From The Editor | September 29, 2017

How Can Biosimilars Remain Politically Relevant?

anna rose welch author page

By Anna Rose Welch, Editor, Biosimilar Development
Follow Me On Twitter @AnnaRoseWelch

biosimilar industry

Though I’m somewhat ashamed to admit it as the editor of “Biosimilar Development,” one of my favorite presentations at the recent Association for Accessible Medicines (AAM) Biosimilar Council’s Leading on Biosimilars conference was only somewhat related to biosimilars. In his presentation, Andy Slavitt, senior advisor of the Bipartisan Policy Center and former acting administrator of the Centers for Medicare and Medicaid Services (CMS), provided a thousand-foot view of the current, contentious healthcare landscape and what he expects it will look like in the future.

According to Slavitt, the U.S. healthcare space is likely to see yet another federal healthcare debate in 10 years. (And to think, we’re not even through this one yet.) He posed the important question: “If we are going to have this debate again in the 2020s, and we want to get what our country deserves out of it, what do we need to do now?” But I’d also like to “extrapolate” his discussion to discuss a more biosimilar-centric question: What does the biosimilar industry need to do now to ensure it’s a relevant and central part of current and future healthcare reform?

Healthcare Innovation, Affordability Means Fewer Gadgets, No More Platitudes

Though the Affordable Care Act (ACA) is not perfect, Slavitt argued it has accomplished a few key things, like cutting the uninsured rate in half and adjusting healthcare costs and quality. But to him, the most important accomplishment of the ACA was that it “changed the compact between the American citizen and the government around what they can get and should expect from healthcare,” he said. “For the first time, we, as a country, said that an individual’s health history and financial status did not matter. They were entitled to insurance.”

As I highlighted in my previous article on this event, there was great emphasis on expanding accessibility so even more citizens have access to innovative treatment — which is where biosimilars fit in. But in order to truly “unlock the innovation potential of a country,” according to Slavitt, we need to redirect our focus and broaden our views of the country’s differing populations. The person who is going to benefit from healthcare the most is not the retiree who has a rigid exercise and diet plan; it’s the woman who needs dialysis but lives far enough away from her treatment center that missing the bus to the hospital one day could be a matter of life and death.

“The social determines the physical and mental health,” Slavitt stated. “We have to figure out all the things outside of the healthcare system that we, as healthcare people, can’t control. We have to redirect innovation away from the gadgets — the Fitbits and the artificial intelligence — toward figuring out how to take care of all the populations in this country.”

However, there are several imbedded perceptions holding the healthcare and pharmaceutical industries back from realizing affordability and, in turn, greater accessibility. In conversations with a number of healthcare system CEOs, Slavitt has heard several increasingly familiar arguments/platitudes. There are three in particular he touched on: “Don’t look at me, look at them;” Don’t worry about the price — no one pays it anyway;” and “If you want innovation, you’ve got to pay for it.”

Many of us have likely heard these phrases, which Slavitt acknowledged are all accurate. “From where these healthcare CEOs sat, they were certainly telling me things that were true,” he explained. “But if you brought in a lens to look at the whole healthcare system, you would also see places where you might disagree.” For instance, if you were to consider the situation from the consumer’s point of view, it doesn’t matter the reason or who/what is responsible — if they cannot get their necessary medications, it’s a problem.

Slavitt also acknowledged that innovation does cost money. But it’s important to consider that innovation and efficiency are expected in all other industries. Technology companies and online retailers like Amazon have established a model to provide us with more for less. “We have to ask ourselves, as a country, is that really the tradeoff with demand?” Slavitt asked. “Do we have to choose between innovation or efficiency and affordability? The answer is, no, we can’t. We can’t afford to have to choose. We have to figure out how to have both.”

Where Biosimilars Fit In: Crafting The Right Story

We’ve heard biosimilars are the gatekeepers to both innovation and affordability. Not only are the products challenging to make, but the savings they invite can also help increase healthcare budgets for innovative novel drugs. Since affordability is likely to be a high-ranking concern throughout the next five to 10 years, it’s a good time to be in the biosimilar space — especially during the drafting of important legislation and policy.

However, Slavitt cautioned that one of the greatest challenges facing biosimilar makers is going to be remaining part of the solution to high healthcare costs. In some cases, being the solution might mean not always getting everything the industry feels is necessary. “I think the greatest opportunity and challenge with the biosimilar industry is to remain part of the solution, which means there will be opportunities where, by giving a little, you can gain a lot,” he said. For instance, he mentioned the industry might not always gain everything it wants as a policy option, but it’s important to keep progressing.   

Another challenge will be to amplify the biosimilar industry’s messages so they are heard on The Hill and remain politically relevant. In many cases in the U.S., there has to be a highly vocal grassroots movement to ensure key messages are heard. Though organizations like The Biosimilars Council and the AAM are out in force, many citizens remain unaware of some of the contradictions in our healthcare space today. Take, for instance, the outcry for cheaper medicines, but the legal IP and payer contracting strategies standing in the way of biosimilars. To “connect these dots,” Slavitt said, will involve a “multi-pronged effort.”

At this point, the biosimilar space faces great competition for congressional focus, not only from the ongoing healthcare policy debates, but also from Russia, North Korea, taxes, and infrastructure. One of the most interesting takeaways I garnered from Slavitt’s talk was the need for the biosimilar industry to find new ways to increase its relevance in the midst of these issues. As he described, “Having biosimilars fit into some of that overall story besides just offering healthcare affordability — whether it be through jobs or other initiatives — will be important over the next couple of years.”

Since the conference, I’ve been thinking quite a bit about what this could look like. If you look at the efforts of the FDA thus far, it hasn’t been afraid of doing things its own way (for better or worse), whether developing a new naming system or regulating interchangeability. The FDA seems intent on putting its own unique stamp on the biosimilar industry. In fact, I’d go so far as to call this amount of attention to blazing new(ish) trails almost patriotic.

Though Slavitt did not highlight any specific ways companies could fit into the overall story, one of the closest examples that came to my mind was Coherus’ strategy to differentiate with American-made biosimilars. Though Coherus hasn’t yet launched a product and didn't release its research reinforcing the claim that American-made biosimilars will be preferred, there’s something to be said about the company’s claim given the current emphasis on bringing back and bolstering American jobs. Biosimilar trust and use will come down to a number of factors, with safety and efficacy being the key (regardless of manufacturing location). But in this space, where I truly believe there’s plenty of room to explore new stories and styles of messaging, this example certainly takes us into new territories beyond affordability.