What are digital therapeutics?
The field of digital therapeutics (also known as DTx), a subset of digital healthcare and digital medicine, is moving quickly. More than any type of digital innovation, DTx provide the opportunity to change, and perhaps improve, the therapeutic value proposition for patients. The optimism in this field is palpable, driven by concrete regulatory steps forward. For instance, the FDA has issued precise guidance regarding the use of digital therapeutics and has been approving an increasing number of solutions, such as therapeutic software. These solutions touch on a variety of diseases : diabetes, cancer, behavioral health, mental diseases. However, developing digital therapeutics is far from being easy. Digital health companies, however big or small, have been facing regulatory or business challenges for years now. This nascent field opens the door to companies such as Apple, Google and Microsoft, ready to advance by trial and error and ultimately bring to the market new solutions.
How do digital therapeutics work ?
Digital therapeutics are the embodiment of what pharmaceutical companies call approaches “beyond the pill”. As Nassir Ghaemi, translational medicine director at Novartis says “People need help and the medications aren’t enough”. Indeed, companies such as Novartis increasingly work on digital therapeutics, as they believe it is going to be another important aspect of treating illnesses, besides the traditional approach with drugs.
Phones are a great example of how technologies have been used to improve care in addition to traditional treatments. Indeed, patients can increase their knowledge about their pathology directly through their phones, by searching the Internet or using data-collecting applications. In France, the app Moovcare increased the overall survival of lung cancer patients by 7 months simply by asking them to fill a weekly survey about their health.
According to the Digital Therapeutic Alliance, DTx are “evidence-based therapeutic interventions with an emphasis on therapies that are driven by high quality software and that could either prevent, manage or treat a disease. And they can be brought in spectrum so that can go from physical to mental behavioral.”. To treat mental health disorders for example, the digital mental health company SilverCloud Health has partnered with Microsoft Labs in Cambridge to explore how machine learning and artificial intelligence (AI) could be used to personalise mental healthcare. But there is more than that, digital therapeutics are being developed to treat many types of pathologies like diabetes, obesity, psychiatric diseases or COPD. And they come in many shapes and forms : virtual reality headsets can, for example, guide anxiety patients through fearful situations and EEG headbands can help a patient relax or prevent an episode of migrain. The company Healium utilizes augmented and virtual reality and wearable technology to enable patients to “see their feelings”, with all the biofeedback collected by an Apple Watch or an EEG headband.
What are the different types of digital therapeutics?
Using digital therapeutics is no more complicated than taking a regular pill. The interaction with the digital device works like this : the patient provides data which, once processed and exploited, are intended to act effectively on the care and health of the user in order to increase the effectiveness of traditional therapies. The formats of “delivery” vary greatly from one solution to another: application, sensor, virtual reality, medical intervention, cloud platform, independent algorithm, etc.
Digital therapeutics could be classified as follows :
- Those combined with a drug treatment as a “digital option” : dosage algorithm, integrated sensor to monitor compliance, companion applications to improve the management of adverse effects, etc. To understand fully how this could work you can look at the CureApp, a prescription medical device specifically designed to aid patients who are receiving outpatient smoking cessation treatment. It truly provides doctors with greater insight into the patient’s data and responds to treatments between checkups, allowing them to provide higher quality smoking cessation treatments and then achieve greater efficiency. And, more recently, the FDA just approved the first prescription video game made by Akili Interactive specifically for kids suffering with ADHD. And, as Eddie Martucci, co-founder and CEO of Akili Interactive said in a recent interview : “This is a very different mechanism of action than how a pill works as it is working on the sensory-cognitive networks of the brain and can be used alongside a drug treatment”.
- Those which are independent solutions, they are used alone or in addition to medication: symptoms analysis algorithms, virtual reality programs to manage pain, online behavioral therapies or video games to treat neurological or behavioral disorders. For example, to monitor and diagnose Parkinson patients, voice recognition may be a very useful tool. In fact, those computer-based analyses of the voice could be used for at-home monitoring of symptom severity. Moreover, we know that dopaminergic therapies are very short-acting leading to periods where patients see their symptoms return. So, those non-invasive methods and digital options are now being considered very seriously.
How are digital therapeutics regulated?
Digital therapeutics always need to go through rigorous clinical testing, leading to a regulatory approval to demonstrate safety and efficacy. Here is the difference between those with a medical device (MD) status and those without:
- Those falling under the MD status have a medical claim and for which the regulation reinforces the evaluation and approval requirements. In fact, the clinical evaluation and approval by the competent authorities, as well as a possible reimbursement by the insurers and prescription by a healthcare professional, marks the difference with other e-health solutions available on the market. The necessity for clinical evidence helps to demonstrate their therapeutic efficacy, as well as the central role played by the software or the algorithm, at the heart of the device. In Chicago, to treat irritable bowel syndrome (IBS) which is a devastating chronic condition, DTx company MetaMe Health is developing its own DTx treatment program. And, they are actively pursuing FDA clearance to become a DTx that can be prescribed by a qualified healthcare provider. We can also talk about connected watches from the company Withings, made available to hospitals. It will be put on the market in September for the general public. Indeed, this was made possible thanks to the fact that they have validated the clinical tests necessary for its marketing as a medical device.
- Those that do not necessarily fall under the MD status are, most likely, positioned in the well-being and prevention market. They are nevertheless based on a scientific approach allowing clinical evidence of their performance and safety to be provided. There is therefore a gray area regarding their status as well as the necessary regulatory procedure, in France but also abroad.
Digital therapeutics are creating a new way of consuming healthcare for patients and a new way of creating care for providers. Often, these therapies come from startups that combine their expertise with pharmaceutical companies and other health providers to reach the market. However, these technologies also offer a unique opportunity to include the patient at every stage of the development to ensure optimal use and a strong impact in the healthcare journey.