The goal of this project is to expand FDA's current opioids systems model to enable multidimensional outcomes and cost-effectiveness analyses. Steep increases in opioid misuse and disorder, overdoses, and deaths since the 1990s represent a public health crisis with far-reaching impacts on society. Rising OUD and overdose deaths are linked with the decline in life expectancy in the United States each year from 2015 to 2017, which was the first multi-year decrease since 1993. While mortality is clearly an important outcome to consider when analyzing the effects of a policy, decision makers and stakeholders also care about how policies affect other outcomes that matter to society. This project will expand FDA's opioids systems model to include additional outcomes and enable cost-effectiveness analyses of policies and interventions meant to reduce opioid misuse, OUD, and overdose. We will develop the proposed model expansion as a team of experts with extensive experience in health economics and outcomes research, simulation modeling, and substance use disorder health science and policy. We will first expand the model to include additional impacts of opioid misuse, OUD, and overdose on quality of life and productivity loss, and societal costs to criminal justice and health care systems (Aim 1). We will then estimate costs and examine both intended and unintended outcomes associated with interventions and policy changes meant to reduce misuse, OUD, and fatal and non-fatal overdose (Aim 2). Finally, we will examine potential policy strategies under the frameworks of effectiveness and cost-effectiveness analyses. In these analyses, we will compare the effectiveness and cost-effectiveness of combinations of interventions and policies meant to reduce opioid misuse, OUD, and overdose (Aim 3), such as implementation of prescription controls, expanded access to MOUD, and increased distribution of naloxone.
These aims will ultimately deliver: 1) an expanded model that is able to represent new outcomes as well as costs; 2) insight for policymakers regarding how various combinations of policy options will affect these multidimensional outcomes; and 3) the ability to discern which policy options represent the most efficient allocation of resources while minimizing unintended consequences. The proposed model expansion and accompanying analyses will enable FDA's policy tool to broaden the lens through which FDA and other government agencies consider the impact of policy solutions meant to reduce opioid misuse, OUD, and overdose.

Public Health Relevance

The goal of this project is to work collaboratively with FDA to expand its current opioids systems model to include a cost-effectiveness analysis of interventions and policies to reduce opioid-related illnesses, including opioid misuse, use disorder (OUD), and overdose. We will broaden the scope to account for impacts resulting from opioid-related illnesses?such as reduced quality of life, lost productivity, costs to society, and the intended and unintended outcomes resulting from opioid-related policies and interventions (e.g., increased untreated pain)?on individuals and society that go far beyond the outcomes currently included in FDA's model. The expanded model will draw from the unique combination of skills and expertise offered by individuals on our team and will be ready for incorporation into FDA's opioid policy tool for decision makers to choose policies that balance desirable health and societal outcomes in a resource-efficient manner.

National Institute of Health (NIH)
Food and Drug Administration (FDA)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZFD1)
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Glos, Lucas
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Massachusetts General Hospital
United States
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