Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP: Dispensation and switching—that’s a great question. We often have to take a look at what that means. When we’re looking at switching—you know, interchangeability—a number of different names are out there, and they all don’t mean the same thing. If a product is actually being utilized, for example, under one indication—and we have a P&T, pharmacy and therapeutics team, which addresses that—in many cases what will actually happen is we will switch those therapies based on something called a therapeutic interchange.
We can switch that based on current lines of treatment indications and also current lines of indication based on the support within your healthcare system, or a large system overall.
Now, can switching automatically be done? Absolutely not. It has to be aligned based on your own institution’s formulary. Where it is automatically being done is not so much the institution. If this is an inpatient-based treatment designation, in those cases what’s happening can be done. That therapeutic interchange, which we’ve been doing many years, can be done automatically. However, when it comes to the outpatient setting, many of the guidelines or criteria for a P&T are often invalidated based on payer preference. If one payer actually defines to use a biosimilar, another may actually find another biosimilar preference.
Across the board, you may actually have to align with what the payer says. Therefore, they will dictate what drug product you can dispense. And substitution, based on a physician preference, is not always the case or even the hospital preference. What it comes down to in the outpatient setting is a payer preference, and we’re seeing more of that. By next year, I think we’ll have a more defined premise for what those will be and how different institutions—whether a small community practice, a large community practice, or a large hospital or health system—may have some of those discussions early on. But one of the concepts is we have to address what the payer defines when looking at the actualization in the outpatient setting.
The definition of “highly similar” means you’re mimicking a similar structure and pattern to what you would see in the biologic or brand-name product. The originator product, again, can have some similar changes as time passes. We often hear that a biologic today is what a biosimilar used to be. Now that change over time can actually occur regardless of the biologic, and that can also occur regardless of the biologic, and that can occur also with manufacturing changes.
When they’re taken with that highly similar profile of biosimilar, when it comes to these mechanisms, these workflow patterns, we’re looking at some of the actual postanalytical, preanalytical data sets in clinical studies. Those clinical study pieces will also help address that similarity in terms of outcomes and efficacy. We have to actually have a bifurcation, a split in which you’re taking a look at the preanalytical phases—the early phases of clinical development coming into pretesting within a human—and actual clinical studies. That includes your pharmacokinetic and pharmacodynamic capabilities and lastly your sensitive population with that phase 3 study.