Digital Therapeutics Could Be Coming to Your Health System

Are we getting near a tipping point where the advice of the harried physician to “take two aspirin and call me in the morning” is about to be changed to “take two apps?” Probably not, but we’ve taken the first steps in that direction.

The U.S. Food and Drug Administration (FDA) has already approved a number of prescription software applications — known as software as a medical device, or SaMD — for treatment of various conditions, and it’s indicated interest in fast-tracking further development in this emerging segment of medical technology. While there will always be a need for molecule-based medications, prescription apps are ascendant.

3 Main Drivers of Growth in Digital Therapeutics

SaMDs can span a wide range of uses and applications. In some cases, they may be interfaced with other medical devices, either hardware or medical software, but SaMDs are capable of running on general-purpose devices like a smartphone. Some of the ways that prescription apps will be used probably have not even been conceived of yet, but their current potential is focused in three main areas:

• As a way for pharmaceutical companies to forge closer connections with patients, extend product life and improve efficacy and engagement
• As adjuncts to existing therapies to help improve compliance and provide a data feedback loop
• As digital therapeutic products to directly treat conditions such as substance abuse disorder, schizophrenia, post-traumatic stress disorder and similar healthcare problems

The Appeal to Pharma Companies

Greg Raiz, Chief Innovation Officer, Rightpoint

Pharmaceutical companies invest tremendous amounts of money, time and research to develop specific molecules, medicines and therapies. They conduct extensive clinical trials before putting new products out to market. While their investments in new products are protected by patents for a period of time (typically 20 years from the date the patent application is filed), eventually the drugs go off patent.

Naturally, pharma companies are interested in protecting their customer base over the long term. Traditionally, they’ve done this in a number of ways, such as changes in formulation and then a re-patent of the new version. Lately, however, they are exploring digital medicine as another strategy.

In most cases, a drug company has no direct connection with the end user of its product. Medication is typically prescribed by a healthcare practitioner and filled by a pharmacy. Inserting a digital app into the loop provides the missing connection. In the case of a product recall or changes in dosage, interactions with other drugs or usage instructions, prescription apps can provide pharma companies with a direct means of communication with patients. They can simply update the app on their phones. This requires no collection or storage of personally identifiable information about individual patients by the pharma company.

Pairing Digital Products with Physical Devices

Therapeutic compliance is a major issue in some treatment protocols, especially for certain chronic conditions. A prescription app can help improve compliance by doing something as simple as reminding patients to take their medication and making sure they take the right dosage. At the same time, the app provides data that can help healthcare providers track compliance with their treatment regimen.

One area where digital therapeutics show particular promise for improving compliance is in treatment regimens that require complex patient interaction. Diabetes is a great example. Diabetic patients being treated with insulin are supposed to do a titration calculation to determine the correct dosage each time they inject the drug. It’s not a simple calculation, so patients often skip it and just take the same dose as last time. Even when they do the calculation, the manual process is highly error-prone, so patients frequently end up taking an incorrect dose anyway.

Automating such calculations on a mobile prescription app has the potential to greatly improve patient outcomes. It’s still the drug that lowers their blood sugar, of course, but pairing the physical medication with a digital therapeutic product to ensure proper dosage can make all the difference.

Pure Digital Therapeutics — SaMDs as Direct Treatment

The cutting edge of the prescription app movement is FDA approval of digital therapeutics as direct treatment of specific medical conditions. It represents the intersection of the broader health and wellness trend with the rigorous scientific scrutiny that characterizes modern medical treatments.

In September 2017, the FDA permitted marketing of the first mobile medical application for the treatment of substance use disorders (SUD). Developed by Pear Therapeutics, reSET includes a patient application and a clinician dashboard. It provides cognitive behavioral therapy to patients to increase their abstinence from substance abuse and increase retention in outpatient therapy programs. Late last year, Pear Therapeutics initiated a Phase 2 proof-of-concept study for a prescription digital therapeutic for treatment of schizophrenia. This product is designed to deliver multimodal neurobehavioral interventions to improve symptoms and functioning of people with schizophrenia.

While prescription apps are still a nascent technology, the progress made so far and the FDA’s demonstrated interest in mainstreaming this new form of treatment bode well for the future. The day when your staff doctors tell their patients to download an app and text them in the morning may be closer than we think.

Greg Raiz is chief innovation officer at Rightpoint, the independent customer experience agency with technology at its core.

Get the best insights in digital health directly to your inbox.

Related

Otsuka and Click Partner to Develop Digital Therapeutic for Depression

After FDA Approval, Pear Therapeutics Releases Drug Treatment mHealth App reSET

There’s a Prescription App for That? Digital Therapeutics on the Rise