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challenges & potential barriers to CAR-T access

with recent health canada approvals of two new car-t cell treatments [tisagenlecleucel in september 2018 and [axicabtagene ciloleuce] in february 2019], canada is slowly starting to join the car-t club [at this time car-t has been approved in the USA and the UK]. despite its significant potential as a game changing treatment with extraordinary promise for hematologic cancers, this scientific progress comes with challenges and potential barriers to access. 

because car-t is an unprecedented therapy, it will only be available at specialized centres determined by the manufacturers. for canada, what that looks like at the moment is two [2] sites for adult DLBCL [tisagenlecleucel], available at the juravinsky cancer centre in hamilton, ON and the centre hospitalier de l’université de montréal [chum] in montréal, QC and two [2] sites for pediatric ALL including sickids in toronto, ON and ste. justine’s in montréal, QC.

the complexity of bringing car-t to patients requires an infrastructure and expertise to deliver it safely and effectively.  the toxicity profile is also another consideration, especially with the anti-CD19 car-t, and only the treatment centres with the experience to respond and manage these toxicities will be capable of offering this therapy. [to-date the most prevalent adverse event cited in the use of car-t therapy is [cytokine release syndrome]

because car-t is currently being offered in specific academic centres, it will not be widely disseminated in the community setting. this means patients will need to travel to the treatment centres, which will become an important barrier to access. patients residing outside of these treatment centres [in province and out of province] will be required to not only travel but will need to remain near infusion sites for a set time pre- and post-infusion [to be monitored for adverse reactions]. interprovincial agreements for patients who are eligible for this treatment will need to consider these nuances, including travel and accommodations for patients and their caregivers. [let’s not forget these patients are not in early stages of disease and car-t is an end of line treatment for them].

which makes reimbursement another hurdle that needs to be overcome in utilizing the full potential of car-t for patients. once the pan-canadian pharmaceutical alliance [pCPA] and the manufacturer agree on a negotiated price and a letter of intent [LOI] is signed, each province then decides if they will make this therapy available on their provincial formularies and no province is under any contractual obligation to provide access to this therapy. several factors can play into a province’s ability to offer a therapy, and healthcare budgets is a major influence in this.

we face a fundamental challenge in canada and that is how to pay for these therapies and make them available to patients in need. is it time then for canada to explore innovative payment models?

beyond the issue of reimbursement, healthcare process’ and policies are still trying to understand how to deliver disruptive technologies into our healthcare system – and we have seen this as one of the major challenges in getting car-t in canada. all stakeholders will need to work together to shape the regulatory and reimbursement environment that not only lets the science lead the way but creates optimal access for canadian patients who should be at the centre of every decision.

car-t is really at the forefront of personalized medicine, but the disruptive nature of car-t doesn’t fit neatly into government or even private [insurance] payor models, but these challenges should not deny patients who could potentially benefit from car-t therapies from having access to them. 


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