The panel discusses patient awareness of biosimilar products and whether they provide supplemental patient education through patient information sheets.
Anthony Mato, MD, MSCE: We should talk about patients, because as clinical pharmacists, I suspect there’s a lot of pharmacist-to-patient contact in the clinic. The physician may glance over the details and then say, “I’m going to have the pharmacist come in to do the education.” This happens a lot, and I acknowledge that. What are the challenges for describing a biosimilar to a patient? How do you provide assurance? What are the key points that you review with them when you’re discussing the biosimilar? I’m sure you don’t want the whole conversation to be around what biosimilarity is. Obviously, the big picture is that we’re treating a disease and trying to potentially save a life. How do you mix that into the conversation?
Tim Peterson, PharmD, BCOP: Right. It’s definitely going to be an uphill battle initially. This is because there are still a fair number of patients that are averse to generic versus brand small-molecule drugs.
Anthony Mato, MD, MSCE: I guess the first question is, do you feel like you even have to have that conversation?
Tim Peterson, PharmD, BCOP: The biosimilar conversation?
Anthony Mato, MD, MSCE: Yes.
Tim Peterson, PharmD, BCOP: As of right now I haven’t had to have that conversation much because at Memorial Sloan Kettering Cancer Center, we just started to unroll our biosimilar pathway in the past few months. So it’s not something that’s come up very often. I work in multiple myeloma, and we don’t have a biosimilar to daratumumab yet, so I haven’t had to cross that personally. But I would say in educating patients and comforting them to know that we are comfortable clinically with these biosimilars, you do need to explain a little about the development pathway.
If they just consult Google, and they see what the pathway is called, they see it’s an abbreviated licensure pathway, that even, just that word, abbreviated, can scare people and make them think it’s a lesser approval process. It definitely isn’t, because it takes into account the clinical data that went into the originator product. We have significant analytical data that Bhavesh has touched on.
I think you do need to talk a little about that pathway-profit process, but then I think more importantly it’s going to come down to the guidelines that we have, right? We have our guidelines again that Bhavesh has touched on, the National Comprehensive Cancer Network Guidelines. That’s what we’re using to guide most of our therapies anyway. That’s what’s guiding payers, our frontline therapy for numerous disease states, our relapsed/refractory regimens that we have and the appropriateness of those. We’re going to be able to cite that, and that’s going to be something important that’s very telling. That’s something that I bring up to patients at baseline when I’m discussing different daratumumab-based regimens. I bring up the studies that were done and the fact that we have the support of this expert consensus. I think that’s going to be important for adoption.
Anthony Mato, MD, MSCE: What about the bigger picture? If I have a patient who’s on a brand name of a beta-blocker, I admit them to the hospital, and I put them on metoprolol—which is the exact same drug minus the brand name—we don’t ever have the pharmacist sit down and have a conversation with them for why we switched them to generic acetaminophen or generic metoprolol. My question is, do you feel like that conversation does need to happen, particularly with a new start? Do we need to have a pharmacist sit down and say, “We’re using a biosimilar on you rather than the referenced product”?
Bhavesh Shah, RPh, BCOP: I think so because first of all, you’re changing the patient’s drug.
Anthony Mato, MD, MSCE: Well, what if you’re not changing it? What if you’re just starting them out, “I’m starting R-CHOP [rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone] on you tomorrow for the first time. This will be cycle 1, day 1.” Is that a conversation that has to happen?
Bhavesh Shah, RPh, BCOP: I think you make a good point. If they’re actually just starting the biosimilar, then basically you’re explaining to them, “This is what you’re getting.” But if you’re switching, you need to have that conversation of what you’re switching to and why you’re switching to that. The most complicated aspect is telling a patient, “This is a highly similar product to a reference product. There are no clinically meaningful differences.” They just get lost. You need to create an educational format that is at the level of the patient. The FDA has actually put out some great material. What I can also recommend is a lot of the patient advocacy foundations also have a lot of great material on their website where patients talk about it, and providers talk about biosimilars and what that means. So I think having those multiple venues that they can actually access for education is important.
Marc Earl, PharmD, BCOP: The dialogue that I’ve heard work well is, “The FDA has approved many types of trastuzumab, and this is the type of trastuzumab that our hospital has decided to use.” To Bhavesh’s point, I do think the biosimilar pathway can get confusing.
The other piece I’ll add is to think about any other touch points the patient could come in contact with the provider. This could be a nurse or an advanced practice provider. It could be anybody who could try to explain this process, and it’s important to make sure everybody is on the same page with what our explanation is. We need to put some time and effort into what that message is, so that the patient is hearing the same thing no matter what type of provider or caregiver it is.
Anthony Mato, MD, MSCE: I have a question. Oftentimes when we prescribe a drug to a patient, we use a resource like Lexicomp to provide them a patient information sheet. Are there patient information sheets that are developed specifically for the biosimilars? The amount of data supporting that particular product is a lot less than the originator product. Do you think those have to exist? Do they exist? Do you give those to patients when you’re educating them specific to that agent?
Tim Peterson, PharmD, BCOP: They definitely do need to exist. One thing when we rolled out our biosimilar pathways is we have those very resources. Similar to your Lexicomp resource and Micromedex for medications, we have 1 that describes, in patient terms, what the biosimilar process is. Just as Marc was discussing, “This is the type of trastuzumab that we’re going to give you. This is the type that we have. Your insurance favors it.” It goes through that process, and I think an educational fact sheet for patients should be mandatory at any institution now that it’s starting to become more and more common.
Marc Earl, PharmD, BCOP: Yeah, we typically don’t develop separate education sheets for each biosimilar. We have the trastuzumab education sheet, and we list the different types of products that are available.
Bhavesh Shah, RPh, BCOP: Same. We actually have developed educational material around biosimilars, specifically patient-geared ones. This is because if you look at a lot of the Lexicomp and other material that’s standard, it’s the same as the reference products, so they have no visibility of exactly what the difference is. We try to actually do a little more.
Anthony Mato, MD, MSCE: Essentially, it’s supplemental educational material.