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Harness the spirit of experimentation to maximize RWE potential for OTC
Matt Stewart, Global Marketing Manager, IQVIA Consumer Health
Dec 03, 2021

Real world evidence (RWE) has been a driving force in prescription drug development and commercial decision-making for years, but it has yet to take hold in the over the counter (OTC) medicines landscape. It is a missed opportunity to use existing data to validate OTC product safety and efficacy, to monitor real world outcomes, and to understand when and why consumers purchase and use these products.

Evidence to support decision making during the lifecycle of OTC drugs has been primarily generated through traditional clinical research methods, however real-world data (RWD) and RWE can fill the knowledge gap between what happens in a clinically controlled environment and how consumers use products in the real world. In the OTC market, where consumers make most of the purchasing and usage decisions, insights from RWE could have a powerful impact on market strategies.

To explore this topic, IQVIA Consumer Health recently hosted a panel discussion with four industry experts:

  • Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager for the Pan-European industry Association (AESGP)
  • Emese Csoke, Global Regulatory Medical Safety and Compliance Strategy Director and Chief of Staff for Bayer Consumer Health
  • Dr. Sabine Landes, Medical Head of Consumer Healthcare in Germany for Sanofi Consumer Health
  • Denise Pohihaus, Director of Digital Solutions for GSK Consumer Healthcare
  • Dr. Volker Spitzer, Senior Director, Global Consumer Health R&D Services, IQVIA Consumer Health

The discussion was inspired by their collaborations on the RWD/RWE working group at AESGP, and their recently published article: How Can Real-World Evidence Aid Decision making During the Life Cycle of Non-Prescription Medicines?i in Clinical and Translational Science.

In the hour-long conversation, we discussed how RWE can be used to close data gaps in the OTC product lifecycle, where it can aid in decision-making, and what industry leaders can do to ensure this valuable data becomes an integral part of the product lifecycle.

When and how to use RWE

One of the biggest opportunities for using RWE in OTC medicines is to support products changing their legal status from Rx to OTC. “This is the domain of excellence where real-world data can aid the decision-making,” Anquez-Traxler said. It can answer questions about the ability to self-diagnose, safe use, and improved public health outcomes and economic benefits related to ease of access. “These questions are important components of the decision-making process for switches.”

It can also be valuable for post-marketing safety studies, which is the most common area of use for RWD in the OTC space, Pohihaus noted. “(RWD) has been well-regarded as a source of safety signal evaluation, risk management, and ongoing benefit/risk data for decades.”

Studies of real word effectiveness can also be valuable for products that have been in the market for a long time, to provide insights into additional real-world benefits not measured during original clinical trials, Landis noted. These could include patient-reported outcomes about the impact on sleep, quality of life, or stress levels, “These offer exciting opportunities to learn more about the benefits of nonprescription medicines,” she said.

Closing data gaps

The challenge in capturing these real-world insights is where to find the data. One of the biggest obstacles OTC medicine developers face is that the RWD commonly used to support prescription drug development doesn’t exist in the OTC landscape. Prescription drug developers rely on RWD captured in electronic medical records (EMRs) and claims databases; and the decision to use the drug always ties back to the prescriber.

With OTC drugs there is no formal ‘paper trail’ and the decision-making lies almost entirely with the consumer. Even if the sale is captured in retail pharmacy records, the condition and the outcome are not, and there is no follow-up or prescription refill to track adherence and outcomes in the real world. This limits the resources OTC medicines manufacturers can use to understand real world implications of their products.

One of the best solutions in this environment are observational studies, where researchers observe individuals using a product and record outcomes with no attempt to interfere with when or how it is used. These long-term light-touch studies can deliver valuable insights however, they haven’t been used much in the OTC space, which makes it difficult to predict how regulators will respond to them.

Exposing regulators to these types of studies can start a more virtuous cycle

Anquez-Traxler suggested companies talk with regulatory authorities during scientific advisory meetings about using these studies in their research, and what they are looking for in terms of data and participation. “Exposing regulators to these types of studies can start a more virtuous cycle,” she says.

OTC companies can also consider patient-generated data recorded by individuals. These data can come from electronic patient-reported outcomes, wearable health trackers, consumer diagnostics, medical devices, and even social media.

This data is already being collected, and it can be captured in real time, from a broad range of consumers and environments, Pohihaus noted. “It offers a tremendous opportunity to understand the patient in the ecosystem of how they're living…and to understand the effectiveness of the medicine.”

Though again this is new territory, and there are few guidelines for how to capture and interpret user generated RWD, validate devices and measures, and ensure data privacy. “The biggest hurdle is that we are lacking relevant published evidence,” Csoke said.

The lack of examples means manufacturers and regulators have no visibility into how to structure studies or vet their outcomes. “People are thinking about how to use real-world evidence, but there is little visibility,” she said. “Bringing greater visibility would help to close the gap.”

Where to begin?

RWE has the potential to guide decision making and drive commercial impact in the OTC environment. But to leverage the value of RWE, industry leaders must educate themselves on how they can conduct rigorous studies that will deliver valid and valuable evidence.

“The most critical next step is to develop new methodologies and applications that will unlock the potential of RWE to allow meaningful outcomes and ensure the results can be trusted,” Landes said.

To do that, OTC product manufacturers need be willing to run their own studies, publish papers, and generate evidence to present to regulators to make their case, Pohihaus concluded. “Unless we have that spirit of experimentation, this trend won't move.”

iAdditional authors include Matthew J Francis, Global Safety Surveillance & Analysis, The Procter & Gamble Company; and Larry Ma, Office of Consumer Medical Safety, Johnson & Johnson.

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