Clinical Advances and Challenges With Biosimilars - Episode 10
Bruce A. Feinberg, DO: Marcus, you probably have had the only significant experience with a therapeutic, and that’s infliximab. Have you seen any patient pushback at all? And, again, how is it discussed to even get that pushback?
Marcus H. Snow, MD: At this point, our institution does not have the biosimilar for infliximab. But, at the same time, I’ve talked to other community physicians and, right now, as far as purchasing, I have not encountered anybody who has been giving that in their facility. However, I think that the discussion with patients will be the easiest when you start someone de novo, on a biosimilar. And to your point, my previous experience with the patients and concern about generics is now completely flipped 180 degrees. When I prescribe something, the first question out of their mouth is, “Is it available in a generic?” It’s totally flipped, 180 degrees, from what it used to be. I think that with time, explanation, and physician buy-in, it will be accepted very quickly.
Bruce A. Feinberg, DO: Brandon, in your role you do a lot of patient education. How much detail do you look into with perspective to the drug and its manufacturer? Is it enough to say, “This type of drug is called a taxane?” Do you have to get into the specific manufacturer and the name? What do patients really want to know? What do they need to know? Part of this would be that it only becomes an issue if we make it an issue. If we believe, as the clinicians and the providers of care, that the drug is the drug based on the mechanism of action that we’re intending to use, do we need to get into that next level? Do we need to create a controversy when maybe there shouldn’t be a controversy?
Brandon Shank, PharmD, MPH, BCOP: I think it goes back to the patient’s perception. Some patients don’t have a preference, and those may be the ones that are not as health literate. Those who have done a lot of research online may find they have specific questions with those. But, my experience with patients in having the substitution of the growth factors is that they have questions such as, “Does it work the same way as how it was approved?” And those are the patients that have a scientific background.
Bruce A. Feinberg, DO: Those are your engineers who come in with their spreadsheets.
Brandon Shank, PharmD, MPH, BCOP: Yes. So, from my end, I think if the healthcare—including physicians, most importantly—advocate that there’s not a significant difference, the patient trusts that. The physician wants the patient relationship with them, and I think there’s a trust there. If an insurance is dictating the switch, then I think the patient is a little bit more hesitant and may have a lot more questions for us when we’re doing patient education sessions.
Bruce A. Feinberg, DO: Marcus, what is that level of disclosure? What’s appropriate? What’s necessary? And what’s even good patient care?
Marcus H. Snow, MD: When I prescribe any medication to a patient, I try to spend extra time making sure that they have all their questions answered. I think that’s where it starts. And I think that this is going to be mandated by the formulary of their insurance company—their coverage. Most likely, all biosimilars will be mandated by their insurance coverage. However, if the physician walks in and says, “This is getting forced upon us,” I think the patient will be up in arms. But, if you explain to them, “Look, these medications have been proven to be similar in structure, similar in efficacy, similar in side effects, and similar in anybody, and we can manage and evaluate these things,” I think that patients will buy in very quickly.
The final piece is, I’ve had this discussion with insurance companies before. They’ll say, “Well, you can write the prescription, but we’re just not going to cover it.” And if they want to pay $35,000 a year to pay for their name brand medication, they can do that. Ultimately, the patient is kind of stuck. But, I think it goes back to the physician—the provider/patient relationship. And if that’s a solid one, and you spend time discussing things, I think this almost becomes a non-issue.
Brandon Shank, PharmD, MPH, BCOP: Route of administration also plays a role. For an oral agent or something that the patient is self-administering, they may have more ability to know what they’re getting. Whereas, if a drug is administered by a nurse, or at an infusion center, the patient may be blinded about the specifics of their drug distribution. But, in our education sessions, we provide a lot more detail when patients are self-administering the medication.
Hope S. Rugo, MD: I think that’s absolutely the case. It’s so funny that patients will say, “But my aromatase inhibitor was yellow this time and not white, and I have more joint pain. It must be due to whatever it is.” And, in truth, it may be that some people are a little bit more sensitive to specific carriers or formulations than others. We don’t know. Nobody has ever really studied the topic that well. Some of my patients will actually pay for the originator product even though it costs considerably more.
And some people just get irritated because it keeps changing. Sometimes it’s made in India, and sometimes it’s made in Canada. They feel unsettled by that change. For biosimilars, it’s going to be interesting. We already have some difficulty educating our colleagues about biosimilars, and it really does take quite a bit of education. I think it’s going to be way over the top in terms of education for patients. So, we’re going to have to say, “This is an accepted product and our regulatory agencies feel that it’s reasonable to give this product” and “We feel secure with it.” And then, I do think, as we just discussed, that patients will feel comfortable with that. Switching is a whole different idea.