Emergence of Biosimilars in Oncology - Episode 2
Adam Brufsky, MD, PhD: I think Kashyap, the real issue here, and I think Lee has done a very nice job of talking about the FDA approval process for biosimilars and how biosimilars differ from reference biologics. The real issue for us is, can you walk us through how you in the COA [Community Oncology Alliance], and ION [International Oncology Network], and your own individual practice adopted biosimilars? How did you go through that? There must have been a difference between all the 3 ways of doing it, 3 different roles you’ve had.
Kashyap Patel, MD: Absolutely, Adam. Before I begin how we moved into that, my passion for biosimilars has arisen since I’ve seen that as the only possible logistical solution to address Medicare Part B drug price. Every time we go to Capitol Hill, we go to the Senate and Congress, we get asked by senators, “Are you interested in working with us in reducing the drug price?” And I see biosimilars as one of the only lifetime opportunities of reducing the cost of care when we look at the potential for savings with the biosimilars. Now, let me look at this system-wide. International Oncology Network and Community Oncology Alliance are the 2 different large associations, one is the business group, the second is a not-for-profit advocacy group. They both have put their full force behind supporting biosimilars, again understanding that if you want to address drug price, this is a way to go.
And at the individual level, at our clinical level, being one of the oncologic care model sites and the alternate payment model sites, we choose to add the biosimilars the moment they’re approved. And we’ve assimilated them very quickly into our practice. It’s not been an easy journey though, I think with the multiple issues with the payers, multiple different companies coming back with a product. So it’s been a journey, but I think we’ve been able to integrate biosimilars substantially within our armamentarium of tools to help address drug price.
Adam Brufsky, MD, PhD: The first question, let’s start with ION. ION is a large purchasing cooperative.
Kashyap Patel, MD: Correct.
Adam Brufsky, MD, PhD: And so, what were the issues for a large purchasing cooperative? I’m sure they’re different for individual clinics. What were your issues in adopting it?
Kashyap Patel, MD: At the ION, the first thing we were concerned about was the education, and I did multiple educational events at the ION national meetings. I was quite surprised, unpleasantly, to find that most of my colleagues did not even know the difference between the generics and biosimilars. So it took us about a year-and-a-half to 2 to educate my colleagues at the system-wide level, as a GPO, group purchasing organization. And then started challenges of the payer coverage, of the regional variation, of the contracting by the state Medicaid systems. We had to form a biosimilars committee, which I’m chairing for the ION as well as for the COA. We do feel that by bringing education for the physicians, for the payers, for the pharmacist, and for the patients, we definitely can start surmounting the challenge of getting biosimilar adoption.
Adam Brufsky, MD, PhD: Who really are the decision makers? I want to talk in a few minutes about, if you have several biosimilars in the same class of drug, like several biosimilar trastuzumabs, for example. We’re going to talk in a minute about how you decide which of the 5 to do. But before we do that, I’m really curious, who makes the decisions then at the ION level? Does ION decide we’re going to purchase this 1 of the 5? How do you do that? Who decides?
Kashyap Patel, MD: ION tends to be agnostic of the manufacturer. I think they want to work with all the manufacturers who are willing to work. And there’s going to be regional variation based on the payer coverage.
Adam Brufsky, MD, PhD: Got it.
Kashyap Patel, MD: ION probably has to be more like Switzerland, but at least they encourage all the manufacturers to have expected supply chains, so that there’s no issue about supply, there’s no issue about the quality. ION’s role is to help steer the contracting piece, and then they leave it to the individual practice about how they want to work with the suppliers.
Adam Brufsky, MD, PhD: So, ION will contract with everybody.
Kashyap Patel, MD: Absolutely.
Adam Brufsky, MD, PhD: And you have a committee that decides, okay, we believe this biosimilar, or whatever the biosimilar is you’ll take it? Or do you have certain characteristics that you would use in ION to say, “We’re not going to contract with this person but we are with this?” Do you do that, or no?
Kashyap Patel, MD: We typically don’t do that, but I think ION’s committee sits down every 6 months to look at the contract. Essentially, it’s based on the contract.
Adam Brufsky, MD, PhD: Got it.
Kashyap Patel, MD: The predictability of supply and also are they willing to work with us. Because sometimes a manufacturer may straightaway go to the payer and say, “We want to have our drug,” and so that complicates the issue. So ION’s role again is to break down the barriers for adoption of biosimilars, understanding that even though…if you look into, ION may be at a loss because if they’re making quite a point or a point on each purchase that they do through the GPO, the less expensive the drug is, the less profit that they take. But still in the holistic view of society as a whole, ION has chosen to go with supporting biosimilars as a part of a social responsibility.
Adam Brufsky, MD, PhD: Right. But the bottom line is, you’re going to use, if there are 5 different, I think there are 5….
Kashyap Patel, MD: There are.
Adam Brufsky, MD, PhD: Different biosimilar trastuzumabs. Again, being a breast doctor, I’m familiar with that. You’ll say, okay, we will contract with all 5 of them, and it’s going to be up to the individual purchasing physician to make that decision.
Kashyap Patel, MD: Exactly.
Adam Brufsky, MD, PhD: Got it, okay.
Kashyap Patel, MD: I will make sure that if a physician in Pittsburgh wants to buy drug A, a group in South Carolina wants to buy drug B, they want to make it available, and again because of the contracting variation.
Adam Brufsky, MD, PhD: And COA, is that any different, or it’s pretty much the same thing?
Kashyap Patel, MD: Community Oncology Alliance’s role is totally being agnostic. Our role at COA is just to make sure that we bring every toolkit for our teams’ colleagues and also work with the payers to help them understand the relevance of the biosimilars in addressing Part B drug price. So COA looks at it a lot more as part of what we call a steward or trustee for the society, and we want to do everything possible we can to reduce the drug price in conjunction with the government, Senate, Congress, and payers.
Adam Brufsky, MD, PhD: Got it.
Transcript Edited for Clarity