EP396: How to Answer This Question: Will Humira® Biosimilars Reduce Drug Spend? With Anna Hyde

There are two facets of the Humira biosimilar market and launch that Anna Hyde, my guest in this healthcare podcast, talks about. One is market dynamics. The second is provider and patient confidence. These two concepts are tangled up together and cannot be separated. But let me back up a sec and explain, although Anna Hyde covers this really well and offers context in the interview that follows. So, first facet: market dynamics. This means fostering competition so the price of something goes down. That is the basis of capitalism. After all, you need competition to get in there and try to steal customers from each other by scuffling over price. In 2023, there's supposed to be 12 biosimilar products for Humira that come out. So, we'll see scuffling and lower prices? Hmmm … maybe not so fast. Second intertwined facet: provider and patient confidence that the biosimilars are as effective and have similar side effects (ie, there is confidence that the biosimilars are actually, for reals, interchangeable with the so-called reference product [ie, Humira]). Bottom line, if providers and patients are not confident in the biosimilar, then no prescribing is gonna happen. Couple those provider and patient clinical concerns with a concern about manufacturer financial assistance. If providers and patients are worried that the out of pocket will be too high and the biosimilar manufacturers are not gonna offer any financial assistance, then, again, no confidence, no prescribing. So, if either or both of these concerns is present and the no prescribing is the result, this vote of no confidence means there will be no or limited uptake of the biosimilars. And what does the no uptake mean? It means no lower prices. Having competition per se isn't gonna lower the prices because the monopoly remains the monopoly. It's having uptake of the competition that will erode the monopoly. It's having patients who are willing to migrate to the competitive products. And this is pretty vital here because, right now, there's a lot of cynicism out there about this biosimilar launch and that it is not really going to lower the cost of these drugs much for plan sponsors. And, you know, is anyone terribly surprised given it sure seems like AbbVie, who is the manufacturer of Humira, still has a lot of dominance in the market? "How do they still dominate the market even though their patent thicket years are officially over?" you might ask. For one, they have payers over a barrel because members who need the Humira molecule are still 100% on Humira. Thus, AbbVie can still demand contract terms for Humira like the demand that Humira has the lowest patient out of pocket for patients or has an equivalent out of pocket to any formulary biosimilars. And this is currently going on. (Listen to the show with Dea Belazi [Encore! EP293] for why that matters so much from a market dynamics standpoint.) A second reason why Humira can still dominate the market even after their patent expiry is that plans and PBMs (pharmacy benefit managers) are, as Chris Sloan put it in episode 216, "addicted to rebates"; and Humira offers big rebates, which they will likely increase to match any pricing pressure from biosimilars. Here's a quote from the Goodroot white paper on this Humira biosimilars business, which is otherwise known as the "hottest topic in pharmacy." Goodroot says, "Given the cost-rebate power play—and the monetary loss that PBM[s] ... assume when rebate dollars are removed—we don't anticipate any significant shift to biosimilars or cost savings as Humira biosimilars become available." So ... doom? Not so fast. The Goodroot white paper continues with this next quote, and this is exactly what Anna Hyde also talks about and gives some historical proof points for, actually. Goodroot says, "There may be a tipping point in biosimilar pricing where the net cost differential will be significant enough to force [plan sponsors/payers] to make their PBMs prefer the biosimilars." And then the white paper says exactly what Anna Hyde also says, and which I reiterated moments ago: "[For this tipping point to happen], this significantly lower net price must be coupled with a significant shift in market share to make up for the loss of [the] Humira rebate." Let me translate that: Provider and patient uptake has to happen here for the prices in this therapeutic category to go down across the board to meet that tipping point. Anna Hyde gives some great advice, and this advice is all summed up on a landing page on the Arthritis Foundation Web site. This landing page includes advice for health plans, and a big part of that advice is to communicate clearly with physicians and other providers and also, essentially, with members and patients. Patients cannot find out that they just got switched to a biosimilar when they get a different box in the mail with a different med with a different delivery device that they have never seen before with a needle that's gonna pop out from some mystery location. This is a Fail (with a capital F) for all kinds of reasons that could ultimately undermine the whole Operation Biosimilar some plan is trying to pull off in an effort to try to lower prices to a tipping point so everybody can save money. There is evidence to suggest that, over time, biosimilars can reduce costs—maybe a lot. But for this to happen, it's gonna take really a thoughtful approach filled with bidirectional communication with providers and patients. Cannot forget this step. If everybody's on the same page, it may take a bit; but market dynamics will eventually kick in and prices will go down across the board. Everybody wins. My guest today, Anna Hyde, is VP of advocacy and access over at the Arthritis Foundation. She's a federal lobbyist and helps advance legislation and policies so patients can have better access to affordable medications and specialists. If you're looking for more insights into topics we discuss today, I suggest listening to the encore with Dea Belazi (Encore! EP293) about co-pay assistance programs; the show with Chris Sloan (EP216) about how plans get addicted to rebates; and if you really want to take a deep dive, check out this playlist of eight specialty pharmacy episodes. Listen to all of these shows and you will know more than 99% of healthcare insiders about who is kicking back to who and where the dollar is going in the specialty pharmacy market—which is essential background information if you're planning to evaluate the impact or the potential impact of these biosimilars.   You can learn more by emailing Anna at [email protected] and connect with her on LinkedIn.  Anna Hyde is the vice president of advocacy and access at the Arthritis Foundation. She oversees both the federal and state legislative programs, in addition to grassroots engagement. Her focus is to raise the visibility of arthritis as a public health priority; build support for federal and state legislation that ensures access to affordable, high-quality healthcare; and enhance patient engagement in the policy-making process. Anna previously served as senior director of advocacy and access, managing the federal affairs portfolio and overseeing the state advocacy team. Prior to joining the Arthritis Foundation in 2014, Anna worked as senior manager for federal affairs at the American Congress of Obstetricians and Gynecologists, where she managed a portfolio of issues, including appropriations, physician workforce, and health IT. She began her health policy career as a Congressional Fellow for Energy and Commerce Committee members, where she drafted legislation and staffed committee activities. Anna received a bachelor's degree in history from Southern Methodist University and taught junior high and high school history before moving to Washington, DC, in 2007 to pursue a master's degree in political science from American University.   07:38 What does a successful biosimilar market depend on? 09:07 Why does uptake seem to reduce prices? 10:24 How important is the relationship with the healthcare provider? 11:35 Where are we in getting these biosimilars to market? 13:02 Are there differences between the reference product and biosimilars? 19:26 Why does the way you approach the patient matter? 22:36 Why do providers feel like they don't have a lot of agency in the biosimilar conversation? 24:50 What should health plans be thinking if they want to go down the biosimilar path? 27:36 "Our goal is to keep a feedback loop such that no patient falls through the cracks." 28:21 What is the "nocebo" effect? 31:27 What is Anna's advice to plan sponsors on communicating with providers and plan sponsors?   You can learn more by emailing Anna at [email protected] and connect with her on LinkedIn.   Anna Hyde of @ArthritisFdn discusses the #humira #biosimilar market and launch on our #healthcarepodcast. #healthcare #podcast   Recent past interviews: Click a guest's name for their latest RHV episode! Dea Belazi (Encore! EP293), Brennan Bilberry, Dr Vikas Saini and Judith Garber, David Muhlestein, Nikhil Krishnan (Encore! EP355), Emily Kagan Trenchard, Dr Scott Conard, Gloria Sachdev and Chris Skisak, Mike Thompson, Dr Rishi Wadhera (Encore! EP326)