Why are payers reluctant to employ real-world evidence in rare diseases?
Syneos Health® (NC, USA) has published a report detailing survey results of US and European payers. The report highlights current barriers to payers’ implementation of real-world evidence (RWE) in rare diseases and defines potential means for increasing payer engagement with real-world evidence.
Syneos Health® (NC, USA) has published a new report highlighting current barriers to payers’ implementation of real-world evidence (RWE) in rare diseases. The report — entitled ‘Real world value: advancing payer understanding of RWE in rare disease’ — also defines potential means of increasing payer engagement with real-world evidence.
Healthcare stakeholders, particularly regulators and industry members, have been increasingly employing and integrating RWE into their drug design, testing and review processes. This has the potential to more rapidly market essential treatments to patients, particularly for rare diseases.
How are regulators using RWE?
Payer perception of RWE, and the benefits it may confer, however, has seemingly lagged behind that of regulators and industry experts. This report details the results of a survey of 64 US and European payers; all respondents are on pharmacy and therapeutic committees, have experience in rare diseases, are involved in decision making rare disease therapeutics and formulate medical policies.
Key report findings include the need for the development of a standardized vocabulary surrounding RWE. 55% of US payers reported that RWE terminology is not widely used at their institutions. By contrast, only 37% of European payers attested to this.
The report also highlights that significant heterogeneity exists in international perceptions of the benefits RWE can offer. For example, 60% of US payers attested to the ability of RWE to provide robust pharmacovigilance data. By contrast, 58% of European payers felt that RWE did not accurately mirror real-world conditions.
Alistair Macdonald, CEO of Syneos Health, commented: “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. Multi-stakeholder feedback points to the need for collaborative, well-structured exercises and standard setting for payers to advance at the same velocity as other industry stakeholders. Dialogue is key, and the time to facilitate these conversations is now.”
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How are regulators using RWE?
Regulators use RWE to obtain extra information regarding the use, compliance, safety and efficacy of a marketed drug product; this is critical for regulatory decision making and can help inform a study’s applications, by supplementing extra clarity around a study’s design. This can then help enlighten regulators concerning submissions.
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