure of 2 TKI‑containing regimens.	Covered

Line of Therapy Requirements

inv-15: second-line_or_later

Required prior lines of therapy — request meets criteria when at least one of the following prior-therapy scenarios is documented:

Prior therapy requirements: Relapsed/refractory Philadelphia chromosome–negative B-ALL progressed after 2 cycles of a standard chemotherapy regimen for initial diagnosis OR progressed after 1 cycle of a standard chemotherapy regimen for relapsed leukemia OR Philadelphia chromosome–positive B-ALL progressed after failure of 2 TKI-containing regimens OR lymphoma progressed after two or more lines of systemic therapy when Kymriah or Yescarta have not been previously given

This node represents the top-level prior-line requirements as queried on the form.

Biomarker and Test Requirements

CD19 — demonstration and documentation

Biomarker requirementCD19 demonstrated in bone marrow or peripheral blood by flow cytometry

Indications requiring CD19Required for Acute Lymphoblastic Leukemia (ALL) and B‑cell lymphoma checkboxes on the form

Documentation to submitProvide clinical documentation showing flow cytometry results from bone marrow or peripheral blood

Consequence of absent documentationLack of documented CD19 expression may render the request ineligible per form criteria

Key Definitions

CD19 expression (definition)

DefinitionConfirmed CD19 tumor expression

How confirmedDemonstrated in bone marrow or peripheral blood by flow cytometry as specified on the form

ScopeApplies to ALL and B‑cell lymphoma eligibility checkboxes on the prior authorization form

SCT — allogeneic stem cell transplantation

TermAllogeneic stem cell transplantation (SCT)

Policy mentionForm asks whether member experienced disease relapse after allogeneic SCT as an eligibility criterion for ALL

Timing thresholdMember must be ≥ 6 months from allogeneic transplantation at time of infusion to meet that criterion

Documentation to submitProvide transplant date and evidence that infusion would occur ≥ 6 months after allogeneic SCT

Billing and Coding

Requested J-CodesHCPCS

Requested J-code(s)

J-code(s) for the entire treatment regimen as provided by requester

Requested CPT CodesCPT

Requested CPT code(s)

CPT code(s) for services related to administration as provided by requester

Diagnosis CodesICD-10

Diagnosis/ICD-10 code(s)

ICD-10 diagnosis codes to be provided by requester

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for both initial and continuation requests. Providers must complete and submit the Kymriah prior authorization form and include all requested information.

Fax: 1-844-639-7906
Pharmacy Dept. Phone: 1-401-427-8200
Complete form and submit to Neighborhood Health Plan of Rhode Island

Documentation Required

Therapy History Documentation

Document prior therapy history on the form, including prior lines of therapy and any prior exposure to CAR-T therapies such as Kymriah® or Yescarta®. Indicate whether the member has relapsed after stem cell transplant or failed prior regimens as applicable.

Record prior lines of systemic therapy
State prior exposure to Kymriah® or Yescarta®

Documentation Required

Required Documentation

Submit complete clinical documentation with the form: diagnosis and ICD-10 code(s); requested J- and CPT code(s); dates of service; directions and number of units; evidence of CD19 tumor expression when applicable; and any other pertinent records. Failure to provide the required documentation may delay review.

Diagnosis and ICD-10 code(s)
Requested J-code(s) and CPT code(s) for entire regimen
Directions, dates of service, and # of units requested
Evidence of CD19 tumor expression (if applicable)

Denial Risk

Incomplete Form Risk

Failure to fill out the form in its entirety may delay the review process. Ensure every section is completed and supporting documentation is attached before submission.

Incomplete forms may result in processing delays or denial of the request

Background

Kymriah (tisagenlecleucel) is an autologous anti-CD19 CAR-T cell therapy referenced on the form for use in relapsed/refractory B-cell malignancies. The checklist on the prior authorization form captures disease-specific confirmations (for example, CD19 expression by flow cytometry) and prior treatment history that are required to establish medical necessity for a CAR-T infusion with tisagenlecleucel.