Earlier last week, three of our researchers on our life sciences team, Fanta Cherif, Pamela Divack, and Solomon Banjo sat down to discuss how they think about disruptive therapeutics
Q: What are disruptive therapeutics?
Fanta: What even are disruptive therapeutics? This phrase gets thrown around a lot and often as a synonym for innovation. Personally, I think of disruptive therapeutics as products whose adoption holds the potential to force a meaningful reaction from multiple ecosystem stakeholders.
There are four ways in which these therapies can be disruptive to the ecosystem.
- Clinical evidence, where we may lack longitudinal data or effective endpoints and will need to rely on less-traditional clinical evidence from trials and use RWE instead.
- Care delivery, where care deviates from the status quo and is offered through new routes of administration which typically requires different in-kind coordination and collaboration.
- Cost/payment models, because most of these are high cost and may need outcomes-based contracting or are so novel that it's unclear who should be paying for them.
- Regulation because, for something as complex as psychedelic assisted therapy, regulation is a key factor in adoption and implementation.
Q: What do you see as the benefits of defining what disruption means in this way?
Fanta: Reaction is an implication of disruption that's not always talked about. These are all areas where various stakeholders might have to react in response to one of the therapies that our teams would define as disruptive.
If a therapy is disrupting more than one bucket then I believe that it's going to create enough of a reaction to be meaningfully disruptive and therefore worth health systems, health plans, and other stakeholders accounting for them proactively rather than reactively.
Pam: Agreed. Defining "disruptiveness" along these lines lets us better evaluate the novel opportunities and challenges that these therapies create for the ecosystem. But a key distinction I want to call out -- something can be disruptive, even if it's not revolutionary from a scientific or technological perspective.
Q: How do you think about the magnitude of disruption of these therapeutics?
Solomon: There are a few ways to look at it, with the market penetration being an obvious one. But we actually scoped that out because something might be so disruptive that it's never going to gain acceptance without the right plan and partnerships on the part of its creator. In that case, the lack of penetration is actually a consequence of its disruptive potential.
So, I really think it's important to focus on how many of the elements above it disrupts. The more areas, the more disruptive, and the more necessary it is for us to prepare as an industry. And there are also levels to how disruptive something can be even in a specific area.
Pam: I agree with Solomon, but I also think cost is an important factor that often has a ripple effect on the others. The magnitude of a therapy's cost—and how that changes from the cost of previous treatment options, if any—will likely force a reaction and create new opportunities and challenges for evidence generation and regulation.
For example, we're already seeing payers, providers, HTAs, and other groups that evaluate the "value" of therapeutics raise the bar for the evidence needed to cover emerging high-cost drugs and look to a broader range of endpoints and outcomes to justify that cost. This is where regulators are getting involved, too.
Fanta: One thing that came to mind as a potential critique is that we're talking about things that have the potential to be disruptive. In these buckets, we don't yet know for a fact what its uptake or market saturation will be. That is what takes something from disruptive potential to being an absolute game changer.
And in some ways, it is about the ecosystem's ability to solve for some of these things early on and grapple with them. Like if we can say, here's what the care delivery model will look like, here's how it fits into this, then I'm more likely to subscribe to its utility, and if it has good evidence that I can believe in.
Q: What do you think will change with how we define disruptive over time?
Pam: None of these disruptive therapeutics will actually be disruptive unless different parts of the health care industry collaborate to answer a few key questions. What does it actually mean to go from being potentially disruptive to being "game-changers"? What will be our bar for evidence in each of these categories? What endpoints matter, and how long do we need to assess "value" for? Who else needs to be part of this conversation?
I also think that our understanding of disruptive will probably keep changing over time, and that's not a bad thing. The way we define characteristics of disruptive today could absolutely change in two months, and we need to be okay with that and not view that as a failure but view that as a success, similarly to how we did with Covid-19.
Solomon: Over time, we move the bar because science will continue to progress. Because eventually these treatments should become routine elements of care for eligible patients. An open question is whether we will revisit their value over time if/when better products come on the market. That's not something we have traditionally done.
Q: Why do you think it's so important to be discussing this topic right now?
Fanta: I think it's important to stay ahead of the curve when discussing these innovative therapeutics, because they are in the pipeline and will affect your market and patients at some point in the near future. We hope that the ecosystem can be proactive and not just wait for the inevitable reaction that will accompany the market entrance of these products.
If the health care ecosystem doesn't prepare adequately, in terms of patient and provider education, staff training, working collaboratively with external and internal stakeholders, etc. then these innovations will absolutely be disruptive and the benefit to patients may be curtailed.