Closing the Knowledge Gap with Real-World Evidence (RWE) Studies: The Importance of Starting Early

Successfully demonstrating product safety and efficacy in a randomized clinical trial is a monumental event, but it doesn’t always translate to market access and uptake one it’s launched. Since clinical trials are limited to a controlled sub-set of patients, observations recorded in the clinical trial setting can vary from what actually occurs in clinical practice. That’s where real-world evidence (RWE) can help pharmaceutical companies to inform development planning and also to demonstrate a product’s comparative effectiveness, safety and value from the viewpoints of various stakeholders, including regulators, payers, prescribers and patients.

This article discusses the role of RWE, the different information needs among stakeholders and potential solutions for meeting their evolving requirements.

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Real-World Evidence Applied in Real-Life Case Studies

Real-world evidence (RWE) can be used to meet different objectives, and RWE studies can be designed using different study types and methodologies, as well as multiple sources of real-world data (RWD). Teams often work separately and could benefit from a shared learning experience in the planning and execution process. A publicly-available RWE framework tool was recently released to help enhance collaborative efforts in RWE studies.

Clinical Trial Data Xcellerate Informatics Covance Blog

Earlier blogs in this series discussed closing the knowledge gap with RWE studies and how Covance and industry professionals worked to develop an RWE framework tool. This third and final blog further explores how the tool was applied in actual case studies to better support RWE efforts in treatments for diabetes and pain management.

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Customizing Real-World Evidence (RWE) Study Designs: A New Framework Tool That Incorporates Elements of Virtual Study Design

While assisting clients with their clinical development plans, and post-marketing studies, our team is witnessing a trend in designing RWE studies with both traditional and virtual elements. With growing interest in hybrid designs, Covance is exploring how we can help our clients incorporate their study objectives while evaluating a range of alternative options for evidence generation that enable faster, less resource intensive and more patient-centric, study execution.

In this second article in our series of three, learn how we collaborated with RWE professionals to create a unique RWE framework tool that can help your teams with study planning in today’s rapidly evolving environment.

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Road Map of Real World Evidence (RWE) in Europe

Several European countries have been utilizing big data together with randomized control trials to guide healthcare decision making and to address market access issues. The Region Europe RWE Advisory Board was formulated to explore potential areas of real world evidence (RWE) use in countries like UK, France, Portugal etc. The board engages stakeholders including payers, providers, and patient organizations with the intent of developing a platform and widening the community for RWE. The board has developed a three-year road map of initiatives for the enhanced use of RWE. The contributors are spread across the areas of licensing, commissioning and access, clinical decision-making and patient outcome decision-making to prioritize four key action points.

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The Pharma Lens On Real World Evidence (RWE) For Payer and Patients

Real World Evidence (RWE) helps payers make reimbursement decisions and assists patients in budget management and estimating risk benefit of interventions. The integration of RWE in value assessment frameworks, used for ascertaining drug value, can help payers make informed evidence-based reimbursement decisions. RWE provides insight into real world impact of an intervention; facilitating “performance-based risk-sharing arrangements” between payers and manufacturers. United Health and Merck have collaborated to link payments to drug performance by utilizing RWE. Similarly, Amgen and Humana have partnered to target chronic diseases by generating RWE.

Patient engagement is another core component for RWE generation as well as its dissemination. Prescription Drug User Fee Act (PDUFA) re-authorization and the 21st Century Cures Act emphasize the use of patient data for drug development. Patients can make better-informed health decisions based on information from Patient-Centered Outcomes Research Institute, National Health Council, virtual networks and digital technology like mHealth. Johnson & Johnson collaborated with Aetna to use wearable technology in atrial fibrillation screening for RWE generation. Health PROMISE, a patient reported outcome tool integrated with EHRs, helped IBD patients and providers to visualize real time data; thus improving their quality of life.

Conclusion
Real World Evidence can help payers and patients assess cost-benefit analyses of an intervention through real world patient data. Innovative use of technology can show the way forward in enhancing patient engagement and creating opportunities to access, integrate, analyze and effectively utilize RWE.

[For more on this topic, please listen to our recent RWE strategy webinar on ‘Leveraging Real World Evidence to Drive Patient Access and Affordable Care’. The webinar includes insights from Subject Matter Experts from Roche, Janssen Global Scientific Affairs, and Novo Nordisk as they discuss the challenges facing the industry and share best practices.]

Originally posted on Sciformix, a Covance Company blog.

Original Author: Madhur Garg 
Director, Real World Evidence and Market Access

Real World Evidence (RWE) and Market Access in the US

Randomized control trials demonstrate drug safety and efficacy and hence are fundamental for regulatory approval. However, real world data (RWD) becomes a progressively more important source of evidence as we move across the development continuum of a drug. RWD can be potentially useful for obtaining regulatory approval as well. Communicating the value of a health technology is critical for supporting the market access of a drug. Favourable comparative clinical profiles and cost effectiveness can influence the position of a drug in the formulary of a payer.

The 21st Century Cures Act (Section 3037) amended the US FDA Modernization Act 114, directing real world evidence (RWE) utilization to support recommendation of a new indication for an approved drug. This allowed manufacturers to communicate wider scope of a product’s value such as comparative patient reported outcome data. The change broadened the audience covered and helped to expedite market access. The FDA has also acknowledged the importance of RWE for closing evidence gaps while making healthcare decisions. Avelumab was granted accelerated approval due to supportive data from an observational study that described poor outcomes in Merkel Cell carcinoma patients treated by cytotoxic chemotherapies.

Conclusion
Real World Evidence obtained during pre and post phases of drug development provides an opportunity to accelerate market access and facilitate quicker approvals. RWE can be potentially utilized by regulatory authorities to close the evidence gap associated with real-world effectiveness.

[For more on this topic, please listen to our recent RWE strategy webinar on ‘Leveraging Real World Evidence to Drive Patient Access and Affordable Care’. The webinar includes insights from Subject Matter Experts from Roche, Janssen Global Scientific Affairs, and Novo Nordisk as they discuss the challenges facing the industry and share best practices.]

Originally posted on Sciformix, a Covance Company blog

Original Author: Madhur Garg 
Director, Real World Evidence and Market Access