| Summary: | Axicabtagene ciloleucel is a chimeric antigen receptor (CAR) T-cell therapy for several subtypes of B-cell non-Hodgkin lymphoma (NHL). It is approved for use by regulators in European Union and the US, and is pending approval from Health Canada. Where approved, it is indicated for patients with eligible subtypes of B-cell NHL who are relapsed or refractory (r/r), meaning patients whose cancer has returned or relapsed, sometimes more than once, or whose cancer has never gone into remission. This means that prior to receiving axicabtagene ciloleucel, patients would have undergone two or more lines of therapy including chemotherapy, immunotherapy, radiation therapy, or autologous hematopoietic cell transplant (HSCT). Typically only non-curative treatment options remain for these relapsed and refractory patients. This protocol is one part of a larger health technology assessment (HTA) to support evidence-based decision-making relating to the provision of axicabtagene ciloleucel in Canadian health care systems. This protocol encompasses a plan to conduct an Implementation Analysis, an Ethics Review and Patient and Stakeholder Input to complement the larger HTA.
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