Digital therapeutics (DTx) is a fast-growing field, as pharmaceutical companies seek to provide solutions to meet the needs of our increasingly digitized society.
Bringing DTx to market successfully is associated with a number of challenges that pharmaceutical companies need to be prepared for. In this article, we look at:
- What is DTx + real world examples
- What are the challenges of bringing DTx to market and barriers to adoption
- The role of big pharma in DTx adoption
- The future of DTx
Defining DTx
The Digital Therapeutics Alliance (DTA) defines DTx as "evidence-based therapeutic interventions driven by high-quality software programs to prevent, manage, or treat a medical disorder or disease".
Most importantly, DTx products must be clinically approved based on clinical trials published in peer-reviewed journals, demonstrating clinically meaningful outcomes. The clinical evidence and real-world outcomes are the threshold that separates DTx from digital medicine and digital health.
DTx has the potential to revolutionize healthcare in numerous ways, though one of its most noteworthy applications is its ability to alter and change patient behavior. Through this mechanism, DTx can be used to correct harmful habits, treat behavioral disorders and encourage positive lifestyle changes, and even rewire an individual's thinking process.
Real world examples
The FDA has approved more than 40 Prescription DTx since Pear Therapeutics obtained the first approval in 2017. Here, we will take a look at 2 real world examples.
Daylight is a DTx intended for the treatment of generalized anxiety disorder in adults as an adjunct to their usual medical care. The program provides tailored exercises and activities that are largely based off cognitive behavioural therapy (CBT), teaching and honing the necessary management skills to put into practice. The product has demonstrated clinical improvements in anxiety in 13 randomized control trials and is prescribed additionally to standard mental health treatment. It guides its users on techniques designed to address the following:
- Reduce tension
- Reframe anxious thoughts
- Develop helpful behaviours
Daylight is made by BigHealth who became the first DTx company to receive NICE guidance in the UK for their leading product, Sleepio.
Freespira is an FDA-cleared DTx that is designed to treat panic attacks and symptoms of PTSD via an advanced digital breathing program in the comfort of patients' homes. The program works by monitoring a user's levels of carbon dioxide in their breath - this is measured by a breathing sensor. There is also an audio component that helps guide users through various breathing exercises, with the goal of regulating their breath and managing their emotions more effectively. Users also have access to personalized coaching calls and ongoing support from trained professionals to ensure they are getting the most out of the program. Users do not need to see a doctor or therapist to get started; they receive training and weekly check-ins from a 'coach' throughout the program, who is neither a clinician nor a therapist.
Other DTx products address a variety of disorders known to be impacted by behavior modification:
- Substance use disorder
- Chronic insomnia
- Posttraumatic stress disorder (PTSD)–driven traumatic nightmares
- Attention deficit hyperactivity disorder
- Irritable bowel syndrome (IBS)
- Reduction of pain in patients (18 years and over) with chronic lower back pain
- Amblyopia in children aged 4 to 7 years
- Abdominal pain associated with IBS in adults
Challenges of bringing DTx to market and barriers to uptake
Recent primary research from Bryter has identified notable challenges that will need to be overcome for DTx to succeed.
Education
Just 8% of EU and US physicians believe that DTx will have a positive impact on care provision in the next 5-10 years. However, once provided the DTA definition of DTx, 72% agreed that it would help physicians better manage patients. This means that educating both physicians and patients on what DTx are, how to use them, and how they can benefit clinical care will be essential to overcoming market barriers. Education on how to use DTx was identified as the main barrier to use: 63% of physicians indicated this.
Believers and non-believers
Primary segmentation data from Bryter surveying those working in the life science industry has shown that around two-thirds have positive perceptions towards DTx. Those particularly enthusiastic about DTx are more likely to work for a large pharma company and have spent more than 10 years in the industry.
Similar data but amongst physicians has shown that around a quarter remain skeptical towards DTx. This cohort of physicians are least likely to believe that DTx will have a positive impact on clinical practice in the future. They have no prior experience of DTx nor any digital tools; thus, even if provided with a definition of DTx this cohort will not be the ideal target population.
Data privacy
Just 20% of physicians surveyed by Bryter indicated that adhering to data privacy regulations is a concern to potential market uptake; this was their second least important concern. In contrast, data privacy adherence was the greatest concern for those currently working in the US life science industry (biotech, pharma, MedTech, etc.) - with nearly two-in-three indicating them as potential barriers to market. Around half identified regulatory frameworks around safe / reliable products as well as a restrictive regulatory burden as further challenges to market uptake.
The pharmaceutical industry is very cognizant of the regulatory and compliance issues connected to and beyond patient data.
Clinical approval
As all DTx needs to be clinically approved before usage, gaining FDA approval can also be a challenge as the product must have demonstrated clinically relevant outcomes via trials. This was identified as the second greatest barrier to market amongst those working in the life science industry (47%).
Research published data in Nature's Digital Medicine Journal has revealed that only a fraction of DTx applications have demonstrated positive outcomes in randomized controlled trials. This lack of efficacy makes it harder for healthcare stakeholders to embrace digital health—patients are less likely to become engaged with the application, providers are less keen on suggesting them, insurers may not offer coverage for them, and employers are less likely to make them available to their staff.
The role of big pharma in DTx adoption
Primary data from Bryter has shown that nearly seven-in-10 of those working in the life science industry believe that specialist digital pharmaceutical companies and tech startups are best placed to successfully develop DTx. Fewer than one-in-three indicated that DTx is in the remit of large tech and pharmaceutical companies. Physicians surveyed expressed similar views. DTx is different to other types of digital health as it has the potential to be the whole ball game.
Up until now, specialized digital tech pharma companies and tech start-ups have been driving innovation in this space. They are likely to continue to drive the development of technology and will play an important role going forward.
It will be important for big pharma to partner with smaller companies containing the expertise in relation to DTx development. Additionally, one would think that a DTx that is working together with pharmacological solutions could potentially replace pharmacological intervention altogether in some cases.
The future of DTx
Seven-in-10 currently working in the US pharmaceutical industry believe that DTx represents the next generation of innovation in disease treatment. They also believe that DTx has tremendous potential for application in oncology, neurology, and mental health.
68% of life science industry workers believe DTx to be appealing for pharmaceutical companies to develop it further and as such there is clearly a strong desire to evolve even more.
DTx currently functions as a supplement (or adjunct) to standard pharmacological treatment. However, DTx represents an exciting part of the rapid wider growth of digital health. Over half working in the pharmaceutical industry believe that DTx can speed up the development of pharmacological therapies. DTx plays to drug developers' core strengths and scientific expertise and presents saleable, high value products delivered to end-users via prescribers.
About Bryter and digital pharmaceutics
Bryter is an international market research and insights consultancy specialising in pharmaceutical research. We work with leading manufacturers and service providers to better understand the role pharma plays in people’s lives, enabling them to develop & market their products and services more effectively.
Read more about innovation in digital health and its impact on patient experience and the delivery of healthcare
You can read more about digital therapeutics and access a variety of other reports and resources at our website bryter-global.com
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