Article Figures & Tables
Tables
Characteristic No. (%) of participants
n = 30Role Decision-maker 14 (46.7) Academic 5 (16.7) Industry representative 4 (13.3) Patient advisor 4 (13.3) International expert 3 (10.0) Institution type Academic 6 (20.0) Industry 4 (13.3) Government (e.g., ministry) 4 (13.3) Health technology assessment or health economics not-for-profit organization 4 (13.3) Federal or provincial health authority 6 (20.0) Federal or provincial pharmaceutical pricing negotiation 2 (6.7) Patient advisory board 4 (13.3) Sex Male 14 (46.7) Female 16 (53.3) Region Central Canada 15 (50.0) Atlantic Canada 2 (6.7) Prairie provinces (Manitoba, Saskatchewan, Alberta) 6 (20.0) British Columbia 4 (13.3) Outside Canada (Scotland, England, United States) 3 (10.0) Theme Description Illustrative quotes Stakeholders value RWE in cancer drug funding decisions Stakeholders expressed enthusiasm and optimism about the possibility of incorporating RWE into cancer drug funding decisions to address the limitations of RCTs and provide evidence on whether a drug provided “good value for money spent” (interviewee 5, Canadian) in the real world. So, I think real-world evidence is an essential part of what we need to do in terms of bringing sort of science to real world decision-making. … We need [RWE] and I think we are in a very, we are at a point where certainly decision-makers must have that information. (Interviewee 13, Canadian) Rather than us accepting these [cost-effective] models that are fanciful, in which there’s tremendous uncertainty in them, you’d be better to make an additional recommendation to fund and collect data prospectively in the real world to see, What is the duration of survival? What is the duration of treatment? What are the long-term toxicities? Things that you don’t pick up in a clinical trial. … There has to be much more certainty of their benefits and with certainty on the benefits, then we could … if we’re going to require drugs to be cost-effective, we’re in a better position to negotiate what those prices might be and get it into what we consider a cost effective range. (Interviewee 2, Canadian) A cultural shift is required to adopt RWE in decision-making Although participants were enthusiastic about RWE’s potential for greater external validity than RCTs, they recognized that a cultural shift is required for decision-makers to move beyond “gold standard” (interviewee 11, Canadian) evidence from RCTs. I guess it’s just easier with randomized controlled trials, because I think the approach and the accepted analytic methods are much better known. And there’s a lot more debate, and I guess uncertainty about what the best methods would be in real-world evidence because there’s so many variables. It creates a situation where it’s easy to criticize any analysis that’s done. (Interviewee 14, Canadian) Canadian RWE data infrastructure is currently inadequate for decision-making Participants saw challenges with data quality and access as the biggest barriers to using RWE at present. As such, participants were uncertain of how our current data infrastructure could be transformed so that it can be used to inform quality decisions. I also think that there’s still a scarcity of data, that we don’t have data for everything yet. We have a lot of data, but it seems to be unorganized and lack of consistency of how people are gathering data. So, until we really can get our data together, and that it’s shared, it’s consistent, it’s gathered in the same way, and it’s pool-able, until that is done I think it can be challenging to really use the data. (Interviewee 10, Canadian) Linking the different data sets and different electronical health records together is still a huge challenge especially here in the US where you have so many different payers, so many different systems. (Interviewee 19, international) Committed investment in building capacity is required Stakeholders perceived the Canadian drug funding decision-making system as stretched beyond capacity in terms of finances, expertise and leadership and saw these factors as a barrier to the adoption of an RWE framework. So, it’s a kind of problematic issue right now to be pursuing real-world evidence-based agreements for too many products because they’re very complex and it takes a long time and it takes a lot of resources because capacity is very stretched. (Interviewee 7, Canadian) There is a need for increased collaboration among key stakeholders Participants noted that systems are currently operating in silos and emphasized the need to increase engagement among stakeholders. There was a diversity of opinion on whether and how to engage industry. If you’re going to do these studies, there has to be a change in the attitudes between the players. Like, the payers, government and cancer agencies, typically don’t have a really good relationship with industry … only if you have that kind of collaborative environment, would you actually be able to undertake some of these studies efficiently and effectively.” (Interviewee 2, Canadian) Note: RCT = randomized controlled trial, RWE = real-world evidence, US = United States.
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