Introduction- Why We Need Precision Medicine?
Precision medicine promises a paradigm shift in the care delivery arena. It is a new model of medicine with new disease taxonomy. In future, precision medicine will be enabled by data both from direct and indirect sources, probing the deepest mysteries affecting individual health and well-being. Applying precision medicine into mainstream clinical workflow will eventually facilitate preventative care by bringing new targeted therapies to improved patient outcomes and cost savings. Below are some of the prominent trends that reflect the evolutionary journey of precision medicine in the healthcare space.
1. Unreasonable cost of trial-and-error medicine makes precision medicine imperative for targeted therapies
Rising pressures to decrease healthcare cost globally, emergence of value-based reimbursement models, and healthcare digitization trends are transforming the medication model from ‘One-size-fits-all’ to stratified and outcome based targeted therapies. As per Nature article, an estimated 90% of the conventional and top selling blockbuster medicines only work for 30% to 50% of the patients. Moreover, the side effects and adverse reactions caused by these imprecise medications account for 30% of acute hospital admissions every year. In order to mitigate these inefficiencies, health authorities are introducing transparency measures around drugs pricing and deployment of sophisticated outcome-based compensation models for consumer-centric targeted therapies. Entailing these trends, pressures such as declining R&D productivity and eroding operating margins are also forcing pharmaceutical companies to review their traditional blockbuster business model and consider ulterior strategies such as precision medicine to augment current areas of focus and open new revenue streams. Precision medicine that involves multi-level patient stratification holds the promise to optimize pharma clinical trials cost, time, and success rate by co-development of drug (Rx) and diagnostics (Dx) for future targeted therapies.
Today, the drug development industry is betting big on precision medicine, with leading pharma/biopharma companies have nearly doubled their investment in personalized medicines in the last 5 years, and expect an additional 1/3 increase in the next 5 years. This has created a sense of increased commitment toward personalized medicine across leading pharma competitors, irrespective of their current drug pipeline portfolio. In addition, as per a 2015 Tufts Center’s Study of Drug Development, 73% of cancer and 42% of non-oncology compounds in the clinical trial have some form of biomarker drug label and can be categorized as precision medicines for targeted therapies.
2. Scientific and technological advancements in the genomics space make cost and time no more a barrier for precision medicine
Scientific knowledge and technological advancements around genomics has increased substantially during the past few decades, to facilitate diagnostic-based targeted therapies. Moreover, plummeting cost of NGS tests and emerging alternative point-of-care molecular tests are shifting the application focus for molecular diagnostic technologies from research to clinical use cases. Culmination of these trends has activated large scale population genome sequencing programs globally with million-person cohorts providing plethora of quantitative and qualitative data to advance precision medicine initiatives. Integration of these genomic data into clinical workflow to derive deeper insight into genetic and chronic deceases is unique to precision medicine concept. Today, innovative companies such as IBM Watson, N-of-One (a molecular decision support system provider) and 2bPrecise LLC (an Allscripts company) are coming up with advanced clinical decision support solutions that are capable to combine genomic data with clinical and lifestyle data to bridge the last miles for precision medicine practice. Integration of these genomics data into clinical workflow will create learning health systems with a similar trajectory to that of EHR systems, and will be eventually widespread in next 3-5 years albeit at varying degrees across countries.
3. Precision Medicine focus goes beyond oncology – new companion diagnostic (CDx) and biomarkers for non-oncology therapeutic areas
Increased knowledge around the human genome and correlation with disease progression are expected to shift the current CDx and biomarkers focus beyond oncology and spread more toward non-oncology therapeutic areas. For example, a recent analysis by Diaceutics Group suggests that 93% of the current phase 3 pipelines are diagnostic dependent and, interestingly, about two-thirds are focused on non-oncology areas. This creates a strong impetus for scaling the existing CDx platform technologies and tests to find precision medicine value beyond oncology. Both the drug and diagnostics companies are recently increasing their investment into exploratory biomarkers that focus on non-oncology areas such as infectious diseases, CNS, and cardiovascular diseases to broaden their overall biomarker research and diagnostic strategies. For example, CNS disease conditions such as Schizophrenia, Parkinson and Alzheimer that have strong genetic correlation with disease progression are finding initial success in biomarkers identification for targeted therapies.
4. Precision medicine will harness healthcare big data to elevate preventive care for chronic disease management:
In the last few decades, modernization-driven lifestyle changes have created significant implications in people’s health and social wellbeing. Today people are living longer with poor health condition at the cost of high medical care, making lifestyle-driven chronic diseases a major public health concern globally. As care for these chronic diseases expands in scope, prevention and recovery are becoming the new focus areas, apart from diagnosis and treatment. This demands a holistic view of individual health, lifestyle, and environmental data beyond the clinical health records to efficiently stratify at-risk patients for preventive and targeted treatment paradigm. The evolving ecosystem of precision medicine practice promises to look beyond the intrinsic omics and clinical factors and incorporate exogenous end-points by capturing critical data such as family history, food habits, alcohol, smoking, weight, salt intake, activity, and so on, to eventually facilitate stratified medicine practice. Today, there are many innovative digital health coaching platforms and wellness programs with proven behavioral therapies such as Omada (digital behavioral therapies for diabetes patients), and Zipongo (personalized nutrition solutions) are finding their way as an efficient alternative therapies for prevention and management of acute chronic health conditions.
5. Precision Medicine will boost the healthcare consumerism moment
One of the most transformative shifts we are starting to see in healthcare is the rise of this concept called ‘Quantified-Self’. Advent of digital health solutions is creating a plethora of personalized health and lifestyle data, manifesting a sense of healthcare consumerism. With this thriving consumer engagement movement today, people are more receptive to healthcare information and want to actively participate in their healthcare decision making process. These trends sync well with the evolving precision medicine practice that aims to extend a sense of accountability for patients and their caregivers, while playing prominent roles in future research and innovation to create a learning health system. In addition, convergence of precision medicine practice with evolving consumer centric-care business models such as direct-to-consumer (DTC) diagnostics, telehealth, and e-prescriptions will promote awareness and cost transparency for lab procedures, hospital visits, and medications. This in turn will provide patient greater clarity about the actual cost of care for their specific health condition, making them more conscious of their health and therefore reducing the overall cost burden. Undoubtedly, technology will continue to play a pivotal role in this journey toward precision medicine paradigm, where an evolving ecosystem of connected health technologies such as wearables, telehealth, artificial intelligence, and virtual reality will empower consumers to be the new king for their healthcare decision-making process.