Rome, Italy
History and Structure
The Italian National Agency for Regional Healthcare Services (AGENAS) is a non-economic public body funded in 1993 and subject to oversight by the Ministry of Health.
Its tasks are identified by the Standing Conference on the Relations between the State, the Regions and the Autonomous Provinces, and it also carries out the tasks laid down by the existing legislation.
It has been re-organized in 2012 and, recently, with the 2018 financial law. AGENAS’ mission of “technical and scientific body of the Italian NHS carrying out research activities and supporting the Ministry of Health, the Regions and Autonomous Provinces of Trento and Bolzano according to the provision of Law n. 244/2007, item 2 paragraph 357” has been consolidated over the years. This is furthermore affirmed in the Agency Statute approved in May 2018.
Acting as a link between the central, regional and local level, AGENAS provide technical and operational support to Regions and healthcare organizations with regards to organizational, economic, financial aspects and efficacy of health interventions, as well as patient centeredness, quality and safety of care.
The Agency also participates in several projects co-financed by the European Union and coordinates health research programs financed by the Ministry of Health.
The HTA activity started as a research program, when the Agency became partner in different national projects and in the EUnetHTA project. The Financial Act of 2007 has determined that the Agency would support the Ministry of health in the evaluation of biomedical technologies.
Mission
In the field of HTA, the role of the Agency is:
- To participate in the activities of the Control Room, set up at the General Directorate for medical devices and of the pharmaceutical service of the Ministry of Health, with the task of defining the technologies that should have priority in being assessed, for healthcare purposes;
- To coordinate the national network for collaboration among the Regions for the definition and use of instruments for governing medical devices and for Health Technology Assessment (HTA), called “National HTA Program of medical devices”;
- To support the Regions through the establishment of the Interregional HTA Network (RIHTA) to enable the sharing of expertise available in Italy in the sector, and avoid duplication of assessments;
- To promote the activities of the Centre for the observation of emerging health technologies (COTE) dedicated to technological advances that are likely to have a major impact on the NHS over a 3-5 year period, in view of the proliferation of emerging technologies requiring different evaluation methods.
Aim
Our aim is to provide the methodological instruments needed to strengthen the Italian Health Service. We achieve this by defining methodological standards for evaluating medical devices and by assessing innovations, new technologies, organizational and administrative tools which can be used to provide solutions to enhance the efficiency and quality of the health services. We provide the instruments used for planning and carrying out checks and controls at different levels within the Health System.
How Agenas Works
Agenas manages four national programmes:
Health Technology Assessment (HTA);
- Clinical risk and patients’ safety;
- Clinical and organisational guidelines;
- Core benefits and health expenditure monitoring.
To achieve these objectives the Agency has four technical departments:
- Innovation Research and Development (IRD) which includes HTA and Horizon Scanning;
- Healthcare quality and accreditation;
- Healthcare planning and organisation;
- National framework for health services (core benefits and health expenditure).
Agenas employs epidemiologists, health economists, social scientists, bio-statisticians, clinical engineers, information specialists and administrative support staff.
Knowledge Transfer and Dissemination
Transfer and dissemination are realized through the Agenas website, through a periodical publication called “Monitor”, articles in national and international scientific journals, meetings and seminars.
Current Projects Related to HTA (A Selection)
In 2015 we have produced:
- HTA Report on “Implantable LVAD (Left Ventricular Assist Device) in addition to guideline directed medical therapy GDMT in end stage heart failure”
- Adapted HTA Report on “Different HD (Hemodialysis) modalities in Italy”
- Rapid HTA Report on “Sutureless aortic valve replacement for aortic valve stenosis”
- Rapid HTA Report on “Transcatheter implantable devices for mitral valve repair in adults with chronic mitral valve regurgitation”
The full list of ongoing and completed projects (HTA reports, Systematic reviews, Adaptation HTA and Rapid HTA) can be found at the following links:
http://www.agenas.it/aree-tematiche/hta-health-technology-assessment/attivita-hta/report-hta
and
http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=1202&area=dispositivi-medici&menu=tecnologie
Since 2009 Agenas has organized a national system of horizon scanning (COTE) and a knowledge exchange platform for HTA. In addition, the Agency acts as national hub of the network of regional authorities interested in performing HTA activities in collaboration. The full list of Horizon Scanning reports can be found at http://www.agenas.it/aree-tematiche/hta-health-technology-assessment/hs-horizon-scanning/report-hs
At international level Agenas is designed as member of EUnetHTA Network by the Ministry of Health and participates to the third European Joint Action on HTA. In the JA3 EUnetHTA Agenas is co-leading the Work package 7 on the implementation and is member of the Executive Committee of the Joint Action.
Future Plans
At national level the Agency is managing a process to establish formal relationships among different actors involved, setting up relations with health workers, with universities, with ISS (Istituto Superiore di Sanità – National Institute for Health), with scientific societies, with industries and Regions. We look for a more advanced legal framework to improve HTA coordination and a wide process of dissemination.
We are also engaged in capacity building in the field of HTA at regional and local level, both on the side of production and use of already available information.
Agency Information
Country: Italy
Description of population served:
Population served (mil): 60
Current HTA budget (mil USD): 5.34
Permanent staff: 45
Consultants: About 160 collaborators
Ongoing TA projects: 1 Full HTA report, 2 Rapid HTA reports; 1 Adaptation report; 3 Horizon scanning reports
Contact Information
Director: Dr. Domenico Mantoan
Contact person: Laura Velardi, Nicola Vicari
The Italian National Agency for Regional Healthcare
via Puglie
23 – 00187 Rome Italy
Tel: +39 06 42749700
Fax: + 39 06 427491
Internet: http://www.agenas.it
Email: velardi@agenas.it ; vicari@agenas.it