[Report: axicabtagene ciloleucel for the treatment of relapsed or refractory large B-cell lymphoma]

N’Diaye Mombo N, Martin P, Beha S, Arbour S, Nshimyumukiza L
Record ID 32018000854
Original Title: Avis: axicabtagene ciloleucel pour le traitement des lymphomes à grandes cellules B récidivants ou réfractaires
Authors' objectives: The Ministère de la Santé et des Services sociaux (MSSS) has commissioned the Institut national d’excellence en santé et en services sociaux (INESSS) with the mandate to evaluate the relevance of offering axi-cel to patients r/r LBCL.
Authors' results and conclusions: RESULTS OF THE DELIBERATION Members of the deliberative committee unanimously recognized the promising nature of axicabtagene ciloleucel (Yescarta) for the treatment of adult patients with r/r DLBCL who are deemed to be at a therapeutic impasse. The members considered that the submitted and available evidence was too immature for them to confidently recognize the therapeutic value of this therapy. However, they did recognize the severity of the disease and the existence of an important unmet need. The members of the deliberative committee are of the opinion that this therapy should be available for r/r DLBCL patients, but only under coverage conditions which would take into account the high degree of uncertainty regarding the situation.
Authors' recomendations: INESSS recognizes the promising nature of axicabtagene ciloleucel (YescartaTM) for the treatment of patients with refractory or recurrent large B-cell lymphoma (r/r LBCL). However, the long-term safety, clinical efficacy and cost effectiveness of this therapy remain highly uncertain. INESSS considers that covering it could be a fair and reasonable option to the extent that the following goals are met:  a considerable mitigation of the economic burden;  the introduction of a temporary status for such coverage until more robust data are available (2- or 3-year time horizon);  the continued development of evidence concerning axicabtagene ciloleucel’s therapeutic value and safety.
Authors' methods: Data from a literature review as well as data provided by the manufacturer were analyzed in order to document the efficacy, safety and efficiency of axi-cel. In addition, data from surveys conducted by Lymphoma Canada and the Leukemia & Lymphoma Society of Canada were combined and analyzed (secondary analysis). Some elements resulting from the general public consultation carried out during the evaluation of tisa-cel by INESSS were also included in this evaluation. A cost-utility analysis and a budget impact analysis are presented, as are contextual data issued from consultations with clinical experts in the field of CAR-T cell therapies.
Project Status: Completed
Year Published: 2019
Requestor: Minister of Health
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: Canada
Province: Quebec
MeSH Terms
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Antineoplastic Combined Chemotherapy Protocols
  • Immunotherapy, Adoptive
  • Cyclophosphamide
  • Non-Hodgkin's Lymphoma
  • Immunotherapy
  • B lymphocytes
Organisation Name: Institut national d'excellence en sante et en services sociaux
Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369
Contact Name: demande@inesss.qc.ca
Contact Email: demande@inesss.qc.ca
Copyright: Gouvernement du Québec
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