InnomarLive 2023: Part Two

Facilitator:
Grant Perry, Senior Director, InnomarConsulting

How can HTA systems (payers, evaluators and industry) evolve together so that Canadian patients may benefit from scientific breakthroughs?

Carlene Todd: We need to involve the voices of patients as well as the voices of all stakeholders. Look at the entire continuum, not just one point in time. Think about evidence more broadly, from all over the world. Innovative licensing pathways and HTA collaborations across countries are necessary.

With the HTA challenges of assessing long-term impact, what is the mandate and how are you managing that?

Brent Fraser: There are tools available that manufacturers do not take advantage of (e.g. scientific advice). We have no concerns about receiving data beyond Canada, but it should still be relevant to the Canadian population. Data should be robust and answer the clear question, which may not always be straightforward, but there are opportunities to assess how we evaluate new treatments moving forward. Also, recognize it is difficult
for us to commit to a certain path if we do not have the support from the jurisdictions.

Dr. Batist, beyond the clinic, you engage in a lot of the ancillary pieces discussed today. You are in a unique position to have a voice in this.

Gerald Batist: Yes, and it helps me appreciate all the constraints everyone has. We are working in a system that is not easily modified. On the other hand, approval and access to drugs must start moving faster for cancer patients. It really has to move at the speed of cancer, not at the speed of regulatory bodies. We used to take inspiration that this was possible, in terms of listening to the patient’s voice earlier on, from the start-up activists in the AIDS community in the 80’s and they were able to push FDA regulations in challenging and creative ways.

We only have to look back at the past years, another disruptor that showed that regulations can be modified so that drugs can be studied, approved, and accessed very rapidly. My focus is on innovation and urgency. There are many more people going to die of cancer than those who died of COVID in the past 3 years. All the elements are there, but we need major restructuring, which everyone understands - we just need to figure out how to proceed.

Daria, your customers play a different, yet integral role. Any thoughts from your perspective?

Daria O’Reilly: There was a question about using CADTH (public payer HTA) material. I would hope that our clients will start to get skills in being able to interpret HTAs that they receive. I hope that HTAs would consider private payers’ perspective as well.

Audience Question: We have the necessary processes now to offer innovative treatments to patients (although it needs improvements) but when it comes to diagnostics, we do not have the same rigor and each province tends to take it on their own, because of that, the inequity in access is quite diverse. Will there be more of a framework for this?

Brent Fraser: We had a round table around genetic testing and companion diagnostics (in December) to get a sense of what is required to move a recommendation for funding. The devices team within CADTH is looking at that more closely. We want to put a process in place such that when a technology comes forward that requires some sort of testing, we can try to merge the two. INESSS does this much better than we do. It does come up in our cancer reviews, but often the provincial bodies say it is great we have this technology, but we don’t have the funding for the diagnostics. Considering that our primary customers are drug plans, it is an issue for us. We don’t know often where to set recommendations to make people aware that there may be a gap within their industries. In addition, they do not have the connections due to the decentralization of some of the services.

Gerald Batist: When companion diagnostics make their way into the clinics, they struggle. Meanwhile, clinicians and scientists have produced better diagnostics called laboratory derived diagnostics, but they haven’t been fully adjudicated where they fit in. Another way of doing it is doing a fulsome molecular diagnostic on every patient. This would be a simple bioinformatics exercise to look for a specific variant, amplification, etc., but this is only going to get more complicated. We need a comprehensive plan and should be done proactively. This should be a major push for all of us together.

Daria, with the number of private plans in the thousands, how does the companion diagnostic piece fit into your world?

Daria O’Reilly: Private payers do not pay for diagnostic tests. It’s part of the public space, so it delays things further. It gets more complicated with sharing information and confidentiality. Unfortunately, there’s several reasons why access gets delayed.

Gerald Batist: This is an opportunity to redefine cancer as a collection of uncommon and rare sub-groups looking at specific molecular profiles. We need to start thinking in those terms.

Carlene Todd: I wonder if there are learnings from the CAR-T space that we can apply to precision oncology?

Companion Diagnostics – no one owns it – has this been discussed during your round table discussions?

Brent Fraser: It does come up in the discussion, but it usually happens too late in the process. It would be helpful to have it upfront as we go through the reviews. A lot of the issues that come up, like interprovincial billing, we cannot do anything to resolve those issues. It is a government issue that needs to be taken back and dealt with under their processes. But we can bring more people to the table and engage our clinical experts. We do an ethics review (not all) but for these more complicated ones where things like access, remote versus urban, centers of excellence, genetic testing all get raised and taken to a separate table and then have a discussion with the drug plans to understand what the
implications may be related to funding. None of us want to go through this process, issue a recommendation and have it fall flat because of issues around implementation. Our committee struggles with a lot of those issues, so we are trying to figure out ways to have those conversations upfront. And it’s not because people aren’t there to talk about the issue, but whether it is within their mandate to start looking at how to access a specific
type of genetic test, interprovincial billing, as patients need to go to other centers to get access to therapy. Discussions just get harder and harder.

Dr. Batist: Another element that needs more discussion is the concept of value-based care. We get caught up in the cost of the drug rather than the cost of the treatment and all its elements. We need to take this approach to the ground. E.g., An example would be a mechanism whereby a clinician can submit their case for access (medicaments d’exception). We are just analyzing the data that comes from that and it is quite striking
that we can predict and show patient benefit. We can also predict whether INESSS will approve that drug within 6 months based on the data available to us at that time.

OBAs and their challenges within the provinces, the jurisdictions, generating data, who owns it, etc., it’s a BIG question.

Daria O’Reilly: RWE is not new. We have been talking about it for at least 20 years and there are a lot of challenges, but I think it’s time we started somewhere. I know CADTH’s initiative is to start looking at RWE. We need to find out where the data is, partner with academics on sound methodologies to generate evidence. I’m motivated by the fact that we are talking about opportunities and a plan moving forward as opposed to just talking about the challenges all the time.

Brent Fraser: One of the key things is we have to understand what the right outcome is and that is where we all get hung up as there are different perspectives on what the outcome should be within an agreement. Some of the experiences talking with NICE and their Cancer Fund and the Innovative Life Sciences review – it feels like (based on anecdotal information) they are not getting as much success as they are hoping to achieve with these agreements mainly because the data coming doesn’t support the outcome that is intended to be measured. There is a lot to learn. We do not advocate one way or the other. That’s really within the provincial jurisdiction to determine if that is something they can move forward with. CADTH is certainly there to help. If they need guidance around RWE, available data sources, we have our own perspective on which outcomes are important. However, patients are going to have a different perspective and we see that in the patient submission when we have our reviews, there can sometimes be a disconnect. We can work to see where the data sources are. There is a wealth of information out there and it’s about making the right connections.

Gerald Batist: I think it does come down to data and finding a solution to standardize operations. It should be a big push across the country, whether pan-Canadian or provincial. There are multiple databases that are not connected and should be. We need a data infrastructure that is strong enough to support this before we can even ask the regulators to follow down this path.

Carlene Todd: I agree with everything that was said. But the point here is starting early, and we need to bring the right people together at the right time. It would be helpful to bring together CADTH, pCPA, and provinces to identify the right outcomes and data sources.

End of panel discussion