Paul Chernin

Implementation of a PGx + CMM program in a self-insured employer setting is feasible, detects risks in prescription regimens, and offers opportunities to improve medication management and reduce the burden of healthcare expenses.

The scalable, broad utilization of genetic testing in personalized medicine requires many factors working together to achieve value for patients, providers, and payors, and to avoid disruption of existing clinical workflows. We catalogue those factors and describe the historic context of each towards maturation and scalable deployment. Specifically, we make clear the compelling case that the tipping point has been reached for the five factors – clinical utility, laboratory technology, user… Show more

The scalable, broad utilization of genetic testing in personalized medicine requires many factors working together to achieve value for patients, providers, and payors, and to avoid disruption of existing clinical workflows. We catalogue those factors and describe the historic context of each towards maturation and scalable deployment. Specifically, we make clear the compelling case that the tipping point has been reached for the five factors – clinical utility, laboratory technology, user acceptance, implementation models, and economic value – in favor of large scale pharmacogenomic testing in a global context. As a treatise on the current state of clinical pharmacogenomics, health systems, payors, and population caretakers can leverage this research as guiding evidence pointing squarely in favor of acting now to stem the tide of rising healthcare costs. Codified in a key central figure, this paper promises to be a seminal reference to advance this field of genetic science towards becoming an international clinical standard of care. The use of genetics as standard of care has the potential to provide all stakeholders a low-cost solution to poor health and rising healthcare costs. Show less

Since its founding in 2013, Coriell Life Sciences (CLS) has built technologies leveraging genetic testing to empower physicians and has invested in research that advances the field of personalized medicine. The company focuses on development, implementation and research with expertise in medication safety, pharmacogenomics, infectious diseases and healthcare analytics. CLS works with healthcare institutions, laboratories, pharmacy benefit management companies, self-insured employers and public… Show more

Since its founding in 2013, Coriell Life Sciences (CLS) has built technologies leveraging genetic testing to empower physicians and has invested in research that advances the field of personalized medicine. The company focuses on development, implementation and research with expertise in medication safety, pharmacogenomics, infectious diseases and healthcare analytics. CLS works with healthcare institutions, laboratories, pharmacy benefit management companies, self-insured employers and public sector entities and actively contributes to scientific and clinical consortia. This overview summarizes the CLS service architecture and delivery capabilities for medication safety and risk reporting for pharmacogenomics, comprehensive medication management and infectious diseases. It includes the development and ongoing curation of genetic and non-genetic knowledge repositories, technology infrastructure and end points and research endeavors and it reviews economic, clinical and humanistic outcomes of CLS’ pharmacogenomics-enriched comprehensive management program. Show less

The clinical implementation of pharmacogenomics (PGx) in the context of inpatient and outpatient medical care represents a feasible and likely influential enhancement to the therapeutic management of medications. Specifically, the utilization of genetics to identify efficacy and tolerability issues has been shown to impact economic, clinical, and humanistic outcomes that are realized by patients, healthcare providers, and payers. These positively influence healthcare’s Quadruple Aim of… Show more

The clinical implementation of pharmacogenomics (PGx) in the context of inpatient and outpatient medical care represents a feasible and likely influential enhancement to the therapeutic management of medications. Specifically, the utilization of genetics to identify efficacy and tolerability issues has been shown to impact economic, clinical, and humanistic outcomes that are realized by patients, healthcare providers, and payers. These positively influence healthcare’s Quadruple Aim of enhancing patient experience, improving patient outcomes, reducing costs, and improving clinician experience. The understanding of the genetic impact on pharmacokinetics and pharmacodynamics provides the foundation for the clinical utility of PGx. Layered on top are the technical, regulatory, and implementation challenges associated with providing real-world clinical decision support for personalized prescribing based on genomic data. While the recent years have delivered improvements, policy changes, and learnings from implementations of pharmacogenomics, we are now living in a unique time where technology, regulatory policy, payer policy, and medically relevant and clinically actionable science are aligned to support rational healthcare implementations. To ensure that patients are provided the opportunity to benefit from these technologies, feedback loops between molecular mechanisms, patient outcomes, and clinical implementations must be created. This Research Topic brings together seven articles focusing on PGx, affording readers the opportunity to learn about the intricacies of specific gene variants on clinical outcomes; to study the challenges, enablers, and impacts of clinical PGx implementations; to consider how to communicate often esoteric details to expand the research, clinical, and economic benefits of PGx to all stakeholders; and to contemplate the immediate and future impact of these findings. Show less

The availability of clinical decision support systems (CDSS) and other methods for personalizing medicine now allows evaluation of their real-world impact on healthcare delivery. For example, addressing issues associated with polypharmacy in older patients using pharmacogenomics (PGx) and comprehensive medication management (CMM) is thought to hold great promise for meaningful improvements across the goals of the Quadruple Aim. However, few studies testing these tools at scale, using relevant… Show more

The availability of clinical decision support systems (CDSS) and other methods for personalizing medicine now allows evaluation of their real-world impact on healthcare delivery. For example, addressing issues associated with polypharmacy in older patients using pharmacogenomics (PGx) and comprehensive medication management (CMM) is thought to hold great promise for meaningful improvements across the goals of the Quadruple Aim. However, few studies testing these tools at scale, using relevant system-wide metrics, and under real-world conditions, have been published to date. Here, we document a reduction of ~$7000 per patient in direct medical charges (a total of $37 million over 5288 enrollees compared to 22,357 non-enrolled) in Medicare Advantage patients (≥65 years) receiving benefits through a state retirement system over the first 32 months of a voluntary PGx-enriched CMM program. We also observe a positive shift in healthcare resource utilization (HRU) away from acute care services and toward more sustainable and cost-effective primary care options. Together with improvements in medication risk assessment, patient/provider communication via pharmacist-mediated medication action plans (MAP), and the sustained positive trends in HRU, we suggest these results validate the use of a CDSS to unify PGx and CMM to optimize care for this and similar patient populations. Show less

Clinical manifestations of biological aging can be remarkably similar to the side effects of frequently used medications. Fatigue, muscle pain, and confusion are common and often not shared as part of proper geriatric patient history. When patients report them, a root cause is usually confounding. These symptoms not only negatively impact health and wellness outcomes, patient quality of life, and increase costs to the healthcare system, but also may be a limitation on provider best practices… Show more

Clinical manifestations of biological aging can be remarkably similar to the side effects of frequently used medications. Fatigue, muscle pain, and confusion are common and often not shared as part of proper geriatric patient history. When patients report them, a root cause is usually confounding. These symptoms not only negatively impact health and wellness outcomes, patient quality of life, and increase costs to the healthcare system, but also may be a limitation on provider best practices. The patient, a 71-year-old female of European descent, enrolled in pharmacogenomics-enriched comprehensive medication management (PGx+CMM) program through her retirement benefit. At the time of testing, she was approximately 18 months post cerebrovascular accident and was being observed by her primary care provider for common chronic conditions. Of interest, she had been manifesting unreported clinical symptoms of fatigue, hypotension, and myalgia. Addressing these patient concerns and specifically focusing on an individual’s goals, fears, and basic needs, rather than concentrating merely on the absence of disease, is the crux of personalized medicine and programs that address the notion of healthy aging. The patient’s therapeutic regimen was adjusted based on PGx+CMM pharmacist review, use of a clinical decision support system (CDSS), and communication of recommendations to the prescribing physician. The patient saw rapid improvements in symptoms, suggesting they were caused by medication side effects. Her blood pressure and cholesterol levels remained controlled while noticeable side effects were eliminated. This case study demonstrates the positive impacts of personalized medicine and shows how pharmacists can be empowered with a CDSS to positively impact healthcare. Show less