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. 2023 Oct 10:11:1211208.
doi: 10.3389/fpubh.2023.1211208. eCollection 2023.

Access and use of WHO essential medicines in Italy

Alessandro Petrella  1 , Filomena Fortinguerra  1 , Agnese Cangini  1 , Andrea Pierantozzi  1 , Francesco Trotta  1
Affiliations

Access and use of WHO essential medicines in Italy

Alessandro Petrella et al. Front Public Health. .

Abstract

Background: Many countries use the WHO Essential Medicines List (EML) as a guide for health policy choices to promote the efficient use of healthcare resources or adopt the concept of essential medicines (EMs) to develop their own national list of essential medicines. The aim of this study is to analyse the availability and use of medicines included in the 22nd WHO EML in Italy.

Methods: Using the ATC code (5th level), a comparison was made between the medicines included in the WHO EML and those retrieved from the Italian Medicines Agency (AIFA) database. The availability (regulatory and reimbursement status) of EMs, as well as the market share in expenditure (million euros) and consumption [measured in WHO-defined daily doses (DDDs)], compared to all reimbursed medicines in 2021, were analysed.

Results: In 2021, approximately 85.2% (n = 414) of medicines included in the WHO EML were commonly marketed in Italy. Of these, 396 EMs were fully reimbursed by the Italian National Healthcare Service (INHS), corresponding to 81.5% (396/486) of the WHO EML, while the remaining 18.5% (90/486) were neither authorised (n = 72) nor reimbursed (n = 18). The study found a low coverage for anti-parasitic, insecticides, and repellent products (ATC P) in addition to medicines for the genitourinary system and sex hormones (ATC G). Even though medicines on the WHO EML, including therapeutic alternatives, accounted for ~48.5% of the expenditure for medicines reimbursed by INHS, the list covered 74% of all national drug consumed. Novel high-cost therapies indicated in high-prevalence diseases and rare conditions, mostly antineoplastic and immune-modulating agents (ATC L) not included in the WHO EML, were also guaranteed.

Conclusions: In Italy, high coverage of EMs was found. It was largely reimbursed by the INHS, even when compared to other European countries. Essential medicines represented a high percentage of the overall expenditure and consumption in Italy. The WHO EML could be an important tool to guide the health policy choices of high-income countries, although a more frequent update and easier access to information on rejected medicines are needed.

Keywords: drug consumption; essential medicines; expenditure; health policy; national formulary.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Availability of WHO essential medicines in Italy.
Figure 2
Figure 2
Medicines included in the expenditure and consumption analysis in Italy in 2021.
Figure 3
Figure 3
Reimbursement status of WHO EMs by ATC (1st level) in Italy in 2021 (N = 486: 396 reimbursed and 90 not authorised or reimbursed).
Figure 4
Figure 4
Distribution of the four groups of medicines reimbursed in Italy in 2021 by ATC (1st level) (N = 1,599).
Figure 5
Figure 5
(A–D) Expenditure (million euros) and consumption (measured in DDD) of WHO EMs (including alternatives) and analogue ATCs (5th level) by ATC (1st level) compared to the overall of medicines reimbursed in Italy in 2021.
See this image and copyright information in PMC

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