# Precision Medicine Policy and Treatment (PreEMPT) Model

> **NIH NIH R01** · HARVARD PILGRIM HEALTH CARE, INC. · 2021 · $516,162

## Abstract

ABSTRACT
Advances in technology have led to the availability of genetic testing for a wide range of
conditions for healthy or high-risk newborns. It is expected that the funds spent on genetic
testing in the U.S. will reach $25 billion by 2021. With the numerous uses of genomic
information, understanding the clinical value and long-term impact of genomic technologies on
morbidity, mortality, quality of life, and diagnosis and treatment costs is essential. Conducting
genomic sequencing in the newborn period of life has compelling logic, as it may provide
insights for an active illness that a baby has, or early warning for future illnesses in childhood or
adulthood. While providing genomic sequencing and interpretation for all newborns may be
unrealistic at the present time, rapid advances in genomic technologies and informatics may
make this feasible. Regardless of the cost of sequencing newborns, what is as yet unclear is
how beneficial and valuable such population-based testing might be.
A randomized clinical trial to study and provide timely estimates of the lifetime health impact and
cost of population-based newborn genomic sequencing is infeasible given the sample size and
time horizon needed. Thus, in this proposed study, we aim to develop a detailed mathematical
model to simulate the natural history, clinical outcomes, and cost-effectiveness of integrating
various genomic sequencing strategies into clinical care in the U.S. The model will provide an
important link between scientific developments in genomics and the policy implications of using
this information, both in clinical and economic terms. We will create a flexible model that will
allow updating with the most current evidence in genomic medicine as it evolves. Thus, as new
genomic technologies and screening tests are developed, we can quickly assess their clinical
utility and economic value. This study will leverage the direct sequencing experiences of the
NIH-funded BabySeq Project, a first-of-its-kind randomized controlled trial designed to examine
how best to use genomics in clinical pediatric medicine by integrating genomic sequencing into
the care of healthy and high-risk newborns.
We have assembled an interdisciplinary team of experts in simulation modeling, health
economics, genomics, pediatrics, predictive modeling, and health systems research. We
propose a highly innovative application of modeling methods to genomic technologies and will
develop a novel analytic framework, with the goal of synthesizing available clinical and
epidemiological data into a unified modeling effort. The goal is to project clinical and economic
outcomes associated with alternative strategies to assess the potential value of genomic
technologies for newborn screening. This study will provide a durable platform for integration of
genomic information into clinical care and health policy over the next decades.

## Key facts

- **NIH application ID:** 10167747
- **Project number:** 5R01HD090019-05
- **Recipient organization:** HARVARD PILGRIM HEALTH CARE, INC.
- **Principal Investigator:** Ann Chen Wu
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $516,162
- **Award type:** 5
- **Project period:** 2017-09-11 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10167747

## Citation

> US National Institutes of Health, RePORTER application 10167747, Precision Medicine Policy and Treatment (PreEMPT) Model (5R01HD090019-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10167747. Licensed CC0.

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