The Changing Treatment Landscape of B Cell Malignancies - Episode 7
Specific considerations for the future roles of payers and care providers as the B-cell malignancy treatment landscape evolves.
Michael A. Kolodziej, MD: The payers initially will manage these like they manage all other drugs, which is that they’ll pay for them grudgingly. They’ll manage them in any way that they have at their access. It’s funny, I just recently completed a project where I spoke to a number of payers about step therapy in Medicare Advantage plans. As you know, Medicare Advantage plans were empowered to exercise step therapy even across benefits and they included medical injectables. They’re hesitant to do that, they are. People laugh at me when I say this, but it’s true. Payers hate disruption. They don’t want to make their beneficiaries angry, they don’t want to make doctors angry. That makes more work for them. And they don’t want to get it wrong. They don’t want to hurt people and that’s good. So we haven’t seen much of that, but the more drugs you have in a class, the more the drugs look the same, the more tempting it is to go after that.
We’re seeing that now, of course, in biosimilars. In biosimilars, I think payers have largely come to the conclusion that the regulatory universe, the regulatory pathways for biosimilar approvals are good, and they can trust the Food and Drug Administration [FDA] in this. They also have the advantage that this has been going on in Europe for a decade and there have been no ill effects, so they’ve got a little bit of a track record to go on. But they haven’t done it in other either supportive or more importantly, therapeutic, classes.
So we’ll see how that plays out. I expect that to happen. I can’t imagine, and I know it drives some people crazy when I say this, that they won’t do that, for example, in the PD-L1 space, PD-1 space. In the PD-1 space there are a lot of drugs. The FDA labeled indications overlap a great deal, not uniformly. And so it’s tempting to think about how payers might manage I/O [immune-oncology] therapy, which is quite expensive, very effective but quite expensive. So we’ll see what happens. I don’t think we’re going to have to wait very long. I think we’re going to see things in the next year or two.
There have been a number of articles written about how challenging it is for physicians to manage the rapid developments in this space. One approach has been for the specialization of oncologists, even the community setting; much already occurs in the academic setting. Pathways actually help a lot because they operationalize, for example, guidelines. But I don’t know that I have a great answer for this question. I think that this is going to continue to be a challenge. I think as we, for example, get more and more molecular testing and therapy guided by somatic mutation analysis, it gets even harder. We’re in the infancy of that. We’re using monotherapy—1 drug, 1 mutation—but that can’t be how this goes. This is going to wind up being combinations inhibiting multiple pathways. So we will continue to be challenged by this. I think actually technology may be the key to solving this.
As you may know, I worked at Flatiron Health for a while and we had these sessions where we just ideate. And I told one of my friends there that my vision of how an oncologist is going to manage their patient is not exactly like Watson on Jeopardy, but it’s not terribly different. So what we’d like to do is provide the physician at point of care with the “appropriate treatment options” in a probabilistic format because that’s how people make decisions, right? It’s very rarely binary, black and white, this is going to work, not going to work. More likely it is, well, we think there’s about a 35% chance this is going to work.
And we want to somehow pull in what my friend, Amy Abernethy, MD, PhD, was always interested in, which is a rapid learning system. Every patient that we treat, we learn from. It feeds back into the system and that real-world evidence continues. So, when you’re seeing that patient and you have that critical clinical information, critical genotypic information, it all goes in the machine and it spits out information for you. And your job as a physician is to interpret that in the context of the patient’s needs and desires because the machine can never capture that, but true shared decision making will. Now, that’s not going to happen any time soon, but ideally that will ultimately be what happens.
And then the question about whether or not you can keep up with all the publications—which I think most people cannot right now, and it’s not going to get any easier—becomes a little bit less important because there will be a repository of knowledge that can present at a point of care that will help you take care of patients.