Multiple Biosimilars for a Single-Reference Biologic

Bruce Feinberg, DO: Kathy, you could realistically have 3, 4, or 6 biosimilars to the same reference brand and your desire is to have 1. Your payer complexity might dictate that you have 2 or 3. How do you make the decision? It’s hard to make that decision clinically because they’re all proven based on the same data. It’s not a tremendous amount. It is 1 inferiority study for each of them.

Is it a throw of the dice or a flip of the coin? What is the mechanism?

Kathy W. Oubre, MS: Evaluate your patients who are currently on those drugs. Then take that number, see who their payers are, and look at formulary design for that. Put all that into a spreadsheet. I would love to be able to pick 1. That’s not our reality. Then I have to look at what I’m required to carry and what pieces I can move around within my patient population to achieve some good performance on 1 or 2, or maybe 3 contracts.

Bruce Feinberg, DO: Let’s just say you have an outlier. Let’s say you have a national payer or small regional payer who has a 2% market penetration for your practice, but they have a fourth. Do you have to stock it on formulary, or do you tell them, “sorry?”

Kathy W. Oubre, MS: No, we’ll stock it. We’re going to treat the patient. I can’t take a loss on the product, but then you get into a little bit of operations. We set up pop-ups for the nurses and everyone who would even be close to touching that product, because I can’t give the wrong product to the wrong patient.

Bruce Feinberg, DO: Karina, we’re dealing with, let’s say, 6 potential biosimilars of the same reference brand. Do you have to have all 6 available? Can you approve 1 and not another when the basis for most plans is medically necessary and not experimental? Can you make 1 not medically necessary if the other 5 are? Can you restrict them that way?

Karina Abdallah, PharmD: Well, I have 2 answers for that. On the commercial side, yes, you can choose whichever 1. Costs to the health plan are going to be a factor. The other factor is any sort of abrasion to the patients or providers. We do take that into consideration and make the decisions based on those inputs. On the Medicare side, you really could do only step therapy. If it’s available, on the market, and FDA approved, you can require step therapy. If for some reason they have a trial and failure, or they have some issue with the biosimilar, we would have to be able to pay for whichever product the physician feels is most necessary.

Does that change how they access it? No. If it’s not there—if the hospitals are not stocking it and if the outpatient facilities are not stocking it—then they’re going to have to use what’s available.

Bruce Feinberg, DO: For Michael and Bhavesh, it is related because you both represent entities that have considerable size and market influence.

Do you tell payers, “This is what we’re using,” if they’re a small payer, and there’s not an option? Will you do what Kathy said, and try to limit it to the fewest number but end up stocking all of them, if any payer comes along and says, “Yes, you’ve got to use this?”

Bhavesh Shah, RPh, BCOP: Similar to Kathy’s approach, we would actually work with our local payers to see if we can negotiate a preference based on our preference. If not, then we may have to carry 1 or 2 for formulary. We’ve been pretty fortunate in the market in Massachusetts, where we’re able to use 98% of the formularies that we have for biosimilars across various institutions.

Bruce Feinberg, DO: All right.

Michael Diaz, MD: In my practice, in an ideal world, you would like to try to have everyone agree on 1 biosimilar option. It just makes things much simpler and reduces chances of errors in any shape or form. In the future—say, if we have 10 or 12 different options available and we have different payers saying that they’re only going to provide 1 over the other option, and it’s not necessarily 1 that’s our preferred—obviously, we’re going to try to do everything we can to encourage acceptance of our preferred medication. I think everything else may have to be on a case-by-case basis.

If it’s something that is not economically viable and puts us underwater and they’re not willing to budge, then we might not be able to treat that patient. It’s just that simple. If it’s something we could permit and it’s not an alternative that would put us underwater, we might be willing to entertain it. We haven’t faced that reality yet because there isn’t that wide number of biosimilar options.

There’s going to be a bit of a wait and see as things evolve, but we’re always going to be pushing for 1 preferred biosimilar option.