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

Respiratory viruses continue to present a burden for the United States, despite the advancement of medical products that effectively prevent or mitigate severe illness, hospitalization, and death. These medical products have received marketing approval and coverage based on benefits to individuals, yet they also likely have indirect benefits that can play an integral role in reducing wide-spread disease transmission. In order to realize the population health outcomes from current products and facilitate the development of next-generation technologies that focus on reducing disease transmission, a systematic, shared framework is needed to promote multi-stakeholder led deployment.

In November 2023, the Duke-Margolis Institute for Health Policy hosted a public meeting and concurrently released a strategy document to present a framework for incorporating population considerations into the regulatory and reimbursement processes. Duke-Margolis has refined our framework to describe assessment of indirect benefits for vaccines, therapeutics, and diagnostics in addition to direct benefits and risks with the goal of clarifying pathways for systematically incorporating indirect benefits into regulatory reimbursement policy.

On March 20, 2025, Duke-Margolis will present our refined framework alongside proposed policy reforms to improve evidence generation on indirect benefits and population health outcomes as well as leverage existing decision-making capacity by the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services. The refined framework along with companion papers outlining the policy reform will be published in soon-to-be-released documents.

This public workshop will cover: 

• Strategies to incentivize the development, authorization and reimbursement of products that address population health outcomes and consider indirect benefits.
• Past examples and future use cases that provide context and real-life application for the potential benefits of implementing evidence generation, legal, and regulatory reforms; necessary steps towards their implementation; and opportunities to collaboratively support their implementation.
• Policy steps to facilitate multi-stakeholder collaboration to implement a framework for reducing disease transmission, as well as advancing the use of evidence to support and evaluate claims of indirect benefits.
• Further considerations that Federal agencies, state and local public health authorities, providers across all health care settings and services, commercial payers, employers and community organizations can implement to realize the public health impact of vaccines, therapeutics, and diagnostics.

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