Italy

The HTA unit of the Lombardy region opens the possibility for the public to comment on the health technologies which are in the assessment phase. The call is open until February 28, 2020.

With a regional decree of December 18, 2019, Tuscany Regional Healthcare has published assessments of thirteen medical devices belonging to various therapeutic areas.

In late November 2019, new HTA activities were published on the website of regional HTA program of Lombardy Region, after a period of inactivity. Twenty-six (26) new technologies are currently in various stages of the HTA process, and they should all be completed in 2020.

With the regional decree of April 23, 2019, Tuscany Regional Healthcare has published assessments of six medical devices belonging to various therapeutic areas, including a system for monitoring in heart failure, TAVI, glaucoma drainage system, intravascular lithotripsy system.

Italian Ministry of Health, together with the national HTA agency, AGENAS, has published two Horizon Scanning reports in December 2018. Public consultations are open until May 25, 2019.

With a regional decree of March 7, 2019, Tuscany Regional Healthcare has published assessments of seventeen medical devices belonging to various therapeutic areas.

In late March 2019, the Italian Minister of Health announced that the European Commission has decided to adopt the Italian national classification system for medical devices for the database at European level.

In late March 2019, the Italian Ministry of Health has published a new document on medical device governance. The document presents the guidelines for a new governance of medical devices, which aims at the efficient allocation of the NHS resources, the sustainability of innovation, the strengthening of supervision and the transparency of actions and reports concerning the procurement and use of medical devices.

In early February 2019, the entity that performs health technology assessment for medical devices in Italy, AGENAS, has called for the voluntary contribution of the clinical experts and/or reviewers, as well as for the participation of the manufacturers for announced that they’re working on several HTA projects on different medical devices and procedures, including bariatric surgery, continuous glucose monitoring, Elecsys®sFlt-1/PlGF test and others.

At the beginning of December 2018, the HTA entity of the Region of Tuscany has released a list of the upcoming assessments of the medical devices. Assessments include among others Impella ventricular assist device from Abiomed, Endocuff Vision colonoscope from Olympus, VascuFlex® Multi-LOC multiple stent delivery system from B Braun.

In late October 2018, Assobiomedica, the body that represents the companies that operate in the medical device sector, published the fourth edition of the document “Public policies for the purchase of medical devices.”

On November 7, 2018, the Italian Ministry of Health announced the document which should serve as a tool for the acquisition of medical devices through tenders.