Overview
A new evidence paradigm is emerging with the availability of additional real-world data sources facilitated by technological innovation and the evolving adoption of real-world evidence (RWE) in regulatory, reimbursement and other health care decisions. The intent of this presentation is to describe the new evidence paradigm and why generating payer insights and relevant, impactful evidence is now a ‘must have’. The presentation will describe opportunities, including tech-enabled solutions, which can add speed, agility, and scientific rigor to the generation of payer insights and evidence generation.

Description
In an evolving healthcare environment with continuous economic pressures, clinical innovation alone is not enough to achieve optimal reimbursement and patient access. Payers, regulator, and health technology assessment (HTA) agencies prioritize products that demonstrate the most compelling clinical and economic value, including improvements in patient outcomes.

Timely payer insights can inform a relevant evidence package and development strategy by defining the data required to support an optimal place in therapy/treatment pathways and by describing the value of the product in populations of unmet need. However, heterogeneous evidence requirements from different HTA agencies make it challenging to use the same evidence package across markets. HTA policies and stringent data requirements mean payer insights are critical throughout the product life cycle to understand what is most meaningful to them. When products come to market with a limited evidence package, HTA agencies and payers are likely to turn to credible and robust RWE to assess the value of a product post-launch. This adds complexity because companies have a need to gather payer insights and customize each evidence package to support the value assessments at launch and then update evidence for post-launch reviews.

In demonstrating the full value of a product and customizing evidence packages, consideration should be given to emerging RWE data sources to capture the data elements required to differentiate products in competitive disease areas. Many if these emerging data sources include supplementary elements such as patient outcomes, genomics, biomarkers, etc., which may allow companies to address research questions with greater precision. Opportunities also exist to integrate data across sources; however, this requires complex analytical RWE expertise. Clearly defining the analytical approaches using reliable scientific methods is critical for gaining acceptance among regulatory and HTA agencies, especially when RWE is being considered as confirmatory evidence.

In summary, the dynamic global healthcare environment elevates the need for scientifically rigorous and fit-for-purpose evidence generation, informed by payer insights, throughout the product development life cycle and continually updated following product launch. This iterative process of insight collection and evidence generation is critical to build an evidence package that is relevant and informative for decision-makers.