White paper reveals pathway for digital therapeutics use in Italy

A white paper has outlined a pathway that could allow Italy to realise the potential of digital therapeutics (DTx).

The official journal of the Smith Kline Foundation, Tendenze Nuove, has published the paper entitled “Digital Therapeutics, an Opportunity for Italy” earlier this month.

The book features insights and recommendations from 40 leading experts in the field, who hope that Italy will begin to follow in the footsteps of early adopters of digital therapeutics  such as Germany, France and the US.

The experts were also involved in the “Digital Therapeutics for Italy – #DTxITA”, established in 2019 to encourage the implementation of DTx in Italian institutions and healthcare systems.

Healthware Group, an international integrated consulting group also based in Italy, contributed to the white paper.

CEO and founder Roberto Ascione noted that Italy could follow the example of Germany, which has taken steps to reimburse DTx at a national level.

He said: “As recommended in the white paper, the structure implemented by Germany could represent a valid and useful reference for Italy to deploy in order to facilitate and encourage the access to digital therapies.

“Regarding the reimbursement procedures and their inclusion in the national system formulary, we suggest to establish a dedicated Commission at the General Directorate for Medical Devices and the Pharmaceutical Service of the Ministry of Health, for the evaluation and negotiation of DTx.”

Giuseppe Recchia, director of Tendenze Nuove and promoter of the project said several steps must be taken to integrate DTx into Italy’s healthcare system.

There needs to be widespread information available to the general public, training for professionals and patients and targeted communications to health and political institutions.

Several vertical projects should address specific issues, such as the creation of a national observatory of digital medicine and decentralised clinical trials.

There needs to be more interest from innovative companies and research and clinical trials to ensure DTx have credibility with doctors and clinicians, he added.

“At European level, EMA has an important role in facilitating the appropriate recognition of DTx and introducing a seal of recognition that indicates the DTx products has an effect recognised by EMA may be an important first step.

“The Ministry of Health has an equally important role, ensuring the reimbursement of prescription digital therapeutics that meet the quality criteria defined in the documents we have published.

“We believe that without reimbursement there is no equity of access to digital therapies and no real place for digital therapies in medical practice.”

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