844 Form

CAR T-Cell Therapy Services for the Treatment of Diffuse Large B-cell Lymphoma (tisagenlecleucel) Prior Authorization Request Form #844

Medical Policy #066 Chimeric Antigen Receptor Therapy for Hematologic Malignancies

CLINICAL DOCUMENTATION ▪ Clinical documentation that supports the medical necessity criteria for CAR T-Cell Therapy Services for the Treatment of Diffuse Large B-cell Lymphoma (tisagenlecleucel) must be submitted.
▪ If the patient does not meet all the criteria listed below, please submit a letter of medical necessity with a request for Clinical Exception (Individual Consideration) explaining why an exception is justified.

Requesting Prior Authorization Using Authorization Manager Providers will need to use Authorization Manager to submit initial authorization requests for services. Authorization Manager, available 24/7, is the quickest way to review authorization requirements, request authorizations, submit clinical documentation, check existing case status, and view/print the decision letter. For commercial members, the requests must meet medical policy guidelines.

To ensure the request is processed accurately and quickly: • Enter the facility’s NPI or provider ID for where services are being performed. • Enter the appropriate surgeon’s NPI or provider ID as the servicing provider, not the billing group.

Authorization Manager Resources Refer to our Authorization Manager page for tips, guides, and video demonstrations.

Complete Prior Authorization Request Form for CAR T-Cell Therapy Services for Treatment of Diffuse Large B-cell Lymphoma (844) using Authorization Manager.

For out of network providers: Requests should still be faxed to 888-973-0726.

Patient Information Patient Name:

Today’s Date: BCBSMA ID#:

Date of Treatment: Date of Birth:

Place of Service: Outpatient  Inpatient 

Physician Information Facility Information Name:

Name:
Address:

Address: Phone #:

Phone #: Fax#:

Fax#: NPI#:

NPI#:

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  Please check off if the patient is enrolled in a Clinical Trial: Clinical Trial #

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  Please check off if the patient has ONE of the following histologically confirmed diagnoses and HAS RELAPSED or is REFRACTORY a: Histologically confirmed diagnosis of: • Diffuse large B-cell lymphoma not otherwise specified (including diffuse large B-cell lymphoma arising from indolent lymphoma), OR

   • High-grade B-cell lymphoma, OR

   • Primary mediastinal large B-cell lymphoma, OR

   • Follicular lymphoma grade 3B.

   c Relapsed or refractory disease is defined as progression after 2 or more lines of systemic therapy (which may or may not include therapy supported by autologous cell transplant).

  Please check off that the patient meets ALL the following criteria:

  1. Histologically confirmed diagnosis of diffuse large B-cell lymphoma not otherwise specified, high grade B-cell lymphoma, or diffuse large B-cell lymphoma arising from follicular lymphoma; AND

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  2. Relapsed or refractory diseasec defined as progression after ≥2 lines of systemic therapy including anti-CD20 monoclonal antibody for CD20-positive tumor and anthracycline-containing chemotherapy; AND

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  3. When the individual has histological transformation of follicular lymphoma or nodal marginal zone lymphoma to diffuse large B-cell lymphoma: prior chemotherapy for follicular lymphoma and ≥2 chemo-immunotherapy regimens for the transformed disease; AND

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  4. At least 18 years of age at the time of infusion; AND

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  5. Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist; AND

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  6. Have not received prior CD19-directed chimeric antigen receptor T-cell therapy treatment, any other cell therapy, or any gene therapy or are being considered for treatment with any other cell therapy or any gene therapy; AND

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  7. Do not have primary central nervous system lymphoma*.

   cRelapsed or refractory disease, defined as progression after 2 or more lines of systemic therapy (which may or may not include therapy supported by autologous cell transplant). *Central nervous system (CNS) disease for B-cell acute lymphoblastic leukemia is defined by the following groups: • CNS 1: Absence of blasts on cerebrospinal fluid cytospin preparation, regardless of the white blood cell (WBC) count • CNS 2: WBC count of less than 5/mL and blasts on cytospin findings • CNS 3: WBC count of 5/mL or more and blasts on cytospin findings and/or clinical signs of CNS leukemia (e.g., facial nerve palsy, brain/eye involvement, hypothalamic syndrome).

  Please check off if the facility is part of Risk Evaluation and Mitigation Strategy (REMS) The facility delivering the therapy is certified by Kite Pharma that it has an adequate REMS protocol (Risk Evaluation and Mitigation Strategy) to address a cytokine release syndrome and neurotoxicity

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  Note: Other adoptive immunotherapy, using adoptive cellular therapy for the administration of cytotoxic T-lymphocytes, cytokine-induced killer cells, tumor-infiltrating lymphocytes, antigen-loaded autologous dendritic cells, or genetically- engineered T-cells is considered INVESTIGATIONAL.

  CPT CODES/ HCPCS CODES/ ICD CODES HCPCS codes: Code Description C9399 Unclassified drugs or biologicals  J3490 Unclassified drugs  J3590 Unclassified biologics  J9999 Not otherwise classified, antineoplastic drugs  Q2042 Tisagenlecleucel, up to 600 million car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose  S2107 Adoptive immunotherapy, i.e., development of specific anti-tumor reactivity (e.g., tumor infiltrating lymphocyte therapy) per course of treatment 

  Providers should enter the relevant diagnosis code(s) below: Code Description

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  Providers should enter other relevant code(s) below: Code Description

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