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.

Contents

• Background and Purpose
  • Implementation Analysis
  • Ethics Review
• Policy Question
• Objectives and Research Questions
  • Implementation Analysis
  • Ethics Review
• Methods
• Ethics Analysis
  • Methods of Inquiry
• Implementation Analysis
  • Overview of Approach
  • Subanalysis One: A Rapid Qualitative Evidence Synthesis of Patients’, Families’ and Providers’ Perspectives and Experiences
  • Subanalysis Two: A Rapid Qualitative Evidence Synthesis of Implementation Issues
  • Stakeholder and Patient Input
  • Additional Information Sources
  • Implementation Analysis
• Protocol Amendments
• References
• Appendix 1. Literature Search Strategy — Patient Perspectives and Experiences Search

Suggested citation:

Tisagenlecleucel for B-Cell Acute Lymphoblastic Leukemia and Diffuse Large B-Cell Lymphoma — Project Protocol, Implementation and Ethics Section. (CADTH optimal use report; vol.8, no.3b). Ottawa: CADTH; 2018 Sept.

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