as groundbreaking as car t-cell therapy is, it’s also incredibly complex and expensive to deliver. the rapid advances in and growth of car t-cell therapy has exceeded the expectations of even those who were early believers in its potential. the one time infusion therapy has had incredible response rates for patients in relapse or refractory blood cancers [paediatric ALL and adult DLBCL]. with current clinical trials in acute myeloid leukemia [AML], multiple myeloma, chronic lymphocytic leukemia [CLL], non-hodgkin lymphoma and solid tumours and the potential to reach hematologic cancer patients as an earlier line of therapy continues to provide promise.
however, there is a misconception, especially within canada, that these therapies are available in all provinces, and reimbursed by the government. the truth lies somewhere in the middle and approval doesn’t always mean funded.
in september 2018 health canada approved the first chimeric antigen receptor therapy [tisagenlecleucel]. in january 2019 both the canadian agency for drugs and technology in health [CADTH] and the institut national d’excellence en santé et services sociaux [INESSS] made their recommendations to approve tisagenlecleucel with certain conditions, including a price reduction in both the paediatric and adult populations. negotiations are currently underway with the pan-canadian pharmaceutical alliance [pCPA]. once these negotiations are complete and letters of intent [LOIs] are signed, each province then decides whether they will list the therapy on their formulary and make it available to patients. this process can take anywhere between several months and years, as we have seen previously with other expensive therapies [think immuno-oncology].
car-t, once listed for reimbursement on provincial formularies, will be accessible to patients in two [2] provinces [québec and ontario] and while there are talks that will expand car-t availability to other provinces, the appropriate facilities for both treatment infusion and post infusion care are required, much like bone marrow transplant centres, of which only five [5] provinces in canada have the required facilities.
meaning that barriers such as travel and accommodation become an important obstacle to care. this then begs the question, who will pay for this? and what does this mean for patients outside of the major centres that will offer car-t; outside of the two current provinces or outside of the five possible provinces that can potentially offer car-t down the line? how will decision and policy makers take into consideration the ethics of delivering car-t to all canadians?
will the provinces be slow to offer this ground breaking therapy because of the cost and complexity? or will the scientific innovation, as well as the medical, patient and societal value and overall impact to the healthcare system be fully appreciated and taken into consideration as reimbursement pathways are set in place for each province⏤ to provide equitable access for patients to this potentially life saving therapy.
pricing and pathways for reimbursement will certainly pose challenges as we start to implement car-t into real world practice. but price is only part of the cost of delivering the treatment. these nuances continue to make it an interesting puzzle to solve.
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