Your Treatment and Your Community: Advancing Evidence and Policy for Medical Products that Impact Others

Many infectious diseases, such as respiratory virus infections, are easily transmissible from person to person and present a high burden to the U.S. population. Because of this transmissibility, medical products to diagnose, prevent, and treat these infections have implications for both the individual users of the products (direct effects) and the community (indirect effects). However, currently, individual-level benefits and risk of medical products form the basis for marketing approval and coverage from insurers.  A greater understanding of indirect effects, such as transmission reduction effects, and integration of this evidence into decision making by regulators, payers, health care providers, and patients could further reduce the infectious disease burden.

To advance strategies around infectious disease management, Duke-Margolis has explored how policy approaches can inform transmission reduction. In November 2023, the Duke-Margolis Institute for Health Policy hosted a public meeting and concurrently released a strategy document that presents a framework for incorporating population considerations into the regulatory and reimbursement processes. Duke-Margolis has refined this framework to focus on integrating indirect benefits for vaccines, therapeutics, and diagnostics into evidence generation and decision-making. The goal of this refined framework is to clarify regulatory and reimbursement pathways to encompass these indirect benefits.

Duke-Margolis will host a virtual workshop on March 20, 2025, to present this refined framework alongside proposed policy reforms to improve evidence generation on indirect benefits and build on existing federal capacity to incorporate indirect benefits in approval, reimbursement, and use pathways. The workshop presentations and discussions will include the following:

• Generating transparent and improved evidence for direct and indirect benefits and risks to enable voluntary and informed decision-making about treatment options;
• Advancing evidence generating infrastructure on indirect benefits to better capture the full benefits provided by vaccines, therapeutics, and diagnostics to individuals and communities;
• Elaborating on past Federal agency actions that have alluded to indirect benefits and can be expanded upon to further incentivize incorporation of indirect benefits in product approval and coverage decisions; and
• Discussing how policy approaches that stimulate the integration of indirect benefits can combine improvements to the evidence generation infrastructure with enhanced regulatory and reimbursement pathways

Click here to read a related article by Duke-Margolis authors entitled "A Framework For Considering Indirect Benefits Of Products With A Public Health Impact" published by Health Affairs on March 17, 2025.

This workshop is supported through funding provided by the Gates Foundation.