Gary Lyman, MD, MPH, an oncologist and hematologist, discusses how financial incentives, concerns for patients, and interchangeability impact biosimilar prescribing patterns.
Gary Lyman, MD, MPH, is an oncologist, hematologist, and public health researcher who has long been an advocate for biosimilars. He has also developed guidelines in support of using biosimilars in the oncology space.
Do you believe that changes in biosimilars reimbursement or incentives for biosimilar use will help uptake?
Lyman: Depends on the level at which they are likely to impact, like if it's at the health system level or the provider level in a small practice. I think ultimately, our concern is about the patient. If all else is equal, cost drivers will generally went out. If either the health system pays less for a specific favored biosimilar or if patients are not left with as much out-of-pocket costs, because the agent is not fully reimbursed, I think those will be strong motivators to utilize 1 biosimilar or another.
In the end, everyone, including patients, providers, and the health system, should all consider patient safety and efficacy as the primary concern. If you're not convinced with all that I've said and others have said about why we believe that these FDA-approved alternatives are just as good as the originator across disease settings, then you need to find out more. I've talked about this for many years and major meetings like the ones for ASCO [American Society of Clinical Oncology], and ASH [American Society of Hematology], and NCCN [ National Commprehensive Cancer Network]. I think once clinicians take the time to be fully educated on these issues around drift and extrapolation, and so forth, they will accept and utilize the version of biosimilar that is preferred and available.
Where there's still some issues for discussion is the process of interchangeability that that the FDA has set up that only exists in the United States. It's not something that exists in Europe or elsewhere in the world. [Only 1] biologic that is a biosimilar version [Semglee, insulin glargine biosimilar] has been granted [interchangeability]. In principle, it's a higher level of approval, that is once a biologic has been approved as a biosimilar, [companies have] the option, with additional comparative clinical trial data showing that switching back and forth between the reference product and the biosimilar doesn't impact on safety and efficacy, for a biosimilar to be granted a higher level approval as an interchangeable biosimilar. And perhaps some company will feel this provides them with some market advantage or as a reason to choose their agent over another. So far, that [marketing has] not been done.
One provision in that regulation is that if a drug is granted this higher level of approval, that substitution for their agent could be made without intervention of the provider automatically, and there would be no requirement for notification. Well, this has led more than half the states in the country to put together their own laws to intervene to say, "We don't fully accept that process and we do think providers need to be notified." That's ASCO's position as well. Clinicians may not have a choice as to which agent is used for their patient, but they at least need to be informed of what their patient has been given. If you prescribe 1 agent, and they're given another agent, even if there's strong evidence that is just as safe and effective, you want to know which agent they're receiving. If for no other reason for pharmacovigilance to make sure if there's any new, rare, unexpected effect that you can report exactly what agent so that it can be linked back to in their reporting. So, it's really important that clinicians know what patients are getting, even if they don't necessarily have control over the switching or substitution that takes place.