Clinical Advances and Challenges With Biosimilars - Episode 4
Bruce A. Feinberg, DO: Marcus, do you see that as well? And, probably, rheumatology has been much more affected.
Marcus H. Snow, MD: Absolutely.
Bruce A. Feinberg, DO: In regard to oncology, there is political correctness of putting in step edits and formulary management, maybe, for growth factors, but not typically for therapeutics. But, in rheumatology, this has been the way for a decade.
Marcus H. Snow, MD: Yes. For example, if I’m starting a patient on a tumor necrosis factor inhibitor, I will write for etanercept or adalimumab. That medication will be altered by the formulary of the insurance company of this patient, and usually it will be altered with a preferred product. There are 5 tumor necrosis factor inhibitors on the market. Usually, they prefer 2 or 3, or they’ll shunt me one way or the other. In general, we have no head-to-head studies of these medications. But, we generally think of them as equivalent. That’s the reality.
Bruce A. Feinberg, DO: But, there are scenarios where—maybe in early, rapidly progressive rheumatoid arthritis—it may be that these agents don’t work as well, and you want to use a different mechanism of action drug to begin with, or you may want to be able to challenge that. Can you successfully challenge those decisions?
Marcus H. Snow, MD: You can try. Generally, the lack of head-to-head data has, in essence, kept some of these discussions from happening. I do think that, in rheumatology, we tend to think of aggressive control. It doesn’t really matter, necessarily, which agent you use, but we need to get control quickly. And whether that involves simply methotrexate or whether it involves a biologic medication, we have tons of options, thankfully, right now. You can push along. The biggest determining factor for me, when I’m prescribing medications, is my patient side effect profile. If they have a history of cancer, I may shy away from one medication or another. If they have a history of multiple sclerosis, I’m going to head away from the tumor necrosis factor family. Obviously, you have to choose based on your patient profile, so that’s where my objection to a step edit that exists will end up in a peer-to-peer review. Depending on the situation, that has been successful at times. But, it takes time, and it takes effort. It takes me taking time out of clinic. It takes a delay from my patient. We know that rheumatoid arthritis is a progressive disease, and the longer you wait to get control of their disease, the more damage you can have.
Hope S. Rugo, MD: Can I just be clear? If you’re talking about a step edit, it’s like using the same drug but a different brand?
Marcus H. Snow, MD: No.
Hope S. Rugo, MD: It’s a different drug that they want you to use.
Bruce A. Feinberg, DO: With the same mechanism of action.
Marcus H. Snow, MD: So, for the most part, if you graduate from our traditional disease modifying agents—methotrexate, hydroxychloroquine, sulfasalazine—and with few exceptions, you have to start off with those, if I wanted to move to a medication that is not a tumor necrosis factor inhibitor, it would be rejected by the pharmacy until I fail 2 tumor necrosis factor inhibitors. Once that happens, then the armamentarium is opened up from there.
Hope S. Rugo, MD: And that’s what a step edit is. They say, “No, you can’t.”
Bruce A. Feinberg, DO: Yes. You have to take “this” step before you can go…
Hope S. Rugo, MD: To the next step.
Bruce A. Feinberg, DO: To the next step, yes.