CurrentAvMedPolicy Pub. 100-2

Kymriah (tisagenlecleucel) prior authorization requirements

This form and policy govern pre-authorization and step-edit requirements for administering Kymriah (tisagenlecleucel) under AvMed's medical benefit, including clinical criteria, documentation, and site/provider requirements for members in North Carolina.

Policy Summary

PayerAvMed

PolicyKymriah (tisagenlecleucel) prior authorization requirements

Policy CodePolicy Pub. 100-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionFax a completed Medical Prior Authorization/Step-Edit Request form signed by the prescribing physician to AvMed for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1billable units for B-cell precursor ALL

3billable units for large B-cell lymphoma

3-25age range for ALL indication

ECOG 0-1performance status required for large B-cell lymphoma

Coverage Criteria for Kymriah (tisagenlecleucel)

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General eligibility: Member does NOT have an active infection or inflammatory disorder; Member has NOT received live vaccines within 2 weeks prior to the start of lymphodepleting chemotherapy and will not receive live vaccines until immune recovery following Kymriah treatment; Member has been screened for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines prior to collection of cells (leukapheresis); Prophylaxis for infection has been followed according to local guidelines; Healthcare facility has enrolled in the Kymriah REMS and training has been given to providers on the management of cytokine release syndrome (CRS) and neurological toxicities; Member has NOT received prior CAR-T therapy; Member has NOT received prior blinatumomab therapy; Member has CD19-positive disease; Medication will be used as single agent therapy (not applicable to lymphodepleting or bridging chemotherapy); Member has a life expectancy > 12 weeks

All documentation, including lab results, diagnostics, and chart notes, must be provided to support each line checked.

B-cell precursor ALL criteria: Member is between the ages of 3 to 25 years old AND Member's disease is refractory or in second or later relapse as defined by one of: second or greater bone marrow relapse; any bone marrow relapse after allogeneic stem cell transplantation (SCT); primary refractory (not achieving a complete response after 2 cycles of standard chemotherapy); chemorefractory (not achieving a complete response after 1 cycle of standard chemotherapy for relapsed disease); Members with Philadelphia chromosome (Ph)-positive disease have a contraindication, intolerance, or have failed two prior lines of tyrosine kinase inhibitor (TKI) therapy; Member is NOT eligible for allogeneic SCT AND Member has a performance status (Karnofsky/Lansky) ≥ 50

FDA-approved and compendium-recommended indications cited.

Large B-cell lymphoma criteria: Member is 18 years of age or older AND Member has one of the following aggressive B-cell non-Hodgkin lymphomas: diffuse large B-cell lymphoma (DLBCL) not otherwise specified; high grade B-cell lymphoma; DLBCL arising from follicular lymphoma AND Member's disease is relapsed or refractory after two or more lines of systemic therapy which included an anthracycline and an anti-CD20 monoclonal antibody (unless tumor is CD20-negative) and is defined as one of: relapse after autologous hematopoietic stem cell transplantation (HSCT) or refractory disease to the most recent therapy AND Member has an ECOG performance status of 0-1 AND Member does NOT have primary central nervous system lymphoma

FDA-approved and compendium-recommended indications cited; primary CNS lymphoma excluded from this indication.

Follicular lymphoma criteria: Member is 18 years of age or older AND Member has a diagnosis of Grade 1-2 follicular lymphoma AND Disease is relapsed, refractory, or progressive after two or more prior lines of therapy

Compendium-recommended indication.

Regimen	Coverage status	Notes
Tisagenlecleucel (Kymriah) single-agent CAR-T	Covered	Used as single-agent CAR-T cell therapy; lymphodepleting or bridging chemotherapy allowed separately. All general pre-treatment criteria and disease-specific criteria must be met; documentation (labs, diagnostics, chart notes) required to support each checked clinical criterion.

Coding and Billing

Covered HCPCSHCPCSCovered

Q2040

tisagenlecleucel, CAR-T cell product

NDCNDC

NDC: 00078-0846-xx

Kymriah infusion bag (10-50mL) — NDC format listed

inv-06: Billable unit limits

B-cell precursor ALL billable units1 billable unit — 1 infusion of up to 250 million CAR+ viable T-cells

Large B‑Cell Lymphoma billable units3 billable units — 1 infusion of up to 600 million CAR+ viable T-cells

Unit definition (infusion)Each billable unit corresponds to a single infusion preparation (infusion bag 10–50 mL listed in product NDC), as specified on the request form

NDC association for billing capNDC listed for infusion bag: 00078-0846-xx (10–50 mL)

Documentation requirement for unitsAuthorization may be delayed if documentation is incomplete; all clinical criteria must be supported by lab results, diagnostics, and chart notes

Provider Actions and Prior Authorization

Prior Authorization

Prior authorization submission

The prescribing physician must sign and clearly print their name on the completed Medical Prior Authorization/Step-Edit Request form (preprinted stamps are not valid). All other information may be completed by office staff and the form must be faxed to 1-844-668-1550. For Medicare members, applicable Medicare Benefit Policy Manual (Pub. 100-2), NCDs, and LCDs apply. If documentation supporting each checked clinical criterion is not provided, including lab results, diagnostics, and chart notes, the request may be returned or denied. If information on the form is incomplete, incorrect, or illegible, authorization may be delayed.

Fax completed, signed form to 1-844-668-1550
Preprinted signature stamps are not acceptable
Medicare coverage references: Pub. 100-2, Chapter 15, §50; check CMS coverage database for NCDs/LCDs

Step Therapy

Step-edit / sample policy

Use of sample product to initiate therapy does not meet step-edit or preauthorization criteria. Prior therapies will be verified through pharmacy paid claims and/or submitted chart notes; prescribers must document prior treatment history where required by the clinical criteria.

Samples do not satisfy step-therapy requirements
Previous therapies may be confirmed via pharmacy paid claims or chart notes

Documentation Required

Required forms and supporting records

The prescribing physician’s signature is required on the Medical Prior Authorization/Step-Edit Request form (preprinted stamps are not valid). Supporting documentation must include member and prescriber information, clinical notes, relevant lab results, diagnostics, hepatitis/HIV screening results when applicable, and any other records necessary to support each checked clinical criterion.

Signed Medical Prior Authorization/Step-Edit Request form (physician signature required)
Member identifiers (name, DOB, ID) and prescriber contact information
Relevant chart notes, lab results, diagnostics, and screening tests

Denial Risk

Incomplete documentation

If documentation supporting each checked clinical criterion is not provided, including lab results, diagnostics, and chart notes, the request may be returned or denied. For urgent review requests, contact AvMed Pre-Authorization Department; AvMed defines urgent as lack of treatment that could seriously jeopardize life, health, or the member’s ability to regain maximum function.

Requests missing supporting documentation may be returned or denied
For urgent reviews, contact AvMed Pre-Authorization Department

Line of Therapy Criteria

second-line_or_later

Large B-cell lymphoma: Relapsed or refractory after two or more lines of systemic therapy which included an anthracycline and an anti-CD20 monoclonal antibody (unless tumor is CD20-negative); defined as relapse after autologous HSCT or refractory to the most recent therapy

Member must be age ≥ 18 and have ECOG 0-1; primary CNS lymphoma is excluded.

second-line_or_later

ALL relapse/refractory definitions: Second or greater bone marrow relapse OR any bone marrow relapse after allogeneic stem cell transplantation (SCT) OR primary refractory (not achieving a complete response after 2 cycles of standard chemotherapy) OR chemorefractory (not achieving a complete response after 1 cycle of standard chemotherapy for relapsed disease); Ph-positive members must have contraindication/intolerance or failed two TKIs; member is NOT eligible for allogeneic SCT

Applies to B-cell precursor ALL patients age 3-25 with performance status Karnofsky/Lansky ≥ 50.

Biomarker and REMS Requirements

inv-16: CD19 — CD19 antigen requirement for therapy eligibility

CD19 antigen requirementMember must have CD19‑positive disease — tumor expresses CD19 antigen; this is required for therapy eligibility

DocumentationCD19‑positivity must be documented on the form and supported by medical records provided with the prior authorization

Related exclusionMember must not have received prior CAR‑T or prior blinatumomab as additional pre-treatment criteria alongside CD19 requirement

inv-12: Kymriah REMS — REMS enrollment required for facilities and training on management of CRS and neurologic toxicities

REMS enrollment requirementHealthcare facility must be enrolled in the Kymriah REMS prior to administration

Provider trainingTraining must be given to providers on the management of cytokine release syndrome (CRS) and neurological toxicities

Documentation linkageREMS enrollment and provider training are listed among the pre‑treatment criteria that must be met and documented for approval

inv-13: CD19-positive disease — Tumor expresses CD19 antigen; required for therapy eligibility per form

CD19‑positive disease definitionTumor expresses CD19 antigen; required for therapy eligibility as indicated on the prior authorization form

Form checkboxThe request form includes a specific checkbox confirming the member has CD19‑positive disease which must be checked for approval

Supportive documentationCD19 positivity should be corroborated by pathology or laboratory reports submitted with the authorization request

Background

Kymriah (tisagenlecleucel) is a CD19-directed CAR-T cell therapy indicated for certain relapsed or refractory B‑cell malignancies. It is administered as a single‑agent CAR‑T product (lymphodepleting or bridging chemotherapy may be given separately), and dosing/billable unit guidance specifies 3 billable units for Large B‑Cell Lymphoma corresponding to one infusion of up to 600 million CAR+ viable T cells per infusion. Administration requires enrollment of the treating facility in the Kymriah REMS and staff trained to manage cytokine release syndrome and neurologic toxicities.