# Expanding FDA's Opioids Systems Model to Enable Economic Evaluations and Outcome Analyses of National Opioid Policies

> **NIH FDA U01** · MASSACHUSETTS GENERAL HOSPITAL · 2020 · $999,840

## Abstract

PROJECT SUMMARY/ABSTRACT
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.

## Key facts

- **NIH application ID:** 10167485
- **Project number:** 1U01FD007064-01
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** Mohammad S. Jalali
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $999,840
- **Award type:** 1
- **Project period:** 2020-09-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10167485

## Citation

> US National Institutes of Health, RePORTER application 10167485, Expanding FDA's Opioids Systems Model to Enable Economic Evaluations and Outcome Analyses of National Opioid Policies (1U01FD007064-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10167485. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*