Integrating Indirect Health Benefits into Biomedical Policy: Key Reforms for Federal Agencies to Reduce Disease Transmission

Introduction

Biomedical innovation continues to provide unprecedented opportunities to diagnose, prevent, and treat infectious disease. Infectious diseases pose harm not only to those who have been infected but may also harm those in contact with the infected individual through disease transmission. A leading set of examples is respiratory viruses like respiratory syncytial virus (RSV), influenza, and SARS-CoV-2. Diagnostics, vaccines, and therapeutics for respiratory viruses have the potential for important health benefits beyond the direct benefits to individuals who use them, by reducing risk to others of viral transmission and the consequences of infection. These indirect health benefits are a potentially important consideration in assessing and communicating the overall impact of these products to inform individual and clinical decision-making on product use. Yet despite the potential importance of effects of infectious disease products on non-users, federal agencies do not have a systematic approach to integrate consideration of such indirect benefits into regulatory and reimbursement policies.

Consequently, evidence on indirect benefits can be useful to patients, health care providers, regulators, and payers. Such evidence could be the basis of additional labeled claims related to indirect health benefits for a medical product, and in turn the basis for clinical guidelines and better information to patients to health care decision-making. More favorable coverage and payment policies for products with larger demonstrated indirect health benefits could lead to better overall health for the covered population.

There is precedent for such consideration of indirect benefits in authorization and reimbursement of medical products. For example, certain current products have labeled indications for use that primarily reflect indirect benefits to non-users, e.g., newborns who benefit from treatments administered to the mother. Despite such examples, FDA approval, recommendations from CDC’s ACIP, and most subsequent coverage decisions are largely based on evidence demonstrating reduction in risk of serious illness and favorable demonstrated safety profiles for individual users. Coverage for such preventive vaccines and therapeutics typically occurs with no copays, and use of some childhood and adult vaccines is linked to quality measures and payments in Medicare and Medicaid. However, many treatments and diagnostic tests that may significantly reduce transmission typically require copays. Further, there is no clear regulatory pathway or special supports for demonstrating indirect benefits on top of major health benefits to individuals, or clear standards for differential coverage or payment incentives for infectious disease products that reduce the risk of serious illness complications to the user but also have a significant impact on transmission reduction.

This paper is the third in a three-part series focused on the indirect benefits of biomedical products. In this paper, we assess the authority and past actions by the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) to consider indirect benefits of medical products and identify regulatory and reimbursement reforms that could clarify how these benefits are considered. In turn, this could provide clearer pathways and greater incentives to develop such evidence, using the approaches described in our companion paper on generating better evidence on indirect benefits. We begin with an assessment of how FDA might support more systematic benefit-risk assessment to consider indirect benefits in market authorization and labeling decisions, including through post-market opportunities available to improve evidence related to indirect benefits and risks; and how FDA could build on past regulatory actions to provide a clearer pathway for labeled claims based on evidence of indirect benefits and encourage development of relevant products and evidence. In the subsequent section, we identify ways for CMS to build on its current authorities and past policy decisions to incorporate indirect benefits in coverage and payment policies.

Read the full paper here.