Digital therapies are proving particularly useful in pathological conditions linked to behavioural and psychological factors, such as Alzheimer’s, dementia, type II diabetes, and even serious respiratory problems. Let’s take a look at how they are made, how they work, the indications and market perspectives.
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Digital therapies (DTx) represent one of the most interesting and innovative strands of digital health. This definition identifies software-based solutions or software in combination with hardware devices that can complement or replace traditional therapies.
Digital therapies, like drugs, are subject to clinical validation through efficacy studies and are proving particularly useful in pathological conditions linked to behavioural and psychological factors, such as Alzheimer’s, dementia, type II diabetes, serious respiratory problems such as COPD (chronic obstructive pulmonary disease), asthma, gastrointestinal problems, obesity, substance abuse, ADHD, insomnia, hypertension, anxiety, depression, autism, and cardiovascular diseases.
A classification of digital therapies
Digital Therapeutics Alliance, a trade association of industry leaders and stakeholders committed to the advancement of digital therapeutics, proposes an interesting classification of digital therapies into four categories:
- Address a medical condition
- Manage or prevent a medical disorder or disease
- Optimising a drug or therapy
- Treating a medical condition or disease
The table below lists the following for each category:
- The criteria – regulations for risk, efficacy and intended use claims of the product
- Product claims related to a disorder or disease
- How clinical evidence are generated
- Patient access to the product
- Relationship to concomitant therapy
As can be seen, the first category is not about an actual therapy but about how to deal with a clinical condition.
Digital therapies have applications in many fields of medicine, as illustrated by the following figure:
Psychiatry is the most explored area, both academically and industrially, followed by cardiovascular diseases, addictions, endocrinology, neurology, respiratory diseases, oncology and sleep disorders.
What digital therapies look like
Drawing a parallel with the components of drugs, digital therapies also have an active ingredient and excipients, both of which are digital.
The digital active substance is the element of the therapy responsible for the clinical effect (either favourable or undesirable, as in the case of adverse reactions). Digital therapies may use, as an active ingredient, a therapeutic intervention already available in the scientific literature (in which case they represent an alternative modality of delivery of a known treatment, such as Cognitive Behavioural Therapy – CBT) or they may be created from scratch, using elements of different therapeutic options or employing technologies or biotechnologies.
Digital excipients perform the same function as chemical excipients, serving to shape the active ingredient and facilitate its uptake, making it as bioavailable as possible. In DTx, the digital excipient may include a virtual assistant capable of communicating in natural language with the patient, modules for rewarding the patient, reminders to take the digital therapy and complementary therapies, and modules to connect the patient with his doctor. The aim is to try to achieve the longest possible use of the digital therapy and thus ensure maximum digital availability of the active ingredient. Among the different elements of the excipient, the user interface is fundamental, as it is able to condition the user’s experience, the acceptability of the therapy, the adherence to the treatment and consequently the therapeutic outcomes.
Digital therapies can take different forms, similar to drugs which can be distributed in tablets, drops, creams, sprays. The most common is an app for smartphones, which is downloaded from a store (Apple or Google) and then activated using a code. It can also be a video game for a console, a sensor for an inhaler, software for an augmented reality display.
Modalities of action
Digital therapies can be used independently, as an alternative, in addition or in combination with other drugs. They can also act as a ‘therapeutic plug-in to the drug’, to enhance or extend its therapeutic action, for example by monitoring adherence to treatment or managing side effects.
Validation and certification
DTx therapies are evidence-based through clinical trials. Although it has many similarities with the drug, the research and development process of DTx is characterised by an iterative and evolutionary process based on experience, unlike drug development which is a linear process in which no intervention on the active ingredient is possible.
The development of a DT starts in the laboratory and consists of the development of the therapeutic intervention and its subsequent digitisation, with the achievement of the digital form appropriate to the therapeutic indication (app, video game, etc.).
Once the first version of the software has been obtained, pilot clinical development begins, conducted on a limited number of patients, with the aim of producing the data and information to allow an appropriate assessment of the advisability of continuing the development of the therapy.
If the results are positive, we then move on to the full development phase, which essentially consists of randomised, controlled clinical trials that must ensure proof of the clinical benefit of the therapy for the purposes of regulatory approval, reimbursement by public health systems or insurance companies, prescription by the doctor and uptake by the patient.
In the case of development of DTx “plug-in” or in combination with a specific drug, the trial must demonstrate the therapeutic superiority of the drug-digital therapy combination with respect to the drug and non-inferiority with respect to tolerability.
If, on the other hand, DTx are developed independently of the drug, as an add-on to the patient’s usual therapy, the trial must demonstrate the therapeutic superiority of the digital therapy over the digital placebo, both of which are added to the usual therapy.
In this case, the digital placebo is an app that is similar in form, but only provides general, descriptive health information without any intervention.
In the USA, digital therapies and related medical devices are subject to FDA approval.
In Europe, there is no EU legislation yet. Some countries, such as the UK with NICE and Germany with the Federal Institute for Drugs and Medical Devices (BfArM), have established their own validation and certification processes.
How to access digital therapies
As with traditional medicines, access to digital therapies can be through a prescription or without (such as OTC and SOP medicines). In the former case, the National Health Service or insurance companies (in the US) support the payment/reimbursement of digital therapy, as is the case for example in Germany (I discuss this here), the UK and France.
Market and outlook
According to a study by Juniper Research, the number of people using therapeutic and wellness applications will grow from 627 million in 2020 to more than 1.4 billion in 2025.
The research states that this growth will be largely fuelled by the acceptance of digital therapy technologies by institutions such as health insurers and employers, which are expected to contribute more than half of the revenues from digital therapies.
Which digital therapies are already available?
According to Mercom Capital Group, more than 200 digital therapies have been certified or approved worldwide. There are all kinds as I summarised in the mind map at the beginning of the article.