Digital Rx treatments offer advantages for patients, not the least of which is in encouraging behavior modifications that result in better compliance and better patient outcomes. And doctors reap benefits as well. So let’s start with the basics in digitalized health—the “Why,” “Who,” “When.”

WHY?

Digital medicine is in its infancy and will eventually improve how we treat chronic illnesses.

Digital tools can strengthen the physician-patient relationship, improving patient engagement and care, but this will require a closer collaboration among all healthcare participants. There is a growing demand for digitalized healthcare. Rock Health, a healthcare-focused venture fund group, reported that 87% of patients surveyed would like to use digital healthcare services, provided that those services meet their needs and provide the level of quality they expect.1 Patients already monitor their health through digital apps, and knowing that their information is secure and clinically useful can increase engagement.2 As we move away from fee-for-service towards a fee-for-quality model, healthcare systems and payers are seeking ways to improve outcomes. Marketers, too, must innovate in order to improve care, particularly in today’s digital world.

Digital tools can be separated into two categories—healthcare-collected data and patient-collected data. Healthcare-collected data includes electronic health records (EHRs), and patient-collected data includes sources such as wearables, connected devices in patients’ homes, or associated digital health apps such as the popular Fitbit or Vivofit, and an emerging field called digital therapeutics, or digiceuticals. Voice-activated assistants such as Amazon Echo can exist in both realms. Digiceuticals exist in the hands of patients, and can also fill the role of both healthcare-collected and patient-collected data. They can be divided into those that augment medications and those that replace medications. Generally speaking, digiceuticals, unlike wellness apps, undergo testing, and in some cases, clinical trials; however, as of yet they do not require FDA approval.

WHO?

Digiceuticals may reduce costs. Cognitive behavioral therapies (CBTs) are proven to improve outcomes in many chronic health conditions. While a CBT is delivered by a human being and vulnerable to variations in delivery, digiceuticals rely on algorithms and feedback loops to ensure consistent delivery of the ’ceutical, much like one expects from the consistency of modern medicines. Big Health, a digital medicine company focused on mental health, suggests that unlike pharmaceutical products with billions of dollars in developmental costs, digiceuticals rely on algorithms with feedback loops offering personalized care for patients at marginal costs. Unlike a human administering CBT, the digiceutical provides consistent therapies without variation.3

As per Big Health, if 20% of patients receiving antidepressants in the U.S. accessed effective digital medicine, over 60 million prescriptions per year could be avoided. This has immediate benefits, and sustainable patient outcomes with less risk than pharmaceutical alternatives. Physicians will be empowered to recommend guideline-directed, non-drug solutions.3 Given the ubiquity of smartphones and internet access globally, patients in regions of the world without developed healthcare infrastructures will be able to access care. Chronic diseases will now be treatable globally.

In many chronic diseases, behavioral or lifestyle modifications are classic first-line recommendations. Logically, digiceuticals that change behaviors have an immediate role. While lack of patient adherence to therapy might be a significant challenge with pills and injectables, there is good news—unlike pills or injections, patients already incorporate digital technologies into their daily routines. At present, over 318,000 health apps and over 340 consumer wearable devices are available worldwide.4 In other words, behavioral patterns that support the use of digiceuticals already exist in modern life. Patients monitor their caloric intake, activity levels, and a myriad of other activities with the assistance of wearables and apps; in some cases, there are apps that serve as remote echocardiograms, or evaluate for hyperkalemia based on heart rhythms.

Contemporary wellness apps and technologies solve another challenge—rebuilding the patient-physician relationship, encouraging partnership through wellness. Digital therapies offer more than an acute treatment at the bedside. The collected data can help physicians treat patients with real-time information, complementing diagnostic laboratory tests, augmenting medical therapies, and ultimately personalizing the clinical plan.

Real-Time and Remote Monitoring

Personalization can be improved with clinical trial data investigating digiceuticals in combination with guideline-directed therapies. More than behavioral modifying tools, digital treatments can offer real-time and remote monitoring of patients, providing deeper insights into respective trial populations, while also reducing overhead costs of trials. Digiceuticals can also provide flexibility to trial designs. It is estimated that 48% of clinical trial sites miss their enrollment targets. In addition, 11% of investigators never enroll a single patient.5 Situations such as these lead to expensive protocol amendments. Digiceuticals can plausibly expand enrollment for trials while reducing the need to collect data at designated centers. These efficiency improvements should, at least in part, reduce the bottom line for development costs, while expanding trial enrollment opportunities to more patients.

WHEN?

As opposed to wellness apps, which generally guide healthy living decisions, digiceuticals have direct action on a disease. Between 2015 and 2017 the digital health app space saw a decrease of 18% in wellness management apps (those that track fitness, diet, etc.), and a 48% increase in health condition management apps (those that are disease specific).4 Patients are clearly seeking solutions to their problems. Unfortunately, many patients seek out in-person care on an acute, as-needed basis, but good healthcare involves physicians and patients working together through illness and wellness in collaboration; it is not a transactional relationship, but a partnership.

However, for a digiceutical to effectively treat a chronic illness, like many treatments it should be prescribed early in the disease course. Patients must be engaged early and work with their physicians before they are ill. Fortunately, the steady adoption of digital health apps permits physicians to remotely monitor their patients during wellness and act swiftly at the first signs of illness, possibly recommending a digiceutical at that point. However, before digiceuticals can provide their maximum value, the healthcare industry must improve the EHR systems and link those systems with today’s wellness apps. This linkage will provide physicians with incredibly powerful data to help guide patients through their wellness, and ideally assist patients and physicians in detecting disease earlier in the clinical course. Once an ailment is identified, a digiceutical could be recommended or prescribed. Digital connectivity such as this could restore mutual collaboration between the physician and patient, moving the relationship beyond a transaction during time of acute illness to one of long-term collaboration focused on health.

In regions of the world lacking significant healthcare infrastructure, advances like these may be limited in scope, but conceptually, the integration of wellness app data and digital medicines is still a valid and noble endeavor.

Integrated Information Creates Personalized Treatment

The digiceuticals on the market have been relatively focused on psychiatric and neurologic indications, but the possibilities are broad. Digiceuticals can be designed around a variety of existing platforms, messaging apps, wearables, voice assistant interfaces, plausibly even webpage-based platforms. Each digiceutical will have a specific purpose in its design or execution. Chronic diseases due to poor lifestyles are a likely entry point for digiceuticals.

A particular behavioral modification that works for many patients might not be successful for everyone, but lack of adherence is not always evident. Unlike pills or injections which do not inform the physician of patient behaviors, digiceuticals offer the opportunity to collect patient data and to record that information in an EHR system. This is not an invasion of privacy. Patients, when prescribed a digiceutical, must adhere to the therapy, and one should view this scrutiny as part of a personalized treatment plan, empowering physicians and patients to make educated and informed decisions together, based on real information. If a digiceutical fails, the physician will have information suggesting a reason that could guide and improve therapy, perhaps influencing the decisions between a daily or twice-daily medication.

Patients with diabetes or hypercholesterolemia, for example, already treated with statins can benefit from an ongoing digiceutical to improve dietary modifications, augmenting pharmaceutical therapies. The digiceutical can be designed to track behaviors and caloric intake, and it may use messaging to ensure that a patient adheres to a plan. If prescribed as a first-line therapy, the digiceutical may even replace medications, depending on the condition.

Many advanced chronic diseases require intensive communications between physicians and their patients typically performed by physician extenders by phone since improved frequency of contact improves outcomes. Likewise, voice assistants and messaging apps may allow patients real-time contact with healthcare professionals. Artificial intelligence is promising in this arena as well and could serve as a first-line communication, flagging and escalating patients to a specialist based on criteria ranging from voice quality, patient requests, or other criteria. The possibilities are vast.

The volume of data generated is also vast and must be used to improve patient care. The pharmaceutical, device, and health technology industries must build partnerships among all healthcare stakeholders that enhance the physician-patient relationship through these tools. Healthcare companies cannot expect physicians to sort through the tremendous amount of data on their own. These data must be incorporated into the EHR systems in a practical and actionable way.

A well-engaged patient can result in the entire patient record spanning wellness and illness stored in the EHR. These EHR systems can thus reveal population and personalized habits, adverse events, successes and failures, and ultimately, with the assistance of marketers, help physicians risk-stratify patients and tailor therapies that will likely succeed. Marketers can analyze these data to ensure that patients receive the correct message at the correct times to maintain their health. This is more than selling a product. This transcends marketing—it is the modernization of our healthcare system in the digital age.

We must act quickly, utilizing modern tools to restore the physician-patient relationship and champion the idea of wellness to our patients.

Resources:

1. https://rockhealth.com/reports/healthcare-consumers-in-a-digital-transition.

2. Beisdorf, S., Niederman, F., (2014). “Healthcare’s Digital Future.” Retrieved August 27, 2018 from McKinsey and Company: https://www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/healthcares-digital-future.

3. http://blog.bighealth.com/digital-medicine.

4. Aitken, M., Clancy, B., Nass, D., (2017). “The Growing Value of Digital Health: Evidence and Impact on Human Health and The Healthcare System.” Retrieved August 28, 2018, from IQVIA Institute for Human Data Science: https://www.iqvia.com/institute/reports/the-growing-value-of-digital-health.

5. Rickwood, Sarah. (2018). “Next Generation Clinical Trials at the Heart of Innovation and Launch Excellence, The Case for Integration and Focus Document.” IQVIA.

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