Leo Grimaldi

There is rapidly growing and sizeable evidence which shows that innovating is the most important factor in pharmaceuticals. The industry is a field which itself has developed and evolved on the basis of disruption and innovation.

Digital Therapeutics (DTx) are at the cutting edge of this new disruptive tech-led industry. They form part of the wider jigsaw of patient support and treatment services which are seeking to enhance and optimize medicine and medical treatment for those at its center-the patients.

In my former role as a Governmental advisor for the U.S. Patient Protection and Affordable Care Act-also known as Obamacare-I helped to provide insights on how new technologies could be used to improve and reform the U.S. healthcare system. These kinds of digital interventions enable better patient outreach, sign up rates, and crucially the ability to capture real-world data.

As evidence-based interventions, driven by state-of-the-art software programs, DTx contribute to the prevention, management, and treatment of a plethora of medical conditions and illnesses. By their very nature they also have the ability to capture real-world data on usage, engagement, disease progression, healthcare outcomes, and therapeutic efficiency and in doing so, can demonstrate value to patients, payors, and providers.

Integral to the successful roll out of DTx is the need for a solid digital therapy management platform. Such a platform integrates the tools and support needed for the holistic treatment of the patient’s condition.

These platforms can help to empower patient self-management, enhance clinical care coordination, and capture the real-world data.

By integrating behavioral science into these platforms, we can also get a better understanding of both the needs of the patient and of their clinicians, when particular treatments are prescribed.

I believe that the pharmaceutical industry is now slowly getting up to speed on digital interventions. What, in the past, was a software solution developed by cutting-edge start-ups, has now become the core focus of attention of much larger industry players who are realizing the importance, both from a financial and public health perspective, of producing better outcomes for patients.

The reality is that life science companies require real-world data, and relevant statistics that show the value delivered to the healthcare system beyond what can be seen through clinical trials alone. As a result, there has been an increased focus on digital technologies that can generate data to demonstrate value. For the pharmaceutical industry this has meant a shift from seeing digitally-enabled interventions from a ‘nice to have’ to a ‘must have.’

Challenges

Until recently, there has been a disconnect between start-ups, pharmaceutical companies, and payors. Going forward, partners working together on DTx will need to agree on their definition of, and the opportunities in DTx.

It is crucial to put the patient at the center of any solution that is provided-imagine yourself as a patient with hypertension who is taking four different drugs to manage your condition.  

Assuming each of the drugs is supported by an app, patients will not want to be using four different apps.

For DTx to work at scale, and to gain broad adoption by patients, they need a solution that will combine the various elements of their treatment to support them to effectively manage their condition and achieve the best possible healthcare outcome.

Crystal ball gazing

One thing is certain, we will continue to see regulatory bodies and industry associations adapt and define the evolving DTx space for some time to come.

Recent examples include the U.S. Food and Drug Administration’s Digital Health Innovation Action Plan, the Digital Therapeutics Alliance, and the Digital Medicine Society.

There is now a real opportunity for pharma companies to think about breaking down the historical barriers between them to collaborate in designing digital solutions that put the patient, their journey, and their experience at the center. It is here that digital therapy management platforms can play the most important role.

Leo Grimaldi, MD, is S3 Connected Health director of digital therapy management and patient support services.