| Summary: | Tisagenlecleucel is a new chimeric antigen receptor (CAR) T-cell therapy that may offer clinical benefit for adults with relapsed or refractory diffuse large B-cell lymphoma and children and young adults (25 years or younger) with relapsed or refractory acute lymphoblastic leukemia. It is a multi-stage procedure involving T-cell harvesting, transportation and storage, and manufacturing (which involves modifying the DNA of harvested T cells to include CARs), and then reinfusion. The purpose of this analysis is to support decision-making relating to the provision of tisagenlecleucel in Canadian health care systems. The purpose of the ethics review is to identify, describe, and provide guidance on key ethical considerations in the implementation and provision of tisagenlecleucel for adults with relapsed or refractory diffuse large B-cell lymphoma and children and young adults with relapsed or refractory acute lymphoblastic leukemia. The issues raised in this review necessarily go beyond narrowly defined ethical concerns to encompass broader legal, social, and cultural considerations, as well. It is common in the ethics literature, across a broad range of health-related issues, to refer to ELSI --ethical, legal, and social issues -- when addressing broader values and related considerations. While the primary emphasis here will be on ethical considerations, legal and social issues may also figure in the analysis
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