In our last issue, we ran an article featuring Dr. William H. Carson, President and CEO, Otsuka Pharmaceutical Development & Commercialization, Inc. He outlined Otsuka’s history of introducing Abilify MyCite, an innovative first in digital therapy.
As a sign of the growing importance of this area of investigation, there is now a publication devoted entirely to it, npj Digital Medicine. It defines the term as meaning “using digital tools to upgrade the practice of medicine to one that is high-definition and far more individualized,” and says it gives us “the means to process the vast data generated via algorithms, cloud computing, and artificial intelligence. It has the potential to democratize medi¬cine, with smartphones as the hub, enabling each individual to generate their own real world data and being far more engaged with their health.”
As a follow-up on this exciting area, we asked Chris Bergstrom, a member of our Editorial Board, to provide a broader view of digital medicine and its implications for the future of the industry. Here is his report, developed with his colleagues at BCG Digital Ventures and Ryan Sysko, CEO of Amalgam Rx.
WHAT IS DIGITAL MEDICINE?
Digital medicine, also known as digital therapeutics, is a new frontier in healthcare at the intersection of medicine and technology.
This novel field of healthcare technology has the potential to transform the way in which pa¬tients and doctors manage disease and disorders. While software has been a part of healthcare for de¬cades, digital medicine has unique attributes that set it apart. Indus¬try experts generally characterize digital medicine according to the following qualities:
- Clinically & behaviorally oriented
- Regulatory cleared/approved
Digital medicines can manifest in many forms, from software-only to any combination of software, hard¬ware and human support. For life sciences companies, digital medi¬cine represents a radically differ¬ent, yet exciting, opportunity as we explore ways to create new value. Whether used alone or in combi¬nation with traditional medical de¬vices and pharmaceutical products, digital medicines have the poten¬tial to improve clinical outcomes and reduce healthcare costs.
WHAT’S THE POTENTIAL FOR DIGITAL MEDICINE?
Digital medicine is gaining trac¬tion. Governments and health sys¬tems around the world are begin¬ning to integrate digital medicines. Signs of acceptance and adoption abound, with the inclusion of digi¬tal medicine in official policy and payment strategies in the U.S. and U.K. For example, the National Health Service in England is now providing some reimbursement support for digital mental health services.
In the U.S., many private and governmental payers are reimburs¬ing for digital solutions supporting diabetes management and/or pre¬vention. The attractiveness of these solutions lies in their potential to help improve patient outcomes and accelerate the transformation of healthcare systems from fee to value-based.
Digital medicine holds promise in three key areas:
1. Transforming Care Delivery
Healthcare systems globally face a massive and well documented challenge: successfully managing an ever-increasing population of chronically ill patients, including more than 100 million Americans with diabetes or pre-diabetes, 75 million Americans with hyperten¬sion and nearly 50 million Ameri¬cans with respiratory disease (asth¬ma and COPD). In many cases, managing these diseases requires more frequent intervention than a provider can offer through tradi¬tional office visits.
To this end, digital medicine offers the opportunity to scale health¬care providers’ reach, and can also transform the way that care is de¬livered through automated inter¬ventions. Technology can enable patients to access the knowledge and support they need to manage their conditions—anywhere, any-time—under the auspices of their healthcare providers.
Technology also enables support to be delivered through multiple modalities, including curated content, asynchronous messaging, real-time feedback loops, video conferencing, as well as connecting the digital care world to hardware such as IoT (Internet of Things) and virtual reality. Transforming care delivery from episodic to real-time and continuous is critical to achieving optimal disease manage¬ment; digital medicine enables this transformation.
2. Impacting Social Determinants of Health
There is strong evidence that stress, nutrition, exercise, social, environmental and other fac¬tors significantly impact clinical outcomes. In fact, these factors contribute to epigenetic modifica¬tions in patients and, depending upon the therapeutic area, may be as or more important than tradi¬tional therapies. Unfortunately, these factors are often ignored or undertreated, often because the systematic collection and analysis of the data signatures cannot be connected to appropriate interven-tions. This is the perfect domain for digital medicine.
Evidence-based interventions that change patient behaviors, self-management and self-efficacy can be delivered through digital means and create dramatic improvement. Pervasive consumer technologies provide the mechanism to capture and analyze self-management data, provide instant feedback and support, triage critical patient and connect patients and providers.
Digital medicine provides a level of scale and frequency of care that cannot be matched using traditional means, and it requires a careful approach to design an implementation to ensure that interventions are matched to new clinical endpoints. Clinical studies of digital medicine are required to validate these improvements and can also secure a competitive edge as new modes of therapies are brought to market. It’s not unthinkable to imagine a time in the near future when digital medicines are defined and compared based on their digikinetics (DK) and/or digidynamics (DD).
3. Creating Digital Biomarkers and Care Pathways
Historically, data collection in healthcare has been relegated to physical exams and laboratories (“traditional healthcare data”), which is episodic and often in¬complete in terms of formulating understanding among patient, doctor and condition. Further, the multiple modes of data collec¬tion have led to a disparate mix of siloed datasets, which have to be manually mined, matched and analyzed to unlock any value.
When designed right, digital technology is changing the ef¬ficiency with which data signa¬tures can be identified and tied to interventions. High mobile phone penetration coupled with inexpensive biosensors allow for continuous capture of physiologi¬cal, behavioral and other patient self-management data, previously only possible within inpatient set¬tings. Combining this data with traditional healthcare data, such as EHR records and insurance claims, presents new possibilities to rede¬sign chronic disease management.
Additionally, in very recent years, major investments in machine learning and artificial intelligence along with increased processing speed have unlocked the potential for almost real-time analysis of pa-tient data. In the future, combining these approaches with—omic data, such as genotyping, next generation sequencing and proteomics, will unlock a future of truly personalized medicine.
WHAT DOES THIS MEAN FOR LIFE SCIENCES COMPANIES?
The landscape in healthcare is shifting faster than ever. The skyrocketing costs of care supporting existing commercial and business models is not sustainable, increasing at more than than 5% a year. Meanwhile, outcomes have not shown a concomitant increase with average life expectancy in the US at 78.6 years and decreasing for the last few years. Winning in the healthcare market of the future will be defined by value creation–not “widget” sales. And the underpinnings of value creation start with the ability to transform data into actionable knowledge and meaningful outcomes.
For life sciences companies, this means combining traditional therapies, digital medicines, and other services to create new value for customers and users. These new offerings will allow life sciences companies to leverage their size and scale to make meaningful change. This change will manifest in the following areas:
• Business Model Innovation & Pricing
Enhanced information and im¬proved outcomes will enable life sciences companies to rethink their approach to contracting from fee to value-based. Digital approaches will be required to understand out¬comes based on precision, accura¬cy and timing intervals needed to create a sustainable value-pricing model. Ultimately through incen¬tive alignment, there will be greater revenue-generating opportunities through risk-sharing and success-based payment models.
• Data-Driven Product/Drug Development
Big data will fuel the drug discovery of the future at all stages in the R&D process through clinical development. It will decrease development life cycles and lead to more effective and precise medicines.
• Enhanced Customer Relationships
Life sciences companies have traditionally maintained strong relationships with healthcare pro¬viders. However, moving towards more solution-oriented products will enable them to build deeper and more meaningful relationships with patients and payers.
Amalgam’s team helped pioneer the field of digital medicine and built a leading technology platform and quality systems designed to support clinically-validated, behav¬iorally-driven and FDA-regulated digital solutions. Together, DV and Amalgam are helping healthcare partners accelerate and de-risk their Digital Medicine efforts.
BCG Digital Ventures’ global team of experienced digital entre¬preneurs, design and technology experts help corporate partners think and act like nimble startups and venture capitalists. They build and launch strategic ventures with clients. To best support bio/phar¬ma, medtech, payer, provider and other life sciences companies, DV has partnered with Amalgam to expand its offerings into the field of digital medicine.