Peter L. Salgo, MD: There may be an argument that you could make that dosing and storage conditions of biosimilars are a little bit different. They’re not quite the referenced biologic, and there’s a cost difference. Does that make any sense?
Allan Gibofsky, MD: You could make it, but it would be wrong.
Cole Wilson, PharmD: For the biosimilars and the biologic agents, there’s still the complexity in the structure. There’s complexity in the stability, but they’re very, very similar in that nature. So, the refrigeration products, how we deliver, and how we ship these medications—they’re going to be the same for the biologics as they are for the biosimilars.
Vibeke Strand, MD: They actually have to be.
Cole Wilson, PharmD: They have to be.
Gary R. Lichtenstein, MD: It’s a mandate.
Peter L. Salgo, MD: It’s a mandate. If I understood what everybody was telling me, this thing here—the dosing and storage and all of that—is off the table, because these are effectively similar drugs with similar properties.
Allan Gibofsky, MD: Right.
Peter L. Salgo, MD: So, we forget about that. What about talking to patients now? We’ve been dancing around this—switching drugs with those 4-letter suffixes. What are some of the challenges in talking to patients about biosimilars?
Allan Gibofsky, MD: Well, let’s start with the patient who is going to be put on a biologic for the first time. That becomes an easier discussion because it’s basically the same discussion that you would have about putting the patient on the reference biologic. And, though Vibeke has correctly told us before that biosimilars are not generic biologics, it helps the patient’s frame of reference to use the term “generic biologic,” even though they’re not the same. That’s one of the things that patients need to understand—that there are different forms of the molecule, and they’re getting this version, but all the same risks and benefits apply. For the new start, it is not a problem. For the patient who’s not doing well on what they’re currently on, it’s not a problem. You’re switching them to another agent, and it is the same educational process.
Really, where the rubber hits the road reverts back to the sleeping baby argument. And when you say to the patient, “You’re going to be switched from what you’re stable on to another agent that’s similar,” they go, “Why?” “Well, your insurance company says you can save money.” “I don’t want to save money. Why?” And that’s what patients ask me: “Why are you switching me?”
Cole Wilson, PharmD: And if you want to quantify that, really, if you look at, through our healthcare system, the data, only about 20% of patients are new starts each year. Eighty percent are those who are already established on therapy. So, it’s not like you’re talking about affecting a small group of individuals here. You’re really affecting the majority in those switches.
Peter L. Salgo, MD: It’s also an “us versus them” scenario, right? If—and I’ll use a number that I heard—you have a $500 co-pay, and you’ve maximized out that co-pay on drug A, and the insurance company says, “We’re going to switch because drug B is cheaper,” but it’s still going to cost you your $500 co-pay, to the patient, there’s no difference. So the patient says, “I’m just helping the insurance company. Why should I help you?”
Allan Gibofsky, MD: And that’s an argument that’s very hard to overcome.
Peter L. Salgo, MD: But it’s up to you to make it. How would you make the argument?
Cole Wilson, PharmD: Well, again, speaking from the healthcare system, I see both sides. I see the patients that we assist and have cared for every day that ask us those questions, and then, also, we’re self-insured. So we administer the plan as well. In that position, we try to shift as much savings to our patient as we possibly can. Typical PBMs (pharmacy benefit managers) and plan sponsors—I don’t know, but it’s certainly a fair question to ask.
Vibeke Strand, MD: Guessing the minds of the PBMs is beyond me.
Gary R. Lichtenstein, MD: We have the same scenario. We serve as our own specialty pharmacy in the health system, so it’s a cost savings to the health system. One would say that we potentially have a conflict of interest to some level, because the health system tries to save, and if we don’t have data to do certain things, should we be doing this?
Peter L. Salgo, MD: What you’re saying is that the patients see the benefit to the system but not to them directly?
Allan Gibofsky, MD: Agreed.
Vibeke Strand, MD: That’s true.
Peter L. Salgo, MD: That’s a problem of psychology. How do you assure patients, with that problem on the table, that these products really are the same? “They really have the same clinical effect. I pinky promise.”
Gary R. Lichtenstein, MD: You have to educate them as to what exactly a biosimilar is and go through, at least, an educational process. There are now programs being developed with the societies that will enable this. I think viewing something of that sort will help them understand. It’s a fingerprint that’s very similar, but it’s got a little difference in the whorls, if you would. But overall, in aggregate, it’s about the same.
Peter L. Salgo, MD: They would come back and say, “Look, small changes may be big changes to me.”
Gary R. Lichtenstein, MD: But they’ve been tested in aggregate and looked at in different disease states that we have good data for. And that will be forthcoming. I think that as we initially impose different things, people are going to be reluctant to change, because they worry that change is not necessarily good.
Peter L. Salgo, MD: But in this case, you’ve got data.
Vibeke Strand, MD: Yes. Not only data, but we know what changes would affect the performance of a product. And so, they’ve been characterized in far more detail than the reference products ever were, because the technology has evolved.
Allan Gibofsky, MD: Yes. In one instance where I had to deal with a patient switch, I basically said, “Look, here’s the package insert of what you’re getting now, and here’s the package insert of the biosimilar. Find me the differences, because there really aren’t any.”