[00:00:00] Neil: When we talk about biosimilars, there's a lot of confusion because sometimes people think that a generic could be a biosimilar or a biologic could be a biosimilar. So talk to me about the difference between the three. What is exactly a biosimilar?
[00:00:15] Kathy: Sure. So biologics are large complex molecules that are manufactured from living cells. So, you know, because of that, they can't be identically replicated. Hence the term of this new thing that we'll talk about as a biosimilar. Biosimilars are FDA approved biologics that are highly similar to, and you'll hear this a lot, highly similar to in safety and efficacy to an existing FDA approved biologic.
And that would be termed the reference product. And just for clarity's sake, biosimilars are not generics because generics are small, chemically synthesized molecules, which are relatively simple to replicate and manufacture.
[00:01:09] Neil: So a biologic is analogous to the reference product?
[00:01:14] Kathy: Yes. And it's a large complex molecule. Living cells.
[00:01:18] Neil: So I've heard a lot of people say from time to time that even the biologic batches, the reference products, in and of themselves, because they are large complex molecules have some batch variability and almost could be considered biosimilars in and of themselves. What are your thoughts around that?
[00:01:38] Kathy: It depends who you ask. But yes, I do subscribe to that theory that there will be a variability over time that, you know, over five, 10 years of manufacturing, you know, these reference products are essentially biosimilars of themselves.
[00:01:59] Neil: So Kathy, you run a successful practice and I would imagine that when biosimilars first came out, you were excited about the opportunity because it meant lower patient costs. But there must have been some challenges in terms of operationalizing new products into your system.
They have their own J codes. They require their own, I assume, verification of benefits from each insurance company. So talk to me about that process.
[00:02:32] Kathy: Sure. So we were watching biosimilars, you know, the Pegfilgrastim biosimilars came out first and our working hypothesis as a practice was that, you know, these products were going to hit the market at a lower ASP and therefore be able to increase access to care for patients. And we were very early adopters of biosimilars. We started offering and utilizing biosimilars within seven working days of the initial Pegfilgrastim launch.
And we were able to watch those products over time. And if you do watch those products over time, it did prove that working hypothesis, ASP drop and therefore cost to patients through that insurer drop because it was a lower cost share. And by making these products more affordable, especially in the Pegfilgrastim space where patients may not always, you know, opt into that day two injection, we saw a large increase in access, and then it just continued to build upon itself when, you know, the three 'mab products hit the market probably about a year later.
And again, in patients that have large cost shares or high deductibles to meet, these biosimilars, through high quality, but at a lower cost, they really did drive an increase in access to care, which we saw within my practice, but across community oncology practices in the nation. It did present its challenges, not so much at first, but then because you know, these are individual J coded products, we have to get them approved by a payer, just like you would any other product.
We weren't concerned about billing. You get the correct product approved by the payer. We did those by printing out who was coming into the clinic for the next week and just pulling their treatment plans, contacting the payer and redoing their benefit analysis and authorization. And, you know, we were kind of off to the races on that. It did get more complicated as more biosimilars came to the market because individual payers approved different biosimilars. So for example, in the 'peg space, there are now seven, nine, Neil, you might know, but there are quite a few pegs in the space now. And several payers pick individual ones to approve or, you know, a one of one or a two of two. Medicare is really the only payer that I can think of off the top of my head that allows for parity in the space.
So it does become a little bit of an operational consideration that when your nurse or your pharmacist is pulling that biosimilar, that they're pulling the approved biosimilar for that specific patient. And we put some checks and balances in place when they're pulling from the cabinet and then another stop gap prior to the administration of the product.
Because the last thing a practice wants to do is administer the non-approved biosimilar to the wrong patient, because then that becomes a cost recovery issue that, you know, the payer's likely to not reimburse for that. And that becomes a slippery slope. You know, practice can only afford to do that once, maybe twice and then, they go upside down.
[00:06:31] Neil: I've got one last one for you. When you think about patients and a patient who might be on an innovator and they're switching to a biosimilar, or conversely from a biosimilar to another biosimilar, how do you handle that conversation with them? What are the talking points that you use to them to make them comfortable about the interchangeability of these products?
[00:06:52] Kathy: Well, I think it needs to start with the physician education and that physician's comfort level with biosimilars. Cause ultimately, you know, bringing any new drug to a patient is a conversation between that physician and their patient. Those are very trusted, sensitive conversations. So it starts with the physician. It also though extends to every stakeholder in the practice, which is what we saw.
We did physician education, we did nurse practitioner education. We also really focused on nurse education because, as most practices can attest to, those nurses are spending the most time with those patients when they're in the infusion room. And that level of relationship is much more, um, intimate sometimes than it is with the physician and the nurses really need to believe in the products that they are administering to their patients and they take that very seriously.
So we did spend a lot of time on that, but we also spent time educating our financial counselors because they were the ones who were doing the original approvals, the re approvals, and then working up those individual call shares for the patients because they needed to understand why we were doing this and the benefit that it made for the patients that they take care of.
And then if there's a phone call between the financial department and the patient, and the patient asks, we felt it was best for us all as a practice, to be on the same page and drive the same message about why we believed in biosimilars and what they meant for the patient as well as the practice.
