Digital Therapeutics Day 2021 – Year 3

Digital Therapeutics Day is an initiative launched in 2019 to support Italy in the development and adoption – by National Health Service – of the new therapeutic option offered by Digital Therapeutics.

The 2021 edition, promoted by daVi Digital Medicine srl and Springer Healthcare Italia srl and chaired by Alessandro Gallo and Giuseppe Recchia, aimed to review what happened in 2021 and to anticipate initiatives and trends for 2022, through the interventions of some of the major national experts of Digital Medicine.

These are some of the most important remarks from the conference:

Managing the risk of confusion

The term Digital Therapeutics is often used – sometimes intentionally – to refer to other categories of devices, such as drug supports.

Research by Eugenio Santoro et al (1) on the database ClinicalTrials.gov shows that out of 560 studies identified using the string digital therapeutics OR digital therapeutic OR digital therapies OR digital therapy (associated with the concept of digital therapeutics) in the fields intervention/treatment and title/acronym, only 136 (24.2%) randomised controlled trials consistent with the definition of digital therapeutics.

The risk of confusion can be managed through an update of the different subsets of Digital Medicine and of the descriptions provided in the current taxonomy (2), a constant activity of training of healthcare professionals and expert patients and of information to citizens and institutions.

Not only Digital Therapeutics

There has been much discussion in recent years about Digital Therapeutics. As a result of that, these therapeutics are now receiving increasing attention from doctors, pharmacists, patients and institutions. The same visibility has not been given to other Digital Medicine products, with as much potential for health delivery and with more opportunities for use, such as

a.   Digital Drug Supports

b.   Digital Self-Management, Education & Supports

c.   Digital Rehabilitation

d.   Digital Monitoring.

The taxonomy proposed by the Digital Medicine Society et al (2) highlights the Digital Therapeutics as a subset of the Digital Medicine products, without further description.

Digital Therapeutics has become – not infrequently in an intentional and opportunistic way, sometimes in an unintentional way not knowing how to give a specific name to other applications – a refuge term for other categories of digital health applications, first of all those supporting the drug.

It is now necessary to update this taxonomy and include the other categories

Update definitions

The current taxonomy defines Digital Therapeutics as: “Digital therapeutic (DTx) products deliver evidence-based therapeutic interventions to prevent, manage, or treat a medical disorder or disease. Clinical evidence and real world outcomes are required for all DTx products. DTx products must be reviewed and cleared or certified by regulatory bodies as required to support product claims of risk, efficacy, and intended use” (2).

This definition, which was crucial in the early stages of discussion and research, has not prevented the risk of confusion from arising. Terms such as evidence-based and clinical evidence can be ambiguous if not properly qualified, as is the case with clinically tested used for various wellness products.

It must be made clear that the clinical evidence on which the approval and use of Digital Therapeutics are based is only that which comes from confirmatory randomised controlled clinical trials, as recently proposed in Italy (3).

The concept of “independence” (stand alone) from other therapeutic interventions, particularly pharmacological ones, which may also be associated or combined, should also be highlighted.

Real world outcomes are certainly useful and important, but in addition to and not as an alternative to the outcomes of a previous clinical trial conducted in a more controlled context.

The definition must also contain the qualification of Medical Devices, which together with drugs are the category of health products with a therapeutic purpose.

An update of the original definition could therefore state that “Digital Therapeutics are Medical Devices that deliver independent therapeutic interventions to prevent, manage, or treat a medical disorder or disease. Clinical benefit must be documented by confirmatory RCTs. DTx products must be reviewed and cleared or certified by regulatory bodies as required to support product claims of risk, efficacy, and intended use“.

Reimbursement of digital therapeutics

Without reimbursement, it is unlikely – if not impossible – for a therapy to enter normal medical practice. Access to reimbursement for Digital Therapeutics requires managing the confusion, informing and educating institutions, and ensuring proof of efficacy of devices. All of this must be within a regulatory framework that ensures the quality of the devices and the appropriateness of their use.

The national observatory on Digital Therapeutics, which is currently being under discussion, intends to represent this framework to support and guarantee the adoption of DTx by the National Health Service

For an Italian Law on Digital Health

First Germany in 2019 (4), now soon France (5), will approve laws on Digital Health to introduce digital technologies in the processes of prevention, diagnosis, treatment and rehabilitation of patients. When Italy?

A “Thought and Action Group” has started an analysis of the German law to identify appropriate ways to adapt it to the Italian legislation. This is a process to be carried out within the current legislature, together with bodies and associations able to contribute both to the drafting of the law and to the creation of a broad consensus in support of its approval, which are necessary conditions for our country to close the gap that separates it from the most advanced countries.

As a “process catalysis intervention“, using the experience gained in countries with greater vision and ability to adapt to the rapid digital transformation of health, medicine and healthcare, the drafting of a bill was proposed:

  1. inspired by the Digitale Versorgung Gesetz (Digital Health Law) of Germany
  2. incorporated into Italian health legislation
  3. adapted to the Italian National Health Service
  4. drafted by experts in constitutional law and digital medicine, patients, doctors, pharmacists and others
  5. discussed with all interested parties
  6. open to contributions from social partners
  7. supported by a network of institutions, universities, associations, companies, enterprises
  8. submitted in time for evaluation by the end of the current legislative period.

An ambitious goal, but within the country’s reach, for which it must represent a fundamental element of the recovery and resilience path it is embarking on.

Towards new diagnosis and treatment pathways (Smart Diseases)

The development of digital health technologies is bringing an increasing number of devices available to doctors and patients for the management of different diseases, able to support diagnosis, treat the disease, promote rehabilitation, monitor disease progression and therapy outcomes.

The time has come to approach the discussion no longer or not only from the perspective of technology and devices, but from the perspective of the pathway that the patient has to take to reach the desired health goal.
At least for some diseases, it is now possible to start a process of “disassembling” the current diagnostic and therapeutic pathways, of evaluating the relevant digital technologies and of “re-assembling” the new “analogue and digital” pathways that will characterise the next phase of evolution of medicine and that will lead to an increasingly smart and informed management of the different diseases.

 References

  1. E Santoro, L Boscherini, A Lugo. Terapie digitali: una revisione degli studi clinici. R&P 2021; 37: 112-116
  2. Goldsack J, Coder M, Fitzgerald C, Navar-Mattingly N, Coravos A, Atreja A. Digital Health, Digital Medicine, Digital Therapeutics (DTx): What’s the difference? https://medium.com/digital-medicine-society-dime/digital-health-digital-medicine-digital-therapeutics-dtx-whats-the-difference-92344420c4d5
  3. G Gussoni. Executive Summary. Tendenze Nuove Numero Speciale 1/2021. Pagg. 3-7
  4. Rimborso delle Digital Health Technologies – Germania https://www.digitalmedicine.it/2022/01/09/rimborso-delle-digital-health-technologies-germania/#primary
  5. Rimborso delle Digital Health Technologies – Francia https://www.digitalmedicine.it/2022/01/08/rimborso-delle-digital-health-technologies-francia/

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