01.

ACCELERATING ADOPTION THROUGH COLLABORATION

car-t cell therapy has entered clinical practice, especially for the treatment of b‐cell malignancies, in the us market in 2017 after being granted priority review and breakthrough therapy designations by the fda. in 2018, the most commonly investigated, cd-19 targeted car-t cell therapy was considered by health canada and cadth (pcodr) and inesss.  both cadth and inesss published their recommendations on january 15 2019.

with the almost infinite options in car specificity and design as well as in delivering, regulating, and genome editing to insert the car gene, it is easily conceivable that many more car-t cell‐based products will enter into clinical research in future. this may result in better options for treating solid tumours and for simplifying the car -t cell production process. such a paradigm-shifting and novel cancer therapy that relies on viral production, genetic- modification, cell expansion, quality control/quality analysis, as well as clinical application and toxicity management poses significant challenges to regulatory and reimbursement approval in canada.