Syneos Health Releases Report Identifying Barriers to Payer Use of RWE in Rare Disease and Recommendations for Advancing Payer Engagement
Drug developers and global regulators are rapidly expanding RWE use to design, test and review rare disease treatments, unlocking the potential to speed innovative treatments to market. When used in tandem with other pricing and reimbursement innovations, RWE can contribute to a multi-dimensional value picture. However, payer perception surrounding RWE benefits for rare disease therapies lags behind the industry and regulators as payers may not be as receptive to or as familiar with RWE-based presentations.
“Our research reveals that payers are positively disposed to use RWE, but knowledge gaps around the validity and value of RWE must be closed to improve access for rare disease patients,” said
Language Barrier Indicates Need for Standard RWE Lexicon:
- European payers have greater familiarity with RWE and Real World Data (RWD) terminology that is routinely used by regulators in the U.S. and
- 55% of U.S. payers and 37% of European payers said RWD and RWE terminology is not used widely at their institutions.
Perception of RWE Benefits Varies Among Payers Worldwide:
- 60% of U.S. payers said RWE can provide robust data on how an agent has behaved in real-world conditions where population, diversity, comorbidities and adherence variability come into play, while only 42% of European payers say that RWE mirrored real-world conditions and would eventually inform clinical practices.
- Variations of RWE acceptance and influence exist across
Europe. For example, RWE can influence payer decisions in Italyand Spainon national and regional levels, but in Germany, payers question the validity of RWE submitted by manufacturers.
RWE Data Submission Limitations:
- 100% of payers in the U.S. and
Europeexpressed a version of the view that all data are not equal in clinical decision making. Furthermore, there is no single accepted hierarchy of persuasive data on either side of the Atlantic.
- In the U.S., 100% voiced concern surrounding the lack of standardized – or even interoperable – electronic health records (EHRs), with more than half describing this barrier as the biggest limitation compared to European countries that have national health systems.
- 34% of European payers identified lack of standardization as the biggest limitation creating uncertainty around RWE utility.
Reputable Sources for
- 77% of U.S. payers said primary peer-reviewed literature is “always meaningful” in their coverage decision making vs.48% in Europe.
- Subsequently, European payers put more trust in internal data, such as internal claims, health economics and outcomes research (HEOR) analysis from trusted academic or institutional partners (87%) than their U.S. counterparts (66%). European payers are also more likely to trust sponsor dossiers (42%) than U.S. payers (only 16%) seeing them as “always meaningful.”
“While payer engagement surrounding RWE in the rare disease space differs from industry and regulators, our research uncovers no trend or obstacles to advancing their understanding as long as regulatory bodies and industry groups are attentive to their concerns,” said Macdonald. “Our Insights Hub allows us to share these insights broadly across industry stakeholders to accelerate innovation and speed market access to change patients’ lives.”
Download the full report, including qualitative feedback and recommendations for accelerating payer understanding. Contact our cross-functional Value and Access team who can help biopharmaceutical companies close evidentiary gaps across all therapeutic areas, including tapping into our robust
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About the “Real World Value: Advancing Payer Understanding of RWE in Rare Disease” Survey
The survey included 64 respondents, evenly divided between the U.S. and
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Source: Syneos Health, Inc.