Part 2: Jorge Garcia on Giving Pharmacists Latitude to Switch to Biosimilars

To watch part 1, click here.

The Center for Biosimilars® (CfB):I'm Tony Hagen, senior editor for The Center for Biosimilars®. Today, we're talking with Jorge Garcia, assistant vice president of the Oncology Service Line at Baptist Health South Florida and also a member of the Association of Community Cancer Centers' Board of Trustees. Garcia explained how Baptist Health gave pharmacists latitude to issue biosimilars to patients to reduce administrative complications and save money. He also discussed strategies used by innovator companies to keep biosimilars off the market and the effect this is having on patient access.

Reimbursement is a significant barrier [for biosimilars]. At Baptist Health, you've managed to increase biosimilar use by putting the pharmacy in charge. Can you describe how you achieved that and what you learned from this experience?

Garcia: Absolutely. So, I think for a successful biosimilar implementation, one of the key components is that for every patient and every administration, you have to [check] out the benefits. And we do that, again, for every patient on every administration, because the patient's benefits could change throughout the course of the therapy. We see that a lot with Medicaid patients and older patients that have life changing events and other things of that nature.

So, prior to our new process, our authorization team would go ahead and get an authorization for whatever the doctor was prescribing, and when they were not successful getting an authorization, they would have to contact the provider again and have them write for a different product based on what that health plan required. And that process was convoluted. The physicians, sometimes, would not get that message on time, or it would take them some time to update the system to the new orders. And this would be, obviously, frustrating to the authorization team and very stressful as the date of treatment got closer and closer and we still didn't have the right orders for that patient.

What we did to eliminate that is we, today, follow a facility preference approach where when we review biosimilars in P&T [pharmacy and therapeutics committees], we provide our authorization team with our facility preferred products. So, regardless of what the prescriber prescribes, our authorization team will always try to get an authorization for our preferred product. And if they're not successful getting an authorization for our preferred product, then they tailor to whatever the health plan provides. And they document that in the EMR [electronic medical record]. When our pharmacists are verifying that product under the product dispensation, we see the notes from the authorization team, saying specifically which product the health plan approved, and our pharmacists are able to independently switch to the product that the patient has benefits for.

What that did in turn is it eliminated the providers from being a part of that workflow. We do have an automatic substitution policy that we had in place way before biosimilars existed. And we just added our biosimilars to that policy. And of course, we have provided input about what goes into that our substitution policy that basically allows us to independently make those changes without having to consult with the providers every single time.

This has been a huge satisfier for the providers, because what they want is for the patients to get the drug. They know that a lot of this is heavily payer dictated and they don't want to be involved in the logistical piece of it. All they want to know is that their patient is going to get the drug that they intended. Our authorization team is also not having to constantly be contacting the providers to have things changed. So, this has really been a best practice that has been transformational in our ability to manage the day-to-day, where we leave very little room for error there, because we do that benefits investigation on a dose-by-dose basis, obviously, patient-by-patient.

CfB: So, a doctor will not prescribe by brand; he or she will prescribe by the generic name of the product, say trastuzumab or bevacizumab. And your team will decide on whether you can get preauthorization for the biosimilar that goes by that name or whether you have to use a brand product or something else, is that correct?

Garcia: That is exactly correct. And if, in any way, the provider wants to keep the brand names, they have the ability to write ”medically necessary,” just like we would write in a prescription. But we don't see that very often at all.

CfB: To make a system like this work in harmony, you need to overcome certain complexities. You may need to educate all the stakeholders in your institution. Can you describe how you accomplished this and how you smoothed the way for a process like this?

Garcia: Absolutely. I think when we think about a biosimilar implementation, a few stakeholders come to mind. Obviously, the pharmacy, nursing, and the providers. But there's more. There are the IT [information technology] teams. Typically, those IT teams have a long agenda of priorities, so the biosimilar agenda has to fit into those. They’re an important stakeholder to keep in mind. Also, with the type of capabilities that they can provide to support this process, I mentioned that we moved our program to document it in our EMR and that required a simple interface that IT was able to do for us. And we also have drop-down options for multiple products, and you just have to work with your IT team to understand what kind of capabilities they can lend to you to make this process successful.

But it also requires including the registration team for some products, like pegfilgrastim. What product you choose dictates whether the patient is going to get treatment that day or the day after. So, [the registration department] has to understand that to be able to register patients appropriately. And then, the business office, the authorization team, and others. In my experience, those clusters of teams can vary within one organization. So, I will have to meet with a group of folks if I do a biosimilar implementation in an outpatient facility. If I am doing the same biosimilar implementation in an inpatient facility, there is a different nursing team, a different pharmacy team, and a different authorization team. So, you have those clusters of teams that are going to work closest to that site of care to be able to have it be successful.

CfB: We've discussed the pegfilgrastim differentiation and how an innovative product can take market share away from biosimilars, just as Neulasta Onpro has done. Patent thickets around adalimumab [Humira], have prevented biosimilars from reaching the US market. How are these things affecting the success and the sustainability of the biosimilar market?

Garcia: Yeah, there's so much that goes into this. And I really appreciate this question. But I think the important thing to recognize is that biosimilar companies take a lot of risk when they decide to pursue a biosimilar. We know that there is no patent protection for biosimilars. So, you could have any number of players in that market when you decide to pursue biosimilar adalimumab. You know that many other companies may develop a biosimilar and they will play in that space. You’re never guaranteed a market share of that, if at all. We need to recognize that component.

In the space of adalimumab specifically, we know this is the one biologic with the highest cost at a global scale. Here in our country, we see that that product has lifted the entire patent exclusivity period. And we still cannot pursue biosimilar options due to patent litigations and other things until 2023. That's concerning. We know, per the FDA website, if we go today, we know that there are several adalimumab biosimilar programs that have been completed and approved. And those companies are standing by until 2023 to be able to give us a biosimilar option.

And again, I think, in our industry, we all understand the full patent exclusivity period and how necessary that is to support innovation and innovative companies. That's not the argument here. The concern is more so that once those products have gone through the entire path and exclusivity period, how many more years in addition to that do we provide exclusive market access? That's a concern. I think it is less of a concern in other countries that have completely different patent protection laws, and I think that is why Europe has been so successful and we have seen a lot more market penetration of biosimilars in general.

One other point to make here, specifically in the case of adalimumab and specifically as it relates to the level of risk that pharmaceutical companies have when they pursue biosimilars, is that by 2023 when biosimilars for adalimumab may be able to enter the market, the standard of care may be something different. AbbVie [Humira's manufacturer] itself has a couple of new products that are demonstrating better outcomes. And so, when we get to 2023, again, the standard of care may no longer be adalimumab or the biosimilar version of that, but it may be something else. However, these companies have already invested a ton of resources to get their product studied and approved. So, again, lots of risks are involved when it comes to pursuing a biosimilar.

CfB: A recent report by Amgen was very positive on the health of the biosimilar market, and they described rising market share in a number of the 7 different basic drug categories for which biosimilars have been approved. But then if you talk to other people, such as consultants and so forth who are trying to open up those corridors to biosimilar access, they are very discouraged. And they say that the market is not very healthy at all. Depending on who you speak to, it's a great market or it's a very sour market.

Garcia: Absolutely, and what we see is that a number of biosimilar development programs have actually been dropped by multiple companies. Obviously, companies try to have their intel on this, and they assess, through the development period, if it's still worth the risk that they are taking based on the evolving market. In the case of adalimumab, like I talked about before, clinicaltrials.gov is listing a number of studies just trying to assess outcomes with adalimumab compared to all other options. So, depending on where those studies go, again, by 2023, the recommendations may be very different from what they are today.

CfB: Yeah. And, of course, if the recommendations for your products aren’t good, this could be devastating for these 9 companies that are lined up to bring adalimumab products to the market.

Garcia: Exactly.

CfB: And caught in the middle of this issue are the patients. They'd like cheaper medication, but they've got to wait, in case of adalimumab, wait until 2023 to get a cheaper product. So, alongside access to lower-cost products goes affordability. So, you cannot expand the number of patients being treated if you can’t lower the price. Can you discuss these issues?

Garcia: Absolutely. So, a couple of angles that we could take with that question there. I think, especially looking at European models, when you have access to products at a lower cost, you can get more units of that product to make available to more patients. And so, with biosimilars you do look at increased access. It is believed that that access is going to translate into better outcomes. We have ongoing studies trying to paint the full picture there. I think again, Europe is a little bit more advanced that than we are with that regard.

But in models, when we think of the patient out-of-pocket [costs] we think of the typical insured patient, but the reality is that we have patients that are underinsured or completely uninsured. In our geographical area of South Florida, we have patients that are self-pay and we have patients that are international patients [who have to] cover a lot of those expenses directly. So, this means different things to many of those patients' categories. But to your point, in the case of adalimumab, they're not having a biosimilar option at a fraction of the cost the way that they do for other biologics that there is a biosimilar available for.

And I really think, from a provider standpoint, our goal is to make sure that we have a parity approach, so that we present that provider and that patient with options, and based on their situation, they can decide financially what is the best choice. And we do see in our experience that patients are highly sensitive to their financial responsibility, even when it may come down to just their out-of-pocket responsibility. So, when you have that discussion with the patient, and you educate them, in our experience, we see a lot of patients favor biosimilar options.

In our practice, we have a class—a chemotherapy biotherapy class—that every patient must undergo before they begin treatment. We talk to them about biosimilars. I cannot give you any examples of a single patient that have reached out and said, "I am not comfortable with the biosimilar options," and we've had hundreds and hundreds of patients.

So, again, I think patients as stakeholders in understanding the clinical part of the discussion, which is done by a nurse navigator, and the financial part, the out-of-pocket with our financial navigators, tend to be very supportive of biosimilars. But we have to be able to present them with that opportunity. And that's what it boils down to. Sometimes due to a payer restriction, we cannot present them with a biosimilar opportunity or some other times due to just no access in the marketplace, like in the case of adalimumab. Patients are not able to drive that benefit today.

CfB: Providers are often concerned about using biosimilars and they prefer to look at clinical data rather than the type of evidence that the FDA relies upon for biosimilar approval. Can you discuss this issue here? Why can't doctors be persuaded on pharmacokinetics and other types of evidence rather than going for comparative data, which is not considered all that reliable?

Garcia: Yeah, but I think we have to really look at the approval process for biosimilars, which is not to reestablish the safety and efficacy of the compound because that has already been done by the innovator company. The goal is really to demonstrate biosimilarity and or interchangeability. And so, we do rely heavily on analytical studies. But we also do clinical studies for pharmacokinetics [PK], pharmacodynamics [PD], and immunogenicity. And I think that's [where there are] misconceptions. I think some believe that there are no clinical studies at all. But we know that that PK, PD, and immunogenicity studies are there to support every FDA approval.

I think the other component to keep in mind is that if those studies do not yield sufficient evidence, that pathway definitely does call for a phase 3 clinical trial; in this case, it will be more so a confirmatory trial to just try to resolve remaining uncertainty.

Now, the way things have been going here in the US, the FDA has been able to gather enough evidence just by having the PK ,PD, and immunogenicity studies and not requiring those phase 3 studies. But we are seeing that some companies are taking the initiative to have more of a phase 3 type of study design, or, we have not seen it yet, but again, the FDA can request that study if they deem that necessary.

I think what we have to keep in mind here is that balance. The goal of biosimilars is to try to bring product options to the market at the lowest feasible cost. And if we have very robust confirmatory trials, that can get very, very expensive. We already talked here about how there is no path and exclusivity for biosimilar companies. So, they will be doing all of these trials pretty much like the innovator companies did to bring their product into the market with no guarantee of product utilization because there's no patent exclusivity. So, the model itself is not sustainable by just having multiple companies do all of these studies at the phase 3 level.

We followed a different approach looking at most sensitive patient populations and looking at extrapolation and other methodologies, to, again, show that there is biosimilarity. The safety and efficacy of the compound has already been proven.

And I guess, just to close with this question, today, we do have 5 years of pharmacovigilance of biosimilars being exposed to large patient populations in things like extrapolated indications or patients that were interchanged because their insurance required them to change between products. And so far, we are not seeing any indications to pharmacovigilance that there is any clinically meaningful difference in terms of safety or efficacy. Furthermore, beyond the use of biosimilars in our country, we know Europe has another 6 years on top of our 5 years of experience. And in both of these 2 markets that I follow closely, we have not seen any incidents of any biosimilar that have been removed from the market due to a safety or efficacy concern.