Meeting the Evidence Needs of Regulators, HTAs, and Payers – Optimizing Fit-for-Purpose Real-World Data and Analytics

Agencies responsible for market authorization and health technology assessment (HTA) around the world are increasingly using real world evidence (RWE) to enhance their decision-making. Life sciences companies must ensure that the evidence they present – both the data and the analytics - will be considered by those agencies to be appropriate and fit-for-purpose.

This HEOR Theater presentation will highlight ways to build confidence that both real-world data and analytics will be considered fit-for-purpose in meeting those varied needs.

Focusing on data requirements for worldwide regulatory pharmacoepidemiology, first we will share lessons learned highlighting the advantages of a data-agnostic approach, informing data decisions with relevant evidence synthesis, understanding regulatory expectations, and obtaining diverse stakeholder insights. Examples will be provided to portray these lessons from multiple perspectives, including submissions targeted to regulators, HTAs and payers.

Audience Objectives:

• Appreciate challenges and opportunities related to meeting diverse regulatory and HTA RWE needs and expectations.
• Understand how to systematically evaluate RWD sources to meet different regulatory HTA and payer expectations for various uses, such as market authorization, pharmacovigilance and coverage & reimbursement.
• Learn how to design RWE studies to meet regulatory and HTA needs with relevant evidence synthesis, stakeholder insights, and other means.

Sponsored by Genesis Research Group