Decision Makers for Formulary Approval of Biosimilars



Adam M. Brufsky, MD, PhD: Now, get into the role of, and the decision makers are committees I’m assuming where that’s multidisciplinary. You probably have a pharmacist on it, a physician.

Kashyap Patel, MD: Correct.

Adam M. Brufsky, MD, PhD: Maybe nursing. I don’t know how you guys do it. So, you do that. But now as someone who runs his own practice, how do you make the decision there? That’s different. You’ve got the global perspective, now you have to decide which one you’re going to use. How do you do that?

Kashyap Patel, MD: Here is actually where the meat comes to the table. Individual practices will make their own decision. The decision is based on multiple aspects. One is the reputation of the manufacturers because once you start treating patients with a drug A, drug B, drug C, we want to make sure that the company has a history of maintaining supply chains. That is the first requirement. The second part is the patient assistance program, because a lot of these patients may not have adequate insurance. What kind of support program do they have? What kind of resources do they provide to the practice to ensure that practice can sustain the support for the patients? And the last thing is payer coverage because each region has Medicare Advantage Plans, you probably have MCOs [managed care organizations], you have Medicaid, and commercial insurance. And there could be huge variations. So we factor all of these aspects before we make a decision about where we want to go. And we may end up keeping 2 or 3 biosimilars at the same time.

Adam M. Brufsky, MD, PhD: Right. Okay, the interesting thing and we’re going to come to this a little later. It’s not just the cost. You figure, okay, they’re all the same cost, but there are all these other things that go into it.

Kashyap Patel, MD: Yes. Cost is just 1 part of that. The more we learn about biosimilars, the more I’m learning as well that cost is just 1 piece. There are about 4 other pieces of the puzzle that we need to solve to identify what’s going to be the best fit for our practice.

Adam M. Brufsky, MD, PhD: Got it. Okay, I understand that. One other question before we move on a little bit is how do dosage and storing conditions compare with reference biologics? Do they really make a difference? Are they changed? I don’t really think they are, are they?

Kashyap Patel, MD: No, they typically don’t change. We’ve not seen any issues about dosage or storage conditions. In general, I think we’ve not had any issues since we switched over to biosimilars.

Adam M. Brufsky, MD, PhD: Got it. And so again back to the more global issue. I’m assuming when a new biosimilar comes on the market, you’ll meet with say the representatives of that particular biosimilar company.

Kashyap Patel, MD: True.

Adam M. Brufsky, MD, PhD: And they’ll make a presentation about all of these various things that you go through.

Kashyap Patel, MD: We will discuss that even at the ION [International Oncology Network] business committee as well and make sure that our expectations, our check box list is fulfilled. Then after we have meetings, I talk to my partners and then present it to our team and say we have these 3 different choices we can make. Drug A has a better profile because the supply chain has been established. There’s been no issue about interference with the supply. The contract seems to be doable. And the payer coverage seems to be favorable as well, and the patient assistance program. For us, with 20% of patients either who are underinsured or Medicare only, we need to make sure that the patient assistance programs are adequate.

Adam M. Brufsky, MD, PhD: Okay. That’s important. Another thing you mentioned I really want to touch on, too, is the education of the physicians.

Kashyap Patel, MD: Correct.

Adam M. Brufsky, MD, PhD: I think that I agree, they don’t know the difference between a generic and a biosimilar. And we know that, and this is what I tell people, that a biosimilar by law has to be similar. It has to have, at least with whatever test you’re doing or whatever small clinical trial, the same PK [pharmacokinetics] in terms of the same pharmacodynamics. It has to have the same effect within a confidence interval. It can’t be better. It can’t be worse. There is a particular biosimilar in breast cancer, a trastuzumab biosimilar, where it was a bio-better.

Kashyap Patel, MD: Exactly, yes.

Adam M. Brufsky, MD, PhD: And in fact, it has to be studied in a phase III trial. You can’t just say, “Oh, it’s a biosimilar.” So this is important. But I think the important thing, at least when I talk to my colleagues about it, is by law, by the regulations, it has to be the same pretty much. It has to have the same efficacy, chemical structure as far as you can possibly do. And how do you find your colleagues responding to that?

Kashyap Patel, MD: That’s a very interesting topic you bring up, Adam, because when I spoke for the first time at one of the national meetings about 2 years back at the ION, one of the colleagues stood up and asked me why they are so expensive. Generics were not so expensive. So I had to take time to explain to him that a generic drug is a small molecule, which probably has about 180 to 300 dalton atomic weight. When we look at the biosimilar, it’s about 180,000 dalton atomic weight. It’s much more complicated. And the manufacturer has to spend hundreds of millions of dollars. It’s not like buying a 1 kg molecule for $1 million and then start cutting pills or filling bottles. This a lot more complicated to make. It undergoes rigorous evaluation, as going back to the totality of evidence, the immunogenicity, the comparator to the parent compound, and then they’re approved. It’s a lot more arduous. It’s not like going to an assembly line and starting to fill the bottles.

Adam M. Brufsky, MD, PhD: Right, I agree with you 100%.

Transcript Edited for Clarity

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