At Facet Life Sciences, we understand that the product development landscape is evolving, and one of the key drivers of this evolution is the growing importance of real-world evidence (RWE). It has the potential to accelerate and enrich product development, leading to faster FDA approval and optimal US commercial success. RWE can also provide valuable information on how your product performs “in the real world”, outside of the artificial setting of a clinical trial. 

FDA is using RWE for regulatory decision-making, including the use of patient reported data to support efficacy determinations, and payers expect to see RWE to make decisions about pricing and reimbursement. RWE should be considered an integral part of the regulatory and commercial strategies for a product in development.  

 

What is Real-World Evidence (RWE)?

Real-world evidence refers to clinical evidence derived from the analysis of real-world data (RWD) such as electronic health records (EHRs), claims and billing activities, product and disease registries, patient-reported outcomes (PROs), and other data collected outside of traditional randomized clinical trials (RCTs). By capturing information from everyday healthcare experiences, RWE provides a more complete picture of how a product performs outside of clinical trials.

Why is RWE So Important?

One of the primary reasons for the increasing reliance on RWE is its ability to supplement traditional clinical trial data. While randomized controlled trials remain the gold standard for establishing safety and efficacy, they are conducted under ideal, controlled conditions that may not fully reflect how a product performs in real-world settings. RWE fills this gap by providing insights into how diverse patient populations respond to a treatment, how a product is used in different healthcare settings, and how it impacts long-term outcomes.

At Facet, we believe that RWE can play a pivotal role in accelerating drug development, facilitating a deep understanding of the effects and value of a product on patients, and optimizing the regulatory approval process. By utilizing existing data, companies can reduce the time and cost associated with product development while ensuring they meet both regulatory and commercial requirements. Here are some key reasons why RWE is becoming integral to the product development process:

FDA’s Embrace of RWE for Regulatory Decision-Making

FDA has increasingly recognized the value of RWE in making regulatory decisions. In recent years, FDA has begun to incorporate real-world data into its evaluations of a product’s safety, efficacy, and overall benefit-risk profile. For example, FDA accepted a non-interventional study using historical controls as an adequate and well-controlled study that could be used to support the approval of a new indication for Prograf (tacrolimus) in conjunction with randomized controlled trials of the product in other related patient populations and publications cited in the literature.

For companies seeking faster regulatory approval or line extensions, the inclusion of RWE in submissions can enhance the robustness of the evidence package and potentially streamline the review process. As FDA continues to encourage the use of RWE, it’s clear that this approach will become an ever more important component of the regulatory landscape moving forward.

Commercial Value of RWE for Pricing and Reimbursement

In addition to regulatory applications, RWE has become crucial for securing pricing and reimbursement decisions from payers. Healthcare providers, including insurance companies and government programs, are looking for evidence that demonstrates a product’s value in real-world practice. RWE offers a more comprehensive view of a product’s effectiveness, safety, and cost-effectiveness, providing healthcare providers with the data they need to make informed decisions about coverage and pricing.

For pharmaceutical companies, RWE can be a valuable tool for differentiating their products in the marketplace, especially when negotiating with payers. By demonstrating that a product performs well in real-world conditions and provides value to the healthcare system, companies can strengthen their position in pricing negotiations and improve market access.

Enhancing Post-Market Surveillance and Safety Monitoring

Beyond the approval and commercialization stages, RWE plays a vital role in post-market surveillance. Once a product is on the market, it is essential to continue monitoring its safety and effectiveness in a broader population over time. Real-world data enables ongoing surveillance and provides early warnings of potential safety issues that may not have been evident during clinical trials.

For companies developing drugs, biologics, and medical devices, incorporating RWE into post-market surveillance plans can help mitigate risks, improve patient outcomes, and support the long-term success of a product in the market.

RWE as a Cost-Effective Solution

Conducting traditional randomized clinical trials can be costly and time-consuming. RWE, on the other hand, leverages existing data, potentially reducing the need for additional clinical trials and expediting the decision-making process. Proactive discussions with FDA should be undertaken to ensure agreement on controlled data collection and reporting in order for RWE to be used successfully for regulatory purposes.  However, the promise of using real-world data to satisfy regulatory and commercial requirements exists. Used effectively, companies can save both time and money.

RWE: A Strategic Imperative

Given the regulatory, commercial, time, and cost benefits, RWE should be considered an integral part of the development strategy for any pharmaceutical product. At Facet, we recognize the immense potential of RWE to accelerate timelines, enrich data, and enhance market access. By adopting a proactive approach to real-world evidence, companies can stay ahead in an increasingly competitive and data-driven market.

Whether it’s to support FDA approvals or to secure favorable reimbursement outcomes, RWE is no longer a “nice to have”—it’s a strategic imperative. Facet Life Sciences is here to help you navigate the complexities of RWE and integrate it into your development and regulatory strategies for optimal success.

Facet Can Help You Leverage RWE for Optimum Success

As the importance of real-world evidence continues to grow, pharmaceutical companies must adapt by incorporating RWE into their product development, regulatory, and commercial strategies. At Facet, we believe that real-world evidence has the potential to transform drug development, leading to faster FDA approval and more successful market access. By leveraging RWE, companies can meet the evolving expectations of regulators and payers, ensuring that their products perform optimally in the real world. If you’re ready to explore how RWE can benefit your product’s development, contact Facet Life Sciences today to learn more.