Supporting Evidence Generation of Indirect Benefits and Risks for Medical Products Used for Infectious Diseases

Introduction

Unlike many other diseases, infectious diseases can negatively impact the health of the affected person as well as those around them, through transmission of the infection. Public health consequences from infection transmission have been particularly impactful for respiratory viruses such as respiratory syncytial virus (RSV), influenza, and SARS-CoV-2. Consequently, the development and evidence-based use of diagnostics, vaccines, and therapeutics for respiratory viruses have the potential for substantial health benefits not only for the individuals who use these medical products, but for others who can benefit through reducing transmission.1 The “indirect” health benefits for others are important for assessing and communicating the overall value of these medical products.

While there is recognition of the importance of indirect health benefits, there is not yet a systematic approach to quantify, incentive, or integrate assessments of indirect benefits and risks for these products (please see Integrating Health Benefits into Biomedical Policy: Key Reforms for Federal Agencies to Reduce Disease Transmission). As a result, clear evidence on indirect benefits to inform decisions by individuals and their providers — as they assess benefits and risks to themselves and those in their immediate and broader communities — has not been a well-defined and consistent policy priority.

This paper is the second in a three-part series focused on understanding and increasing the indirect benefits of biomedical products. Here, we provide an overview of sources of evidence on indirect benefits, define the evidentiary needs for capturing indirect benefits, and provide a description of current and proposed approaches for evidence generation. We also highlight action steps for developing evidence on indirect benefits and propose policy recommendations for Federal agencies to generate and leverage evidence on the transmission reduction capacity and capability of vaccines, therapeutics and diagnostic products. Policy recommendations are summarized in Table 1.

Read the full paper here.