Medical Policy: 08.01.34 

Original Effective Date: February 2021 

Reviewed: February 2021 

Revised:  

 

Notice:

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 Application:

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.

 

Description:

Breyanzi (lisocabtagene maraleucel, also called liso-cel) 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.

 

Breyanzi (Lisocabtagene maraleucel) was approved by the FDA for the treatment of patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL), diffuse large B-cell lymphoma not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.  

 

Large B-cell lymphoma also known as Non-Hodgkin’s lymphomas (NHL) are a heterogenous group of lymphoproliferative disorders originating in B-lymphocytes, T-lymphocytes, or natural killer cells (NK) cells (NK/T-cell lymphomas are very rare). The most common B-cell lymphoma subtypes are listed below: 

  • Follicular lymphoma (FL)
  • Marginal zone lymphoma (MZLs)
    • Gastric MALT lymphoma
    • Non-gastric MALT lymphoma
    • Nodal MZL
    • Splenic MZL
  • Mantle cell lymphoma (MCL)
  • Diffuse large B-cell lymphoma (DCBLC)
  • Burkitt lymphoma (BL)
  • AIDS – related B-cell lymphomas
  • Post-transplant lymphoproliferative disorders
  • Castleman’s disease

 

In 2021, an estimated 81,560 people will be diagnosed with NHL and there will be approximately 20,720 deaths due to the disease.

 

NHL can be divided into two prognostic groups: indolent lymphomas and aggressive lymphomas.

  • Indolent lymphomas: Grow slowly; considered low grade lymphomas
  • Aggressive lymphomas: Grow at a faster rate; considered high grade lymphomas

 

Sometimes lymphoma changes from a slow growing type into a faster growing type, this is known as transformation. The transformed lymphoma has to be treated as a high-grade lymphoma.

 

Non-Hodgkin’s lymphoma is called “high grade” when the cells appear to be dividing quickly. These may be called aggressive lymphomas.

 

Defining Relapsed and Refractory Disease 

Refractory (resistant) disease is suggested by a less than 50 percent decrease in lesion size with treatment in the absence of new lesion development. In contrast progressive disease usually manifests as the appearance of any new lesion, a 50 percent increase in the longest diameter of a previously identified lesion or new/recurrent involvement in the bone marrow. Relapsed disease reflects the appearance of any new lesion after attainment of an initial complete remission.

 

Refractory or progressive disease is identified during the post-treatment response evaluation. The majority of relapses occur during the first two years after completion of treatment. However, as many as 18 percent of relapses occur more than five years after initial treatment. Relapses are usually symptomatic and rarely identified solely on the basis of routine imaging. Progressive or relapse can present with systemic B symptoms (i.e. fever, night sweats, weight loss), cytopenias, the development of an extranodal mass, or as the symptomatic or asymptomatic enlargement of the lymph nodes, liver or spleen.

 

When relapse is suspected, a biopsy of the involved lymph node or mass is recommended to confirm relapse and evaluate a potential change in histology, for example indolent non-Hodgkin’s lymphoma to an aggressive non-Hodgkin’s lymphoma.

 

Treatment for Relapsed or Refractory Disease 

Outcomes for patients with refractory diffuse large B-cell lymphoma (DLBCL) are poor.

 

Relapse or refractory diffuse large B-cell lymphomas is treated with systemic chemotherapy with or without rituximab with plans to proceed to high dose chemotherapy and hematopoietic stem cell transplantation (HSCT) in those with chemotherapy sensitive disease. The treatment of patients who are not candidates for HSCT, who fail to respond to second-line chemotherapy regimens, or who relapse after HSCT is generally palliative.

 

In the absence of HSCT, conventional chemotherapy regimens provide only transient disease control for the majority of patients with relapsed or refractory disease. Patients with primary refractory disease rarely achieve complete remission when treated with a second chemotherapy regimen. Following relapses from a first complete remission, a subset of patients will achieve a second complete remission with chemotherapy; however, these remissions are generally not durable, and long- term disease free survivors are rare. In contrast, approximately half of patients who respond to a second chemotherapy regimen and proceed to HSCT will maintain their response for two years. Given the lack of options for these patients, despite the high risk of adverse events Breyanzi (lisocabtagene maraleucel) is now being considered as a treatment option for adult patients with relapsed or refractory diffuse large B-cell lymphoma (de novo or transformed from any indolent lymphoma), high -grade B-cell lymphoma with rearrangements in MYC and either BCL2, BCL6, or both (double- hit or triple- hit lymphoma), primary mediastinal B-cell lymphoma or follicular lymphoma grade 3B after two or more previous lines of systemic treatment including previous chemoimmunotherapy containing anti-CD20 and anthracycline with subsequent relapse, and they could have received a previous autologous or allogeneic HSCT. 

 

The FDA has approved Breyanzi (lisocabtagene maraleucel) for the treatment of patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL), diffuse large B-cell lymphoma not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.  Continued approval is based on verification of clinical benefit in confirmatory trials.

 

The safety and efficacy of Breyanzi (lisocabtagene maraleucel) was established in a multicenter, multicohort, seamless design study (seamless design study: which combines two or more phases into one adaptive design study) at 14 cancer centers in the United States (TRANSCEND). Eligible patients in this study included adult patients aged > 18 years with PET-positive relapsed or refractory large B-cell lymphomas (de novo or transformed from any indolent lymphoma). Eligible histological subgroups included diffuse large B-cell lymphoma, high-grade B-cell lymphoma with rearrangements of MYC and either BCL2, BCL6, or both (double-hit or triple-hit lymphoma), diffuse large B-cell lymphoma transformed from any indolent lymphoma, primary mediastinal B-cell lymphoma, and follicular lymphoma grade 3B. Patients must have received two or more previous lines of systemic treatment (including previous chemoimmunotherapy containing anti-CD20 and anthracycline) with subsequent relapse, and they could have received a previous autologous or allogeneic hematopoietic stem cell transplant. Unlike ZUMA-1 and JULIET studies, this study allowed patients with moderate comorbidities of renal (creatinine clearance > 30 or < 60 mL/min) and cardiac (left0ventricular ejection fraction ≥ 40% to < 50%) dysfunction, low absolute lymphocyte count (no minimum count required), and secondary CNS involvement were eligible. However, the authors do state that additional studies on the management of these patients with moderate comorbidities receiving Breyanzi (lisocabtagene maraleuce) particularly in neurological events are warranted. 

 

Patients were assigned to one of three target dose levels of Breyanzi as they were sequentially tested in the trial (50 × 106 CAR-T cells [one or two doses], 100 × 106 CAR- T cells, and 150 × 106 CAR-T cells), which were administered as a sequential infusion of two components (CD8 and CD4 CAR-T cells) at equal target doses. Primary endpoints were adverse events, dose-limiting toxicities, and the objective response rate (assessed per Lugano criteria); endpoints were assessed by an independent review committee in the efficacy-evaluable set (comprising all patients who had confirmed PET-positive disease and received at least one dose of Breyanzi). This trial is registered with ClinicalTrials.gov, NCT02631044.

 

Between Jan 11, 2016, and July 5, 2019, 344 patients underwent leukapheresis for manufacture of CAR- T cells (Breyanzi), of whom 269 patients received at least one dose of Breyanzi. Patients had received a median of three (range 1–8) previous lines of systemic treatment, with 260 (97%) patients having had at least two lines. 112 (42%) patients were aged 65 years or older, 181 (67%) had chemotherapy-refractory disease, and seven (3%) had secondary CNS involvement. Median follow-up for overall survival for all 344 patients who had leukapheresis was 18.8 months (95% CI 15·0–19·3). Overall safety and activity of Breyanzi did not differ by dose level. The recommended target dose was 100 × 106 CAR-T cells (50 × 106 CD8 and 50 × 106 CD4 CAR-T cells). Of the 256 patients included in the efficacy-evaluable set, an objective response was achieved by 186 (73%, 95% CI 66·8–78·0) patients and a complete response by 136 (53%, 46·8–59·4). The most common grade 3 or worse adverse events were neutropenia in 161 (60%) patients, anemia in 101 (37%), and thrombocytopenia in 72 (27%). Cytokine release syndrome and neurological events occurred in 113 (42%) and 80 (30%) patients, respectively; grade 3 or worse cytokine release syndrome and neurological events occurred in six (2%) and 27 (10%) patients, respectively. Nine (6%) patients had a dose-limiting toxicity, including one patient who died from diffuse alveolar damage following a dose of 50 × 106 CAR- T cells.

 

Study limitations include the open-label single arm design, since this study is non-comparative, and the relatively short follow-up period for patients who were enrolled later during the study. However, plateauing on the duration of response and progression-free survival curves suggests substantial durability. In view of the broad population included in this study, the number of patients in some subsets of interest (e.g., follicular lymphoma grade 3B, diffuse large B-cell lymphoma transformed from indolent lymphomas other than follicular lymphoma, and patients with secondary CNS lymphoma) are small, meaning that to draw definitive conclusions in these subsets is difficult. The authors concluded findings of the TRANSCEND trial show that Breyanzi can lead to rapid and durable remission, with low incidence of all-grade and severe cytokine release syndrome and neurological events among patients with high-risk aggressive relapsed or refractory large B-cell lymphomas. Clinically meaningful activity was noted across populations with unmet medical need, including uncommon histological subtypes and patients with characteristics of poor prognosis. 

 

Breyanzi (lisocabtagene maraleucel) 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. Breyanzi (lisocabtagene maraleucel) also, has black box warning regarding neurological toxicities which could also be severe and life-threatening. Monitoring for neurological events after administration is recommended. Due to these black box warnings Breyanzi (lisocabtagene maraleucel) is only available through a Risk Evaluation and Mitigation Strategy (REMS) called the Breyanzi REMS. 

 

Summary of Evidence

Breyanzi (lisocabtagene maraleucel) is a CD19-directed, genetically modified autologous T-cell immunotherapy, also known as chimeric antigen receptor (CAR) T-cell therapy. The FDA has approved Breyanzi (lisocabtagene maraleucel) for the treatment of patients with relapsed or refractory large B-cell lymphoma (DLBCL), diffuse large B-cell lymphoma not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B under its accelerated approval program. Continued approval is based on verification of clinical benefit in confirmatory trials. The safety and efficacy of Breyanzi (lisocabtagene maraleucel) was established in a multicenter, multicohort, seamless design study (seamless design study: which combines two or more phases into one adaptive design study) at 14 cancer centers in the United States (TRANSCEND) and of the 344 patients who underwent leukapheresis 269 of these patients received Breyanzi for the treatment of relapsed or refractory large B-cell lymphomas (Abramson et.al. 2020). Patients were heavily pretreated with a median of three previous lines of systemic therapy. Out of the 269 patients who received Breyanzi 256 patients were included in the efficacy-evaluable set which included patients who received at least one dose of Breyanzi and had PET- positive disease per independent review committee assessment, an objective response was achieved by 186 (73%), and 136 (53%) achieved a complete response. Responses were durable, with an estimated duration of response at 1 year of 55% among patients who had a complete or partial response and 65% among those who achieved a complete response. Progression-free survival and overall survival at 1 year were 44% and 58%, respectively. Breyanzi was associated with a low incidence of grade 3 or 4 cytokine release syndrome (in six [2%] patients) and neurological events (in 27 [10%] patients). The findings for the TRANSCEND trial show that Breyanzi (lisocabtagene maraleucel) can lead to rapid and durable remission, with low incidence of all-grade and severe cytokine release syndrome and neurological events among patients with high-risk aggressive relapsed or refractory large B-cell lymphomas. Clinically meaningful activity was noted across populations with unmet medical need, including uncommon histological subtypes and patients with characteristics of poor prognosis. Due to the risk of CRS (cytokine release syndrome) and neurologic toxicities, Breyanzi (lisocabtagene maraleucel) was approved with a Risk Evaluation and Mitigation Strategy (REMS) called the Breyanzi REMS, which includes elements of safe use. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. 

 

Practice Guidelines and Position Statements

National Comprehensive Cancer Network (NCCN)

B-Cell Lymphomas Version 2.2021
Guidance for Treatment of Patients with Chimeric Antigen Receptor (CAR) T-Cell Therapy

Lisocabtagene Maraleucel

 

Patient Selection 

  • Lisocabtagene maraleucel is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B.
  • Health care facilities that dispense and administer lisocabtagene maraleucel must be enrolled and comply with REMS requirements.
  • CRS management – See CAR-T Cell Related Toxicities
  • Neurologic toxicity management – See CAR T-Cell Related Toxicities
  • Prolonged cytopenias
    • Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and lisocabtagene maraleucel infusion
  • Hypogammaglobulinemia
    • B-cell aplasia and hypogammaglobulinemia can occur in patients with a complete remission after lisocabtagene maraleucel infusion. 

 

Regulatory Status

On February 5, 2021 Breyanzi (Lisocabtagene Maraleucel) was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory large B-Cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLCBL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.   

 

The FDA approval states Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma. 

 

Pediatric use: The safety and efficacy of Breyanzi has not been established in pediatric patients. 

 

Avoid administration of Breyanzi in patients with clinically significant active systemic infections. 

 

Hepatitis B virus (HBV) reactivation in some cases resulting in fulminant hepatitis, hepatic failure, and death can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV and HIV in accordance with clinical guidelines before collection of cells for manufacturing.  

 

Prior Approval:

Prior approval is required.

 

Policy:

See Related Medical Policies 

  • 08.01.27 Cellular Immunotherapy for Prostate Cancer – Provenge (Sipuleucel-T)
  • 08.01.29 Yescarta (Axicabtagene Ciloleucel)*
  • 08.01.30 Kymriah (Tisagenlecleucel)*
  • 08.01.33 Tecartus (Brexucabtagene Autoleucel)*

 

Breyanzi (lisocabtagene maraleucel) as a one-time, single administration intravenous infusion treatment is considered medically necessary when ALL of the following criteria are met:

  • Individual is 18 years or older; AND

  • Individual has histologically confirmed diagnosis of one of the following:

    • Diffuse large B-cell lymphoma (DLBCL); OR

    • Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS); OR

    • Transformed 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; AND

  • Relapsed or refractory disease, defined as progression after two more lines of system therapy (which may or may not include therapy supported by hematopoietic stem cell transplant) including ALL of the following:

    • Anti-CD20 [ such as rituximab or obinutuzumab]; AND

    • Anthracycline [such as doxorubicin]); AND

  • Individual has adequate bone marrow reserve/function to receive lymphodepleting chemotherapy; AND

  • The member will receive Breyanzi (lisocabtagene maraleucel) at a treatment center that is certified to administer Breyanzi (lisocabtagene maraleucel); AND

  • Do not have any of the following:

    • Diagnosis of primary or secondary central nervous system (CNS) lymphoma; OR

    • History or presence of CNS disorders such as epilepsy/seizure disorder, paresis, aphasia, stroke, cerebral edema, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, or pyschosis; OR

    • Creatinine clearance less < to 30 mL/min; OR

    • Cardiac ejection fraction (EF) less than 40%, or other clinically significant cardiac disease; OR

    • Alanine aminotransferase (SGPT) > 5 times the upper limit of normal; OR

    • History of chimeric antigen receptor therapy (CAR-T) or other genetically modified T-cell therapy, including but not limited to, previous administration of Yescarta or Kymriah; OR

    • Active hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive), if viral load is detectable; a history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing); OR

    • Active systemic infections. 

 

Breyanzi (Lisocabtagene Maraleucel) 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 

Repeat treatment of Breyanzi (Lisocabtagene Maraleucel) 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.

 

Required Documentation

The patient’s medical records submitted for review should document the above medical necessity criteria is met and should also include the following:

  • Office notes that contain the confirmed diagnosis and clinical features of the diagnosis (including laboratory results confirming the diagnosis), relevant history and physical and prior cancer treatment history.
  • Lab work and diagnostic testing within 7 to 14 days of the approval request to determine the individual has adequate organ and bone marrow function and meets the medical necessity criteria above.  

 

Policy Guidelines 

Definitions:

  • Relapsed Disease:  Reflects the appearance of any new lesion after attainment of an initial complete remission. When relapse is suspected a biopsy of the involved lymph node or mass is recommended to confirm relapse and evaluate for potential change in histology.
  • Refractory Disease: Illness or disease that does not respond to treatment.  Resistant/refractory DCBCL is suggested by less than 50 percent decrease in lesion size with treatment in the absence of new lesion development.
  • Line of Therapy:
    • First line therapy: The first or primary treatment for the diagnosis
    • Second line therapy: Treatment given with initial treatment (first line therapy) is not effective or there is disease progression
    • Third line therapy: Treatment given when both initial (first line therapy) and subsequent treatment (second line therapy) are not effective or there is disease progression   

 

Harvesting

Autologous lymphocytes used as part of adoptive immunotherapy may be harvested in a pheresis (leukapheresis) procedure.

 

Black Box Warning

Breyanzi (lisocabtagene maraleucel) has a black box warning because of the risk of cytokine release syndrome and neurologic toxicities that include fatal or life-threatening reactions. It should not be administered to patients with active infection or inflammatory disorders. It is recommended that severe or life-threatening cytokine release syndrome should be treated with tocilizumab. Patients should be monitored for neurologic events after treatment.

 

Because of the risk of CRS and neurologic toxicities, Breyanzi (lisocabtagene maraleucel) is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Breyanzi REMS. The requirement for the REMS components of the Breyanzi REMS are the following:

  • Health care facilities that dispense and administer Breyanzi must be enrolled and comply with the REMS requirements.
  • Certified health care facilities must have onsite, immediate access to tocilizumab, and ensure that a minimum of 2 doses of tocilizumab are available for each patient for administration within 2 hours after Breyanzi, if needed for treatment of cytokine release syndrome (CRS).
  • Certified health care facilities must ensure that health care providers who prescribe, dispense, or administer Breyanzi are trained about the management of cytokine release syndrome (CRS) and neurologic toxicities.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD diagnosis codes.

  • 0537T Chimeric antigen receptor T-cell (CAR-T) therapy; harvesting of blood-derived T lymphocytes for development of genetically modified autologous CAR-T cells, per day
  • 0538T Chimeric antigen receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for transportation (eg, cryopreservation, storage)
  • 0539T Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preparation of CAR-T cells for administration
  • 0540T Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous
  • C9076 Lisocabtagene maraleucel, up to 110 million autologous anti-cd19 car-positive viable t-cells, including leukapheresis and dose preparation procedures, per therapeutic dose 
  • Revenue Code 0891 Special Process Drugs – FDA Approved Cell Therapy

 

Selected References:

  • Abramson JS, Paloma ML, Gordon LI, et al. Pivotal Safety and Efficacy Results from Transcend NHL 001, a Multicenter Phase 1 Study of Lisocabtagene Maraleucel (liso-cel) in Relapsed/Refractory (R/R) Large B Cell Lymphomas. Blood (2019) 134 (Supplement_1): 241
  • Abramson JS, Paloma ML, Gordon LI, et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (Transcend NHL 001): a multicenter seamless design study. Lancet 2020; 396:839-52
  • Abramson JS, Paloma ML, Gordon LI, et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (Transcend NHL 001): a multicenter seamless design study. Supplementary appendix. Lancet 2020
  • Abramson JS, Lunning M, Palomba ML, et. al. Chimeric antigen receptor T-cell therapies for aggressive B-cell lymphomas: Current and future state of the art. American Society of Clinical Oncology Educational Group Volume 39. 2019
  • Bachier CR, Palomba ML, Abramson JS, et al. Outpatient Treatment with Lisocabtagene Maraleucel (liso-cel) in Three Ongoing Clinical Studies in Relapsed/Refractory (R/R) B Cell Non-Hodgkin Lymphoma (NHL), Including Second-Line Transplant Ineligible Patients: Transcend NHL 001, Outreach, and PILOT. Blood (2019) 134 (Supplement_1): 2868
  • Bristol-Myers Squibb Announces Liso-Cel Met Primary and Secondary Endpoints in TRANSCEND NHL 001 Study. Press Release 12/7/2019
  • NCT02631044 
  • FDA Package Insert for Breyanzi (lisocabtagene maraleucel)
  • National Comprehensive Cancer Network (NCCN) B-Cell Lymphomas
  • American Cancer Society Key Statistics for Non-Hodgkin Lymphoma. Last revised January 12, 2021

 

Policy History:

  • February 2021 - New Policy Created

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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