Assessing Burden of Illness and Unmet Need

This guide outlines the concept of burden of illness (BOI) and unmet need, emphasizing their significance in understanding the limitations in prevention, diagnosis, or treatment of medical conditions. It details the factors involved in a BOI assessment, including epidemiology, clinical burden, humanistic burden, economic burden, and the treatment landscape. The guide explains how these factors contribute to understanding the impact of diseases on patients, caregivers, and healthcare systems. Additionally, it discusses the importance of conducting BOI and unmet need reviews early in the product development cycle to prepare for market access. The document also highlights the methods for conducting these reviews, particularly through targeted literature review (TLR) techniques. Key considerations for BOI review methods are presented, focusing on the existing evidence, disease rarity, the timing of the review, intended use, audience, and identification of evidence gaps. This structured approach aims to enhance the understanding of unmet medical needs and inform strategic planning.