According to the NIH, there are hundreds of ongoing clinical trials in the United States and abroad to identify effective Covid-19 treatments. This trial and error process, although necessary, can be lengthy, expensive, and result in sub-optimal outcomes. Pharmacogenomics could potentially streamline this search and help providers make more targeted treatment decisions for their Covid-19 patients.
Disruptor report: Predictive and pharmacogenomic testing
You may be asking: "What in the world is pharmacogenomics?" Don't worry, you're not alone. Pharmacogenomics (PGx) is the study of how a person's unique genetic makeup influences his/her response to medications. When patients go through PGx testing, clinicians receive reports that outline the patient's genetic red flags and the potential impact on their medication regimen. This gene-drug information helps clinicians adjust medications and dosing, reduce the number of medication switches and their associated costs, and prevent adverse drug events.
Today's pharmacogenomics landscape
To date, only a small fraction of provider organizations have established PGx programs, with uptake mostly in the academic medical setting along with a handful of programs at community hospitals and primary care clinics.
These programs identify patients for PGx testing in different ways. Process variations may depend on the service line, specific disease state, or patient risk factors. Many organizations start their PGx testing programs in oncology, mental health, or cardiovascular diseases, since these are the clinical areas with the most pharmacogenetic evidence. For example, PGx testing can guide ADHD medication selection and clopidogrel (Plavix) dosing. Other organizations determine which patients should receive testing on a more individualized basis. Providers or pharmacists may recommend patients for PGx testing if they are polypharmacy, have documented adverse drug effects, or have yet to respond to their prescribed medication regimen.
Using pharmacogenomics for Covid-19 patients
In addition to these established PGx applications, we're now seeing researchers and organizations think through ways that PGx testing may help with Covid-19 patients. These clinical applications largely fall into two categories:
Identifying harmful gene-drug interactions: PGx testing can help prevent or mitigate gene-drug interactions in Covid-19 patients since several of the investigational drugs in clinical trials have established PGx evidence. For example, patients with cardiovascular disease have an increased risk of contracting Covid-19. If they do contract the disease, treating these already at-risk patients with an experimental drug like hydroxychloroquine can have negative consequences because the drug can cause arrhythmia. If these same patients receive PGx testing, providers can more appropriately determine which drugs and therapies would limit the chances of side effects like sudden cardiac death.
We're already seeing some organizations make this information publicly available. For example, PharmGKB’s Covid-19 therapeutic resource page includes a list of drugs involved in Covid-19 clinical trials and identifies which ones have associated PGx information. The page also includes other drug-drug interaction information as well as a list of relevant anti-depressants with PGx evidence.
- Identify at-risk mental health patients: Many experts expect a mental health pandemic to follow Covid-19 as millions of individuals feel distressed, lonely, and anxious from prolonged self-isolation. As we noted before, mental health treatments, as a category, already have strong PGx evidence. That said, providers can proactively use PGx tests to identify genetic variants and their associated gene-drug interactions. Providers can then use that information to get their patients on the right medications early and avoid the trial and error process that’s so common with anti-anxiety and anti-depressant medications.
Additional considerations for operationalizing a PGx program
While the use cases for pharmacogenomics are promising, there are still a number of barriers to overcome before launching a health system PGx program.
First, PGx requires dedicated investment. As health systems face financial pressure from canceled and postponed scheduled surgeries, their ability to invest in PGx software, dynamic workflows, and testing capabilities may be limited. In the short- and medium-term, health system leaders are likely to prioritize reopening over new initiatives like PGx.
Second, it takes time to implement a PGx program. These programs require collaboration from a diverse set of stakeholders including pharmacy, physicians, IT, revenue cycle, medical group leaders, and administrators. Given competing priorities and constraints amid the Covid-19 epidemic, organizations may struggle to create a PGx framework with cross-stakeholder appeal and gain executive buy-in.
Third, successful programs require clinician engagement and education. Despite the benefits of PGx testing, clinicians may be hesitant to implement new PGx programs that require added responsibilities or increased workflow burdens. Clinical and pharmacy leaders should expect clinician pushback in the near future, especially as they recover from the stress and added pressures of Covid-19.
All of these factors have contributed to limited program uptake to date. Inconsistent reimbursement policies, along with a lack of clinical outcomes data, have also contributed to low utilization. Given the stressors of Covid-19, providers will likely be hesitant to order PGx testing if it results in added clinician workload or increased patient out-of-pocket costs.
Reflecting on the moment
Despite these implementation barriers, PGx testing has the potential to help clinicians treat patients in a more targeted way—both during and beyond the Covid-19 epidemic. If PGx testing generates enough evidence to improve the care of Covid-19 patients, then providers, payers, and patients may be more willing to implement PGx moving forward.
Could Covid-19 be the catalyst that organizations need to bring pharmacogenomics to the forefront? If it is, health systems will need to figure out if PGx is a short-term solution to support Covid-19 patients, or if it's a long-term strategy to holistically improve patient care.
Our Advisory Board research team will continue to monitor the pharmacogenomic implications for Covid-19 patients in addition to publishing on the PGx topic writ large. Keep an eye out in the next few months for our first resource: a PGx glossary to clarify terminology and create a shared understanding.
If you'd like to participate in our PGx research, email us at KeenanC@advisory.com or PrescotA@advisory.com.