Reducing the Burden of Respiratory Viral Infections: A Policy Framework to Accelerate Biomedical Innovation to Benefit Population Health

Introduction

Diagnostics, therapeutics, vaccines, and other biomedical technologies are creating unprecedented opportunities to reduce death, disability, and other adverse population health effects from infectious diseases. Over the past few years, important new products have come to market that have the potential to substantially reduce the impact of COVID-19 and Respiratory Syncytial Virus (RSV), as well as help contain influenza. These capabilities benefit individuals who use them by reducing the duration and severity of symptoms, but also benefit people around them by reducing transmission and complications from additional infections. Further biomedical innovations could enable greater progress in containing infectious disease, such as therapies in development that not only prevent severe infection or death, but also hold promise for avoiding contracting and transmitting viral infections. Such treatments have some additional benefits for individuals— e.g., avoiding mild short-term symptoms—but they could also have greater benefits on population health, through a greater impact on transmission that better protects higher-risk contacts in the community. For example, the U.S. government’s Project NextGen is currently investing in COVID-19 vaccines and therapies (including potential prophylactic therapies) that could have these benefits.

As we describe below, while the potential benefits of transmission reduction for population health have long been recognized, U.S. and global public policies do not have clear, well-developed frameworks for assessing, valuing, and supporting the development and use of biomedical innovations that have such population health impacts above and beyond their benefits and risks for individual health. The U.S. has mandated coverage without copays for certain vaccines and other preventive treatments with strong supporting evidence of benefits. But these evidence assessments—and the associated approval, coverage, and payment policies—are generally focused on individual benefits and risks. Indeed, recent US Food and Drug Administration (FDA) guidance on evidence requirements for future COVID-19 vaccines focuses on demonstrating impact on prevention of death and serious complications requiring hospitalization, with less discussion of standards for a further claim related to reducing transmission or infection. Further, as we describe below, there has been little analysis to guide what additional priority, if any, public and private coverage and payment policies should place on treatments that have similar impacts on serious individual outcomes but differ significantly in terms of reducing transmission.

The absence of clear policy guidance on these potentially important biomedical opportunities for reducing transmission has significant public health implications, especially in settings like in the U.S. and many other countries where there is only limited support for vaccine or treatment mandates to contain infections and improve public health. Current regulatory, coverage, and payment policies help encourage use of vaccines and therapies that are safe and effective, but may not fully reflect the potential benefits of more widespread use of products that do more to reduce transmission. Both because some individuals may be more willing to use a product because it is more protective for those at risk around them, and because policy reforms may influence the extent to which such products are used, progress in biomedical innovation is increasing the public health importance of policy steps to support the development and use of products that do more to reduce infection transmission.

An enhanced policy focus on transmission reduction could also result in greater impact of existing diagnostics, therapeutics, and vaccines. Evidence-based policies that encourage greater use of current COVID-19 and flu over-the-counter (OTC), rapid diagnostic tests not only help individuals get treatment to reduce their risk of severe infection; they also can support voluntary changes in behavior like staying home that reduce transmission. The U.S. government has provided limited access to free COVID-19 tests, presumably with both individual and population health benefits in mind. But this has been a short-term policy decision reflecting residual COVID-19 emergency funding, not a systematic policy. Greater voluntary use of respiratory vaccines and therapies with transmission-reducing benefits can similarly improve individual outcomes and contain outbreaks. But current Federal policies involve covering such therapies with traditional copays, at least in private insurance. And while CDC recommendations suggest that millions of Americans should receive COVID-19 boosters, RSV vaccines, and flu vaccines, individual vaccine pricing, coverage, and payment policies are currently on track to result in only a small fraction of that large population being vaccinated.

In this paper, we describe a preliminary policy framework to account more explicitly for the population-level benefits of transmission reduction, with the goal of achieving more effective infectious disease containment. Greater containment is increasingly feasible without mandates by leveraging recent and emerging biomedical technologies. This framework incorporates key dimensions of population benefits to support policies that explicitly account for the value of transmission reduction in addition to individual benefits. We include some examples of policy actions consistent with this framework, and highlight implications of the framework on regulatory, coverage, and payment policies, with an illustrative focus on implications for better reducing or blocking the transmission of major respiratory viruses.

We highlight the following questions related to the potential value of more complete accounting for population health benefits beyond individuals: 

• Under what circumstances is a more explicit focus on population benefits of transmission reduction likely to be worthwhile, and what policy steps would be most effective in achieving these benefits?
• How can such benefits best be measured and validated?
• Do current regulatory policies provide a clear pathway for products that block or significantly reduce transmission, even if they have relatively modest or no benefits compared to existing treatments for individuals (e.g., some reduction in mild or any symptoms, but little or no clear impact on more serious outcomes)?
• Do current payment policies fully reflect the transmission reduction benefits, including transmission blocking, beyond a product’s impact on the health benefits and safety risks to an individual user of the product?

The paper aims to provide a foundation for a more systematic approach to developing and using biomedical products that continue to provide important health benefits to individuals, but that – through greater individual use as well as greater impact on transmission reduction – reduce or block disease spread in communities.

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