Evaluating the Framework and Evolution of the Italian Ministry of Health HTA Reports

Author(s)

Mantuano M1, La Malfa P1, Freddi R2, Urbinati D1, Lombardi G3
1IQVIA, Milan, Italy, 2IQVIA, Milan, MI, Italy, 3IQVIA, Milano, MI, Italy

Presentation Documents

OBJECTIVES: Technology and innovation assume a key role in the current clinical practice, greatly influencing Health Technology Assessment (HTA) development and the role of the International HTA network (EUnetHTA) in standardizing HTA process among Member States. Our objective is to assess the main domains and technologies investigated in HTA reports developed by the National Agency for Regional Health Services (Agenas) in collaboration with the Italian Ministry of Health (MoH).

METHODS: HTA reports produced by Agenas and published on the MoH official website were retrieved and critically analyzed. Descriptive statistics were performed to evaluate the development of reports in terms of technology, therapeutic area and domains investigated.

RESULTS: 24 HTA reports were developed from 2013 to 2020, reaching a peak in 2014 (6 reports). Cardiovascular disease (46%), oncology (13%) and urology (8%) were the most investigated therapeutic areas. Medical devices were the main technologies assessed (79%) mostly focusing on high-risk classes (IIb and III). In-vitro diagnostics, screening programs and other interventions accounted for 9%, 8% and 4%, respectively. All 9 domains outlined in the EUnetHTA HTA Core Model® were investigated in two reports (8%). Health problem and technology use, technical characteristics and clinical effectiveness domains were considered in all reports (100%). Economic evaluation and safety domains were extensively investigated (92% and 88%, respectively) while organizational, patient and social, ethical and legal aspects were less explored, ranging from 29% to 13%.

CONCLUSIONS: The commitment of EUnetHTA in developing guidelines and tools for HTA collaboration shows that there is a clear need for standardized HTA information. However still few technologies underwent a comprehensive HTA according to EUnetHTA Core Model®. Limited evidence available and different level of innovation mainly influence the domains assessed. A broad approach requires further resources and time, and it could be firstly adopted for high-cost or potentially disrupting technologies.

Conference/Value in Health Info

2022-11, ISPOR Europe 2022, Vienna, Austria

Value in Health, Volume 25, Issue 12S (December 2022)

Code

HTA87

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

STA: Drugs

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