Biosimilar drugs have the potential to make a significant impact on prescription drug costs. Optum Rx's Savitha Vivian joins the Weekly Dose podcast to discuss the pipeline of biologic drugs and the impact they could have on access and affordability.
The use of biosimilar drugs – which mimic existing biologic drugs – could reduce U.S. drug costs by more than $100 billion over the next five years. However, there are still challenges in getting these lower-cost medications into the hands of patients. Savitha Vivian, Senior Vice President, Clinical and Formulary Services at Optum Rx, discusses the pipeline of biosimilar drugs – including a highly-anticipated 2023 launch – and how broader use of biosimilars could improve prescription drug affordability for patients.
Ira Apfel
Hello and welcome to UnitedHealth Group’s Weekly Dose podcast where we'll get you up to speed on the latest trends shaping the future of healthcare. And don't forget to subscribe on Apple podcast and Spotify, so you never miss an episode.
In the world of pharmaceuticals, biosimilar drugs are drawing a lot of attention. As their name implies, biosimilars are similar to traditional biologic drugs. However, biosimilars provide a roughly 30% discount of brand biologics in the United States, and they have the potential to reduce spending by more than $100 billion in the next five years, according to one study. The FDA recently approved the biosimilar for ophthalmologists, a biosimilar for blockbuster trick HUMIRA is coming to market in 2023, and the first interchangeable biosimilar was released this year -- all of which are making pharmacy benefit managers increasingly focused on this area.
While the FDA has approved 30 biosimilar since 2015, however, only that 60% had made it to market. Additionally, more than three quarters of physicians in a survey said biosimilars are just as safe and effective as your biologic counterparts. But only 31% said they were very likely to prescribe a biosimilar to a patient already doing well on a brand biologic.
So why are biosimilars rolling out in fits and starts seemingly, here to make sense. The biosimilar landscape is Savitha Vivian, She's the senior vice president clinical and formulary services at Optum Rx. So Savitha Vivian, welcome to the podcast.
Savitha Vivian
Thanks, Ira. It's great pleasure to be here today.
Ira Apfel
So let's start off. Can you first explain what a biosimilar is and what role to has in disease treatment?
Savitha Vivian
Okay, so before we get to biosimilars, let's start with what a biologic is now biologic. biologics are drugs produced in a living system or organism, and because of this, they are very large, they're complex molecules, or even mixtures of molecules. And their exact structures are not easily identified or characterized. Now, in contrast, when you have a non biologic drug, these are typically manufactured through chemical synthesis, which means that's made by combining specific chemical ingredients and an ordered process. Think of it as like a precise recipe that you use to get the same product every time you try to make it. Now a biosimilar is considered to be highly similar to an existing FDA approved biologic known as the reference product. So even though it's highly similar, the FDA requires that a biosimilar has no clinically meaningful difference when compared to that reference biologic so we're expecting the same effect. Now as far as the role and disease state treatment biologics and biosimilars often represent cutting edge biomedical research and in time may offer effective means to treat a variety of medical illnesses and conditions that today we just don't have real good treatment options available.
Ira Apfel
So that gets to the next question that I have was what's the benefit of biosimilars to patients and also just the healthcare system overall?
Savitha Vivian
Great question. So biosimilars are generally up to 15 to 30%, lower in pricing compared to a reference brand. And because of this price pressure, as more biosimilars enter the market, it increases the competition and increases choice in leads to greater savings for patients and clients. And what so this decrease in costs really opens up patient affordability it, it opens up patient access, and biosimilars really provide patients access to some of these effective treatment options at reduced costs and thereby saving 10s of billions of dollars for the healthcare system.
Ira Apfel
Okay, so now we've established what a biosimilar is, what it can potentially do and what it can't potentially do. I'm curious how many Biosimilars are in the pipeline? What is the size of the industry?
Savitha Vivian
So the overall biologic market is really strong. And this is reflected by much of the recent innovation that's happening. Also, it's also indicated by the fact that many of the FDA approvals of recent are in the biologic arena, and there is a huge representation of biologic products in the pipeline. So today, the FDA has approved over 30 biosimilars, and about 20 of these products have launched. The good news. There's many more in the biosimilar pipeline, it's robust and it continues to grow over the past year. Actually, over the past seven years, the number of biosimilar products in the drug development pipeline has increased on average of over 12% each year. Ron has more than doubled in that time frame. Today we counted almost 2000 biosimilar products worldwide and various phases of development. And from a cost perspective, you know, the spending on biologics is continuing to grow and it grows at twice the rate of the total market. So the promise of biosimilars is a welcome competition and I don't see the effort and focus on biosimilars ending soon.
Ira Apfel
So that's interesting to me, because what when I was preparing for this session to interview you, you know, it seemed like the number of biosimilars being approved or being used was low. Again, I'm just I'm just, you know, an immature and you're the expert. What are some areas? I mean, am I wrong about that? Or am I just kind of like at first glance, that may be true, but like really further, if you look further down, it's really a robust growing industry?
Savitha Vivian
Well, I think what we're seeing is that the majority of biosimilars today are focused in areas such as oncology, immunology, hematology, and then most recently insulin. And so as far as prevalence goes, these probably aren't the most prevalent disease states and so therefore, the use of biosimilars is somewhat limited. We're still a few years away from a point in which some of the most widely utilized biologic products in the United States today will be available in a biosimilar form. And we I feel like this is what's going to help us see a much more sizable, impactful effect of biosimilars and its ability to realize some of those bottom line savings that we're hoping for. And I'll give you one example Humira, which is one of the top utilized specialty drugs and trend drivers for many of the payers in the United States is one of the most anticipated biosimilar launches that's coming in, and it's expected in 2023. And some of the other significant launches include noval and insulin which would help with the diabetic population, a very prevalent chronic condition, and then some of the other auto immune disease states that are going to see some impactful biosimilar launches include products such as actemra and Stelara, which is used today.
Ira Apfel
So what's the potential then biosimilars? I mean, I, I don't imagine a lot of patients will be out there asking for a biosimilar tomorrow, but who, who is really interested in this who can really benefit from this in the healthcare industry? And also, how can you how can we help, you know, practitioners and, and hospitals and providers, kind of build up that muscle memory of, you know, using biosimilars and working with biosimilars because it seems like it's just kind of like a new thing to learn for them.
Savitha Vivian
So as far as the the future biosimilars, I think there's tremendous opportunity for quality care to be delivered at a lower cost. So stakeholders such as PBMs, and providers and patients continue to learn from each entry to the market. Initial launches were challenged by multiple unknowns in terms of unclear coverage and reimbursement pathways, but providers, evolving federal and state guidelines and low provider and patient confidence. This was relatively a new area, a non unknown and as expected, yet with experience, it's going to going to change. So with each entry, we're going to build that muscle memory and I believe that it will improve receptivity and adoption. And another piece of the biosimilar puzzle that we're we're looking forward to is interchangeability, which is an important advancement in in helping to create that confidence and the ability to use biosimilars without anticipated change in efficacy, as well as the ability for the pharmacy to start substituting biosimilars. When a biologic is prescribed without the physician intervention. As far as payers, it's been a little bit mixed in terms of coverage. I mean, the ultimate goal of what a biosimilar is intended for is to is to help lower cost and payers are looking for what will lead to the lowest net cost. And you know, as a PBM, we often work with pharmaceutical companies to help negotiate discounts off of the reference brand product and so in our goal to look for lowest net cost products, sometimes it's the biosimilar and sometimes it's the the reference brand with the negotiated discount.
Ira Apfel
Now if Imagine that it might be difficult for some physicians to switch their patients from biologics over to biosimilars. Maybe they never even heard of the biosimilar alternative. Maybe they just don't see the research numbers there yet that data. So what's being done to kind of facilitate that because that seems like another sticking point.
Savitha Vivian
You've hit a great point. I mean, prescriber, prescribing provider comfort, it's a critical barrier to adoption of biosimilars. But there's been an increase in prescriber education that's led to confidence through their experience and using biosimilars, especially in New to therapy patients. There's still some hesitations in switching patients who are stable on therapy. And what we really need is that data that shows no additional risk is going to be seen when you switch a patient who's stable, especially in those hard to control chronic conditions. The other thing that's been a challenge is the lack of interchangeability and how our worth this is starting to change. We now have two biosimilars that have been approved for interchangeability, one in the insulin space and the second in the rheumatoid arthritis space. And what interchangeability can do is that it can facilitate biosimilar adoption for two reasons. One, there's been studies that show additional risk or there's no additional risk or reduction in efficacy for patients which is back and forth. And also now the biosimilar can be substituted for that reference brand at the point of dispensing by the pharmacist without needing a new prescription.
Ira Apfel
So what role does Optum Rx play in all of this? And how are you helping Optum.
Savitha Vivian
So as a leader working to lower cost and improving care, Optum has taken action to support fair and competitive marketplace for these biosimilars. This includes three things. One is positioning biosimilars as an affordable option. Pharmacy care service organizations like Optum leverage the competition among prescription drug products to reduce costs for patients. We increase, increasing competition through the approval of more brand generic biosimilar drug competitors will enable organizations like us to effectively lower that prescription drug costs for patients optimal so closely monitors biosimilars in the approval pipeline and has given biosimilars a preferential position on our formularies to increase use over approved biologics when they drive to lower costs for plants and consumers. Second, we partner with providers to increase awareness of biosimilars, we've partnered with Optum primary care specialists to help prescribing physician prescribing physicians better understand the potential of biosimilars and to improve patient care and lower total cost and this approach has saved over $8 million in the four first four months of 2019. And then lastly, we're working with increasing biosimilar adoption for patients with cancer. Optum is also piloting a program to expand biosimilar adoption among our oncology practice groups. Early results are showing biosimilars driving improved health outcomes and cost savings and applying evidence based prior authorizations requirements to one class of oncology drugs to encourage physicians to prescribe the most cost effective medications Optum has saved consumers, the health systems payers and medical groups more than two and a half million dollars in just four months.
Ira Apfel
It sounds like we biosimilars, it's, there's no like huge, insurmountable sticking point or hurdle, it's just kind of like a slow grind, a slow process to get everyone up to speed and to get more biosimilars in through the pipeline. Do you see it that way? Or? And if so, does that make you in particularly, you know, optimistic for the future?
Savitha Vivian
I do Ira, and this is why I'm who I think so if I think back two decades ago, when generics first started entering the market as a retail pharmacist, I had to do a lot of convincing to get a patient to use a generic drug over a brand. And, and that we thought that that was tough, right and we've gotten over it we've we patients are constantly or consistently looking for generic opportunities to save money, it's become the norm. And, you know, like that I think biosimilars could get there. We're in the early stages of biosimilar introduction to the market. So is going to take time. It's time through experience, it's time through additional data that really offers some huge opportunities in the future for better costs better value. And I think as more products come to the market, especially in those areas where there is broad utilization of the reference brand in chronic conditions, that it really opens up some great opportunity to impact the broader patient population in the healthcare system.
Ira Apfel
Savitha Vivian, thanks so much for being on the podcast today.
Savitha Vivian
Thanks, Ira. Thanks for your time.
Ira Apfel
That's it for this episode of UnitedHealth Group's Weekly Dose podcast. Don't forget to subscribe to the Weekly Dose podcast on Apple podcasts and Spotify. Thanks for listening and have a great rest of your week.