A national program to assess medical devices in Italy

A central assumption in all EU countries is the importance of assessing the clinical, economic, ethical and social impact of health technologies. According to the Italian Ministry of Health, the purpose of Health Technology Assessment (HTA) is to “aid in the identification of safe, effective, patient-centric health policies in order to attain the maximize possible value. The technologies in question include drugs, medical devices, vaccines, medical procedures, and more broadly all program that serve to safeguard and/or improve the health of our citizens.”
This assessment process, initially implemented in the 1970s, has seen a dramatic transformation in recent decades due to rapid innovation of health technologies, a surge in healthcare spending, and a proliferation of scientific evidence on the effectiveness of these technologies. Moreover, while some EU countries adopted HTA by means of centralized processes, in others the process has evolved in a more fragmented way. These discrepancies were partially mitigated thanks to work of the European Commission and the efforts of various countries. Together they have developed international HTA networks (for example, the European Network for Health Technology Assessment). The aim of these organizations is to standardize methods and procedures to make access to health technologies a fair and efficient process in all member states. Likewise, on a smaller scale, the Italian National Health System (NHS), through the Ministry of Health, is striving to achieve similar targets to standardize and centralize HTA at a national level, with an eye to minimizing fragmentation and inefficiency at a local level.

In a recent study, we describe the process that Italy has embarked on to create a national HTA program for medical devices.
Italy’s healthcare system is decentralized; as a result, till today HTA has only been applied in a few areas of the country or for specific interventions. Initial efforts to coordinate HTA at a central level were incorporated into the 2006-2008 National Healthcare Plan. This commitment accelerated rapidly in 2015 when the Stability Law instituted a national HTA program for medical devices.
A steering committee was formed with representatives from public institutions (the Ministry of Health, Regions, AGENAS (National Agency for Regional Healthcare Services) and AIFA (Italian Agency for Prescription Drugs)). This committee launched the National HTA Program for Medical Devices (PNHTADM) to promote the use of HTA tools in selecting and adopting such devices. Thanks to broad stakeholder participation, including representatives from academia, patients, public and private healthcare providers, professional and industrial associations, recommendations and methods emerged for establishing a national program.
This national program (PNHTADM), completed in 2019, consists of five stages: priority setting, assessment, appraisal, decision making and application.
Any medical device can be put forward for evaluation, from emerging technologies (i.e. not yet CE-marked) to obsolete ones. Seven selection criteria are applied when choosing which devices to assess: economic, social, organizational and ethical impacts, effect on patient health, epidemiological relevance and uncertainty in clinical evidence, when applicable. Once a device has been selected, the steering committee tasks a “collaborating center” with the assessment (this might be a central government agency, such as AGENAS or the National Institute of Health, or a regional health authority). The process culminates with a score for each of the following criteria: need, added clinical value, sustainability, acceptability, implementability, and feasibility. On the basis of the assessment, the steering committee makes a final recommendation (appraisal).
The PNHTADM differs from other international programs because it links the outcome of the HTA process with key healthcare policies for the Italian NHS: coverage (the device and related procedures are listed as Essential Levels of Assistance), procurement (adopting a value-based approach in purchase tenders), and reimbursement (remunerating for the procedure associated with the device by modifying the hospital fee structure).

• As we can see from the efforts made by public institutions and stakeholders so far, the time is right to champion a more transparent, objective, and rational process to regulate fair access to innovative healthcare technologies. This is also the only road to keeping the Italian NHS up to speed with the most promising technologies, and to ensure the future sustainability of free, universal healthcare, the principle that was the inspiration for the national healthcare system.  

• Despite recent slowdowns in the PNHTADM implementation process, partially due to the Covid-19 pandemic, the 2020-2021 Healthcare Pact repeatedly emphasizes health technologies assessment. This attests to the relevance of HTA on the government’s agenda, demonstrating a constant commitment to guarantee a universal healthcare system.  
• On the international scene, Italy’s compelling example of HTA could serve as a model for other countries (in particular where healthcare systems are extremely decentralized) seeking to consolidate their own HTA initiatives, especially in light of new EU regulations.

* This article was co-authored by Fabio Amatucci, Patrizio Armeni, Helen Banks, Ludovica Borsoi, Giuditta Callea, Oriana Ciani, Francesco Costa, Carlo Federici, Aleksandra Torbica and Marcella Marletta.