In the opening of his speech at the Digital for Clinical Days, Giuseppe Recchia, Vice President of Smith Kline Foundation and co-founder of daVi DigitalMedicine, recalls the stages covered by the development of digital healthcare in the last years before approaching digital health perspectives for Italy.
Today, the condition of maturity of the Italian context authorizes us to ask ourselves ambitious questions about the destiny we intend to build, in particular, for digital therapies (DTx).
A still low level of knowledge
The number of health apps available today is huge. Yet, most of them fall withing a broader definition of digital health, that does not inlcude any proof of effectiveness nor a regulatory supervision.
But when it comes to digital medicine, a category that includes digital therapies, the protagonists are medical devices, products that require evidence of efficacy and regulatory supervision. From many quarters, for various reasons, doubts arise about the definition of these digital health solutions.
A study published last September by Eugenio Santoro team at Istituto di Ricerche Farmacologiche Mario Negri reported data from an analysis of all the clinical studies published on clinicaltrials.gov. Out of 560 extracted articles, 424 (that means 3 out of 4) improperly refer to digital therapies.
It testifies of a low level of knowledge, that still penalizes the development of these products and their entrance to all effects in healthcare.
How to commercialize?
In Italy there are still no digital therapies on the market.
Having to think about the most efficient way of marketing in our country, according to experts, the only way seems to be the one that passes through the National Health Service. That could happen even in partnership with insurance companies.
A new definition?
The taxonomy proposed at the time for digital therapies is no longer valid today, because the definition included in it is not clear.
A new proposal is based on the fact that:
- the DTx are in all respects medical devices;
- they provide a drug-independent therapeutic intervention;
- they offer a clinical benefit documented through a confirmatory study;
- thus, they require regulatory oversight.
By consequence, for these products the risk class cannot be below II.
Another consequence is that, until a confirmatory evidence of clinical effectiveness is shared and published, we have to talk of a DTx candidate, in analogy to a drug candidate.
More than just digital therapeutics
DTx are just one of the many expressions of digital health.
Here some others:
- Digital Drug Supports (DDS) are closely associated with a drug and allow to achieve the maximum clinical benefit from it.
- Digital Rehabilitation (DR) provide motor and cognitive rehabilitation interventions to promote the recovery of impaired functional abilities. They require experimental clinical efficacy tests and regulatory approval.
- Digital Self Management Education (DSME): in particular, last September was published a review on a product belonging to this category that helps lowering blood sugar with relevant clinical benefit.
- Digital Monitoring (DM): some of these medical devices generate data and monitor passively, others actively (through questionnairs). Of particular interest is a recently published study conducted on the effects of an inhalation system on therapeutic adherence.
Where are we headed
The entry of digital medicine into clinical practice presupposes the exit from a discussion restricted only to professionals, and the involvement of scientific associations.
The premises show that the entire treatment process – from diagnosis to therapy, up to follow-up and the entire rehabilitation phase – could benefit from introduction of these digital solutions.
A law for digital health
The speed at which digital health will enter therapies in Italy will depend on the decisions of institutions.
Some countries, like United States, Germany and Scotland, already thought about this.
In France, President Macron anticipated his willingness to create a regulation modeled after the German one.
Impact on cronicity
According to WHO, cronic conditions absorb as much as the 70-80% of healthcare resources and represent the 71% of all the deaths globally.
Among those instruments that can lower the effect linked to risk factors, the most innovative opportunity is the one offered by the e-Health tecnologies.
Digital health can limit the burden on the National healthcare system and guarantee a multidimensional managing of pathologies, observed Matteo Centola, R&D manager of Theras.
Digital therapeutics can adapt to the patients’ needs and habits, and to the pharmacological therapy already in place. They improve the access to care and, due to their characteristics, can be used for long-term treatments, such as those necessary in the management of chronic conditions.
Their positive impact on therapeutic adherence can significatively improve the clinical outcome.
On the other hand, as Marco Gorini (Head of Innovation in AstraZeneca) points out, the great difficulty they pose is the scalability, which represents a strong impediment for organization and dialogue with institutions.
This aspect has led to reflect on how digital therapies are managed in the health system. The result was the identification of the data-driven approach as capable of generating value from the point of view of healthcare resources, allowing 24/7 monitoring of the patient and better product management.
The stages in the development of a digital therapy
Francesca Mastromauro mentions KidneYou, the digital therapy which AstraZeneca (where she is Head of MEOR) is currently working on, indicated for treatment of chronical renal failure.
She traces the stages in the development of a digital therapy:
- identification of the patient’s medical needs: this step, especially in case of chronical conditions, requires the support of a multidisciplinary team;
- development of software and application, the design of which must take into account the use of a device by the patient and an interface for the doctor. A part of the software is the real active principle, while others constitute excipients useful to convey the therapeutic algorithm, aspect that promotes the patient’s engagement;
- generation of evidence through a randomized and controlled clinical study;
- regulatory approval.
The medical needs in chronical renal failure
A chronicity as heterogeneous as chronic renal failure – that brings together different disorders affecting the kidney and manifests itself with different clinical symptoms, each with different severity – requires a multidisciplinary approach.
It needs the support of a special diet (low in sodium, potassium and proteins), which, however, can cause the patient tiredness. This, in turn, can lead him or her to reduce or cancel physical activity, resulting in a worsening of the quality of life and psychological state.
Hence the use of a digital therapy able to help the patient towards the adoption of lifestyles that also support the long-term management of the disease, acting on various fronts (in this case nutrition, physical activity and mindfulness) in a personalized way.