Use of Biosimilars in Inflammatory Diseases

Peter L. Salgo, MD: Let’s take a look now from the rheumatology perspective. How does the approval of biosimilars (in your world) affect the treatment paradigm for rheumatoid disease?

Vibeke Strand, MD: Well, I don’t think it really has. I think in the US it really won’t, because we’ve been fairly aggressive with early diagnosis, early treatment, and successful treatment. I think that we’ve seen, though, that in Eastern Europe and in other areas where biologic therapies have not had much access, it’s made a huge difference. Thus, now, patients are able to get access to these therapies, which are more effective than our synthetics, by and large.

Peter L. Salgo, MD: What I hear, though, is that (a) the biosimilars start off a little less expensive, but (b) the threat of the biosimilars is causing a drop across the market in the cost of these agents. In my own tutored way—not being a rheumatologist or a gastrointestinal (GI) specialist—it would seem to me that if there’s an expensive therapy that’s getting cheaper, it’s going to make it more likely that people are going to get on these drugs, no?

Allan Gibofsky, MD: Well, yes and no. I’m not expecting that the insurance plan that’s giving me a hard time now to put a patient on a bio-originator is going to welcome me with open arms because I want to put them on a biosimilar. I think that the same prior authorization requirements and the same hurdles, if you will, are going to be in place for these molecules as they were for the bio-originator. I think we are going to see insurance companies selecting favorite agents based on factors unrelated to their clinical applicability.

Vibeke Strand, MD: One of the big expenses, both in time and money, is all these prior authorizations that we have to fill out (in terms of rheumatology practice).

Peter L. Salgo, MD: Oh, there was a little edge to that.

Cole Wilson, PharmD: That’s right.

Peter L. Salgo, MD: I heard that.

Cole Wilson, PharmD: I think, always, we want to make sure that the patient is at the center of what we’re doing, and you can’t really forget the patient in this. Although with the brand biologics (many of them upwards of multiple thousands of dollars), even with the discounts that we’re seeing now, that cost is still going to translate over to the patient. And that financial toxicity that they have can be just as bad as any side effect that they’re seeing, as well.

Gary R. Lichtenstein, MD: If I were a federal government employee, I would think this may not be as good as it sounds. If we open access to more people, we pay more for the government to get more patients taken care of in a more costly way for the entire government. Although you get a cost savings, if you get increased access, that may be a bigger cost to the federal government. So, think of that.

Peter L. Salgo, MD: You’re saying that it’s cheaper per patient. But then more patients come in, and the total bill goes up.

Gary R. Lichtenstein, MD: Aggregate bill.

Peter L. Salgo, MD: But if more people are getting better, is that worth spending?

Gary R. Lichtenstein, MD: Yes, of course. That’s why we do what we do.

Vibeke Strand, MD: Yes.

Peter L. Salgo, MD: Is it? I didn’t get a hard “yes” over there. Is that fair?

Cole Wilson, PharmD: I mean, no. But what is fair?

Peter L. Salgo, MD: Fair is what people think is fair.

Gary R. Lichtenstein, MD: Patient outcome has to be our focus.

Peter L. Salgo, MD: I’ve done this before. Let’s put this on the table. I could give you a drug which costs 1 cent and does nothing. Nobody would want to prescribe that. I could give you a drug which is equal to the gross national product of the United States and is curative for a previously incurable disease. Nobody can prescribe that. So, there’s this gray scale, which is what you’re talking about. Where does fair come in?

Gary R. Lichtenstein, MD: When you do a Markov model, you look at someone and the quality-adjusted life years (QALY) number. It’s something such as, for example, 25,000, that might be a number. And those are the numbers that are bantered about based upon the actual Markov model design.

Vibeke Strand, MD: One hundred thousand.

Gary R. Lichtenstein, MD: Well, it varies with the individual end point that you’re looking at. If it’s death, it’s much more valuable. You’re saving someone from dying, as opposed to quality.

Allan Gibofsky, MD: But what we’re seeing in the European modeling is that they’re bringing their QALYs down in order to save money for the entire system, and it’s something that has to be done. But we’re leaving a dimension out, Peter, and that is, does the patient benefit? The cost of the therapy may be cheaper to the provider. It may be cheaper to the payer but not to the patient.

Peter L. Salgo, MD: What do you mean by that? If it’s cheaper to the system and the patient is getting a good drug, where is the patient losing? What are you implying?

Allan Gibofsky, MD: Well, if the patient has a $500 co-pay for the bio-originator, it’s not clear that their co-pay will change merely because there’s been a discount that’s been related to the managed care company.

Cole Wilson, PharmD: I think it’s also yet to be seen, too, as to what the manufacturer response will be to assist patients. Right now, many branded products of biologics have co-pay assistance and means through manufacturer assistance to help reduce this financial burden. But the same hasn’t been seen with biosimilars yet. And also, when you consider the generic (if that’s kind of what we’re comparing it to—the previous branded generic products), there isn’t a lot of assistance out there for generic-type products. Will that trend follow as we look into more biosimilars?

Peter L. Salgo, MD: Let’s take a look in the GI sphere, Gary. In the absence of what can be termed “head-to-head clinical data,” how do you use this extrapolated data in your area for the infliximab biosimilars, and how do you evaluate the risk and the benefit of these drugs?

Gary R. Lichtenstein, MD: I think, again, you have to look in several ways. Those that are on the originating product feel comfortable that this is the initial product. Those that have had a prior trial with an anti-TNF (anti-tumor necrosis factor) and are not currently on it feel comfortable, perhaps, trying (although we don’t have large, adequately powered studies to look at that). It’s the nonmedical switch and the multiple switches that are the big concerns for the patients and for the providers. So, I think we need better data, if you would, with adequately powered studies.

There was a recent study at the European meetings that looked at 680 patients with inflammatory bowel disease (IBD), particularly. They said that no further signal differences were seen at the end of the trial. So, this is a larger study, if you would, focusing just on IBD because many of the studies have been on other disease states, if you would.

Peter L. Salgo, MD: What I keep hearing—the drumbeat that I hear across this panel—is that biosimilars are, in fact, similar, right? And there’s no signal here. We’d like more data, but the data we have is really good.