Real-World Evidence and the Future of Pharmaceutical Innovation

A breakthrough new drug is only effective if a patient takes it. That may sound obvious, but there is a well-worn path of peer-reviewed research that has found that anywhere from $100 to 300 billion in unnecessary healthcare costs are accrued each year due to medication non-adherence. In fact, the research suggests that for every additional dollar spent on adhering to a prescribed cardiovascular medication, medical costs would be reduced by $7 for people with diabetes, $5.10 for people with high cholesterol, and $3.98 for people with high blood pressure.

Why should these figures matter to the life sciences industry? Because individual patient behavior can mean the difference between success or failure at any step in the drug development process from discovery to clinical research to launch. Multiply that behavior across hundreds, thousands, and even millions of patients globally and the implications of a single variable like adherence can fundamentally alter the healthcare landscape for generations.

Yet, historically, despite the critical role adherence plays in success of a therapeutic, a patient’s statistical likelihood of actually sticking to a prescribed regimen has never really been a significant part of the drug development process. That’s largely because it was impossible to track. Outside of patient surveys and self-reported data, the life sciences industry had no comprehensive way of tracking adherence at scale.

Real-World Evidence to Identify Patterns of Behavior

Today, that is no longer the case. Real-world evidence (RWE) – data drawn from insurance claims, electronic medical records (EMR), disease registries, patient registries, labs, and other sources – is being use to track the behavioral side of the patient experience, and that has the power to change everything.

I recently had the opportunity to sit down with Joe Imperato, Senior Director at Pfizer, and Koustav Chatterjee, Principal Analyst at Frost & Sullivan, to discuss exactly how RWE is being leveraged by leading life sciences companies in their drug development processes. I also got to talk a bit about how Komodo Health is helping in that process by delivering RWE and analytics to help the life sciences industry identify the patterns of patient behavior that drive critical decisions.

Imperato offered a fascinating peek inside his experience using RWE to understand the complete patient journey.

“Advances in RWE over the last three years have been completely transformational. We have the ability now to use RWE to understand the characteristics and demographics of highly compliant patients,” he explained. “We’re using that to work with providers to help them understand how to improve adherence and we’re also using it on the patient recruitment side to recruit patients who are most likely to complete a trial. That’s a game changer.”

Imperato added that Pfizer is working with RWE to create synthetic clinical trials, whereby they are drawing on thousands of patient experiences with a particular therapy to help inform and augment their clinical trials data.

Pfizer, of course, is not alone. As Frost & Sullivan’s Chatterjee illustrated: “Across the life sciences industry, we’re seeing rapid growth in the ability to connect EMR data with other data sets to create a map of patient experience. It’s helping pharma companies make more informed, evidence-based decisions and it’s helping providers make better decisions at the point of care.”

Chatterjee added that the core areas where he’s seeing the most significant growth in RWE in the pharmaceutical value chain are in the areas of drug development, specifically in the identification of new biomarkers to improve the success rate of clinical trials, and in the pharmaceutical lifecycle, where researchers are now able to collect data at scale to identify how patients behave and interact with therapies in the real world.

Applying the Komodo Health Mission to RWE

Our work at Komodo Health is rooted in the idea that by building a canonical representation that traces the journey of 320 million patients, the providers and institutions where they seek care, the therapies and interventions they use to treat those conditions, and the outcomes that result – we will be able to help reduce the burden of disease.

In effect, we’re creating a master view of healthcare that provides a behavioral ground truth. It’s endlessly gratifying to hear how the life sciences industry is now using these solutions to fundamentally improve the drug development process, and we look forward to breakthroughs to come.

To hear more about how RWE is driving innovation in the life sciences industry, read my recent perspective here.