HTA in Italy: results from the national survey by Agenas and SIHTA. Read English summary produced by MTRC

Italian national health technology assessment (HTA) agency Agenas in collaboration with Italian Society for HTA (SIHTA) issued a very informative national survey on the status of HTA.

Only 4 Regions did not respond to the survey (Campania, Friuli-Venezia Giulia, Molise, and Sardegna).

As of today, 11 Italian Regions have issued specific regional laws or regulations to manage HTA activities and processes at regional level: Abruzzo, Basilicata, Emilia-Romagna, Lazio, Liguria, Lombardia, Piemonte, Puglia, Sicilia, Toscana, and Veneto. In another 4 Regions (Calabria, Marche, Umbria, and Valle D’Aosta) and in the 2 autonomous Provinces of Bolzano and Trento, HTA is performed at different levels, even if no legislation has been produced yet.

The survey revealed details about:

• Type of technology: Among the 11 Regions in which HTA is regulated, medical devices (10/11), imaging technologies (10/11), and implantable devices (9/11) are most commonly assessed. In some Regions, organisational procedures, IVD, and information and communication technologies are also assessed.
• Phases of the HTA cycle: Topic identification seems to be mainly performed at hospital level or by regional committees. Prioritisation is performed by regional committees or groups of appointed experts. Assessment is performed by multidisciplinary groups involving administrative staff, clinical experts, epidemiologists, engineers, and health economists. Most of them have are only temporary hired.
• Type of HTA documents produced: Rapid HTA reports and Mini HTA reports are the most common documents. Full HTA reports, HTA adaptation reports, and Horizon Scanning reports are produced only in some Regions.
• Domains analysed: Among the 9 domains defined by the EUnetHTA Core Model®, Description and technical characteristics of technology (TEC), Clinical problem and current use of the technology (CUR), Clinical effectiveness (EFF), and Safety aspects (SAF) are most commonly analysed.
• Production time and language: The most common documents, Rapid HTA and Mini HTA, take on average 3 and 2 months, respectively. Almost all the documents are published in Italian, only a few in English.
• Target audience: Policy makers, hospitals, and healthcare professionals represent the main targets for all the Regions, despite the type of document. Most of the Regions make the documents publicly accessible for any stakeholder via website.
• Update of assessments: The Regions do not commonly update the assessments and, when reassessment is done, it is not performed on a regular basis.
• Regional impact of HTA: Among the 11 Regions in which HTA is regulated, only 6 Regions provided answer about this issue. Results from assessments are always bounding (mandatory for implementation) in one Region only (Veneto). In 2 Regions (Liguria and Lombardia) results from assessments are bounding only sometimes while in the other 3 Regions (Emilia-Romagna, Puglia, and Toscana) they are not bounding at all.
• Stakeholder involvement: Processes and strategies for the involvement of stakeholders in various phases of the HTA cycle have been implemented only in 5 of the 11 Regions in which HTA is regulated (Emilia-Romagna, Liguria, Lombardia, Puglia, and Veneto).
• Networking: Different levels of collaboration with other national/international networks and agencies have been identified among the Regions. Many Regions are part of the national HTA network and have collaboration experiences with other national/international HTA agencies while only a couple of Regions have collaborated with universities or international network.   

A set of face-to-face interviews among the Regions’ delegates has been performed, during a second phase of the survey, to identify critical issues and special needs related to HTA activities.

Lack of knowledge and education on HTA among the different levels emerged as a common issue together with organisational and political instability at local level, and lack of actual interest in implementing HTA processes from the side of the decision makers.

Among the needs believed necessary for a proper development of HTA within the Regions, it has been acknowledged by many that improving collaborative networks and collaborations among agencies would lead to increased levels of activity. Training programmes for current working teams, uptake of specialised staff, and a stronger HTA policy at national level have been also indicated as desired evolutions of the current situation.        

Access full report in Italian here.

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