Adam Friedman, MD, FAAD, The George Washington School of Medicine & Health Sciences

 The pandemic has certainly amplified some of these hurdles for us. Something I noticed when the hammer dropped in March of last year was that we saw a massive push from payers to fax in requests for prior authorizations. They were really ramping up the nonmedical switching and giving us a very narrow window of time to respond before they went forward. I think they were taking advantage of the fact that they knew a lot of offices were closed, that the world was on fire, so to speak, and that people were out or being furloughed. I distinctly remember my medical assistants telling me about this and that they had never seen such an urgency on the payer side to address these things, and I think it was—granted, this is my own personal opinion; I don’t know for sure, but at least this is how I interpret it—that some were taking advantage of the situation. So that’s 1 problem. Even if that was not the case—because of social distancing, offices closing, and furloughing—even if it was the same old rigmarole, balls are being dropped, things are being missed because people are not there, people are not physically in the office. Calling in there should be limited access, so nonmedical switching and parallel patient hurdles certainly jumped through the roof and became much more efficient. That is not a good thing for the patient or for the practitioner.

In terms of the impact of nonmedical switching and how that translates to overall care, let’s start with having a visit. Initially we were, at least at GW [George Washington University School of Medicine and Health Sciences], predominantly doing telehealth, which can make it difficult in certain clinical scenarios to assess the theory of disease. I’m a huge proponent of telehealth; especially in a pandemic, it keeps people home and safe, and it allows them to get the care they need. Even outside of pandemic, it really overcomes some of the costs I mentioned when it comes to nonmedical switching: going in to see a doctor, having to take off work, getting dependent care, keeping someone at home or even at work. Certainly, if someone is flaring up or they are doing worse and you need to really see them firsthand—maybe some new adverse event is emerging that requires a biopsy, or you need to get blood work done because of it—we are limited, or at least more limited than before. Of course, with severe adverse events, patients need to be seen in the emergency department, which was initially flooded with patients with COVID-19. This is overwhelming the medical system if it is happening, and this puts these patients at risk for infection. Let’s think about who we are talking about here. We are talking about patients with chronic inflammatory diseases who are likely more at risk for poor outcomes when it comes to COVID-19 infections. Think about what is killing people. The virus is part of it, but it’s the inflammatory response, the cytokine storm, that is life-threatening. 

All these diseases I’ve been harping on—psoriasis, hidradenitis suppurativa—just want an excuse to set fire to the inflammatory storm, so to speak. These patients, and we know from some registry data, both inside and outside dermatology, are not controlled on systemic agents like biologics. They actually have the worst outcomes when it comes to COVID-19. Nonmedical switching could actually predispose a patient to worse outcomes if they were to get COVID-19, especially if their medication is not working. My opinion based on the data available to us is that in this current climate it is becoming harder to combat, but it also comes with even more baggage, given the new world we live in.

Nonmedical switching is just 1 of many ways payers get in the way of us doing what we do best and what we love to do, which is care for our patients. Those not involved in the care of our patients should not be making the be-all and end-all decisions regarding how these patients—most important our patients—are being managed. We could be part of the solution and not part of the problem. 

Passive observance makes you guilty of being part of the problem, so what can you do? Get involved with the American Academy of Dermatology (AAD). Get involved with the Alliance for Patient Access. Get involved with your local Dermatology Societies. There are so many ways you can be an advocate for your patients. You could be an advocate for your poor but absolutely incredible staff who work tirelessly to make sure your patients are getting cared for. You could also be an advocate for your colleagues, who are banging their heads against the wall when they get those letters from insurance companies that are telling them what they should be using for their patients even if it is not FDA approved, even if what they are proposing is a misinterpretation of a AAD Clinical Guideline that was published 10 years ago. We need to band together. Together we are strongest, and we will overcome this in a way that won’t burn us out. Rather, we will be victorious and once again help our patients and do the best job we possibly can.

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Adam Friedman, MD, FAAD discusses how payors accelerated non-medical switching during COVID-19 and how healthcare providers can respond to new challenges. 

COVID-19 and Payor Strategies for Non-Medical Switching 

What are ways we can help combat this? I’m just having a flashback to this past weekend, when my daughter made me do this Broadway Zoom dance class. They were doing The Lion King, and there’s a song called “Be Prepared” that 1 of the characters sings. Clearly, I paid a tremendous amount of attention to this. They keep repeating, “Be prepared, be prepared.” That is true here more than anywhere else. You need to be prepared for this. You need to have a good and easy line of communication with your patient so that when they get that notice, which you may not get, they can reach out to you immediately. There are easy ways to do this. I am not suggesting you email every patient, though certainly that is 1 way to do it if it’s HIPAA [Health Insurance Portability and Accountability Act] protected or in a compliance system. However, having a portal can be useful; many electronic medical records have a mechanism so patients can send you messages that are recorded in their chart. Another option is having an after-hours line or having, for example, staff assigned specifically to investigate prior authorizations or things related to medication coverage. That will engender a good relationship and maintain that relationship with a patient.

Next is having a good system in your practice. Many are familiar with the concept of a biologics coordinator. Well, we might need to change that title because a big part of the coordination is also really being an aggressive combatant against these new and ever-changing rules and switches that are occurring in the payer system. It is incredibly helpful to have someone who knows what they are doing, and there are a lot of ways for those individuals to get trained. I would argue that a lot of our industry partners have training programs for your biologics coordinators, and I absolutely have to mention the American Academy of Dermatology, because they have a wonderful resource, a prior authorization tool. This resource is growing by the day. If you have not checked it out, please do. I also want to mention the Alliance of Patient Access and the Derma Care Access Network, which have some really nice patient-facing resources to teach patients what is going on. If they are not understanding what’s happening, who are they going to blame? Rightfully so—knowledge is power, and if you do not know what is going on, the practitioner is the 1 who is going to be blamed, and that will strain the practitioner-patient relationship.

Another thing to think about is also what pharmacy you use. Specialty pharmacies, especially ones you trust that are not getting those kickbacks for that nonmedical switching, certainly work with patients. Very often they will try, or do everything in their power, to use coupons. They have prior authorization tools themselves, but some of the big commercial pharmacies have an incentive to switch these medicines without telling you about it. Last but not least, I recommend that practitioner is part of the solution and not the problem. The more research we have—and I would argue that we have a chance partnering with industry—the better. There could not be a better reason to do so as we both benefit from generating these data about what happens when nonmedical switching wins. Having that data per disease state is going to make our job easier when we fight the good fight to ensure this does not happen to our patients.

A key opinion leader emphasizes the importance of discouraging non-medical switching by communicating with patients and partnering with industry researchers. 

How to Discourage Non-Medical Switching 

 When it comes to the economic impact of nonmedical switching on the patient, there are direct and indirect costs. I’m going to pull a doctor move and say that it has bigger costs. This is not just financial but also physical, social, and psychological. Let’s think about the immediate concerns. Nonmedical switching could possibly result, as we know from past studies in disease recurrence, in worsening or possibly exacerbating or causing the emergence of comorbidities that could end up putting a patient back in the doctor’s office or even in the hospital. That is a cost in terms of the cost of care, the cost of missing work, the cost of needing a dependent care, and also the emotional and psychological burden of their disease going backward, because this would be taking a step back in any progress. 

Then we could think about the long-term costs. Now that this switch has affected patients’ care, they can experience an increased sense of distrust and a lack of confidence in the medical care system, which could affect compliance with this medication but also with going to physician visits. It could affect the overall cost of those comorbidities, which we know are rampant with the diseases we are thinking about psoriasis, atopic dermatitis, and hidradenitis suppurativa. We are in the age of comorbidities, and it is easier to say what is not associated with the conditions than what is. This switching has an immediate cost on multiple facets of daily life, but it also has a long-term cost on the comorbidities, which very often could be more costly than the condition or even the medication itself.

Let’s talk about the nocebo effect, which means that the patient has switched and has no impact from the medication whatsoever. Taking a step back, we do have to think about the mind-body or mind-skin connection. There are no questions: The mind-skin connection, given the embryological source, is the same for both the central nervous system and the integument. Say a patient who is doing well on a medication has finally gotten their life under control; the impact of their condition on their quality of life and daily activities has really improved. Now they’re being told, “Guess what? You are being switched to something similar.” That will have a massive impact on emotional state, on patient perception, and compliance, whether a patient even takes the medication, or how the patient even receives the efficacy if there is any. I can tell you, I’ve had patients tell me that the moment they take their medication—I am not going to name names here, of course—but they will say, “I feel better minutes after I have that injection.” We all know that’s not biologically possible, but the patient believes in that treatment course, believes in your medical decision-making, so they’re thinking that all that has overpowered the disease itself. This is the opposite situation; this patient now feels undermined. They feel that their physician, whom they trust and of course adore, is being undercut by an insurance company that does not know them and does not know what is best for them.

Adam Friedman, MD, FAAD provides insight into how non-medical therapeutic switching affects clinical, economic, and psychological outcomes for patients.   

Impact of Non-Medical Switching on the Patient 

When we start to think about nonmedical switching for biologics—and we have seen the emergence of some biosimilars—some questions certainly have to be raised. If you jump from 1 to the other, are you going to have the same exact effect? The answer, from everything we know, which is somewhat limited but growing, is that that is not the case. Personally, I have not been a victim of this, nor my patients as of yet, because the majority of the biosimilars that are available to us are of older biologics in the world of psoriasis. I find myself using newer generations such as IL-17 or IL-23 blockers, for which we do not have biosimilars.

Fortunately, I have not really suffered at the hand of this nonmedical switching. But what we do know, even outside the dermatology world—in rheumatology or possibly even with inflammatory bowel disease—is that these are not created equally. It is also important to note that generics and biosimilars aren’t interchangeable; that language is not interchangeable in terms of what metrics must be met for 1 of these alternatives to receive FDA approval. From what I’ve heard outside dermatology and from peers, this can be exceedingly disabling. But when we think about biologics in particular, the risk of developing neutralizing antibodies—meaning this kind of switching back and forth—increases. The likelihood that someone is going to develop an immune response that will really affect this medication’s ability to do anything actually goes up. Forget the efficacy, forget the baseline safety. One of our concerns when using this medication is actually amplified when you jump around. In dermatology, even though many of us may not have experienced this yet, it is coming, and we must be prepared for it.

With nonmedical switching, there is definitely a good chance for diminished impact or efficacy. This comes in a couple of different flavors. When we think about topical agents, for example, we are always so focused on the active ingredient—whether it’s a steroid, a calcineurin inhibitor, a retinoid, you name it. It is not always just about the active ingredient, for which there are trade and generic, but also about the vehicle, which plays a big role in how a medication will work. When thinking about trade vs generic, the vehicle is not part of that package; it’s just the active ingredient. The generic may be delivered in a vehicle that does not penetrate as well, that does not interface with the skin as well, or that may have ingredients that could be irritating. 

That can affect efficacy overall. Saying that you are going to switch from a trade to a generic form of the same active ingredient is really saying that there could be 2 different drugs in terms of how it behaves on different skin types, in different locations of the body, and with different disease states. Taking a step up in terms of biologics, we have to consider that biosimilars are just that: They may be similar, but they are not the original. Certainly we have to anticipate that they will behave differently in different patients. What it comes down to is that we just need more research; we need to know 1 way or another what happens when you go back and forth. This is a call to action. We should not wait for this to become a bigger problem. We want to know what is going to happen and have the data ready, so we can argue and fight back when this happens to our patients. A lot of these decisions are theoretically data driven, so if we do not have the resources or the data, that makes it much harder for us. I’ll be honest: It is most important for our teams, who were working tirelessly to get these approvals and fight with prior authorizations and for us. A lack of data makes it a lot harder for us to make our point.

An expert in dermatology discusses the potential impact of non-medical switching  to biosimilars and generic formulations on safety and efficacy profiles.  

Adam Friedman, MD, FAAD, The George Washington School of Medicine & Health Sciences

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