By Tricia Lee (Wilkins) Rolle, PharmD, MS, PhD
Government Affairs and Health IT Strategist
While many of us have heard of precision medicine, it’s viewed as a futuristic field, not routinely encountered. That is changing. Precision medicine (PM) is one of the hottest areas of health care today. It will affect all stakeholders and create the need to adjust electronic health records (EHRs), leverage data analysis techniques, and develop new insurance incentives and reimbursement structures.
This is the first of a two-part series on precision medicine. Part I briefly covers how key stakeholders will need to adjust and what to watch for in 2020. Part II will take a deep dive into how EHRs will be addressing the needs and challenges associated with precision medicine.
What is precision medicine? According to the National Library of Medicine, precision medicine is "an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person." PM brings together advances in artificial intelligence (AI), machine learning and biomedical science, including pharmacogenomics and companion diagnostics. The results will more accurately predict which treatment and prevention strategies for a particular disease will work in specific individuals and those with similar unique characteristics. Consider the case of clopidogrel, an anti-platelet therapy, used commonly to prevent blood clots and resulting strokes or heart attacks. However, this drug won’t work as well for individuals with certain alleles of the CYP2C19 gene. Genetic tests to identify persons with this genetic variant are now used to avoid inappropriate prescribing of this medication and to ensure that they receive treatments that will have the intended effect.
How PM will affect major stakeholders. Although PM will affect all stakeholders, here’s a look at some key players who will need to adapt.
- Payers and pharmacy benefit managers (PBMs) have a clear interest in PM and PM’s tie-in to strategies underlying value-based care. These include the need to manage populations; taking a focused view on each individual while maintaining capacity to manage potential outliers; identify diagnosis and treatment modalities that lower costs and improve outcomes; and adjust incentives and reimbursements accordingly. That said, payers and PBMs will need to construct PM-based coverage/reimbursement/benefit designs that keep pace with the evolution of care and necessary coverage for individuals to access these life-saving approaches to care.
- Infrastructure changes. PM will ripple across the health IT ecosystem. EHRs and other technology vendors will have to configure their systems to handle the advanced, complex data analytics and clinical decision support tools that underlie PM in ways that deliver usable and actionable insights at the point of care. Modifications will be needed to address the complex and varied needs for documentation, such as capturing new PM evaluation, procedure and diagnostic codes; genetic information; and data related to outcomes, costs and social determinants of health. Modifications also will be needed to address additional documentation required from payers. Secure, high-volume data storage will be crucial. There also will be related changes and innovation opportunities for drug data compendia, standards and specialty pharmacy.
- Providers understand the benefits of PM but require accurate and reliable tools for implementing it. Building trust will be crucial and may be difficult. Look at how hard it’s been to get physicians to trust formulary and benefit information for electronic prescribing. Formulary data is more accurate today, but pockets of negative perception remain. In the case of PM, we need consistent methods to evaluate PM techniques and validate PM tools. Additionally, investments will be needed in precision medicine education and related training.
- BioPharma and Life Sciences. PM is part of the move to real-world evidence (RWE), which is central to the life sciences today. PM is playing a central role in clinical trial designs by leading the push for a more genetically diverse, yet limited sample of individuals (such as n-of-one trials). Life sciences will have to take a more active role in the generation of RWE, including tracking patient outcomes post approval.
What to look for in 2020. Point-of-Care Partners is tracking the integration of PM into the health IT ecosystem. Here are some of the things we’re looking for in 2020.
- AI. As AI and machine learning mature, they will drive innovation in precision medicine. Critical to clinically useful AI are robust data sets. We expect additional momentum from the All of Us research program, which is a federally funded effort to gather data from one million or more people living in the US to accelerate research and improve health. It has a special emphasis on collecting data from traditionally underserved communities and ethnically diverse participants. This will be an area to watch.
- Health IT. The industry will continue working to figure out challenges concerning EHR limitations for PM. Expect to see leadership coming from medical specialists that continue to innovate. For example, COTA, Inc., is a leading precision medicine technology company (founded by oncologists) that uses real-world data to bring clarity to cancer care. The company also collaborated with Novartis to create the COTA Nodal Address (CNA). It is the first and only digital classification system for cancer patients that focuses on the use of real-world data to determine clinical and economic outcomes across a number of cancer types.
- Consumerism. Consumers are very much interested in genetic testing and its implications for their health. We expect to see more consumer-facing genetic testing (think 23 and Me) as well as new mobile and computer applications (apps) to facilitate testing, analysis and reporting of personalized consumer data. This in turn will push providers to adopt PM, as well as spur supporting infrastructure.
PM is changing the world of health care. This is an area we will be closely tracking in all of its permutations as 2020 unfolds in our newsletters, blogs and industry reports. Visit our subscription center if you’d like to receive these insights as soon as they are published. Or reach out to me at email@example.com to discuss Precision Medicine’s impact on your business.
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