on september 5.2018 health canada gave a notice of compliance [NOC] for tisagenlecleucel [kymriah]. it was the first chimeric antigen receptor [car] t-cell therapy to receive regulatory approval in canada. but here we are one year later after health canada’s approval of this innovative therapy, and where do we stand. sadly, the answer is nowhere.
after receiving the NOC, both CADTH and INESSS made positive recommendations for tisagenlecleucel. this was the first time both CADTH and INESSS reviewed a therapy collaboratively and published those recommendations simultaneously. besides the significant innovation that car-t promises to make in treating blood cancers, it also, i heard someone say, brought this country together. this landmark announcement showed the collaboration amongst HTA agencies across canada to expedite the process for car t-cell therapy review in both québec and across canada. simultaneously. as we say in québec- du jamais vu.
site readiness has been been one of the major concerns with the delivery of car-t. the complexity and uniqueness of car-t requires specialized centres to provide this therapy and expertise to manage the side effects. currently accredited sites to provide car t-cell include ste justine’s hospital for children [montréal QC], the centre hospitalier de l’université de montréal [montréal QC], sick kids [toronto ON] and the juravinski cancer centre [hamilton ON]. these sites are ready to start treating patients, but without a negotiated price or a formal agreement to list on provincial formularies [PLA], these centres are without a therapy to offer.
with car-t not available in canada, some patients are required to travel outside of the country if they meet criteria eligibility [at an estimated cost of almost double what the therapy would cost to receive it here in canada or through clinical trials within canada]. but what about the patients who don’t meet that eligibility criteria, what happens to them?
so, where did we go wrong?
we get it, car-t has been disruptive, not only in canada but globally. but disruptive mostly in how and who will reimburse this expensive yet innovative therapy versus the actual logistics of manufacturing and delivering car-t. but let’s not forget who is being treated. these are relapsed or refractory patients who have failed on several other lines of therapy before being considered for the treatment, and for many this is a last resort.
expensive and complicated?
we get it, car-t is expensive and complicated. we understand that considering alternative, innovative reimbursement models are expensive and complicated too. we get the process too, and constrained budgets and lack of resources. but let’s not forget the patients. some of whom will die waiting for an acceptable price to be negotiated. and that just isn’t canadian.
today, we’re asking for everyone who reads this blog post to use the #cartincanada and help us get car-t reimbursed and listed on provincial formularies without any further delay!