The simple answer is: yes. Thanks for reading this post, stay tuned for more answers to your burning questions.
DTx are here
More seriously though, software programs that deliver evidence-based therapeutic interventions to prevent, manage or treat a medical disorder or disease[1] (which you may have heard referred to as “digiceuticals” or “digital therapeutics” – “DTx”) are now a scientific and commercial reality. In fact, you may even have heard about DTx in the news as a video game called EndeavorRx recently became the first video game cleared by the US Food and Drugs Administration (FDA) as a prescription treatment for ADHD (attention-deficit/hyperactivity disorder). This follows the trend set by others such as Pear Therapeutics who were the first company to obtain a market authorisation from the FDA for a software as a medical device (for an app[2] that provides cognitive behavioural therapy for substance use disorder). Other applications of DTx include apps that work as a companion to a medication or medical device, for example to help manage the treatment by monitoring side effects, recommending dosage, promoting adherence etc. (see e.g. the work of Voluntis).
A DTx is hard to make…
DTx products live in a challenging environment. Indeed, they have to provide demonstrable therapeutic effects (which need to be backed up by good quality, scientifically credible data) and a high quality user experience (that will be compared to that of consumer electronics and entertainment products from companies that have decades of experience of making a product simple, pleasant or even fun to use). Fail to provide the former and you will not get the seal of approval from the likes of the FDA (and ultimately the possibility for reimbursement that comes with that in some jurisdictions), or the trust from healthcare professionals. Fail to provide the latter and patients simply won’t use the product. For products that can succeed in providing both of these, the potential in improving healthcare is enormous.
A DTx can provide enormous benefits to patients
Areas of healthcare that are particularly poised for an explosion of the DTx market include mental health and some chronic diseases. Indeed, these are areas where “traditional” approaches have seen limited success or are simply not best set up to provide the benefits that patients need. For example, this can be because day-to-day management of symptoms, treatment management, day-to-day treatment delivery, and remote monitoring are where the primary patient need lies. Indeed, DTx are ideally suited to deliver remote treatment, in a manner that is easily personalised both by patients and their healthcare teams to fill the gap that is left in patients’ daily lives with a disease.
DTx in the COVID-19 era
Filling this gap is crucial at the best of time, but is a particularly prominent benefit in the current era, since a large part of the traditional healthcare delivery has been impacted by the pandemic and measures to contain it. This has left many patients without the care that they are used to and need, and has created substantial new needs in terms of mental health. One of the few upsides of this is that it has the potential to boost the adoption of DTx. This is important because many DTx products will get better through use, as they often collect data by design. This data can be used to improve the product by its very nature (e.g. any product that is based on machine learning will benefit from the availability of larger data sets from which it can learn – as discussed in this post), and/or because the providers of the product can learn how their users interact with the product and improve or enhance it accordingly.
A DTx is (currently) hard to regulate
Another potential side effect of the crisis it that it may speed up regulatory changes that are necessary to include DTx in the healthcare landscape. For example, the current crisis has prompted the FDA to publish an enforcement policy for digital health devices for treating psychiatric disorders during the COVID-19 pandemic. The policy aims to help expand the availability of DTx for psychiatric disorders and expresses the FDA’s intention not to object to the distribution and use of DTx for psychiatric disorders without compliance with requirements such as the submission of a premarket notification under the 510(k) pathway for software as medical device.
As discussed in a previous post, regulating software as medical devices is challenging. Although some organisations such as the FDA have made significant progress in this area (as evidenced by the successful market approval of the prescription DTx mentioned above), many open questions remain. Bodies such as the FDA, the US Pharmacopeia (the organisation that creates public standards for medicines), and the European Medicines Agency (EMA) are actively working on defining how they will be handling DTx.
What about IP?
From an IP perspective, DTx solutions live in a surprisingly favourable environment at least in Europe. Indeed, as previously discussed, computer implemented invention that achieve a technical purpose can be patentable (provided of course that they are new and inventive). Further, data showing a therapeutic effect that can be credibly linked to features of the computer implemented invention (as is likely already available as part of the development and regulatory approval process) is likely to be extremely valuable in this context. Patent protection is very familiar to the non-digital pharmaceutical industry. If carefully designed, patent protection can potentially be broad and strong for at least some aspects of DTx. Further, additional forms of IP can potentially apply to aspects of DTx including copyright, database rights and trade secrets (both of which are particularly powerful in Europe under their respective directives here and here). These can be combined into a potentially very valuable bundle of rights.
[1] This is the definition provided by The Digital Therapeutics Alliance, a trade association that performs research, education and advocacy to promote the understanding, adoption and integration of digital therapeutics in healthcare. The DTx Alliance includes members such as Bayer, Novartis, Roche, Philips, etc.
[2] reSET is a prescription DTx for Substance Use Disorder (SUD), providing CBT for patients enrolled in outpatient treatment under the supervision of a clinician (comprising a patient facing application and a clinician facing application).
