The Role of Biosimilars in Oncology - Episode 13
Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP: Challenges of the provider and as a health team of biosimilars—there are numerous ones. I think we’re still at the forefront of discussing it, but we’re toward the back end of implementation. The biggest challenge is addressing what the payer wants us to use. Regardless of the situation of education, the P&T [pharmacy and therapeutics] pieces are understanding what the actual biosimilar or biologic preference is based on indication. It is the most important discussion across the board.
For many of us, that means when we’re looking at a biosimilar or a biologic, if we know beforehand what the payer preference is, that makes us have an easier time in developing our workflow or policies.
It gets tougher if you have 30, 40, 50 different insurances with different preferences. Now you’re just hoping to address this from a standpoint of saying, “Here’s which payer we use the most. Here is their preference.” But what happens if you make a mistake? If you give a biologic or biosimilar that’s not preferred? In those cases, you may actually risk a loss of revenue or giving the drug away for free, because you need to find a priori, or beforehand, when that patient came in.
The discussion on the payer index, the payer piece, to me is the most important. The second thing is clinical trials. In the advent of developing new clinical trials and new curative therapies, we have some protocols that define not using a biosimilar. You may have to have a brand-name product on hand, even though you have a preference for a biosimilar. Another important question as well.
The third, another big piece of this, is going to be the patient assistance programs. Often we rely on our patient team members, our patient assistance members, to address up front what drug will be used, what’s available, what piece of implementation will be available for that patient population as well. If we don’t know or don’t educate those members involved, from the physician all the way down to the patient assistant members—including the patients in that kind of trifecta that we always have an association with—we may cause the risk of actually giving the wrong drug, wrong patient assistance program, wrong co-pay cards, wrong free drug. Again, all important pieces of that as well, as well as billing. If you don’t bill for the correct drug even dispensed, that becomes a problem.
In fact, one biosimilar has a different unit code from the original product they used at hand, too. Now you can see the enlargement of issues occurring—not on the front end, where you’re giving the drug to patient, but on the back end, where you’re looking at all the other things that occur downstream for that patient getting administered their drug.
We have a lot of work to do. Those are some things that keep us up at night, so we try to keep our heads focused on this as well. But other issues that we’re mitigating right now are even changes in workflow development, which may be incurred by a PBM to institute a supportive care biosimilar, and that’s another big issue occurring as well.
Kashyap Patel, MD: To summarize challenges for the biosimilars, let me begin with education. The first thing, I really have to blame the manufacturers. They’ve done an appalling job of putting out resources and educating stakeholders. Unless the prescriber knows the access of liberty and economics of biosimilars, they’ll never be able to use it. That has to be done.
The second part is educating nurses, patients, family members, and pharmacists about the quality of the product, the totality of evidence, the FDA pathway for the biosimilars. The third thing is the payer coverage. Even now, with almost 20% of the patients who are on Medicaid who are not able to access biosimilars, I cannot think why, because Medicaid is a federally funded program. I’m not sure how come CMS is not going to mandate that every state’s Medicaid should cover biosimilars.
The fourth thing we talked about was the contractual agreement between the PBM [pharmacy benefit manager], health plan, and the manufacturer and how they can tie their hands down by policy. These are the big challenges that we have.
At the end of the day, this is the only way I see that we can address drug pricing in our country. It’s becoming increasingly challenging in every wing of the government. Democrats, Republicans, and the local states all are struggling to figure out how best to control drug prices, and biosimilars offer the most realistic, most optimistic view to reduce the cost of care.
Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP: We have heard a lot of discussion about everything from the physician, the patient assistance member, the pharmacist, the advanced practitioner, and all these other people. But what about the patient, right? The patient is who we’re administering the drug therapy to.
There’s a large discussion on this. How do you educate the patient about biosimilars? Do you do that education? Consent forms? Do you consent the patient to a biosimilar as well? These are largely unexplored areas. For the patient, the educational piece is still being developed. We have a lot of patient support groups across the country addressing this.
We still need to maintain and educate our patients too about what are biosimilar needs. Because there can be some misconstrued discussions, you know? For example, when Dr Scott Gottlieb, the [former] FDA commissioner, was discussing the biosimilar action plan about a year ago, there was actually a lot of information in regard to the fact that you can’t create negative information about a biosimilar, which was occurring. This actually allows us to provide the correct patient medication and also helps provide real-world evidence [RWE], something which we didn’t touch upon. The RWE portion, which is part of the pharmacovigilance piece of biosimilars, will also help assuage any fears by the patient and also the physician. There are some interpretations there, there are some education pieces there as well, and they also work for discussion just with the patient in addition to it.
And that’s just on the infusional side. When we have therapeutic agents—some right now, but more in the future—occurring on the specialty pharmacy or pharmacy side, where there is not an infusional center, they’ll all see more pieces to that puzzle as well.
How do we ensure that patients are aware of the actual properties of biosimilars and the pieces for approval of biosimilars? That’s a great question. Again, that’s a key discussion—the educational piece; the counseling piece, which is often done by many of our pharmacists and physicians; and also advanced practitioners—when we’re taking a look at these different pieces. The biggest piece will be to make sure you understand that these are biosimilars. They’re similar to the actual approved product, and they’re also indicated based on clinical studies as well. So making sure they understand the stepwise fashion and what this means in terms of biosimilars.
Don’t forget, about 20 or 30 years ago, we did the same thing with generics. We have already done that switching from a brand name to a generic, but now we’re redoing that same piece as well. What makes it a little more interesting is that it’s a biologic. We haven’t done this approach recently. In Europe they’ll switch almost every quarter or every year from 1 biosimilar to a biologic or a biosimilar itself. They’re switching every year. How do we address that from our own perspective? Again, I’ll be making sure the patient is educated, aware of the drug therapy, aware of the biosimilar, and making sure they have an understanding of what that biosimilar means to them and also to how it was approved as well.
There are a lot of different institutes out there, organizations that have attempted and also developed different educational materials. We have seen a lot of forefront discussions by FDA. The FDA has done a fantastic job of creating different educational resources for patients and providers as well. I give a lot of kudos to the FDA for really not only working on this but also pioneering their efforts to get educational. That’s the major website that I would start to recommend. But we’ve seen a lot of organizations come up with routine ASHP [American Society of Health-System Pharmacists], ACCC [Association of Community Cancer Centers]. A large number of organizations, including ASCO [the American Society of Clinical Oncology] as well. There is a lot of great work being done across the board for biosimilar educational purposes. We’ll need a lot more coming up, patient-specific work for development as well as the resources again to address this. But those are just some great organizations and also great agencies dealing with education as well.