Cheryl Allen, BS Pharm, MBA: Well, we were chatting earlier about the need for patient registry, patient-reported outcomes, and the need to monitor the natural history of this disease over time. As Dr. Silverberg is talking about, we are treating the symptoms today, but we’re going to come to drugs where we’re actually treating the disease. We’re actually working within the immune system, so understanding over time what that’s doing for the disease and for the patient.

Peter Salgo, MD: That’s where I was going with this. It’s one thing to say we’re going to treat all the symptoms, we’re going to get rid of the itch. When it flares, we’re going to do something else, which is symptomatically effective. But these new drugs are getting at the core issue.

Jonathan Silverberg, MD, PhD, MPH: Absolutely.

Peter L. Salgo, MD: Right. They’re getting at the cause of the disease, and if we can fix that, why not just use them long term and forget about flares? So, just give me a drug that fixes the disease.

Ed Pezalla, MD, MPH: I think we’re going to need to understand the safety of the long term, of course, and that’s the issue. We will have patient safety data for a number of patients over a couple of years. But we’re talking about many, many years of treatment, and this is always an issue when a new drug, especially a new class of drugs or a new drug in a particular therapeutic area, is introduced. We’re looking at the potential of using the drug a lot longer and for more people in some way than have been studied already. And so, there’s this big unknown, and that’s where black boxes appear later sometimes and sometimes not.

We may find out, for example, that it’s a great deal safer to use the new drugs than it is to do some of the off-label things that are already happening because those are scary drugs in many ways, and they’re not studied for long-term use in this kind of a disorder. We’re going to need to see that data. That’s why registries are important or other means of following up, even just a long-term study where the patients were in phase II or early phase III and just keep on going. Try to keep track of those patients so that we can get a better handle on the safety issues around the drug. Because when we modify the immune system, there are probably other things or maybe other consequences. And we have found that some of the biologics that we use now are much safer than we had thought when they originally came out. The psoriasis drugs come to mind, but there are still patients who have had difficulty with it. So, this is one where the evidence has to be developed. We’re going to have to start without it, be cautious and keep our eyes open, and develop that evidence over time.

Peter L. Salgo, MD: All I can tell you is that I now have been in medicine a long time, and what has been striking to me—and this is another example of getting to the core of a disease—is we started out by treating a lot of diseases by symptoms. We would say, “Well, if you can’t sleep and you itch, we’ll give you a sleeping pill because we had nothing better.” But, now we’re getting to etiology. This is really exciting stuff. And wouldn’t it be great if we could put somebody on one of these drugs, or something like them, and say, “You’re done”? Wouldn’t that be terrific?

Jonathan Silverberg, MD, PhD, MPH: It absolutely would. And that’s what we’re seeing now, just as an example, with many psoriasis patients, where we can say, “Look, for the first time ever, you’re clear. I don’t have to see you 12 times a year. I don’t have to see you deal with the complications and the infections anymore. Here’s a prescription. You can have your life back, and I’ll see you back 6 months now or a year from now.” We would love it as opposed to the every-3-week follow-up or every-2-month follow-up that we have right now with the monitoring of labs, blood work, and everything else. So, yes, that’s exactly what we would love in the field.

Peter L. Salgo, MD: Do we have the prospect here? Is that what we’re looking at?

Cheryl Allen, BS Pharm, MBA: That speaks to the return on investment that Jeff is talking about. It’s almost like the calculator of what we need. It’s not only pharmacy claims history, it’s the medical claims history to really look at the full cost of this patient.

Peter L. Salgo, MD: I don’t envy underwriters, and I don’t envy insurance companies, looking at these drugs, which have global effects. How do you parse it out, and how do you make that jibe with what we used to pay for? This is a real challenge for you guys, isn’t it?

Jeffrey D. Dunn, PharmD, MBA: Absolutely. If you look at the specialty trends, it’s estimated in the next 3 years that what we’ve paid for drugs is going to double. So, ultimately, it’s the employer or the patients who have to pay for that, and that’s not a sustainable curve.

Peter L. Salgo, MD: I thought I heard you say double. I know it was my ears. I couldn’t possibly have heard that, double.

Jeffrey D. Dunn, PharmD, MBA: Yes. If you look at any of the databases between 2012 and 2018, there is a doubling in per member per year spent on drugs, and it’s driven by these drugs. So, 3% to 4% of the population is driving half our budget.

Cheryl Allen, BS Pharm, MBA: And specialty arena.

Jeffrey D. Dunn, PharmD, MBA: That’s reflected in premiums and everything else. It affects everybody.

Peter L. Salgo, MD: Double.

Ed Pezalla, MD, MPH: Double.

Peter L. Salgo, MD: How do you justify it? I don’t mean how do you justify the price. How do you justify paying that kind of money?

Ed Pezalla, MD, MPH: Right. This becomes difficult because we try not to look at this as a competition between this and a drug that’s going to stop a heart attack, or cure or stop multiple sclerosis, or limit its advance, or many other things. And so, we attempt not to make those sorts of comparisons between people and instead say that we’re trying to help everybody. We have a lot of people who are members. They have a number of different disorders, including people who have nothing particularly wrong with them, and they have health insurance in order to try to prevent financial calamity if something should happen. They’re paying a premium and not getting a whole lot back. And so, we have to be cautious about how we spend money, but on the other hand, you don’t really want to get in the business of making value decisions between one kind of patient and another. We just don’t do that here in America. So, right now, what we try to do is to make sure that if there’s a drug that’s effective for a particular disorder, it goes to the right patients, the ones who really need it. And that’s a partnership with the physicians, and the patients to find out who are those patients and how can we help them. But, at the same time, we have to make sure we’re not overspending. Part of that is to get the right patient started, and if they’re not responding, get them off so you can use that funding for something else.

Peter L. Salgo, MD: Sitting across from a patient and you say to this patient, “What’s bothering you?”, the patient may say, “Well, I’m having angina.” Well, that’s bad. But I have another patient that may say, “I have all this itching, I can’t sleep, my life is a mess.” That’s bad.

Ed Pezalla, MD, MPH: That’s bad, too.

Peter L. Salgo, MD: And it’s difficult to establish a hierarchy. I don’t think we go ahead and say, “Well, preventing heart attacks is life-and-death, but this isn’t.”

Ed Pezalla, MD, MPH: No, we don’t establish that hierarchy, and what we’re trying to do is to make sure that everybody is treated fairly. But that becomes difficult because we’ve got these expensive medicines, and other things in healthcare are expensive, too.