Financial Outcomes of Managed Entry Agreements for Pharmaceuticals in Italy.

Importance: Most countries in the Organisation for Economic Co-operation and Development apply managed entry agreements (MEAs), reimbursement arrangements between manufacturers and payers, to pharmaceuticals. Few data exist regarding their ability to lower expenditures.

Objective: To analyze the financial outcomes of MEAs for pharmaceuticals from 2019 to 2021 in Italy.

Access and use of WHO essential medicines in Italy.

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.

[Pharmacotherapy of Hemophilia A: expenditure and consumption for the year 2022 and future expenditure scenarios.].

In 2021, the national expenditure for blood coagulation factors was 541.4 million, growing steadily over the past decade. Hemophilia A is the congenital hemorrhagic disease with the highest drug consumption and expenditure.

[Parole chiave. Appropriatezza prescrittiva, consumi farmaceutici, emofilia, fattori della coagulazione, malattia di von Willebrand, malattie emorragiche congenite.].

Therapeutic strategies for the treatment of congenital bleeding disorders. Congenital hemorrhagic diseases (CHDs) are a group of rare disorders caused by quantitative or qualitative deficiency of one or more coagulation factors. Haemophilia A, Haemophilia B, and von Willebrand disease are the most common congenital bleeding disorders.

[What is the real price of SOP and OTC drugs? Pilot study on paracetamol].

Objectives: to investigate the actual selling prices of over-the-counter or self-medication (OTC) and non-prescription (SOP) packages of band C medicines, which are freely set by individual pharmacies, para-pharmacies, and corners of the large-scale retail trade. Specifically, the prices charged for paracetamol 500 mg 20 tablets (20 CPR) and 30 tablets (30 CPR) in the online sale, carried out by different retail outlets authorized by the Italian Ministry of Health, were surveyed.

Design: cross-sectional observational descriptive study.

Hospital Antibiotic Use during COVID-19 Pandemic in Italy.

Antimicrobial resistance (AMR) represents a major issue in healthcare being correlated to global inappropriate use of antibiotics. The aim of this study was to compare the data on hospital antibiotic consumption in 2020-2021 with those related to 2019 in order to evaluate the impact of the COVID-19 pandemic on antibiotic prescriptions and appropriate use at national level and in the different geographical areas. To estimate the consumption of antibiotics, two indicators were calculated: "number of DDD per 1000 inhabitants per day" and "number of DDD per 100 hospitalisation days".

Dynamics of price competition in Italian pharmaceutical off-patent market.

Introduction: The aim of the study was to evaluate, in a regulated generics market, the effect of the number of manufacturers of generic drugs on the amplitude of off-patent products price reduction and the price evolution of originators and generics after the patent expiry of pharmaceuticals dispensed by community pharmacies and reimbursed by the Italian National Health Service (INHS).

Methods: The AIFA "transparency list" was utilized to select unbranded and branded off-patent drug dispensed by community pharmacies and reimbursed by the Italian National Health Service between 2012 and 2018. The unbranded drug entry in the transparency list database was considered as a proxy of its patent expiry.

Impact of COVID-19 pandemic on medication use in the older Italian population.

Objective: This study aims to analyse the impact of the pandemic on the amount of use and new medication dispensation for chronic diseases in the Italian population aged 65 years and older (almost 14 million inhabitants).

Methods: The "Pharmaceutical Prescriptions database", which gathers data on medications, reimbursed by the National Health Service and dispensed by community pharmacies, was employed. Data were analysed as amount of use (defined daily dose-DDD per 1000 inhabitants); variation in DDD between 2020 and 2019 was calculated for the 30 categories with major consumption in 2020.

[Direct and on behalf delivery of drugs for human use: opportunities and problems.].

The direct delivery of medicines by public healthcare facilities (Local health authorities, hospitals) is being discussed in Italy: the article considers opportunities and drawbacks of the different options (delivery through health facilities or through specific agreements with public and private community pharmacies) with respect to the characteristics of medicinal products and the needs of patients. The authors of the Italian Medicines Agency (AIFA) identify the main issues to be considered for a possible shift of some drugs from direct delivery to that on behalf, and which mainly concern drugs that must in any case be administered in hospital (see drugs for intravenous use or usable only in hospitals); drugs whose dispensing requires special precautions regarding confidentiality or for which dispensing by the staff of a health facility can improve patient adherence to therapy; innovative drugs monitored through registers.

Medication Use and Costs Among Older Adults Aged 90 Years and Older in Italy.

Older adults are often affected by multiple chronic conditions and experience geriatric syndromes that may affect the risk/benefit profile of medications. Little is known about the use of such medications in the older population. This article describes medication use and costs in Italian adults aged ≥90 years.

Orphan Drug Prices and Epidemiology of Rare Diseases: A Cross-Sectional Study in Italy in the Years 2014-2019.

Introduction: It is well acknowledged that the price of orphan drugs is normally higher than that resulting from the value-based pricing. A correlation between the cost of therapy for orphan drugs and the epidemiology (prevalence and incidence) of the related rare disease can be hypothesized.

Methods: This analysis includes all approved orphan drugs by European Medicines Agency whose reimbursement was granted for the first therapeutic indication in the years 2014-2019 in Italy.

[Medicines use in older adults in Italy. The OsMed National Report 2019.].

The "National Report on Medicines use in older adults in Italy. Year 2019" provides a summary of data concerning the expenditure and consumption of medicines in individuals aged 65 or above in Italy. In addition to general characteristics and considerations, analyzes conducted on specific conditions, situations and settings are reported, such as the concomitant use in patients with chronic diseases, the use of medicines in hospitals and RSA and the impact of the covid-19 pandemic.

[Social inequalities in the use of medicines for the treatment of the major chronic diseases. Evidence from the AIFA Atlas.].

The Atlas of social inequalities in the use of medicines for the treatment of the major chronic diseases is the first national report published on social inequalities in the context of pharmaceutical care in Italy. The results highlighted how the socioeconomic position was strongly correlated with the use of medicines: for many therapeutic categories, the highest per capita consumption rates were recorded in the areas with a higher socioeconomic deprivation index. On the other hand, no correlations emerged between the level of deprivation and adherence and persistence to pharmacological treatment.

Variables affecting pricing of orphan drugs: the Italian case.

Background And Aim: Evidence on determinants of prices for orphan medicines is scarce and not available for Italy. The aim of this paper is to provide an evidence on variables affecting the annual treatment cost of orphan drugs in Italy, testing the hypothesis of a negative correlation with the dimension of the target population and a positive correlation with the added therapeutic value of the drug and the quality of the evidence of pivotal studies.

Methods: Drugs with a European orphan designation reimbursed in Italy in the last 6 years (2014-2019) were considered.

[Medicines use in Italy. 2020 OsMed National Report.].

The 2020 National Report "Medicines use in Italy", produced by the National Observatory on the Use of Medicines (OsMed) of the Italian Medicines Agency (AIFA), describes the Italian pharmaceutical assistance through different available information flows that allow to recompose pharmaceutical territorial and hospital assistance, concerning both the national health service and private citizens. In the Report the results of numerous analyzes, both general and focused on specific therapeutic categories and classes, relating to pharmaceutical expenditure and consumption, are reported, but it is also present an in-depth analysis about monitoring registries and conditional reimbursement agreements, and a comparison between the most relevant Italian data and those of nine other European countries.

[Biosimilar medicines: OsMed reports on monitoring consumption and spending in Italy.].

The results of the OsMed reports of the Italian Medicines Agency (AIFA) on consumption and expenditure related to biosimilar medicines show a high heterogeneity at the regional level, with great differences in terms of both consumption and price. In light of the potential savings and the growing number of biological medicines whose patents have expired or are about to expire, it is therefore desirable that the regions with the lowest levels of consumption take action to increase the awareness of health professionals on efficacy and safety of such treatments and the potential advantages in terms of sustainability of the national health system.

[The use of antibiotics in Italy. The national OsMed report 2019.].

The OsMed report "The use of antibiotics in Italy - 2019", produced by the Italian Medicines Agency, shows how the prescriptions of these drugs are still too high in our country, albeit with high variability between different regions. A significant degree of inappropriate use of antibiotics also emerges, especially in respiratory infections. In general, the results highlight the need to implement prevention and control actions in order to counter antibiotic resistance.

Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines.

The understanding of the benefit risk profile, and relative effectiveness of a new medicinal product, are initially established in a circumscribed patient population through clinical trials. There may be uncertainties associated with the new medicinal product that cannot be, or do not need to be resolved before launch. Postlicensing or postlaunch evidence generation (PLEG) is a term for evidence generated after the licensure or launch of a medicinal product to address these remaining uncertainties.

[Establishing the value of new drugs in Italy.].

Italy was used as a case study to investigate the determinants of the difference between the price proposal for medicines submitted by the industry and the final negotiated price (∆P). Data was gathered through the information system used by Italian Medicines Agency (AIFA) and the time-frame for this analysis is 2013-2017. Factors influencing the delta price were analyzed through a regression analysis.

Determinants of price negotiations for new drugs. The experience of the Italian Medicines Agency.

Objectives: The aim of this paper is to investigate the determinants of the difference between the price proposal submitted by the industry and the final negotiated price. We used Italy as a case-study.

Methods: Data were gathered through the information system used by Italian Medicines Agency.