Considerations for certain patient factors when recommending a biosimilar over a biologic to treat a patient.
Anthony Mato, MD, MSCE: This is a perfect segue into talking about the next topic, because we really need to delve into what determines if you’re recommending a particular biosimilar over a biologic or even another biosimilar. We’ll have Bhavesh try to tackle this. There are certain segments that need to be addressed. Are there patient factors that you consider for choosing 1 over the other? That’s first and foremost. The second is, is this for new patients? Or if I had a patient who had rituximab 6 years ago as part of their initial therapy and they’ve relapsed, how do you decide whether they should have the reference product versus a biosimilar? Then please talk about the skinny label and the implications that it might have on the adoption of biosimilars in a practice. Finally—and this is probably the 1 that has a little more of a sticking point for me—if a patient is midstream through therapy and there’s a potential to switch within the institution, should that happen for a patient who’s already on a particular product? It’s a lot there, but this is really about how we choose on an individual patient level.
Bhavesh Shah, RPh, BCOP: Absolutely. It becomes challenging because you know you have patients who are on short-term therapy and patients who are on chronic therapy. The short term is easy because you’re basically going to have more new patients who will be on therapy, and that’s an easier decision. The most important question you have to have about patient factors is if this patient is a candidate to continue therapy. That can be answered only by the provider. So the patient factor is an important aspect, and it needs to be done in collaboration with the provider who was treating the patient and not at the pharmacy level where we’re going to change everybody, and this is the drug they’re going on. This is especially because you have a lot of different diseases that biosimilars treat, so it’s important that we do it in collaboration with a provider.
With regard to new versus existing, we actually have adopted where we would switch everybody, but there a lot of institutions. This is what actually holds up the biosimilar adoption process, that some institutions will basically do only new patients. Some institutions will basically leave it for the provider to decide if they want to do it now or if they want to do in the midst of the patient’s treatment.
It was interesting because when Inflectra [infliximab] came out, we had this big conversation about when we should switch our patients. We know that there was a NOR-SWITCH trial, which basically switched patients after 6 months of therapy. But Inflectra is essentially the same thing as infliximab molecules.
You can switch patients at any time point, but the provider didn’t feel comfortable switching patients until after 6 months of therapy. We even talked to providers in Europe, and they had confirmed that, “Hey, we switched everybody in 1 day because the government mandated that. We didn’t see any difference in outcomes for our patients.” But our providers still felt comfortable using the data that were published.
So it depends on what the providers also feel comfortable doing in terms of when to switch a patient. That also dictates the disease that you’re treating, the patients you have, and the provider’s comfort. There are a lot of factors that go into it. But it’s really important to actually establish that before you start the process of switching patients in your system.