Axicabtagene ciloleucel for the treatment of relapsed or refractory large B-cell lymphoma

Notice Santécom: 120807

Diffuse large B-cell lymphoma (DLBCL) is a highly aggressive form of non-Hodgkin’s (NHL) which mainly affects adults. The only curative treatment currently recognized is the administration of a combination of antineoplastic agents followed by an autologous stem cell transplantation.

Axicabtagene ciloleucel (axi-cel, Yescarta^TM), recently approved by Health Canada, is used to treat adult patients with relapsed or refractory large B-cell lymphoma. In this guidance, INESSS evaluated the relevance of offering axi-cel to patients with r/r DLBCL. Efficacy, safety and efficiency of this therapy, as well as the budget impact of its use, were examined, in addition to ethical and organizational issues and the perspectives of patients and citizens.

INESSS recognizes the promising nature of axicabtagene ciloleucel (Yescarta^TM). However, the long-term safety, clinical efficacy and cost effectiveness of this therapy remain highly uncertain. INESSS is of the opinion that covering it could nonetheless 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 long-term safety.

The indications recognized for coverage are presented in the guidance as well as implementation considerations.