CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Kymriah (tisagenlecleucel) prior authorization — coverage criteria

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

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKymriah (tisagenlecleucel) prior authorization — coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the completed prior authorization form with requested J‑ and CPT codes, dates of service, units, diagnosis, and supporting clinical documentation (including CD19 expression and prior therapy history).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1prior authorization form

2indications listed

6required form fields

Coverage Criteria for Kymriah (tisagenlecleucel)

Initial and continuation therapy criteria

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General: Member has completed and submitted the prior authorization form with required data (member and provider information, indication selection, requested J- and CPT codes, dates of service, directions, units, and diagnosis/ICD-10 code(s)).

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

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Indication - B-Cell Lymphomas: Member has relapsed or refractory B‑cell lymphoma (including grade 1–2 relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B‑cell lymphoma) AND member has experienced disease progression after two or more lines of systemic therapy (if Kymriah® or Yescarta® not previously given).

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The form does not enumerate explicit "not medically necessary" conditions. Instead, the absence of meeting the stated indication and prior‑therapy criteria as checked on the form implies the request would not meet medical necessity requirements — for example, lacking confirmed CD19 expression or not meeting the specified prior‑therapy/relapse criteria for ALL or B‑cell lymphomas would make the request ineligible.

Initial Therapy

Initial therapy requests must indicate 'Initial Request' and provide full clinical details demonstrating indication and prior treatment history.

Initial: Form is marked as Initial Request and includes dates of service requested, requested J‑code(s) for the treatment regimen, requested CPT code(s), directions, number of units requested, diagnosis/ICD‑10 code(s), and documentation of CD19 expression and prior therapy/transplant history as applicable.

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Continuation of Therapy

Continuation requests require submission of the same form indicating 'Continuation of Therapy' and providing dates of service and clinical documentation.

Continuation: Form is marked as Continuation of Therapy and includes requested J‑ and CPT code(s), dates of service, directions, number of units requested, diagnosis/ICD‑10 code(s), and supporting documentation of response or ongoing clinical need.

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Provider Requirements and Submission Details

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit the completed Kymriah® prior authorization form with all requested J- and CPT codes, dates of service, units, diagnosis/ICD-10 codes, and member and provider details. Failure to complete the form in its entirety may delay the review process or lead to denial/delay of authorization.

Kymriah® (tisagenlecleucel) Prior Authorization Form — Fax: 1-844-639-7906; Pharmacy Dept. Phone: 1-401-427-8200
Include requested J-Code(s) for the entire treatment regimen and requested CPT code(s)
Provide date(s) of service requested and # of units requested
Include diagnosis/ICD-10 code(s) and member/provider details

Documentation Required

Prior Therapy Documentation

Document prior lines of therapy and prior exposure to CAR T-cell products. Specifically indicate whether the member has previously received Kymriah® or Yescarta®; prior exposure may affect authorization.

State prior lines of systemic therapy and outcomes
Clearly note any prior Kymriah® or Yescarta® treatment (yes/no) and provide supporting records

Documentation Required

Required Documentation

Complete and submit the Kymriah® prior authorization form and include supporting clinical records. Clinical information should indicate initial vs continuation request, diagnosis details, CD19 tumor expression documentation (if applicable), transplant and relapse history, and number/type of prior therapy regimens.

Check Initial Request or Continuation of Therapy Request on the form
Provide documentation of CD19 tumor expression when applicable (bone marrow or peripheral blood by flow cytometry)
If ALL: include relapse/chemotherapy/TKI history and stem cell transplant timing (≥ 6 months from SCT at time of infusion when applicable)
If B-cell lymphoma: document histology (e.g., follicular lymphoma, DLBCL) and evidence of progression after required lines of systemic therapy

Denial Risk

Incomplete Submission Risk

Incomplete submissions may delay review or lead to denial. Failure to provide all requested fields on the form and supporting clinical records (including codes, dates, units, diagnosis, prior therapy, and CD19 expression when required) risks processing delays or denial of the authorization.

Omiting requested J/CPT codes, dates of service, units, diagnosis codes, or provider/member information may delay review
Missing prior therapy or prior CAR T exposure documentation may result in denial or additional information requests

Key Definitions

CD19 tumor expression

DefinitionConfirmed CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry.

Location of testingDemonstration may be from bone marrow or peripheral blood specimens (flow cytometry).

Documentation requiredAttach flow cytometry report showing CD19 positivity as part of prior authorization submission.

Relapsed/refractory disease

DefinitionRelapsed or refractory disease as specified on the form: disease relapse after prior therapy or lack of response following defined prior chemotherapy or TKI regimens, or relapse after allogeneic stem cell transplant.

ALL — Ph‑negativeRelapsed/refractory Philadelphia chromosome–negative B‑ALL that has progressed after 2 cycles of a standard chemotherapy regimen for initial diagnosis or after 1 cycle of standard chemotherapy for relapsed leukemia.

ALL — Ph‑positiveRelapsed/refractory Philadelphia chromosome–positive B‑ALL that has progressed after failure of 2 TKI-containing regimens.

Post‑transplant relapseMember who experienced disease relapse after allogeneic stem cell transplantation and is ≥ 6 months from transplant at time of infusion (as an alternative pathway).

B‑cell lymphomasGrade 1–2 relapsed or refractory follicular lymphoma or relapsed/refractory diffuse large B‑cell lymphoma with progression after two or more lines of systemic therapy (if Kymriah or Yescarta not previously given).

Step Therapy / Prior Systemic Therapy Documentation

Requirement	Details
Document prior systemic therapy lines and failures
For B‑cell lymphomas (grade 1–2 follicular lymphoma or relapsed/refractory DLBCL): indicate disease progression after two or more lines of systemic therapy (required if Kymriah® or Yescarta® not previously given)
For Philadelphia chromosome–negative B‑ALL: indicate progression after 2 cycles of a standard chemotherapy regimen for initial diagnosis or after 1 cycle of standard chemotherapy for relapsed leukemia
For Philadelphia chromosome–positive B‑ALL: indicate failure of 2 TKI‑containing regimens
For ALL indications: document prior exposure to Kymriah® or Yescarta® and whether member has previously experienced treatment failure on either product
If applicable, document relapse after allogeneic stem cell transplantation and confirm member is ≥ 6 months from transplant at time of infusion

Site of Care and Billing Method

Billing Rule

Hospital outpatient — specify medication acquisition method and servicing provider/facility details

Indicate on the form how the medication will be obtained (Drop Ship from Specialty Pharmacy or Buy-and-Bill) and, if Buy-and-Bill, provide servicing provider/facility name and NPI/Tax ID (or indicate same as requesting provider).

Check Drop Ship or Buy-and-Bill and provide specialty pharmacy name and NPI if drop shipped
If Buy-and-Bill, provide servicing provider/facility name and servicing provider NPI/Tax ID (or select 'Same as Requesting Provider')

Background

This prior authorization form is used to request coverage for tisagenlecleucel (Kymriah®) for hematologic malignancies. Indications captured on the form include Acute Lymphoblastic Leukemia (ALL) with confirmed CD19 expression and relapsed or refractory B‑cell lymphomas — specifically grade 1–2 relapsed/refractory follicular lymphoma and relapsed/refractory diffuse large B‑cell lymphoma (DLBCL). The form requires documentation of CD19 tumor expression and asks about prior treatment history, including whether the member has previously received or failed Kymriah® or Yescarta®, prior allogeneic stem cell transplant (with relapse ≥ 6 months from transplant at infusion), and details of prior chemotherapy or TKI regimens as applicable.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKymriah (tisagenlecleucel) prior authorization — coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Kymriah (tisagenlecleucel) prior authorization — coverage criteria

Coverage Criteria for Kymriah (tisagenlecleucel)

Initial Therapy

Continuation of Therapy

Requested Codes and Diagnosis

Provider Requirements and Submission Details

Key Definitions

Step Therapy / Prior Systemic Therapy Documentation

Site of Care and Billing Method

Background