Digital therapeutics: A bill for regulation in Italy

Bill 1208 “Provisions on digital therapies” was presented in June 2023. The text of the bill was recently made available on the Italian Chamber of Deputies website^[1].

The document, consisting of four articles, is designed to regulate in Italy new technologies that offer therapeutic interventions guided by advanced software programs, with a focus on reimbursement.

DTx in Europe and overseas

Digital therapeutics (“DTx”) are increasingly common around the world, including in Europe, at least in part due to their potential. In the United States, the Food and Drug Administration has already approved more than 35 DTx, some of which are reimbursed by health insurance or covered under corporate benefits, while others are paid for by patients, often through subscription.

The U.S. market for DTx already tops EUR 2 billion and is still growing^[2]. In Europe, Germany, is the leader in regulation and reimbursement of DTx. In 2019, the country’s Digital Healthcare Act_DVG introduced fast-track assessment of DTx reimbursement. There are currently just under 40 DTx covered. Similarly, France and Belgium are also implementing DTx reimbursement systems.

On the international level, an interesting report from the European Federation of Pharmaceutical Manufacturers and Associations (Efpia) dated June 2, 2023^[3] analyzed the spread of DTx in the European Union. The report looked at major obstacles to citizen access and offered recommendations for EC institutions and Member States. This was done with an eye to crafting a structured approach to DTx regulation on the European market through rules that are as clear and as harmonized as possible. The specific contents of this report were discussed in a previous article of ours.

Definition and areas of use

DTx are defined as “software-mediated therapeutic interventions with specific therapeutic indications designed to prevent, manage, and treat medical disorders and diseases by modifying patient behavior to improve clinical outcomes” in Article 1 of the document submitted to the Italian Chamber of Deputies. The article goes on to explain that such a therapy, like a drug therapy, is composed of an active ingredient and excipients, both of which are digital in this case. The digital active ingredient is primarily responsible for the clinical outcome and can be traced to a therapeutic algorithm, while the digital excipients—such as virtual assistants, reminder services, and reward systems—are value-added services that provide optimal patient experience, improve adherence to therapy, and enable long-term use. While DTx have mechanisms similar to those of traditional medicines, they also involve the use of software for medical purposes and must therefore be CE-marked in accordance with Regulation (EU) 2017/745, as the bill makes clear.

With regard to areas of use, the document explicitly identifies the following:

• cardio-metabolic diseases;
• endocrinology and diabetology;
• neuroscience and mental health;
• respiratory diseases;
• rehabilitation areas;

Evaluation Committee and Permanent Observatory for DTx

The bill envisages the establishment of ad hoc bodies to speed up evaluation of DTx and monitor their adoption across the country.

According to the bill, a decree of the Ministry of Health should establish a ten-member DTx Evaluation Committee chaired by a representative of the National Agency for Regional Health Services (AGENAS)^[4]. The committee, it continues, should provide preliminary guidelines for placing DTx on a fast-track evaluation pathway for inclusion in essential levels of care (livelli essenziali di assistenza – LEA), a necessary step in order for them to be reimbursable. Currently, in the absence of ad hoc rules, the regulations for medical devices (which DTx as software fall under) provide only a tax deduction mechanism, unlike the regulations for drugs.

Article 3 of the proposal envisages AGENAS establishing a Permanent Observatory for DTx to monitor scientific and technological development of these therapies in a timely manner. The observatory will submit an annual report to the two parliamentary chambers on the development of DTx and their dissemination and availability in Italy.

Inclusion in LEA

For evaluation of DTx for the purposes of including them among the services that the Italian National Health Service is required to provide to citizens free of charge (or upon payment of a copay, known as a “ticket”), the final article of the bill provides that AGENAS must identify the digital therapies to be included in LEA via a dedicated accelerated process, similar to what happens in other countries. It also states that for the purposes of inclusion in the LEA, each DTx must be the subject of at least two clinical studies “with high-quality evidence.”

An important step

The bill on the table in the Chamber of Deputies is undoubtedly a positive sign of movement on the issue in Italy, which bodes well for a forthcoming ad hoc regulation for assessment and market access pathway for DTx, beyond the “technical” time required for approval and implementation.

Interest in the subject remains high, not least in view of the fact that talking about DTx frequently means talking about artificial intelligence (AI), another field that is increasingly close to being fully regulated at the European level. Indeed, in DTx there is a great deal of room for implementation of AI technologies, with a significant number of new applications on the global market that use AI to tailor therapies to user behavior as manifested during the therapy itself.

[1] The document is available at this link.

[2] “In the United States, the digital therapeutics business is already worth $2bn (and Italy is still waiting for a law),” article published in Il Sole 24 Ore of May 8, 2023, available at this link.

[3] Available at this link.

[4] This would consist of five people appointed by the Permanent Conference for Relations between the State, Regions, and Autonomous Provinces of Trento and Bolzano; three appointed by the National Agency for Regional Health Services (AGENAS); one appointed by the Ministry of Health; and one appointed by the Italian Medicines Agency (AIFA).