What can digital therapeutics do for chronic diseases?

by Bronwyn Hemus, Sidekick's Senior Content Editor
5 minute read

Chronic diseases such as diabetes, obesity, cardiovascular conditions, and pulmonary diseases are on the increase. And they cost a lot.

Besides being expensive and bothersome, chronic diseases have something else in common: they are deeply linked to patient behavior and psychology. Unhealthy diets, lack of physical activity, and poor medication adherence are all risk factors for many chronic conditions.  The true burden of chronic disease prevention and resolution relies heavily on the patient, although meaningful and long-term lifestyle modification is no easy feat.  We know that simply being told to exercise more and to eat a healthy diet isn’t enough. Patients require carefully constructed treatment plans with personalized goals, as well as a regular connection with their healthcare providers.

“99% of chronic disease management is in the hands of individuals and their families.”  Center for Managing Chronic Disease, University of Michigan.

Can digital therapeutics (DTx) change the landscape for the treatment of chronically-ill patients, and if so, how? 

Why traditional treatment models aren’t enough

Many chronic diseases tend to occur alongside other chronic diseases which makes treating and managing patients much more complex, time-consuming, and expensive. 

“A recent article published in The Lancet suggests that as many as 50-70% of patients have more than one chronic condition.” 

The underlying biology of the disease is one reason for this, and habits and behaviors are the other. Comorbidity is also a challenge for traditional healthcare models which typically lean towards acute interventions within relatively isolated specialties. Additionally, existing chronic disease treatment models are difficult to scale. The reasons for this are:

  1. Healthcare providers can only do so much. HCPs are needed to ensure quality of care for each patient, but the additional tasks of patient monitoring, follow-up, and care organization adds pressure and burden to already stretched schedules.
  2. Care coordination requires collaboration. Comorbidity and the need to ensure sustained behavior change will require a revision of clinical workflows to optimize for long-term collaboration between different members of the healthcare system.
  3. Personalization is hard to achieve. Effective chronic disease management needs to include regular patient tracking on a granular level so that healthcare teams can intervene if the need arises. 

In essence, effective chronic disease management requires a more flexible and durable long-term approach with a deep focus on behavior change as well as coordination between multiple specialties on multiple interrelated diseases. To work, this multi-faceted approach cannot be restricted by the confines and limitations of traditional healthcare.

What DTx can do that traditional treatment models can’t

Digital therapeutics are inherently less risky than surgical and pharmacological interventions as they don’t have any associated side effects or toxicity. They can also reach a patient without the time and costs associated with having to visit a clinical setting.  By leveraging digital healthcare technology, healthcare providers are given an extra pair of hands and the support they need when monitoring a chronically ill patient. They can gain detailed insight into a patient’s state, medication adherence, and the progression of their disease between visits.

This real-world data is a powerful source of information for patients and healthcare providers alike. On the one hand, patients are empowered and can take control of the management of their disease by completing daily PROs, learning more about their conditions, and making positive lifestyle changes with the support of a health coach.

“Targeted behavioral nudges for patients to adhere to their traditional treatments can vastly improve their lives—even save lives. So, we need to empower patients and encourage them to take control of their own health. Digital health solutions are extremely well-positioned to do this, especially since smartphone adoption continues to rise, providing the necessary reach to have a real impact,” Tryggvi Thorgeirsson, CEO & Co-founder of Sidekick.

On the other hand, this data enables healthcare providers to remotely monitor the patient and even intervene earlier by way of adjusting medication doses or requesting urgent appointments. 

Roadblocks for DTx and chronic care

Traditional healthcare categorizations and rules inherently create roadblocks for innovative care models so the adoption of DTx into mainstream healthcare has been somewhat fragmented. 

Payers

To date, the payer mindset towards DTx has been divided. This is largely due to an uncertain regulatory environment and lack of a united approach on how to classify DTx: are they or aren’t they at par with traditional medicines? Such uncertainty has impacted reimbursement decisions for DTx products as their classifications aren’t necessarily clear or unified. 

Regulators

On the part of the regulators, there is an increasing willingness to develop regulations and improve patient access to DTx products worldwide. Some regulators have been proactively bringing out guidelines and regulations for DTx products. For example, in Europe, Germany has paved the way by facilitating reimbursement for DTx products. In the US in 2020, the FDA approved, cleared, or authorized a record 132 novel medical devices, topping the 106 novel device authorizations in 2018 that marked a 40-year high.

Providers

Finally, healthcare providers need support in embracing DTx. Few providers receive formal digital health training in their medical education so efforts need to be made to increase awareness and education on how digital health technologies work. 

Licensing and registration should also be modernized to recognize how digital innovations enable medical care to go beyond in-person visits to encompass care delivered by algorithms or remote providers. It also needs to be made clear to providers which new technologies and care modalities are properly registered and approved for use.

What lies ahead?

The burden of managing chronic health conditions will continue to increase without digital innovation, better forms of intervention, and long-term collaboration. Digital therapeutics presents the possibility to improve quality of life and to alleviate some of the pressure that sickness plays on people and families the world over. 

 

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DTx milestone: a first for payers

Express Scripts, a major US pharmacy benefits manager, created a special formulary for DTx products in 2019. 

This acknowledgment of the effectiveness and usability of DTx sent a strong signal to the rest of the industry. 

Chronic diseases, along with mental health, were the focus of Express Scripts’ formulary and its first formulary was based on a review of more than 70 digital health products using a four-stage process. This process tested for clinical effectiveness, user experience, security and privacy compliance, and value and affordability