Consider patients first. Right now, the healthcare system is not set up to benefit patients. Cost-effectiveness watchdogs are explicit that they consider insurance companies, not patients, in their assessments, and many insurance company plans are designed to cost-shift to patients. There should be a concerted effort to ask whether any given change in the system — including decisions by biopharmaceutical companies — is in the best interest of patients, and discard those that harm access and worsen outcomes.
As a part of my interview series with leaders in healthcare, I had the pleasure to interview Tim Mayleben. Tim serves as the President and Chief Executive Officer at Esperion, the Lipid Management Company, committed to developing and commercializing cost-effective, convenient, once-daily oral therapies for the treatment of patients with elevated LDL-cholesterol (LDL-C) added onto maximally tolerated statin therapy. Bempedoic acid and the bempedoic acid 180 mg + ezetimibe 10 mg fixed dose combination (FDC) tablets’ new drug applications (NDAs) are currently under regulatory review by the U.S. Food and Drug Administration (FDA), and the marketing authorization applications (MAAs) are currently under centralized review by the European Medicines Agency (EMA). Prior to joining Esperion, Tim was President, Chief Executive Officer, and a director of Vericel Corporation, formerly Aastrom Biosciences, Inc. Before Vericel, Tim was President, Chief Operating Officer, and a director of NightHawk Radiology Holdings, Inc. Tim is an advisor to, investor in, and member of the board of directors of several life science companies, including Kaléo Pharma, Marinus Pharmaceuticals, and the Wolverine Venture Fund. Tim earned an MBA, with distinction, from the J.L. Kellogg Graduate School of Management at Northwestern University, and a BBA from the University of Michigan, Ross School of Business.
Thank you so much for doing this with us! Can you tell us a story about what brought you to this specific career path?
I came to the healthcare industry to help patients and families, as cardiovascular disease is very personal for me. My father suddenly passed away from a heart attack when I was younger, and things changed for our family overnight. I had to leave school for more than a year to care for my mother and six siblings. The connection between what we do and those who might benefit remains personal for me today, as my wife has heart disease. These experiences informed my choice to pursue a career in healthcare, and the pressure is on to prevent other families having to go through what we did. I originally joined Esperion not as a scientist or doctor, but rather on the business operations side. Now, as a leader tasked with introducing medicine that can change millions of lives, I drive everyone involved — scientists, physicians, marketers — to keep sight of the bigger picture, which is the impact that disease has on a patient and their families.
Can you share the most interesting story that happened to you since you began leading your company?
I came back to Esperion in 2009 as a board member and then as President and CEO in 2012. In 2014, my wife and I bought a home in South Carolina and, as part of the moving process, she found a new primary care doctor. She came home from her first appointment and told me that her LDL-C was 200 mg/dL. That is a dangerously high LDL-C level. She was prescribed a statin, and then another statin, and another statin after that. She couldn’t continue taking any of the statins because they caused her severe muscle pain and weakness. She was then prescribed one of the injectable specialty drugs — a PCSK9 inhibitor — but each bi-weekly injection caused her flu-like symptoms that lasted 10 days.
My wife’s experience — being diagnosed with dangerously high levels of bad cholesterol and then being unable to tolerate any of the approved LDL-C lowering drugs — has made the mission of Esperion personal for me. I love what I do, I love that Esperion is changing the world and I especially love that my wife, and millions of people like her, could benefit from the work that we’re doing.
What makes your company stand out? Can you share a story?
It is our team and our mission as a company that allows us to stand out. Esperion is a team of “lipid management experts” focused on developing and commercializing medicines for the many instead of the few. The LDL-C, or “bad cholesterol,” lowering market is full of treatment options, from oral therapies to biologics, yet there are still millions of patients and physicians seeking options with better efficacy, cost, tolerability and convenience. We went back to basics and developed traditional oral, once-daily pills for lowering cholesterol. This method is intended to be a win for patients, physicians and payers.
Can you share with our readers about the innovations that you are bringing to and/or see in the healthcare industry? How do you envision that this might disrupt the status quo? Which “pain point” is this trying to address?
We live in a healthcare system that seeks out the latest and greatest technologies to address what patients need, but our team took a step back and looked at the bigger picture. In the case of LDL-C lowering, some of the new therapeutic options on the market are specialty medications that require injection, inconvenient conditions for storing and multiple in-person visits with physicians, not to mention high costs and a more complicated reimbursement path. To encourage compliance while still prioritizing efficacy, Esperion has developed oral, once-daily pills for lowering cholesterol. This approach is designed to address pain points for patients, physicians and payers. Taking a step back and analyzing the healthcare landscape we live in today, there’s merit in developing a treatment option based on what people need rather than what trends in the healthcare industry are pushing for. Science and innovation can sometimes outpace what patients, physicians and payers can handle. To improve the healthcare industry, it’s important for drug developers to balance the desire to develop new innovative treatments with the cost realities of the overall healthcare system.
What are your “5 Things I Wish Someone Told Me Before I Started” and why. (Please share a story or example for each.)
- It’s about people. I’ve learned that we are in the “people business.” It turns out the most valuable asset we have at Esperion is our colleagues and team members, and we have to care for them above all else. They’re the only thing that can create value and make the world a better place.
- Drug development is really hard and can take a really long time.I was with Esperion from 1998 until Pfizer bought the company in 2004. I then came back to Esperion first as a board member in 2009 and then as President and CEO in 2012. I’ve been working for many, many years to get our drugs approved. We overcame a merger, having our drug “put on a shelf,” a drug failure, a shutting down of R&D, the great recession, the FDA wavering on LDL-C lowering as a surrogate for cardiovascular risk reduction, and the unique challenges of being a Michigan-based company.
- Admit to your mistakes. One of the most important things we can do as leaders is to own up to our mistakes and address them honestly.
- Don’t take it personally. As the CEO of a publicly-traded company, it’s true that the buck stops with you. Criticism comes from every corner, including from shareholders, analysts, colleagues, regulators and others. Everyone, including myself, can say it’s business, but it can feel personal. It takes resilience and great support from those around me to get through those times.
- Pace yourself. The old saying “this is a marathon, not a sprint” really does apply. It’s easy to burn yourself out — and those around you, like family and friends — if you don’t take time away. It’s critical to refresh and gain new perspective.
Let’s jump to the main focus of our interview. According to this study cited by Newsweek, the U.S. healthcare system is ranked as the worst among high income nations. This seems shocking. Can you share with us 3–5 reasons why you think the U.S. is ranked so poorly?
- The Commonwealth Fund looks at specific elements of the U.S. healthcare system that are divorced from medications. We do have a system with a lot of administrative overhead and inequity. There are issues with access. Those issues, by and large, are either systemic issues or rest with other parts of the healthcare system.
- One of the biggest challenges the U.S. system faces is drug pricing. In recent years, we’ve seen the trend evolving away from the traditional blockbuster drugs that are priced low for broad patient populations. These drugs are where society and companies benefit from many people — millions or tens of millions — being helped at a very low individual cost while providing great societal benefit. For example, while cardiovascular disease is still the number one cause of death in the U.S. today, the number of deaths each year has decreased dramatically by more than 100,000 deaths over the past 30 years as a result of statin use for cholesterol, according to a report from the American Heart Association. But today, we’re seeing many more high-priced specialty drugs, gene and cell therapies and other biologics being developed for orphan and rare disease indications. While these medicines are very important — and we are seeing dramatic individual results — we are also seeing dramatically high individual costs, which places a heavy burden on individual patients and payers.
- Additionally, through payer consolidation, we have seen a smaller number of pharmacy benefit managers (PBMs) and greater level of control for insurers and PBMs. This increase in market power has magnified the impact of restrictive, non-patient-centric decisions, and often puts both innovators and patients at a disadvantage. The PBM-centric, rebate-first system continues to drive the marketplace in the U.S. and the incentives continue to be misaligned, pushing toward high-price, high-rebate medications. Concentration in the payer landscape is also more likely to push more patients into high-deductible health plans, where more and more of the burden is placed on the patient. These plans have the impact of discouraging appropriate care and continues to hurt patients.
- Despite these reasons, the study did not look at some other areas where the U.S. does quite well. We offer access to more medicines sooner than anywhere else in the world, and we continue to be the world’s drug innovation engine. We use generic medicines more efficiently than almost anyone else in the world, freeing up resources to re-invest in new medicines, all of which means that net spending on pharmaceuticals by insurance companies is now below the rate of inflation.
You are a “healthcare insider”. Can you share 5 changes that need to be made to improve the overall U.S. healthcare system? Please share a story or example for each.
In 2019 and beyond, we need to put our words into action by coming together as an industry and with others across the healthcare system to address several issues:
- Consider patients first. Right now, the healthcare system is not set up to benefit patients. Cost-effectiveness watchdogs are explicit that they consider insurance companies, not patients, in their assessments, and many insurance company plans are designed to cost-shift to patients. There should be a concerted effort to ask whether any given change in the system — including decisions by biopharmaceutical companies — is in the best interest of patients, and discard those that harm access and worsen outcomes.
- Reduce the number of uninsured Americans. We know that better coverage means better health outcomes.
- Reduce the number of under-insured Americans. One of the realities of the last decade is that more and more Americans are being pushed into high-deductible health plans that saddle Americans with enormous out-of-pocket costs, forcing them to defer care and harming their health.
- Consider value across every part of the healthcare system. At Esperion, we are confident that our products will bring enormous value to the healthcare system, and we are willing to prove it. But that same lens should be placed on all healthcare products and services, so we can determine — and flush out — areas of clear low-value care.
- Incentivize innovation. There must be a reward for undertaking risky research that has the possibility of providing transformational and cost-effective new therapies for patients. Removing those incentives, as many current policy proposals would, would have a catastrophic impact on our industry’s ability to innovate.
Thank you! It’s great to suggest changes, but what specific steps would need to be taken to implement your ideas? What can individuals, corporations, communities and leaders do to help?
First, companies must recognize the value in preventative medicines that can help to avoid future surgeries or mitigate more healthcare spending. More can be done to drive focus and innovation in this area. In Esperion’s case, we’re focused on developing future life changing therapies, with the goal of having them be reasonably-priced that can help millions of people with high levels of LDL-C. We want these to be therapies that patients and payers can afford.
We are also entering a position of important policy debates about how elected officials can re-shape the healthcare system to drive out disparities, lower costs and improve outcomes. It’s vital that all sides recognize that there are tradeoffs to every decision. In the case of biopharmaceuticals, the tradeoff to more aggressive regulation on drug industry pricing will be fewer new medicines in the market. It’s critical that everyone takes the time to consider the impact on innovation, especially early-stage innovation in biotechnology, as we consider changes in the healthcare system.
We must also ensure that cost-effectiveness and system-wide assessment of value becomes priorities in this environment. Right now, medicines are held to a high level of scrutiny around cost-effectiveness. This isn’t inappropriate, but the other 85 percent of healthcare spending, by and large, escapes such examination. That needs to change. We will not be able to change the system until we are realistic about examining all costs.
There must also be better consumer education about how the healthcare system is set up so that every American can make more knowledgeable choices about everything from the medicines they are prescribed to the insurance plans they select, so they can push their employers and elected officials to move in a more patient-centered direction.
What are your favorite books, podcasts, or resources that inspire you to be a better healthcare leader? Can you explain why you like them?
I like The ReadOut Loud, Freakonomics, A Healthy Dose, How I Built This, The TED RadioHour, and Planet Money. I love reading almost anything that comes from STAT and Endpoints News, as well.
How can our readers follow you on social media?