Clinical Advances and Challenges With Biosimilars - Episode 16
Bruce A. Feinberg, DO: We talked a little about how you present these drugs to your patients—how you educate them and whether you use the generic name, brand name, or you just talk about them as a class. And we talked about just calling them a “taxane.” If you’re giving a taxane, rather than the drug-specific product, or if you’re giving them an anti-TNF without the specific, how much do you get into that?
There’s more to naming, than just that aspect, to a patient. There’s also the aspect of naming that relates to its code and how you’re billing for that drug if you’re administering it in the office. So, Marcus, I’ll start with you on the naming and coding piece, and then Brandon, I’ll ask you to weigh in.
Marcus H. Snow, MD: The biggest thing that has not yet been defined completely—although there are some biosimilars on the market now that have this—is, how do you name this? The FDA now names infliximab with a dash and then 4 letters. And there’s debate whether these 4 letters should mean something. For example, filgrastim has “sndz” for Sandoz, who made it. But then, infliximab is now on the market, and infliximab has nonsensical letters, basically. They don’t spell a word. They’re not affiliated with the company, and there’s confusion over that. And I think the majority of rheumatology providers would prefer that it have a name that at least they could remember. “Sndz” is much easier to remember than “dyyb.” I think it’s really important, moving forward as we talk about pharmacovigilance, that we know what product my patient is getting.
If they have a huge reaction to the subcutaneous medication and they got drug A, and then we change it to drug B and it went away, we at least know that drug A probably should be avoided in the future. We can document that as an allergy, as an independent medication. So, the naming of this, and the implementation of these medications once they’re approved, I think, will be really important moving forward.
Bruce A. Feinberg, DO: It sounds like you’re going to add another piece to this. From a medical record-keeping standpoint, the charting, that’s not going to be enough. If there are 4 infliximabs, you’re going to need to specify which one. Based on response and tolerance, you may not go back to that same one, again, even though you might go back to infliximab at some time.
Marcus H. Snow, MD: Yes. And also, in reality, what’s probably going to happen is the formulary will be changed—they would change medications. If we realize that they lost response with infliximab-dyyb, then we would want to avoid that in the future. And so, that’s something that we’re going to have to monitor, and it will have to be something that the provider will have to be notified of. The pharmacist will have to notify the provider, and the patient is going to have to know what they’re on and know what the 4 letters are after the name of their medication.
Brandon Shank, PharmD, MPH, BCOP: From a pharmacy angle, with the naming, having a 4-letter suffix can be problematic with look-alike, sound-alike products, since they are not the same. So, making sure that your technician is pulling an accurate drug, keeping the accurate record, and bar code scanning upon dispensing is important. And then, also from an inventory standpoint, maybe having to carry multiple agents may lead to some medication administration errors. Luckily, it’s the same reference product. But if a patient, like you mentioned, had an adverse reaction to the medication, it would be important to eliminate that and, as far as when they are interchangeable, having the reference product named first. Or if they’re not interchangeable, that may infer interchangeability, too, amongst the indication.
Bruce A. Feinberg, DO: Even though they are not interchangeable from a coding standpoint, are they being addressed in a way that would suggest more interchangeability?
Brandon Shank, PharmD, MPH, BCOP: We haven’t addressed that problem, yet, but I would guess that from our medication administration record, we would need to create another line item. The medication systems order sets all would have to be redesigned to have this new biosimilar, depending on what the institution is selecting.
Bruce A. Feinberg, DO: Currently, is it a uniform J-code?
Marcus H. Snow, MD: It is a uniform J-code, right now. There’s a lot of push to try to make multiple J-codes because it could lead to more rapid switching if you have a single J-code. If you get a medication that’s even a little bit cheaper, your profits are going to change based on the fact that the J-code will have the same reimbursement.
Hope S. Rugo, MD: Which is a really fascinating area, I think. I’m guessing it probably will change, even though it complicates things because the insurers want to do that. They want it to be a little more controlled. Don’t you think that we’ll probably end up using the brand names even more because of this issue? If you’re going to order something that’s infliximab-123 versus infliximab-znnd, how are you going to do that? I mean, nobody is going to remember which one is which.
Marcus H. Snow, MD: You bring up a great point. I hadn’t actually thought about that, but you think you would be using the trade name, more commonly, based on that. Because, how do you pronounce “dyyb?”