Key Trends in Digital Therapeutics
Digital medicine has become a major component in an ever-evolving healthcare environment. You’re likely already familiar with digital technologies such as telehealth platforms and electronic health records. Plus, there are hundreds of thousands of wellness apps available to anyone on smartphone app stores.
But there’s a reason digital medicine and even more specifically, digital therapeutics exist in a subcategory of their own. A digital therapeutic is typically described as an evidenced-based software solution, which are held to the same standards of regulatory oversight as more traditional medical devices. Digital Therapeutics can positively impact the trajectory of a patient’s disease and are approved to deliver specific clinical outcomes. In other words, Digital Therapeutics are viewed as clinically validated software solutions used by clinicians to treat, manage, and prevent a broad spectrum of diseases and disorders. This differs significantly from consumer health apps that track health or aid in the care process in some way.
Altering how healthcare is delivered
Digital therapeutics can be enabled by software alone, or combined with other interventions, such as medical devices or pharmaceuticals. The digital therapeutics yield clinical outcomes, making their software programs akin to medical devices. The software programs used in digital therapeutics generally have underlying artificial intelligence capabilities to analyze big data sets and generate predictive insights to improve and initiate care in real time. In this way, digital therapeutics can play a critical role in expanding access and efficiencies, allowing patients to manage their own care with fewer visits to a clinician.
Products and partnerships
On the surface, digital therapeutics may appear similar to wellness apps available on the app stores, but there are subtle yet meaningful distinctions. Welldoc Diabetes, for example, is a Food and Drug Administration (FDA)-approved digital therapeutic available to certain diabetes patients with a prescription. It is a virtual care platform that helps patients track and manage their condition using artificial intelligence to inform clinical decisions. Welldoc has similar offerings for patients with hypertension, heart failure, and mental health conditions, but these arms are not considered digital therapeutics because the platform is not FDA-approved for these uses.
The partnership between Chugai and Biofourmis is another example. Chugai and Biofourmis developed a digital system to measure patients’ pain levels due to endometriosis. The system uses wearables to measure physiological markers for pain and then analyzes that data through artificially intelligent software to detect patterns. At the same time, patients are encouraged to participate in questionnaires through a smartphone app with game-like elements. The program is currently under clinical investigation in an ongoing trial, which will hopefully improve our understanding of the relationship between pain and endometriosis.
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Gaining approval
There are specific standards that a product must meet to be considered a digital therapeutic. Crucially, digital therapeutics must have support from the relevant regulatory bodies and provide a clinically proven benefit through software-enabled interventions. The software must be designed with robust patient privacy standards and other best practices. Digital therapeutics should be validated with clinical trials and high-quality, accepted research.
The approval process for digital therapeutics is not a well-worn path. Platforms that have received FDA approval have done so through the pathway designed for medical devices. Currently, there is no pathway explicitly developed for digital therapeutics, but the FDA is in the process of creating one.
Patient benefits
Digital interventions offer potential benefits on many levels. On the patient side, these innovative technologies can often fulfill unmet medical needs in ways that traditional drugs cannot. Evidence suggests that digital therapeutics can deliver better outcomes, reduced costs, and fewer medical interventions when designed and implemented with the highest standards. In a report from Frost & Sullivan, researchers found that some expert-driven digital treatment plans resulted in a 50% reduction in average hospital and emergency room admissions.
Challenges to adoption
When a digital product reaches the market, the challenge becomes getting providers to prescribe it and insurers to pay for it. Much of the lag in insurer and provider acceptance stems from the novelty of the market. Providers and insurers may feel uncertain about the efficacy of digital interventions. Still, as the standards and regulatory pathways for these products become more established, attitudes are likely to shift.
The aspects of digital therapeutics that make them innovative and exciting can also make them somewhat foreign to companies steeped in traditional biomedical devices and pharmaceuticals that may not have the in-house capabilities to design software-based products. As a result, many companies choose to bring in a partner with expertise in the market to assist with development.
The partnership between Novartis and Biofourmis is a recent example. To improve and gain insight on the heart failure drug Ernesto, Novartis wanted to integrate wearables into a digital platform to adjust dosages of the drug based on data analysis. Novartis is currently working with Biofourmis to develop and implement the program. The goal is to keep patients out of the hospital and improve outcomes.
Market opportunities
Biopharmaceutical companies are increasingly taking notice of digital therapeutics as a new market to break into, with a lot of potential. The U.S. market for digital therapeutics is estimated to have a compound annual growth rate of 29.8% between 2020 and 2025, according to Frost & Sullivan.
For the biopharma industry, these technologies benefit a company’s bottom line because they tend to cost a lot less to develop than traditional drugs and demand a significantly shorter regulatory process before they reach the market. Digital therapeutics also allow companies to expand into entirely new markets, often by targeting conditions that are either underserved by pharmaceuticals or better treated with behavioral modifications.
The information collected by these digital platforms can yield valuable insights, such as how well a drug or treatment plan is working and whether patients are adhering to the protocol. All this population-level data and patient access enables companies to adapt their strategies quickly and based on better information. The rapid expansion of the digital therapeutics market will increasingly drive competition and reward the innovative companies that stay ahead of the curve.
References:
- Biofourmis Whitepaper. “Accelerating Biopharmaceutical Innovation with Digital Therapeutics to Improve Patients’ Quality of Life.”
- Nature. “The emerging world of digital therapeutics.” https://www.nature.com/articles/d41586-019-02873-1
- Deloitte. “How digital health apps are empowering patients.” https://www2.deloitte.com/us/en/blog/health-care-blog/2021/how-digital-health-apps-are-empowering-patients.html
- Welldoc. “Indications for Use.” https://www.welldoc.com/indications-for-use/
- ClinicalTrials.gov. “Objective Pain Measurement Using a Wearable Biosensor and a Mobile Platform in Patients With Endometriosis (OPINE).” https://clinicaltrials.gov/ct2/show/NCT04318275