Apps, software and video games for treatment: soon to be reimbursed by the SSN

Apps, sensors, wearable devices with smart software up to video games. There are also new digital therapies that can help treat or at least mitigate the effects of diseases such as depression, addiction, Adhd or metabolic disorders such as diabetes, hypertension or obesity. Abroad they have been on the market for years - it is estimated that they will be worth close to USD 70 billion between now and 2034 - and are already prescribed by doctors. Now Italy too is taking a first important step with the approval (unanimously) in the Chamber of Deputies of the single text on digital therapies - also known as Dtx - which also provides the pathway for including them among the essential levels of care and therefore reimbursed by the National Health Service.

 Digital therapies are CE-marked (i.e. certified by notified bodies) medical devices intended to alleviate or treat a disease, health disorder, injury or disability. And they can be used alone or in combination with traditional drugs and medical devices to improve clinical outcomes and quality of life for patients by acting not on the patient's biology but on his or her thoughts and behaviour. In fact, these therapies aim to correct disorders such as inattention and wastefulness that cause possible dysfunctionality, especially with regard to chronic conditions such as neuropsychiatric disorders (addictions, depression, anxiety, insomnia, attention deficit or hyperactivity disorder in children) and metabolic diseases such as diabetes, obesity and hypertension.

 As with traditional medicines and medical devices, these digital therapies (which fall under the category of devices) must pass through clinical trials meeting safety and efficacy standards if they are to be reimbursed. Dtx therefore have to comply with medical device regulations: in practice they are therefore regulated in the same way as patches, syringes and medical equipment such as CT and MRI scans.  As mentioned, digital therapies are already widespread in several countries, starting with the US where the FDA has approved Dtx for years - a video game to treat Adhd dates back to 2020, for example - or France and Germany where, for example, Calmeda - an application developed to support people with tinnitus, one of the first digital therapies approved and reimbursed in Germany - and Velibra, a digital therapy to treat anxiety disorders, have been authorised. To be able to activate them, German patients must present a prescription issued by their doctor with a specific activation code.

 The proposal, which must now go to the Senate, first of all defines what digital therapies are and provides that within thirty days from the date the law comes into force, a National Committee for Digital Therapies will be established at the Ministry of Health, also providing that Dtx, as included in the category of medical devices, will fall within the scope of the National Health Technology Assessment Programme. Lastly, in order to start reimbursement, it is envisaged to carry out 'the necessary evaluations for the purpose of including digital therapies in the essential levels of services', emphasising that for such inclusion a 'clinical validation methodologically compliant with international standards' is necessary. For Simona Loizzo, deputy of the League and group leader in the Social Affairs Committee, this law, which she has been working on for some time, 'is a real revolution, a paradigm shift, a new frontier that makes our patients more efficient and in dialogue with the treatment systems, also achieving a 30% reduction in hospitalisations, without forgetting that our country has many small and medium-sized enterprises that are among the main producers of patents and start-ups on this type of therapy. Italia's path is moving towards national governance. I always say that there is no innovation in healthcare if there is no governance'.