The Role of Biosimilars in Oncology - Episode 7
Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP: Luckily I have a lot of experience with biologics. We even have more experience with biosimilars, just based on what we’ve implemented as usual. Across the country I think we’ve seen a large uptake in biosimilars, more simply the supportive care. The only time we’ve seen institutions have issues or address them is based on payer pieces. We’ve seen some variation based on who supports what.
For example, 1 payer may have a preference for a biologic, but then another part of their portfolio may include biosimilars. Or we may have 1 payer request 1 type of biosimilar but not another. So we have a large amount of detailed work on this experience in the outpatient setting and inpatient setting. The identification of biosimilars has been rather easy to address. Implementation has been more from an educational standpoint—there’s still a dire need out there to understand.
But the piece of the puzzle with the actual biosimilar, understanding, utilization, and also education really have been at the level of when to switch. Addressing it with your EMR [electronic medical record] system, looking at it in terms of patient implications and also physician prescriber preferences, and also implementing that based on the payers, because you do have to deal with financial pieces. How to you approve it? If it’s not approved, do they actually want another biosimilar? How does the prior authorization process occur?
That all takes away from direct patient time as you’re trying to get it approved. The payer interaction based on a facility and prescriber has been an important discussion as well.
Kashyap Patel, MD: We have adopted biosimilars very early on in our practice, and as soon as the first filgrastim was approved in 2015, we adopted that in our practice. So we have almost 4-and-a-half years’ experience with the biosimilar filgrastim. As soon as the pegfilgrastim was approved, we adopted that as well, so we have another year and a half of experience of second compound. We’ve recently adopted the 2 new biosimilars, which are bevacizumab as well as trastuzumab. And we have almost 5 years’ experience of biosimilars, and we’ve not seen any difference in the outcome, safety, or efficacy of replacing the referenced biologic to the biosimilars.
Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP: It all comes down to decreasing cost for the patient, which biosimilars do, and also increasing access to the patient, which actually biosimilars do as well. By reducing that overall cost, you reduce not only the overall healthcare cost but also the financial burden to the payer, because of the reduced cost of that drug therapy, and the actual out-of-pocket burden to the patient. If that occurs, it allows for overall decreased cost to the health system for the actual overall healthcare system of the US [United States] and other countries globally.
We have that availability of a drug therapy. The switching is dependent on the preference based on payers’ institutions. But overall utilization is based on decreased cost, which is kind of a switch in this era of increasing cost for globalization of biologic therapies, because newer therapies carry a higher cost. By using the biosimilar, we reduce the overall cost to the patient and other patient populations well.
Kashyap Patel, MD: We choose biosimilars when we can simply because we are part of the value-based care model and part of the Oncology Care Model. One of our targets is to reduce the total drug cost, and biosimilars often reduce the drug cost without compromising the outcome. So when possible, and when the drug is approved by the FDA for an appropriate indication, we rapidly adopt those biosimilars in our clinic as an attempt, and we just go ahead and run with it.
Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP: When do you choose between 2 different formulations of biosimilars for trastuzumab? Right now it’s kind of a mixed question. We only have 1 available in the US. The other 1 is approved but still pending release,* and I think next year we’ll probably expect about 2 or 3 of those same biosimilars in the area as well coming out.
Right now the choice is rather limited. Really the choice would be based on payer preference. Again, insurance preferences. We’ve seen 1 major payer actually approve the biosimilar, so that will be their preferred utilization of that therapy. In addition, there may be certain pieces that preclude us from using that biosimilar. That may be clinical studies, which is an important discussion, or any type of preferences with certain institutions as well.
At this point in time I think it’s very early for us to say when we would choose which 1 or which 1 is preferable. There may be certain variations that make it more likely to use it, like a multidose vial versus a single-dose vial for the actual biosimilar, which has been a question as the initial biologic had a multidose vial that decreased drug waste.
The second piece of that will be looking at what the preference is. For many prescribers, for many physicians out there, there will be some questions as to when to utilize a therapeutic curative indication with the biosimilar versus the biologic. Now that’s come about through several different surveys at ASCO [the American Society of Clinical Oncology Annual Meeting]. It was published in 2017 if I’m not mistaken. There’s an abstract in 2018 as well, in which the authors had found a preference for the use of the brand-name product for up-front curative therapy. Again, there is less hesitance to use a biologic curative therapy in second-line or refractory setting.
Getting familiar with this will take some time. But in the US, I think we’re going to see some major impact coming from the payers to switch automatically, so I think that will be an important discussion.
Kashyap Patel, MD: Right now we have only 1 label, so we don’t have to kind of look into the other part, but we will look into the payer factors that we have to be cognizant about: the payer coverage, the patient’s out-of-pocket cost, what kind of supporting programs that the manufacturer has, the supply chain. When we have multiple competing biosimilars—in the trastuzumab space, for example—we will lean toward the company that has longer experience, that has a predictable supply chain, that has a good patient-assistance program, that has a low patient out-of-pocket cost. And the overall cost to the system is low. We look into multiple factors when we make a choice of 1 versus the other biosimilar. At the same time, we have to look into payer coverage as well.
*as of the time of filming.