The New Quadrivalent Adjuvanted Influenza Vaccine for the Italian Elderly: A Health Technology Assessment

Abstract

Background. The elderly, commonly defined as subjects aged ≥65 years, are among the at-risk subjects recommended for annual influenza vaccination in European countries. Currently, two new vaccines are available for this population: the MF59-adjuvanted quadrivalent influenza vaccine (aQIV) and the high-dose quadrivalent influenza vaccine (hdQIV). Their multidimensional assessment might maximize the results in terms of achievable health benefits. Therefore, we carried out a Health Technology Assessment (HTA) of the aQIV by adopting a multidisciplinary policy-oriented approach to evaluate clinical, economic, organizational, and ethical implications for the Italian elderly. Methods. A HTA was conducted in 2020 to analyze influenza burden; characteristics, efficacy, and safety of aQIV and other available vaccines for the elderly; cost-effectiveness of aQIV; and related organizational and ethical implications. Comprehensive literature reviews/analyses were performed, and a transmission model was developed in order to address the above issues. Results. In Italy, the influenza burden on the elderly is high and from 77.7% to 96.1% of influenza-related deaths occur in the elderly. All available vaccines are effective and safe; however, aQIV, such as the adjuvanted trivalent influenza vaccine (aTIV), has proved more immunogenic and effective in the elderly. From the third payer’s perspective, but also from the societal one, the use of aQIV in comparison with egg-based standard QIV (eQIV) in the elderly population is cost-effective. The appropriateness of the use of available vaccines as well as citizens’ knowledge and attitudes remain a challenge for a successful vaccination campaign. Conclusions. The results of this project provide decision-makers with important evidence on the aQIV and support with scientific evidence on the appropriate use of vaccines in the elderly.

Influenza Vaccination Assessment according to a Value-Based Health Care Approach

“…Of the 40 studies included in our systematic review [ 3 , 4 , 5 , 8 , 10 , 11 , 12 , 13 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 ], seven (17.5%) had a non-European perspective and were conducted in Canada ( n = 1) [ 18 ], the USA ( n = 3) [ 19 , 21 , 42 ], China ( n = 1) [ 36 ], Iran ( n = 1) [ 49 ], and low-income countries (LICs) ( n = 1) [ 32 ]; ten (25%) had a global perspective [ 5 , 10 , 12 , 20 , 22 , 24 …”

“…Among the European studies, eight (36.4%) were conducted specifically in Italy [ 3 , 4 , 13 , 31 , 38 , 39 , 43 , 47 ]. In addition, of the 40 articles included in our work, 17 (42.5%) were systematic reviews or literature reviews [ 3 , 5 , 10 , 11 , 12 , 22 , 24 , 25 , 28 , 29 , 30 , 31 , 32 , 37 , 41 , 47 , 48 ], ten (25%) were economic evaluations [ 8 , 13 , 19 , 21 , 23 , 26 , 27 , 34 , 44 , 45 ], seven (17.5%) were cross-sectional studies [ 18 , 35 , 36 , 38 , 42 , 43 , 49 ], two studies (5%) were HTA reports [ 4 , 39 ], one study (2.5%) was a nonlinear regression model [ 33 ], and three studies (7.5%) were expert opinions [ 20 , 40 , 46 ]. The main features of the studies are shown in Table 1 .…”

“…Health care systems are constantly in search of effective primary prevention strategies, and in recent years, several new flu vaccines have been produced to deliver health benefits and protect communities [ 4 ]. However, vaccine efficacy, effectiveness, and safety assessment include only the minimum information needed for regulatory approval, rather than the full public health value of vaccines, and vaccine efficacy and effectiveness are usually focused on the direct protection of the vaccinated individual [ 5 ].…”

Comparative effectiveness of adjuvanted versus high-dose seasonal influenza vaccines for older adults: a systematic review and meta-analysis

“…At current, MF59-adjuvanted standard-dose and nonadjuvanted high-dose vaccines appear to have similar effectiveness in preventing seasonal influenza in older adults and therefore no conclusive recommendations on the preference of one vaccine over another could be drawn. Considering both a significant reduction in influenza virus detections observed during the ongoing COVID-19 pandemic (WHO, 2022) and the fact that both aQIV and hdQIV were authorized in 2020 (Calabrò et al, 2022;Cicchetti et al, 2021), it is unlikely that new retrospective (e.g., seasons 2020/21 and 2021/22) rVE studies with more specific endpoints will be available soon. Head-to-head RCTs and large multi-season publicly funded observational studies with more specific outcomes are warranted.…”

“…Although this approach may be justified from the point of view of the vaccine procurement, it may lead to significant between-region differences in vaccination policies 6 (Bonanni et al, 2018;Calabrò et al, 2020). The use of both aQIV (Calabrò et al, 2022) and hdQIV (Cicchetti et al, 2021) in the Italian elderly has recently undergone the process of full health technology assessment (HTA). Both vaccines have been demonstrated effective, safe and of valuefor-money; however, these evaluations were mostly conducted through the prism of comparison with sdSIVs, which were considered as standard-of-care.…”