Real-world evidence (RWE) has become increasingly important in proving the value of drugs and differentiating them from their competition.
Real-world evidence (RWE) has become increasingly important in proving the value of drugs and differentiating them from their competition. As healthcare payments shift from volume-based to value-based, payers and providers are focused on outcomes, and RWE is the measure of those outcomes.
RWE is not a new concept, but the number and nature of sources of real-world data (RWD) are proliferating. This has expanded the applications of RWE, and made mastering it far more critical to business success. RWE is no longer just a market access tool; it is also key to identifying unmet needs and, in an age of increasingly personalized medicine, in determining which patients will respond to which products. It can help make R&D cheaper, faster, and more accurate.
This evolution is exacerbating existing challenges around RWE, and creating new ones. RWD comes in multiple forms, and from multiple sources, each with its own strengths and weaknesses. Turning these multiplying data sources into evidence that can reliably and convincingly inform clinical practice is tricky; however, there has been progress. Regulators are starting to consider where RWE may be used to accelerate access to new drugs, and expand the use of existing ones. RWE’s impact on product sales is growing as these kinds of data are more widely available and understood, and as competition increases in many therapy areas.
RWD generation is now being built into pharma’s offerings as companies start to promote integrated solutions that provide not just a pill or an injection, but an entire adherence and disease-management support system. These data, coming from many individuals more or less continuously, will support optimal treatment usage and inform future therapy development.
5 EXECUTIVE SUMMARY
5 RWE: important but not well understood
5 RWE sources are proliferating as healthcare goes digital
5 RWE’s impact is growing
5 Multiplying efforts to set RWE standards and guidelines
5 Companies must embrace RWE across the organization
6 RWE: CRITICAL, BUT POORLY UNDERSTOOD
7 RWD matters across the entire value chain
7 Definitions, standards, and quality control
9 Many payers remain skeptical of RWE
12 RWE SOURCES PROLIFERATE AS HEALTHCARE GOES DIGITAL
12 More digital medical records
12 Democratizing data with improved analysis and visualization tools
13 Connected devices help fill evidence gaps
13 Partnerships for data generation and data-enabled solutions
15 RWE’S IMPACT IS GROWING
15 RWE influence on prescribing is subtle but cannot be ignored
15 Differentiating similar drugs
16 Confirming clinical trial data
16 Salford Lung Study: pioneering data, uncertain effects
18 Outcomes-based agreements
19 Trial feasibility and recruitment
22 RWE STANDARDS AND METHODOLOGICAL GUIDELINES EMERGING
22 Regulators seek a greater role for RWE
22 HTAs adopt “try it and see” approach
25 RWE evaluation tools are emerging
28 RWE MUST BE EMBRACED COMPANY-WIDE
28 Driving a data mindset
28 Partnering for data and skills
29 Integrated evidence planning
30 Data sharing must increase
30 RWD drives new, outcomes-focused solutions
31 The business case for RWE
33 About the author
LIST OF FIGURES
6 Figure 1: Sources of real-world data
8 Figure 2: Advantages and disadvantages of primary versus secondary real-world data studies
30 Figure 3: Real-world evidence is now required across a product’s lifecycle
LIST OF TABLES
9 Table 1: Hurdles to fully implementing real-world evidence
24 Table 2: Selected groups supporting real-world evidence guidelines
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