Robert Rifkin, MD, FACP, oncologist and hematologist with Rocky Mountain Cancer Centers and medical director of Biosimilars for McKesson, discusses how his practice is working to correct biosimilar education gaps among physicians and the consequences if those gaps are not addressed.
The Center for Biosimilars® (CfB): Hello I'm Matthew Gavidia. Today on the MJH Life Sciences™ Medical World News, The Center for Biosimilars® is pleased to welcome Robert Rifkin, MD, FACP, oncologist and hematologist with Rocky Mountain Cancer Centers and medical director of Biosimilars for McKesson. Great to have you on. Robert, to start us off, why do providers think biosimilars are not equivalent to reference products? Haven't biosimilars been around long enough?
Rifkin: Well, thank you, Matt, and it's always a pleasure to work with The Center for Biosimilars®. Biosimilars have been around for quite a long time, as you're aware. All of this really started during when Obamacare legislation was passed, creating what's called the 351(k) pathway leading to the approval for biosimilars. In this pathway, all of the data is really much more heavily weighted towards the analytical side as opposed to clinical trials. And I think that's where some of the issues arose in that as we trained as physicians, when we develop new drugs, we were always trained that the majority really depended upon large phase 3 confirmatory clinical trials.
In the case of biosimilars, as your audience knows, analytics are the key. And I think this has been a little bit difficult for people to really understand, because they're really not generics, but they're highly similar because they're expressed in living cells. And while they've been around for a while, I think the big issue, Matt, is education. So, we've worked very hard to educate not only our physicians, but our advanced practice providers, pharmacists, front end people, and back end people so that it's a seamless exposure for the patients and there's confidence. Really, in short, a lot of it is just making up for an educational gap.
CfB: And addressing this educational gap you just referenced, is there a lack of objective information available on biosimilars?
Rifkin: There's probably not a huge lack, I think what you have to do is start looking. The FDA has an excellent website. And now, actually, some of the biosimilars manufacturers have very good information—patient-facing information and provider -facing information—and it's all pretty accessible now. That wasn't really the case a couple of years ago. So, if you go looking for it, you'll find it and probably if you receive a biosimilar wherever it's being administered, you'll be furnished educational material as well about what you're going to receive, and all the FAQs. So, I think we've come a relatively long way in that regard.
CfB: How much do physicians understand about the FDA review and approval process and what it signifies about biosimilars?
Rifkin: So, that's actually a very interesting question. As you and your readers will know, I've spoken on this for probably at least the past 5 years. And as soon as you start pointing out statutes and regulations to physicians, oftentimes they just unplug. But I think it's very important, whenever you do this, that you compare and contrast the 351(k) pathway for biosimilars with the 351(a) for originator molecules. When you do that, I think people finally get the message. Will they ever understand all the fine details of the pathways? No, but that's probably not really important. It's getting the overall concepts and we're getting better at that. The FDA, again, has very nice graphics that Steve Kozlowski and colleagues has developed.
CfB: We've heard that physicians often simply prefer to use brands, even if they know a lot about biosimilars. What's your opinion of this?
Rifkin: The physicians require more education. It's sort of like, if you remember in the old days, when erythropoietin [Epoetin alfa, Epogen] was developed, the only way we could stop physicians from ordering it inappropriately was to take the pen out of their hands.
In biosimilars, it's a little bit different, but what you really need to do is, when you put the brand up there versus the biosimilar, ask the physicians why they are preferring the brand over the biosimilars. Basically, the majority of physicians have no answer for the question. And so, it really does show a lack of education.
In addition, as we enter the Oncology Care Model and other areas for cost containment episodes of value-based care, the biosimilars are actually going to be the preferred product. And so, it's going to go a little bit different to what people are used to. But we're making it relatively transparent in a lot of our networks, where you're just going to see the biosimilar generic name with a four-letter suffix. I really want people to understand that they're highly similar and there's no difference in efficacy.
CfB: Is disinformation widespread and causing physicians to doubt biosimilars?
Rifkin: I would say it used to be. So, if you went a year or so ago, there was actually a counter detailing going on in nefarious rebates and other kinds of things. I think a lot of that has actually died away. And it's almost ground that people don't tread across anymore. But at one point, there was active anti-competitive practice and disinformation.
CfB: And, additionally, what are physician attitudes towards switching of biosimilars at the pharmacy counter?
Rifkin: So, that's a little bit of a complicated question. In our office, the biosimilars that we're using are therapeutic monoclonal [antibodies] and we're treating breast cancer, lymphoma, and a variety of other things.
At the pharmaceutical counter, it's largely the inflammatory space, where you deal with rheumatology and gastroenterology, and that's a little bit different. Switching has been a huge issue.
Hillel Cohn, myself, and other colleagues published an article about switching where we did a meta-analysis involving about 16,000 patients after we threw out bad trials and there were no safety signals with the switch. One famous study did have a "safety signal" but once they realized it was part of the natural history of the disease, that went away. So, we think switching is quite safe. I think rheumatologists and gastroenterologists are a little more reticent to switch than medical oncologists.
CfB: How do physicians feel about switching from originators to biosimilars for patients who have been using originators, and are these attitudes logical?
Rifkin: So, that's a complicated 2-part question. A lot of the switches, actually, are now being mandated by payers. And although physicians like to think they have control over everything, in the area of switching, oftentimes its payer mandated. I think we have to be careful when we switch amongst biosimilars. A conservative viewpoint would be that all new starts for any given disease should receive the biosimilar. But switching is becoming increasingly common. Overall, we haven't seen any safety signals or deleterious effects. And we haven't really seen the big concern emerge over immunogenicity.
CfB: Are hospitals and clinics doing enough to get their doctors to prescribe biosimilars?
Rifkin: In the clinic, there's a move towards a similar sort of approach. Although, it's a little bit different because all of the clinics operate differently, they're all governed differently, and the GPOs [group purchasing organizations] all function differently to a degree. But a lot of times, you'll find that your options are limited and that a switch is preferred over going back to the branded originator.
In the hospital, it's a much cleaner situation, because if you ask for originator filgrastim [Neupogen], per se, and the biosimilar filgrastim is on the formulary, you will get the biosimilar filgrastim. So, in actuality, the originator may not even appear on hospital order sets anymore.
CfB: What has been done at your institution to get physicians to use biosimilars? And how successful have you been?
Rifkin: So, I guess I'll break the comment up a little bit. Within the various oncology networks governed by McKesson or who we have an active participation role in, we've been very good at switching. We actually are hoping that we'll be known as a biosimilars leader across all of our business units. And I think once you start to see the logistics and, importantly, increasing access and decreasing costs, the premise of adoption is much less painful than it was even 6 to 12 months ago. So, the answer is it's coming and there's a tremendous amount of switching to biosimilars going on.
CfB: And to build on that, have you had results on switching at your institution that you've been able to share with physicians and have those had any effect on prescribing?
Rifkin: We do have internal metrics that we follow that are outside the scope of this discussion. But I think when you provide direct feedback to the providers, not only in not seeing deleterious side effects, but also managing practice economics and containing health care in these difficult times, there are positive responses. So, in short, it's nothing like seeing your own data and seeing how much of an impact you can make for cost savings.
CfB: What has been your experience in getting physicians to switch and any lessons learned in that process?
Rifkin: I think, overall, we've been able to be relatively successful getting physicians to switch. Again, it boils down to education. And then, importantly, I think within each clinic and within each office, there usually emerges a biosimilars champion. And there's nothing like good old-fashioned peer pressure. And so, we've done very well, I think.
CfB: What else needs to be done to improve physician perceptions of biosimilars and usage patterns?
Rifkin: I think, again, perception still goes back to education and really making people understand that these are not just "generic" drugs, but that there's a different set of parameters that are going on, and that no 2 batches are precisely identical, but they're highly similar and follow the goalposts established by the regulatory agencies. So, there's nothing like good hard data to convince people of things. And there's a lot of really good emerging publications demonstrating safety, efficacy, and cost savings.
CfB: What do you perceive as the greater barrier to access? Would it be lack of knowledge of biosimilars or factors such as payer formulary or manufacturer incentive policies?
Rifkin: I think, at the end of the day, education will start to be leveled off. People will really get it. We've, you know, created a saturation bombing campaign for education. I think it gets a bit more complicated when you have payer mandates. If you have 6 biosimilars trastuzumab, I really don't want to carry all 6 on my pharmacy shelf because there's a significant chance for missteps. And so, I think it's a combination of things, again, boiling down to education. When our teams go to the payers, I want them to be more educated about biosimilars than the payers themselves because we really want to put the word out there. I think, as you'll see in the current legislative environment, a lot of things that we had before, under the microscope, such as PBMs [pharmacy benefit managers], and I think you'll see the landscape change.
CfB: And lastly, if generics are so well accepted, why would biosimilars not be and how do we explain this difference?
Rifkin: So, the easy way is to, actually, put up a slide show showing the difference between generics and biosimilars. And, as you know, generics are simple small molecules where an exact copy is made. So, it's a chemical synthesis. And then, explaining to people in terms of biosimilars, that it's a living cell synthesis, if you will, and within that there's inherent variability, but that the goalposts are very tight for what gets out. I think when you do that approach, you build education and you build confidence. Because at the end, we tend to look at all of this from the patient viewpoint. So, I look at it is the patient's journey, and it starts all the way from beginning to end.
We know very well the opportunities for successes and failure. At the very end of the day, when the nurse hangs up the bag of the biosimilar infusion, I don't want that patient to see the nurse who has an interesting look on her face saying, "Wow, I've never given that before," because it's basically the same drug. So, it's a whole process and we tend to look at it from the patient journey from beginning to end.
CfB: To learn more, visit our website at centerforbiosimilars.com. I'm Matthew Gavidia. Thanks for joining us.