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.
Review Confirms Clinical Safety of Sandoz Denosumab Biosimilar vs Originator
December 11th 2024Sandoz's biosimilar denosumab (Jubbonti/Wyost) has demonstrated analytical, pharmacokinetic, pharmacodynamic, and clinical equivalence to reference denosumab (Prolia/Xgeva), supporting its approval and extrapolation to all approved indications.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Pertuzumab Biosimilar Shows Promise in HER2-Positive Breast Cancer Treatment
December 9th 2024The proposed pertuzumab biosimilar QL1209 demonstrated equivalent efficacy and safety to reference pertuzumab (Perjeta) in neoadjuvant treatment of HER2-positive, ER/PR-negative early or locally advanced breast cancer, offering a cost-effective alternative with comparable clinical outcomes.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Switching to Rituximab Biosimilars Is Safe, Effective for Patients With Oncohematological Diseases
December 5th 2024Patients with oncohematological diseases switching to rituximab biosimilars experienced similar safety and efficacy, highlighting biosimilars' potential for cost-effective treatment across various medical conditions.
Commercial Payer Coverage of Biosimilars: Market Share, Pricing, and Policy Shifts
December 4th 2024Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the increasing market share of biosimilars, which contributed to notable reductions in both average sales prices and wholesale acquisition costs.