Exploring Emerging Trends in Real-World Evidence USA

Real-World Evidence (RWE) Transforming Pricing and Reimbursement

RWE and Real-World Data (RWD) have become integral to clinical development and commercialization. According to Boxiong Tang , these data sources are not only vital for pricing and reimbursement decisions but also play a crucial role in regulatory submissions and clinical development. Historically, RWE was primarily utilized in post-market studies; however, a significant shift is now underway, with its application extending to earlier stages of clinical development and regulatory decision-making. This trend highlights the growing importance of RWE across the entire product lifecycle.

Key Themes for EVIDENCE 360: RWE, Pricing & Reimbursement Summit USA

At the upcoming EVIDENCE 360: RWE, Pricing & Reimbursement Summit USA, Boxiong Tang will bring unique insights on the intersection of RWE, digital health, AI/ML technologies, and patient-centric approaches. His session will focus on Patient-Focused Drug Development (PFDD) and Clinical Outcomes Assessments (COA), particularly in light of recent FDA guidance. Key discussion points will include:

• The role of COA and Patient-Reported Outcomes (PROs) in regulatory and reimbursement decisions.
• Global PFDD guidance and its implications for drug development.
• Strategies for integrating COA/PRO within clinical trials and real-world studies.
• Case studies demonstrating COA/PRO in regulatory and reimbursement approvals.
• The significance of a patient-centric market access strategy.

Digital Health Technologies Revolutionizing RWE Collection

The integration of digital health technologies is reshaping how RWE is collected and applied. Boxiong Tang identifies several ways in which digital tools such as wearable devices, electronic health records (EHRs), mobile health apps, and remote monitoring systems are enhancing RWE generation:

1. Expanding data sources for richer insights.
2. Enhancing data accuracy and timeliness.
3. Supporting decentralized and pragmatic clinical trials.
4. Enabling advanced analytics and AI applications.
5. Improving patient-centered outcomes research.
6. Strengthening regulatory and payer decision-making.
7. Facilitating interoperability and seamless data integration.

AI and Machine Learning: The Future of Evidence Generation

Artificial intelligence (AI) is expected to play a transformative role in evidence generation and decision-making. AI’s ability to analyze large datasets quickly and accurately presents new opportunities for:

• Enhanced data analysis, reducing bias and improving accuracy.
• Predictive modeling for better decision-making.
• Personalized, real-time, and transparent insights.
• Automating evidence generation.
• Optimizing resource allocation in healthcare systems.

Global Regulatory Shifts and RWE Utilization

Regulatory frameworks worldwide are evolving to incorporate RWE in market access and reimbursement strategies. Boxiong Tang notes that regulatory bodies, including the US FDA and EU EMA, are increasingly emphasizing the importance of RWE throughout the product lifecycle. The Joint Clinical Assessment (JCA), launching in January 2025 for oncology products in Europe, is a significant step toward harmonizing regulatory and health technology assessment (HTA) requirements.

Overcoming Challenges in Data Quality and Interoperability

While digital health and AI/ML technologies offer immense potential, challenges remain. Key considerations include:

• Data Privacy & Security: Ensuring compliance with HIPAA, GDPR, and other regulations.
• Bias & Data Gaps: Addressing disparities in digital access to create more representative datasets.
• Regulatory Uncertainty: Aligning RWE methodologies with evolving regulatory expectations.

Key Takeaway for EVIDENCE 360 Attendees

Boxiong Tang emphasizes that RWE, digital health technologies, AI/ML, and patient-centric approaches are transforming pharmaceutical development and commercialization, particularly in pricing and reimbursement. The growing sophistication of these tools is making RWE more robust, actionable, and patient-centered. Attendees will gain valuable insights into how these trends are shaping the future of healthcare decision-making and market access strategies.

About Boxiong Tang:

Dr. Boxiong Tang is the Associate Vice President, Head of HEOR and Value Access at Agenus, responsible for establishing HEOR strategies to support product launches and global reimbursement.

Previously, he served as the Head of HEOR at BeiGene and held senior leadership roles at Teva, Pfizer, Johnson & Johnson (JNJ), and GlaxoSmithKline (GSK).

Join Us at EVIDENCE 360: RWE, Pricing & Reimbursement Summit USA

We invite you to be part of this critical discussion at EVIDENCE 360: RWE, Pricing & Reimbursement Summit USA, taking place on 26th-27th June 2025 in Philadelphia, USA.

Register now: https://veridonglobal.com/events/evidence-360-rwe-pricing-reimbursement-summit-usa/evidance-360-usa-registration/