Demand for Real-World Evidence of Medications is Growing

Payers, regulators and clinicians are increasingly looking to health economics and outcomes research (HEOR) and real-world evidence (RWE) as a valuable source for patient-level data, and the demand for this information about patients and their medications will only increase, according to a new white paper in which Trinity Life Sciences interviewed experts in the economics and outcomes field. The paper aims to better understand how these capabilities can be best leveraged across the life-sciences industry to improve patient outcomes.

The demand for outcomes research continues to grow. The growth not only comes from value, access and pricing teams, but from cross-functional teams across life-sciences companies, according to Trinity Life Sciences.

Nandini Hadker

There is a focus on generating evidence, and this is both a top-down and bottom-up effort, Nandini Hadker, partner, evidence strategy at Trinity Life Sciences, said in an interview with Formulary Watch.

“The FDA has embraced economics and health outcomes research. They have given the green light to not just use randomized clinical trials, but also to use real-world data and real-world evidence,” she said. “Pharmaceutical companies want to differentiate their therapies and show the value that they bring to the market and how they improve the clinical paradigm.”

At the same time, there has been an evolution in the health economics and outcomes research industry. The data and analytics industry has grown and matured, with new companies forming and new sources of data now available, as well as new methods for capturing data, such as wearable technologies, which track patient physiological measures over time. “There has been an evolution in evidence generation, moving from the slow and academic studies to a much more strategic, more real-time effort to assess value,” Hadker said.

Additionally, she said, the timeline for beginning to assess patient outcomes of new therapies has shifted. “Pharmaceutical companies are not waiting for the product to get market approval before doing these assessments. They are starting two years before approval, looking at unmet needs today to create a regulatory submission that includes real-world evidence,” she said.

Important elements of these studies now include quality of life, activities of daily living, pre- and post-therapy survey questions. “There is an economic angle to this,” Hadker said. “Patients who are doing better on therapy, that would show up in the system. Patients wouldn’t see doctors as much or go the emergency room.”

Payers, however, want these benefits to be quantified. “Health economics and outcomes research is here to stay. In the future, it’s going to be an integral part of decision making for pharmaceuticals, and even for devices and diagnostics.”

Over the next decade, the paper points out, there will be greater data availability and more high-quality data and will likely include more patient-specific and personalized value narratives. In addition, practices more common in Europe, such as health technology assessments, cost-effectiveness analyses and cost-utility analyses, will likely become more common in the United States and include impact on quality of life.