A pharmacogenomics (PGx) clinical decision support (CDS) alert program has a role in improving outcomes and represents a wholistic approach to care when a PGx testing program is combined with a CDS alert program.
Project Details -
Grant NumberR21 HS026544
AHRQ Funded Amount$300,000
Project Dates09/01/2019 - 10/31/2021
Health Care Theme
Precision medicine is an emerging area in which disease treatment and prevention are tailored to the individual level, taking into consideration an individual’s genetics, environment, and lifestyle. Pharmacogenomics (PGx) uses information about a person’s genetics to guide drug therapy. The adoption of PGx testing by healthcare systems has been slow due to many existing barriers, including the need for more evidence for clinical utility around drug-PGx pairs, the specific PGx biomarkers to test for, availability of test results across organizations, incorporation of PGx information into current clinical workflow, and a lack of training for many clinicians to be able to interpret genomic test results. The use of clinical decision support (CDS) alerts may help to overcome some of these barriers.
This research modeled the cost-effectiveness of PGx CDS alerts and created a publicly available tool that provides estimates of the value of developing and implementing them. The tool may assist those in learning health systems (LHSs) to make informed decisions about the implementation of PGx-CDS alerts specific to their populations that consider trade-offs between the cost of implementation and the potential clinical benefits to patients.
The specific aims of this research were as follows:
- Estimate the cost-effectiveness of PGx-CDS alerts, versus no alerts, on adverse drug events (ADEs) outcomes.
- Create a web-based, interactive, publicly available tool that provides estimates of the value of developing and implementing PGx-CDS alerts, customized to each LHS.
The cost-effectiveness model was created for acute coronary syndrome (ACS) and atrial fibrillation (AF) in which the value of PGx testing has been most widely studied. Three outcomes were modeled: implementation outcome and cost per alert fired, clinical outcomes of adverse events and deaths averted, and economic outcomes in the form of cost per quality-adjusted life year gained (QALY) and incremental cost-effectiveness ratio (ICER). The model found several parameters that were most influential on ICER: QALYs and costs of PGx testing compared to no testing, hours needed to develop the system, and the likelihood that providers would change treatment based on the CDS.
For the model scenario, the researchers found that over 20 years 3,169 alerts would be fired, avoiding 16 major clinical events and six deaths for ACS, and two clinical events and 0.9 deaths for AF. ICER was $39,477 per QALY. A PGx-CDS alert program was cost-effective, under a willingness-to-pay threshold of $100,000/QALY gained, compared to no alert program.
Following the development of the model, an online tool—PRECIS Value application—was built that allows the adjustment of nine key assumptions to assess their impact. These adjustable inputs include population size, proportions of race in the population, duration of screening, and age range for screening, among other variables. This model allows decisionmakers to quickly determine at what point such a program would be cost-effective.
Feedback was overwhelmingly positive from six subject matter experts who were interviewed and indicated that there was value in the tool. Suggestions from these interviews were subsequently incorporated into the tool. The PGx-CDS alert program per the model would help to reduce clinical events and is cost-effective for patients with ACS and AF. The researchers recommend that future research evaluate the cutoff for value of PGx testing to inform where the best value is for money invested in a CDS alert program.