945 Form

Engineered T-Cell Therapy Services for B-cell Acute Lymphoblastic Leukemia Prior Authorization Request Form #945

Medical Policy #066 Engineered T-Cell Therapy for Leukemia and Lymphoma

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 Engineered T-Cell Therapy Services for B-cell Acute Lymphoblastic Leukemia Prior Authorization Request Form (945) 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#:

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

CLINICAL DOCUMENTATION ▪ Clinical documentation that supports the medical necessity criteria for CAR T-Cell Therapy Services for B-cell Acute Lymphoblastic Leukemia (Brexucabtagene Autoleucel) 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.

Clinical Trial # 

Requests for Brexucabtagene Autoleucel (Tecartus): Please check off if the patient has the following diagnosis and HAS RELAPSED a or is REFRACTORYb : Confirmed diagnosis of CD19-positive B-cell acute lymphoblastic leukemia with morphologic bone marrow tumor involvement (≥5% lymphoblasts) 

a Relapsed disease describes the reappearance of leukemia cells in the bone marrow or peripheral blood after the attainment of a complete remission with chemotherapy and/or allogeneic cell transplant. b Refractory (resistant) disease is defined as those patients who fail to obtain complete response with induction therapy, ie, failure to eradicate all detectable leukemia cells (<5% blasts) from the bone marrow and blood with subsequent restoration of normal hematopoiesis (>25% marrow cellularity and normal peripheral blood counts).

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

1. Confirmed diagnosis of CD19-positive B-cell acute lymphoblastic leukemia with morphologic bone marrow tumor involvement (≥5% lymphoblasts); AND 

2. Meet any one of the following: a. Relapsed disease as defined as the reappearance of leukemia cells in the bone marrow or peripheral blood after the attainment of a complete remission with chemotherapy and/or allogeneic cell transplant; OR b. Refractory disease as defined as failure to obtain complete response with induction therapy (ie, failure to eradicate all detectable leukemia cells [<5% blasts] from the bone marrow and blood with subsequent restoration of normal hematopoiesis [>25% marrow cellularity and normal peripheral blood counts]).

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3. When Philadelphia chromosome-positive: failure of tyrosine kinase inhibitors; AND

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

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5. Have not received prior CD19-directed chimeric antigen receptor T-cell 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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6. Have adequate organ function with no significant deterioration in organ function expected within 4 weeks after apheresis; AND

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7. Do not have any of the following: a. Burkitt lymphoma. b. Active hepatitis B, C, or any uncontrolled infection. c. Grade 2 to 4 graft-versus-host disease. d. Concomitant genetic syndrome associated with bone marrow failure with the exception of Down syndrome. e. Received allogeneic cellular therapy, such as donor lymphocyte infusion, within 6 weeks prior to brexucabtagene autoleucel infusion. f. Active central nervous system acute lymphoblastic leukemia (ie, white blood cell count ≥5 cells/μL in cerebrospinal fluid with presence of lymphoblasts).

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   Requests for Obacabtegene Autoleucel (Aucatzyl):

   Please check off if the patient has the following diagnosis and HAS RELAPSED a or is REFRACTORYb : Confirmed diagnosis of relapsed or refractory B-cell precursor acute lymphoblastic leukemia r

   a Relapsed disease defined as the reappearance of leukemia cells in the bone marrow or peripheral blood after the attainment of a complete remission with chemotherapy and/or allogeneic cell transplant within 12 months b Refractory disease defined as failure to obtain complete response with induction therapy (ie, failure to eradicate all detectable leukemia cells [<5% blasts] from the bone marrow and blood with subsequent restoration of normal hematopoiesis [>25% marrow cellularity and normal peripheral blood counts]) after treatment with first line chemoimmunotherapy that included an anti-CD20 monoclonal antibody and anthracycline-containing regimen

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

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

2. Confirmed diagnosis of B-cell precursor acute lymphoblastic leukemia; AND

3. Meet any one of the following: a. Relapsed disease defined as the reappearance of leukemia cells in the bone marrow or peripheral blood after the attainment of a complete remission with chemotherapy and/or allogeneic cell transplant within 12 months, OR b. Refractory disease defined as failure to obtain complete response with induction therapy (ie, failure to eradicate all detectable leukemia cells [<5% blasts] from the bone marrow and blood with subsequent restoration of normal hematopoiesis [>25% marrow cellularity and normal peripheral blood counts]) after treatment with first line chemoimmunotherapy that included an anti-CD20 monoclonal antibody and anthracycline-containing regimen

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

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5. Have not received prior engineered T-Cell therapy, 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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6. Do not have primary central nervous system lymphoma. 

   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  Q2053 Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose  XW23346 Transfusion of Brexucabtagene Autoleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 6  Q2058 Obecabtagene autoleucel, 10 up to 400 million cd19 car-positive viable t cells, including leukapheresis and dose preparation procedures, per infusion (Aucatzyl) 

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

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

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