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if not now, when?

do we want an innovative canada or are we ok with a balanced-book kind of canada?

if that isn’t the million dollar question these days. the proposed PMPRB regulations are in stark contrast to some of the initiatives in innovation and life sciences that some of the provinces have put into place. and so the question remains, do we want to innovate or just balance books?

let’s look at car-t for a minute. car-t is a highly personalized, innovative, novel and expensive therapy that has created impressive responses in patients, mostly patients who have exhausted all other treatment options and are in their last ditch effort to treat their blood cancer. let’s also not forget that most of these responders are paediatric patients.

car-t is complex.  while car-t does create complete and partial responses for some patients, it also involves a complex manufacturing process that takes weeks to deliver and because there are few manufacturing plants, the global capacity to manufacture this therapy for all the patients who will need it is an open debate. it is also highly expensive, and only available to patients who meet very strict selection criteria—it will not respond in everyone who receives the treatment. we can’t forget the sometimes fatal side effects associated with the treatment but clinicians and healthcare teams have quickly learned how to manage these side effects. patients, nonetheless need to be monitored within close range of the treating clinical site. the preparation and accreditation of clinical sites to treat patients has been a long process, ensuring the expertise is in place with appropriate pathways to treat patients pre- and post- infusion. the management of patient expectations has also been a hurdle, with some patients expecting to have side effects, and patient groups being bombarded with calls from patients wanting to receive the therapy, most of whom will not be eligible. and all wanting it in an earlier setting.

all these complexities have created the need for some reorganization of the process of approving and reimbursing therapies, of negotiating prices for therapies and certainly around how the therapy will be rolled out once available. but with all these complexities and disturbances to our canadian healthcare system, none of these complications have led to the delays we have seen with the pricing negotiations being undertaken by cancer care ontario [CCO] in bringing car-t to canadian patients.

as continuous innovations happen in cancer care, we need to start thinking more responsibly about reimbursement and policies that promote innovation in canada while creating efficiency and value. when we start to look at healthcare as an investment in our citiziens, in our economy, we can better determine what is worth paying for and how much we are willing to pay for it. fundamental questions exist worldwide about paying for new therapies, what payors value, what patients and physicians value, and in paying for outcomes rather than drugs.

we need payment models as innovative as the treatments themselves. but are governments willing to adopt these outcomes based payment approaches to address the high upfront costs? in germany, italy, spain, france, the USA, and the UK, alternative funding models are being implemented to pay for car-t but there have been no discussions in canada surrounding this type of approach. the complexity of value-based agreements have deterred our canadian government from considering such a model. there are ways, however, to achieve risk-sharing and predictability without the complexity and an opportunity exists[ed] to use the paediatric population as a pilot project to introduce value-based agreements.

in the interim though, stakeholders have been left alone in a black box—without any communication on implementation or delivery, without pathways for patient criteria or selection, on how patients will be managed or how equitable and ethical access will be provided. there has been no will to work together in managing patient expectations either.

canada had an opportunity to be a leader in the delivery and implementation of car-t for patients, in setting the precedence on creating equitable and ethical access across provinces, in ensuring appropriate reimbursement policies consistently in canada and in demonstrating the value of collaborating with stakeholders across the spectrum. but we failed to capitalize on this opportunity to really become innovators. and it seems like canada is ok with just balancing the books.

we need a better understanding of disruptive technologies and how they can be used to enhance services and the ways they are changing policy, processes and approaches.


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