This policy version was replaced on August 30, 2021. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

Brexucabtagene autoleucel is a genetically modified autologous cellular immunotherapy comprised of chimeric antigen receptor (CAR) T-cells specific to CD19, a cell surface protein found on normal and malignant B-cells. It is a customized treatment that is prepared using an individual patient’s own T-cells. Steps for preparing brexucabtagene autoleucel include: collecting a patient’s immune cells from blood via leukapheresis; sending the cells to a manufacturing facility; genetically modifying the patient’s T-cells to produce CD19-specific CARs on their surface; expanding the number of CAR T-cells; returning the cells to the treatment facility; and infusing the CAR T-cells back into the patient. This process takes several weeks. Patients typically receive lymphodepleting chemotherapy prior to intravenous infusion of brexucabtagene autoleucel. Once infused, the CAR T-cells selectively target and bind to CD19-expressing B-cells, thereby promoting T-cell expansion and activation, B-cell depletion, and persistence of the CAR T-cells.

The U.S. Food and Drug Administration (FDA) has approved brexucabtagene autoleucel (Tecartus™) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The recommended dose is 2 x 10⁶ CAR-positive viable T cells per kg of body weight, with a maximum of 2 x 10⁸ CAR-positive viable T cells for patients 100 kg and above.

Severe and life-threatening adverse reactions have occurred in patients receiving brexucabtagene autoleucel, including cytokine release syndrome and neurological toxicities. Due to these safety concerns, the prescribing information includes a black box warning. The FDA regulates brexucabtagene autoleucel through a restricted distribution program under a risk evaluation and mitigation strategy (REMS). Under the REMS, only certified healthcare facilities can administer brexucabtgene autoleucel.

I.    Brexucabtagene autoleucel (Tecartus™) may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following criteria are met:

• Age 18 years or older; AND
• Diagnosis of relapsed or refractory mantle cell lymphoma (MCL); AND
• Relapsed or refractory disease defined by the following:
  • Disease progression after last regimen; OR
  • Refractory disease defined as failure to achieve a partial response or complete response to the last chemotherapy regimen;
• AND
• Received adequate prior therapy, including ALL of the following:
  • An anthracycline- or bendamustine-containing chemotherapy regimen; AND
  • Anti-CD20 monoclonal antibody (e.g., rituximab) unless tumor is CD20-negative; AND
  • Bruton tyrosine kinase (BTK) inhibitor therapy indicated for mantle cell lymphoma (e.g., acalabrutinib, ibrutinib, zanubrutinib);
• AND
• Not previously treated with chimeric antigen receptor (CAR) T-cell therapy; AND
• No FDA labeled contraindications to brexucabtagene autoleucel (see table below); AND
• Screened for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) infection; AND
• None of the following:
  • Active infection;
  • Prior allogeneic hematopoietic stem cell transplant (HSCT);
  • Detectable cerebrospinal fluid malignant cells or brain metastases;
  • History of central nervous system (CNS) lymphoma;
  • History of CNS disorders;
• AND
• For commercial health plan members only, step therapy supplement criteria may apply for select conditions (see policy II-242: Step Therapy Supplement).

II.   All other uses of brexucabtagene autoleucel are considered EXPERIMENTAL/INVESTIGATIVE due to the lack of clinical evidence demonstrating an impact on improved health outcomes.

Table. FDA-Labeled Contraindications

Documentation Submission:

Documentation supporting the medical necessity criteria described in the policy must be included in the prior authorization, when prior authorization is required. In addition, the following documentation must also be submitted:

1. Clinical notes describing the diagnosis and clinical features of the diagnosis.
2. Laboratory results for HBV, HCV, and HIV screening.
3. Clinical notes describing current and past treatments for the diagnosis, including response to the treatments.
4. For commercial health plan members only, when step therapy requirements apply for the requested indication, documentation for one or more of the step therapy supplement criteria MUST be provided (see policy II-242).