d.health Exclusive Interview
Aetion CEO, Carolyn Magill
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Carolyn Magill MBA
Carolyn is a health care technology executive who brings over 20 years of leadership experience to Aetion. She previously served in senior leadership roles at three of the most important companies driving the transition from fee-for-service to value-based care.
As the CEO of Remedy Partners, she led the market-leading company in providing software and services for bundled payment programs. Prior to that, she was an executive vice president at Evolent Health, where she led the team responsible for operationalizing value-based payer contracts and provider-led health plans serving populations enrolled in Medicare, Medicaid, commercial, and exchange programs. Carolyn has also served in several leadership roles within the Medicare and Medicaid businesses of UnitedHealth Group.
Carolyn earned her undergraduate degree at Harvard University and her MBA in health care management from the Wharton School of Business at the University of Pennsylvania.
D.HEALTH: Aetion is a health care technology company that generates real-world evidence and analysis. Tell us more about what you mean when you talk about “real-world” data and how it can be used in health care.
MAGILL: The demand for value in health care is stronger than ever before. Policymakers want to slow the increase in health care spending. Payers and providers seek the most effective and efficient ways to treat patients – who themselves want to see lower premiums. Biopharma too is increasingly orienting to a value-based world, which requires the ability to understand and demonstrate which treatments work best and for whom, and to invest resources wisely.
Yet often important development, treatment, and reimbursement decisions are made without comprehensive analysis and hard evidence.
The good news is that this is changing – accelerated by the passage of the 21st Century Cures Act and Prescription Drug User Fee Act VI, which require the U.S. Food and Drug Administration (FDA) to develop guidance on how to integrate real-world data into its regulatory decision-making. In an FDA-sponsored study, for example, researchers at Brigham and Women’s Hospital/Harvard Medical School (BWH/HMS) are using the Aetion Evidence PlatformTM to replicate the results of 30 randomized clinical trials (RCTs), to see whether the use of real-world data leads to the same regulatory decisions as RCT data. This project is a step towards implementing real-world evidence for regulatory decision-making. With people living longer and facing the health issues that come with that, getting critical treatments in the hands of patients sooner is more important than ever.
Indeed, one of the biggest imperatives in health care is figuring out how to assess, and ultimately, to maximize a treatment’s impact. Analyzing real-world data – everyday clinical and financial interactions of the health care system, e.g., claims, electronic medical record, and registry data – to produce real-world evidence has a broad variety of applications, including assessing which treatments work best and for whom.
D.HEALTH: How can real-world data be leveraged to improve health outcomes for aging populations?
MAGILL: Adequate representation of certain groups in clinical trials remains a concern. Groups such as African Americans, Asian Americans, and Hispanics as well as children, pregnant women, and older adults are significantly underrepresented in clinical research even though research demonstrates variation in disease pattern, clinical presentation, and therapeutic response. We also know that early users of a newly-approved treatments typically have an existing diagnosis and failed an earlier therapy or suffer from intolerable side effects. Yet, according to researchers at Brigham and Women’s Hospital, “although ischemic heart disease is prevalent in older adults, over 50% of trials registered at clinicaltrials.gov between January 2006 and January 2016 explicitly excluded the elderly.” And according to researchers at Duke University, over one-third of metastatic renal cell carcinoma patients wouldn’t have met eligibility criteria for the Phase 3 RCT – based on their age and severity of disease – that led to approval of the treatment they received.
Real-world data opens the door to specialized analytics that take individual-level randomized controlled trial data and demonstrate the drug’s effectiveness in underrepresented populations, including older adults.
D.HEALTH: What is the single greatest barrier that aging Americans face today?
MAGILL: The greatest barrier that aging Americans face today is the loss of independence from their activities of daily living. These self-care activities, like feeding ourselves, bathing, and dressing, are things most people learn in early childhood and tend to take for granted as they mature. We have not done enough to ease this process for aging Americans. This diminished ability for self-care is a common reason why older people seek help from caregivers, move to assisted living communities, or enter nursing homes.
The health care community must do more to help ease this process for aging Americans. For example, researchers can analyze real-world data to identify deterrents to activities of daily life or use it to better understand outcomes from behavioral or social interventions and how they vary among different settings or support structures.
D.HEALTH: What are your hopes for the future of aging?
MAGILL: That we will consider aging adults as a critical demographic that requires our focused attention and support. Real-world evidence can further this objective by helping us understand what works, for whom, and when – for a demographic that represents 8.5% of the world’s population, a rapidly growing proportion.
On a personal note, I’m hopeful for emerging solutions that increase connectedness. We all encounter evidence of the loneliness epidemic on a daily basis. Loneliness is a major risk factor in the aging population, one that has personal, economic, and societal implications. Tackling this epidemic will require mobilization among business leaders, medical professionals, governments, advocacy groups, and social service organizations. Certainly, real-world evidence has a role to play, and can help guide us through what is largely uncharted territory.
Overall, successful interventions for older adults will benefit from analyzing real-world evidence. Real-world data and platforms like Aetion’s allow us to look at more populations and more care pathways – so we can revolutionize the development, approvals, and impact of treatments.