Clinical Advances and Challenges With Biosimilars - Episode 15
Bruce A. Feinberg, DO: There’s so much, now, that biopharma does in support of their products, from patient assistance programs to patient education programs. Will biosimilars need to be on a par with all of that? And, again, is that one where, when the delta is wide enough, you can get away with something different? Is it going to be all driven by formulary management?
That becomes another consideration in terms of cost of development, manufacturing, and marketing implementation. But, it’s also about the patient benefit that comes from that, and I don’t know that—again, in the institutional settings—much of that has been absorbed. I know that, in private practice, that aspect of what biopharma does is critical to many patients who are being served.
Hope S. Rugo, MD: In breast oncology and, I think, in many different oncologic areas, this really only plays a role with oral medications where there’s a big share of cost. And, in that situation, people are using both company compassionate use as well as foundation support if patients have a large share of cost. We’ve really gotten into this, big time, with the cyclin dependent kinase inhibitors, where a patient’s share of cost could easily be $1000 a month. There’s almost no one who can afford that, or would want to afford it. So, the costs are being covered by foundations, and also to different areas, which is fascinating. I had no idea that was going on, and it wasn’t going on to the same degree. How that’s going to be supported over time is a whole other big question. I don’t know.
For the antibodies, where we give them intravenously and not subcutaneously, in the United States, we really haven’t had that issue. The way our insurance companies pay for benefits is completely different. Because you could have a reaction to these drugs, and because they’re handled differently, they’re never going to be given intravenously at home. So, you have these drugs that are given intravenously, and your share of cost is a visit to a clinic.
Bruce A. Feinberg, DO: Right, but many of these are given subcutaneously. You’re going to have the first one. You’ll have rituximab, subcutaneously. Although not so much in a breast clinic, you’ll certainly have it in some of your clinics.
Brandon Shank, PharmD, MPH, BCOP: We’re going to start to use it—subcutaneous rituximab. And that will just be a quick visit...
Bruce A. Feinberg, DO: But, you’ll still have that first dose. Will you do all your doses on-site?
Brandon Shank, PharmD, MPH, BCOP: We currently haven’t set up a model for doing that, but it will require a quick nurse visit, like an infusion center visit, for now. It may go to another...
Bruce A. Feinberg, DO: In general, infusion reactions are lower with subcutaneous exposure than with intravenous exposure.
Marcus H. Snow, MD: Yes, and most of our medications are given subcutaneously.
Bruce A. Feinberg, DO: And they’re self-administered?
Marcus H. Snow, MD: Yes. Self-administered, at home, subcutaneously. There are rumblings of pushing patients to getting at-home intravenous infusions of infliximab.
Hope S. Rugo, MD: I have a patient who, unfortunately, has breast cancer and is getting at-home infliximab.
Marcus H. Snow, MD: Yes. That’s something that I would have a lot of concern about—if my patients were receiving infliximab at home. But, there are rumblings of that. These medications are mostly given subcutaneously. About the cost—one thing I will mention, though, is, how do we know what the cost is? I’ve really struggled. I try to look at this.
Bruce A. Feinberg, DO: Because of rebates and other elements of design?
Marcus H. Snow, MD: Because of rebates in medications. When you look at the cost of the bio-originators that are coming off patent over the past 5 years, they’ve increased our cost by 50% to 100%. At the same time, the pharmacy is negotiating a price that is lower than that. Ultimately, it filters down and spits out a copay for my patient. Then, there’s a rebate card that exists. I get confused in trying to figure out what the cost is. We’ve talked about it, and I would love for these to become much cheaper. At the same time, if they are cheaper, who is going to benefit from that?
Brandon Shank, PharmD, MPH, BCOP: It’s difficult to determine drug prices because the contracting is all confidential. And as far as rebates with biosimilars, it will be interesting to see if they have as many patient assistance programs as the reference products. For our patients, that’s a huge deal, and it can help them cover these agents as well. With the biosimilars, we’ll see. Also, one thing I wanted to mention in looking at things on an institutional level—I don’t think physicians are going to be knocking at our pharmacy and therapeutic committee’s door asking them to add biosimilars. I think the drivers are going to be different in this case. I think it will be more on the pharmacy end. And then, reimbursement and contracting, along with the insurance providers for formulary addition.