Peter L. Salgo, MD: What I want to do is shift gears again because we’ve been talking around this issue a little bit. I want to talk about payers translating clinical trial results into understanding the appropriate patient type, which is just what you were talking about, for a given drug. Why don’t you continue on with that a little bit?

Ed Pezalla, MD, MPH: Well, clinical trials are set up to determine that the drug works in a particular situation. It’s not set up to find out what is that situation. And so, we have a bit of a disconnect. In other words, it works for the patients in whom the trial was done, but we don’t know if those were all the right patients. They didn’t test that.

Peter L. Salgo, MD: They were preselected for this trial. They weren’t all-comers.

Ed Pezalla, MD, MPH: They were selected for the trial because they clearly have the diagnosis. They have a certain level of severity which is measured by things that are harder to measure. But the clinicians in the trial are willing to do it. And also, usually, they have a lack of other problems. They’re not taking a lot of other drugs, and so you can tease out the effects of the particular drug, both good and bad. So, what happens is we start with, “Well, those are the folks that were in the trial, so we know it works for them.” That’s the base group of patients that we would allow to have the medication. That doesn’t mean that that’s all the patients who are going to respond, but now we have to get to, “Well, what are the other patients adjacent to that? How do we know? Is it okay?” It probably would work if they’re taking a different medication, as long as it doesn’t have some direct effect on bioavailability or something like that. But is it safe? That’s oftentimes the issue. You don’t always know the safety of drug interactions. The problem is trying to expand beyond the immediate trial population to a reasonable population around it, and that’s something that sometimes takes some time. Sometimes we have the data, we understand how the drug works, and we understand the drug interactions. Because of that, we may be able to get somewhere.

So, we look at the clinical trial and who was in it. We look at the efficacy in the trial, and we also really use a lot of the subgroup analysis that comes out of the trial. Who are the patients that really benefit the most? And it might be the patients who are the most severe. It might be the patients who are a particular age, and we’ll look at all of that. That will help us to try to make sure that those patients get the drug first.

Peter L. Salgo, MD: I don’t know how many times I’ve heard this: “I’d like to give it to Joe or Mary, but they weren’t in the study. They were excluded. They were excluded because they had comorbidity A or comorbidity B, so they don’t really fit the profile.” And if I give this guy or this woman this new medication, because it wasn’t typical of the patient that in the study, we may not get reimbursed. We may not within the guidelines set up by the insurance.

Jeffrey D. Dunn, PharmD, MBA: And an insurance company may be on the hook for that if they allow an expensive medication to be used in an inappropriate patient because of reinsurance.

Peter L. Salgo, MD: But how would you know the patient is inappropriate until you start using it a lot? See the chicken, see the egg.

Jeffrey D. Dunn, PharmD, MBA: But who’s responsible for that? Is it the insurer to play that role? I would argue it’s not.

Peter L. Salgo, MD: Let me be devil’s advocate again. Maybe the insurance companies have put themselves there because they’re making that decision. They don’t want to make it. As a physician sitting across from a patient with a terrible problem, most physicians will say, “I’m going to try anything. I’m going to give you what I need to give you. It’s expensive. We’re going to send the bill to him.”

Jeffrey D. Dunn, PharmD, MBA: There it is. Somebody else is paying for it.

Peter L. Salgo, MD: There you go. It’s somebody else’s money. But, to some degree, who else is going to do it?

Jeffrey D. Dunn, PharmD, MBA: The reality is we need to do a better job of getting all the stakeholders together at the same table and addressing the cost, the value, and risk. We don’t do that very well in this country. Right now, the insurer bears the risk, and that’s probably inappropriate. If a drug doesn’t work and the pharma company is not on the hook for that, the provider is not on the hook for it. I would argue the provider doesn’t necessarily need to be on the hook for that, but the insurer should not be the only one on the hook for that. So, we have to practice evidence-based medicine because we have a set amount of dollars.

Peter L. Salgo, MD: Fair enough. But where’s the evidence going to come from? In other words, when we’re working from here, which is a very narrow slice of patients who have been in the study and we’re working our way out, do all-comers in a larger pool benefit or not? Who’s paying for that? And how realistic is it to use these narrow studies to try to define who’s going to get at all-comers?

Cheryl Allen, BS Pharm, MBA: The cost and who bears the cost. The insurers are bearing the cost. But, increasingly, there’s a larger shift to the patients bearing the cost. With these specialty medications, patients are bearing more of that cost, and there are patients who just simply can’t afford it. So, affordability of these newer medications has to be addressed, as well.

Jonathan Silverberg, MD, PhD, MPH: Absolutely.

Jeffrey D. Dunn, PharmD, MBA: And that’s a bigger issue. That’s not necessarily just an insurance issue. It’s a bigger issue.

Peter L. Salgo, MD: Right. People who are rich can get better therapies than people who are poor. We don’t want to be there either.

Jeffrey D. Dunn, PharmD, MBA: That’s potentially the concern with something like this. If you look at multiple sclerosis, 90% of the cost to treat multiple sclerosis is drug-related. So, where’s the ROI (return on investment) on it? I’m not saying we shouldn’t treat MS—that makes no sense—but there has to be some. If we’re investing these types of dollars in the system, then there has to be a better discussion on who pays for that. My opinion is we all need to have a piece of it.

Peter L. Salgo, MD: And we all need to have a discussion as a nation about this, right?

Jeffrey D. Dunn, PharmD, MBA: Absolutely.

Peter L. Salgo, MD: Because you can’t be left on the hook for everything.

Jeffrey D. Dunn, PharmD, MBA: Like I said, if we’re doubling the cost on what we spend on drugs in 3 years and in 3 more years it doubles again, who’s paying for that? Who’s going to get stuck with that? It’s the patient, and that’s unfair.

Peter L. Salgo, MD: It is unfair. Unfortunately, that’s the way it is at this point, right?

Jeffrey D. Dunn, PharmD, MBA: Absolutely.

Cheryl Allen, BS Pharm, MBA: But we have wonderful technologies that are helping to cure patients and helping to take what was an acute disease and now it’s a chronic disease. Look at CML. That was a death sentence 10 years ago, and now people are living, people are functioning parts of society, functioning parts of the workforce. Take MS. We have wonderful therapies now and will we even be having the same discussion about the moderate to severe atopic dermatitis patient population that was not showing up at work?

Jeffrey D. Dunn, PharmD, MBA: We’re keeping them alive longer.

Peter L. Salgo, MD: Look, I want to move on, but it is fair to say that the insurance companies bore a lot of the early on expenses for all of these things until they entered mainstream. And when more people got them, we worked out ways to do it. One would assume we would do this, too. He’s made me feel bad for insurance companies.

Jeffrey D. Dunn, PharmD, MBA: Well, there’s a misperception. I’m here representing payers, and, honestly, we are doing the best we can. We do not want to say no to people. It’s our job because we’re on the hook for our customers to spend their dollars wisely, and it’s a population tool. So, we have to do the best we can. It’s managing around evidence and value, and right now, we’re unfortunately bearing the brunt of this.