Madelaine Feldman, MD: I think there’s polarization, in terms of physician and prescribers’ attitudes toward biosimilars, everywhere from “biosimilars are completely different than the reference product and they should be treated as a completely different drug” to “they’re exactly the same.” And you know, it probably falls somewhere in between, maybe a little bit closer to being exactly the same. So, prescribers can be confused as to, are they the same or are they completely different?
So, there are a couple of issues out there that I think probably create the most confusion, and that’s the idea of interchangeability, and maybe interchangeability versus substitutability, because interchangeability is not a qualitative characteristic at all. It actually refers to a policy where pharmacists can substitute a biosimilar for a reference product without a new prescription, without notifying the physician or the prescriber at the time of switching.
And that becomes a little bit problematic when physicians think, well, we need to wait for a biosimilar to get an interchangeable designation before we should even prescribe it because that must mean it’s better, that must mean it’s safer. And I think that’s one of the main areas of, I don’t even know if it’s a miscommunication but it’s sort of a confusion among prescribers.
And then I think the other thing that’s kind of, in a way, ironic—the biosimilars were fast-tracked through the FDA because they’re going to cost less and supposedly will help bring down, and will, if eventually they can ever make it to a formulary, the cost of medications and general health costs in the United States. One of the problems is reference products. Biologics are expensive and so are biosimilars. So, patients will not be able to afford even the biosimilar unless it’s on their formulary. And to get on the preferred tier of a formulary, you really almost have to have a higher list price and market share. You really look at what the rebate is, the list price times the discount times the market share.
So those 2 things right there, a lower price and new to the market puts the biosimilar behind the 8-ball right away. And I think there is a misunderstanding that a biosimilar is going to be able to just hop right in as soon as it’s approved. Unfortunately, that’s a problem that we’re going to have to deal with in order to get uptake of biosimilars.
I think a lot of the issue revolves around, do providers and prescribers even know about post-manufacturing changes? Years ago, I was completely unaware of that. I think that’s where education comes in. Over the years there’s been a drift in terms of the change in what the reference product is. Perhaps the reference product now is no more like its original than the biosimilar is. So, I think to ask the question, are they concerned about that, I think the first thing that needs to happen is that prescribers need to be educated. And a lot of us, we’re seeing patients every day. We’re dealing with electronic health records. We’re trying to qualify for [Merit-Based Incentive Payment System, MIPS] and [Medicare Access and CHIP Reauthorization Act of 2015, MACRA]. It may seem like this is something everyone should know. But that gets fairly intricate, so I think education about what that really means, and does it have an impact on whether that will determine if you’re going to prescribe a biosimilar or not?