Transmission Reduction of Infectious Disease

Project Highlights

Despite the well-known risk of transmissibility for many infectious diseases—especially respiratory viruses—the value generated by the use of medical products to reduce disease spread is not fully understood. Medical products, including those for transmissible infectious disease, receive marketing approval and reimbursement in the US based on their direct benefits and risks to individuals voluntarily receiving the products. Duke Margolis has worked with stakeholders to highlight the importance of transmission reduction to address the burden of infectious disease and to develop a framework to clarify both direct and indirect benefits into regulatory and reimbursement pathways. To support this framework, Duke Margolis has also highlighted evidentiary needs and opportunities for Federal authorities to lead collaborative strategies for transmission reduction. The ultimate intent of this framework is to provide a comprehensive perspective of the direct and indirect health benefits and risks for medical products used to manage infectious disease to facilitate informed, transparent decision-making by patients, health care providers, policymakers, payers and other stakeholders.

Background

Transmissible diseases, such as viral respiratory infections, are responsible for a very high rate of morbidity and mortality worldwide. Biomedical innovation enhances our ability to diagnose, prevent, and treat many infectious diseases, with unprecedented opportunities to reduce death and disability. Innovative vaccines, therapeutics, and diagnostics are generally approved for use and reimbursed based on evidence demonstrating their direct health benefits to individuals. Claims related to these individual benefits, approved by the Food and Drug Administration (FDA), are included on the product label and in public education campaigns, and they often emphasize their impact on reducing the risk of severe infection or death.

However, because infectious diseases can be transmitted to others, innovative products also provide indirect benefits. These indirect benefits manifest for both the product user and individuals, who did not use the product, leading to health outcomes including community-wide reductions in infectious disease spread, morbidity and mortality. Building upon existing evidence and precedent, combining direct and indirect benefits and risks in a systematic framework shared among policymakers, providers, patients and other stakeholders could catalyze a paradigm shift for infectious disease management that better prioritizes transmission reduction.

Project Overview

Duke-Margolis has explored how policy approaches can be steered to better address the burden of infectious diseases. In this project, viral respiratory infections were used as the primary case example because of their propensity for transmissions and widespread availability of vaccines, therapeutics, and diagnostics to manage disease.

The project team worked with subject matter experts in health economics, epidemiology, and regulatory policy through interviews and workshops to build a generalized framework around improving evidence generation on the indirect benefits of vaccines, therapeutics, and diagnostics. In November 2023, the team published a whitepaper called Reducing the Burden of Respiratory Viral Infections: A Policy Framework to Accelerate Biomedical Innovation to Benefit Population Health and presented this framework during a public workshop. Discussion from health system, government, academic, industry and other regulatory experts helped refine the framework and point future work toward practical policy applications.

The focus of the project has since zoomed in on improvements to evidence generation strategies and policy steps that can be taken by Federal authorities like the U.S. FDA and CMS. A public workshop, convened in March 2025, features regulatory and reimbursement officials and health experts to present a refined framework alongside proposed policy reforms that leverage existing decision-making capacity by the U.S. FDA and CMS to improve evidence generation on indirect benefits and population health outcomes. The publication of the refined framework is accompanied by two companion white papers; one on evidence generation and the other focused on regulatory and reimbursement authorities.