We are experiencing a digital revolution in healthcare that has never been experienced before and Digital Therapeutics (DTx) are the symbol of this radical change. In fact, it is an example of connected assitance where the patient becomes an actor and manages his data with awareness.
DTx are expanding what is globally achievable in healthcare through advanced technologies that offer increased therapy accessibility and personalization. By definition, DTx products deliver therapeutic interventions to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of disorders.
As PPHC wrote in an interesting article, in addition to the technological side, attention must be paid to clinical and scientific aspects of these medical devices because those apps are subjected to randomized clinical trials, just like drugs.
But they are software with the aim of changing the paradigm of healthcare and, maybe for this reason, they are not so easily defined.
So, after the introduction of synthetic active ingredients, biotechnologies and advanced therapies, here comes a new way of treating pathologies, which is based in some cases on a combination of software and drug.
DTx are already proving useful for treating numerous diseases, especially those related to or caused by behavioral and psychological factors, because they act precisely on the behavior of the individual: from gastrointestinal problems to diabetes, from ADHD attention deficit through Alzheimer's disease, insomnia, depression and respiratory diseases such as COPD.
Globally, the reference for DTx is currently represented by the Digital Therapeutics Alliance which brings together the leading manufacturers of clinically validated digital therapeutic solutions in the healthcare sector. The group's mission is to transform global healthcare by advancing digital therapeutics to improve clinical and health economic outcomes.
The alliance works to broaden the understanding, adoption, and integration of clinically evaluated digital therapeutics with patients, clinicians, payors, policymakers through education, advocacy, and cross-industry collaboration.
DTx are devices certified by notified bodies and must be subjected to clinical trials comparable to those carried out for drugs, but with the new regulation, the DM will also have a post-marketing follow-up that will accompany their use.
According to specialized reports, the Digital Therapeutics Market size is projected to reach USD 8.91 Bn by 2027, from USD 2.1 Bn in 2020 growing at a CAGR of 22.93% during 2021-2027.
The growth of the digital therapeutics market is driven by factors such as government initiatives for preventive healthcare, technological advancements in mobile healthcare, a significant increase in venture capital investments, and the benefits of digital therapeutics, such as the ability to induce behavioral change (an important challenge in healthcare), user-friendliness, patient convenience, and improved drug compliance. On the other hand, a lack of awareness and access to digital therapeutics programs in developing countries, patient data privacy concerns, unstable payment models, and resistance from traditional healthcare providers are challenging the growth of this market to a certain extent.
The reference legislation, in Europe, is mainly represented by the European Regulation on Medical Devices 2017/745 (MDR) even if the EU text does not explicitly mention digital therapies, perhaps because when it was written the concept of digital therapy was, precisely, just a concept.
One of the latest digital therapies approved by the US Food & Drug Administration is a video game, called Endeavor, which has been shown to be effective in managing ADHD diseases in children. It is in effect a therapy, has a package insert, the dose is 25 minutes a day, for 5 days a week, for 4 consecutive weeks. It is exactly the scheme that has been implemented in randomized clinical trials, in analogy with drugs.
In Europe, Germany is leading the way. Berlin has already approved 15 digital therapies, while another 21 are in the process of being approved. Germany is also the first country in the world to prescribe digital health apps, called DiGA (Digital Health applications), and reimburse them through the national health system. The country has introduced a "Fast Track" system for the introduction into clinical practice, with testing, experimentation and evaluation of these apps, and is open to all companies in the European Union.
The tools through which to deliver the DTx are many: apps, video games, virtual or augmented reality systems and wearables.
Patients will provide data in real time and the information gathered can be used also to assess the progress of treatment from a real world evidence perspective: to support coverage decisions, to develop guidelines and decision support tools for use in clinical practice, to support clinical trial designs and observational studies and to generate innovative treatment approaches.
The patient can be now an active part in improving the therapy.
It must be specified that DTx not entirely without risk. While they aren't molecules and therefore may not cause toxicity, DTx can have side effects, such as migraine, dizziness, nausea, dependence on the instrument, all symptoms associated with the prolonged use of electronic devices of any kind.
As per drugs, to be truly accessible to all, reimbursement is a key element.
The implementation of policies and regulations to allow access to and reimbursement of digital health applications has been underway in some regions for some time, particularly in certain European countries. Germany is the first country to provide a dedicated route to national reimbursement for these applications. And the use of DiGAs has increased since they were approved for reimbursement.
From a pricing perspective, DTxs cost 1/5 less than drug therapies. There are no studies comparing the two approaches, but generally the costs required for clinical trials are very high for drugs and very low for digital therapies.
It will be interesting to assess the cost-effective potential of DTx for National Healthcare Services. These therapies are expected to enhance health outcomes and optimize healthcare expenditure (e.g. reduction in hospital readmissions) leading to a reduction of costs associated with diseases/condition.
The generation of real-world evidence will surely have a pivotal role in the measurement of patient-centered and value-based outcomes in economic evaluations.
With a view to the management of chronic diseases, and considering prevention for risk reduction by changing lifestyles, digital therapies can mark a turning point in the management of these patients.
In Italy?
As pmlive has recently reported, a plan has already been developed in Italy, and as of early 2021, it is levelling up the score with other countries in the digital therapeutics realm. The white paper ‘Digital Therapeutics, an Opportunity for Italy’, published on 13 January 2021 in "Tendenze Nuove" journal, contains recommendations for the Italian ecosystem to advance in DTx.
Co-promoted by daVinci Digital Therapeutics, FADOI, FSK (Smith Kline Foundation) and Healthware Group, the publication is the outcome of ongoing collaborative efforts by over 40 of Italy’s leading experts in the field.
To summarize, the regulatory management elements of DTx currently exist (although multiple regulatory issues remain partially or even completely unresolved) and there is no document that puts everything together. Further it is probably necessary to set up the structure for the prescription, data gathering, supply chain, and maybe, thanks to the health emergency, we could see an acceleration that in other times we would not have seen.
Given the acceleration of "tele-health", the adoption of remote and other digital health tools as a result of the pandemic, as well as the increasing investment opportunities pouring in to the digital therapeutics space, a comprehensive plan involving all ecosystem stakeholders is required for digital therapeutics to overcome the mentioned and other barriers to patient access.
We believe that digital therapies will help build a more efficient, digital, sustainable health system.
Sources: PPHC.it ; dtxalliance.org ; Pmlive.com; DiGA