Medical Policy: 08.01.33
Original Effective Date: September 2020
Reviewed: September 2020
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Tecartus (brexucabtagene autoleucel) a chimeric antigen receptor (CAR) T-cell therapy and is the first cell-based gene therapy approved by the FDA for the treatment of refractory or relapsed mantle cell lymphoma (MCL).
Mantle cell lymphoma (MCL) is a rare form of cancerous B-cell non-Hodgkin’s lymphoma that usually occurs in middle-aged or older adults. In patients with MCL, B-cells, a type of white blood cell which help the body fight infection, change into cancer cells that start to form tumors in the lymph nodes and quickly spread to other areas of the body.
Tecartus is a CD19-directed, genetically-modified autologous T-cell immunotherapy, also known as chimeric antigen receptor (CAR) T-cell therapy. CAR T-cells are made by first collecting T-cells from the patient. The cells are then sent to a laboratory where they are genetically engineered to produce chimeric antigen receptors. The modified T-cells, now known as CAR T-cells, have the ability to better recognize an antigen (the CD19 protein) on targeted tumor cells. After the CAR T-cells have multiplied in the laboratory, they are then infused back into the patient. The modified CAR T-cells help the body’s immune system better target and treat the tumor cells.
While Tecartus shares the same design as another FDA-approved anti-CD19 CAR-T cell therapy Yescarta (axicabtagene ciloleucel), the difference lies in the manufacturing process for Tecartus. Tecartus undergoes a white blood cell enrichment process, which is necessary for certain types of B-cell blood cancers, such as mantle cell lymphoma, where circulating lymphoblasts are a common feature.
The FDA has approved Tecartus for relapsed or refractory mantle cell lymphoma under its accelerated approval program. Continued approval is based on verification of clinical benefit in confirmatory trials.
The safety and efficacy of Tecartus was established in a single-arm, open-label trial of 60 adults with refractory or relapsed MCL who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody, and a Bruton tyrosine kinase inhibitor (2020 Wang et. al.). A total of 74 patients were enrolled. KTE-X19 was manufactured for 71 patients and administered to 68. The primary efficacy analysis showed that 93% (95% confidence interval [CI], 84 to 98) of the 60 patients in the primary efficacy analysis had an objective response; 67% (95% CI, 53 to 78) had a complete response. In an intention-to-treat analysis involving all 74 patients, 85% had an objective response; 59% had a complete response. At a median follow-up of 12.3 months (range, 7.0 to 32.3), 57% of the 60 patients in the primary efficacy analysis were in remission. At 12 months, the estimated progression-free survival and overall survival were 61% and 83%, respectively. Common adverse events of grade 3 or higher were cytopenias (in 94% of the patients) and infections (in 32%). Grade 3 or higher cytokine release syndrome and neurologic events occurred in 15% and 31% of patients, respectively; none were fatal. Two grade 5 infectious adverse events occurred. The authors concluded Tecartus (KTE-X19) induced durable remissions in a majority of the patients with relapsed or refractory mantle cell lymphoma.
Tecartus has a black box warning for cytokine release syndrome (CRS), and should not be administered in patients with active infection or inflammatory disorders due to risk of life-threatening reactions and death. Severe or life-threatening CRS should be treated with tocilizumab with or without corticosteroids. Tecartus also has black box warning for causing neurological toxicities, which could also be severe and life-threatening. Monitoring for neurological events after administration is recommended. Due to these black box warnings, Tecartus is only available through a Risk Evaluation and Mitigation Strategy (REMS) program.
Tecartus is a CD19-directed, genetically-modified autologous T-cell immunotherapy, also known as chimeric antigen receptor (CAR) T-cell therapy. The FDA has approved Tecartus for relapsed or refractory mantle cell lymphoma (MCL) under its accelerated approval program. Continued approval is based on verification of clinical benefit in confirmatory trials. The safety and efficacy of Tecartus was established in a single-arm, open-label trial of 60 adults with refractory or relapsed MCL who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody, and a Bruton tyrosine kinase inhibitor (2020 Wang et. al.). This trial concluded that Tecartus (KTE-X19) induced durable remissions in a majority of the patients with relapsed or refractory mantle cell lymphoma (of the 60 patients in the primary efficacy analysis had an objective response; 67% (95% CI, 53 to 78) had a complete response). Due to the risk of CRS (cytokine release syndrome) and neurologic toxicities, Tecartus was approved with a Risk Evaluation and Mitigation Strategy (REMS), which includes elements of safe use. The evidence is sufficient to determine that the technology results in meaningful improvement in net health outcomes.
Guidance for the Treatment of Patients with Brexucabtagene Autoleucel
On July 24, 2020, the FDA approved Tecartus (brexucabtagene autoleucel) for intravenous infusion for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Black Box Warning
Warning: Cytokine Release Syndrome and Neurologic Toxicities
Dosing of TECARTUS is based on the number of chimeric antigen receptor (CAR)-positive viable T cells.
Prior approval required
See Related Medical Policies
Tecartus (Brexucabtagene Autoleucel) as a one-time, single administration intravenous infusion treatment is considered medically necessary when ALL of the following criteria are met:
Tecartus (Brexucabtagene Autoleucel) is considered investigational for all other indications, including when the above medical necessity criteria are not met as the safety and efficacy has not yet been established in the peer reviewed medical literature. The evidence is insufficient to determine the effects on net health outcomes.
Repeat treatment of Tecartus (Brexucabtagene Autoleucel) for any indication is considered investigational, as the safety and efficacy beyond one dose has not been studied. The evidence is insufficient to determine the effects on net health outcomes.
The patient’s medical records submitted for review should document the above medical necessity criteria is met and should also include the following:
Anthracycline containing chemotherapy for the treatment of mantle cell lymphoma (MCL) may include the following:
Black Box Warning
Warning: Cytokine Release Syndrome and Neurologic Toxicities
Tecartus (Brexucabtagene Autoleucel) is available only through a restricted program under a risk evaluation and mitigation strategy (REMS). The requirement for the REMS components is as follows:
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD diagnosis codes.
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
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