INTRODUCTION:Treatment options for macular edema include intravitreal corticosteroids (1). Traditionally, an injectable suspension of triamcinolone acetonide (TA) had been employed off-label (2); in recent years, authorities have approved sustained-release drug delivery systems (DDSs) for corticosteroids (3). Considering the hypothesis that the use of these drugs is based on widely variable evidence in terms of methodological quality and robustness, the purpose of this analysis is to compare the quality of the evidence on efficacy and safety of three different formulations of intravitreal corticosteroids: the dexamethasone (DEX) implant, the fluocinolone acetonide (FA) implant, and the preservative-free injectable suspensions of TA, in the management of two retinal pathologies: diabetic macular edema (DME) and macular edema secondary to retinal vein occlusion (RVO).METHODS:A search of clinical trials on MEDLINE from 1 January 2000 to 16 December 2015 was performed. Studies were included in the analysis if they met the following criteria: (i) related to at least one of the preparations of interest in patients with DME or macular edema secondary to RVO; (ii) included a control group treated with placebo, observation, sham procedures or conventional treatments; and (iii) included visual acuity, retinal thickness and/or safety parameters as outcomes. Results were summarized in a narrative manner.RESULTS:Twenty-five publications from nineteen RCTs were included. We observed increased attention of researchers towards TA compared to DEX and FA; however, studies for TA are less robust. Scientific publications related to DEX and FA implants are of higher quality, especially in terms of randomization and masking procedures.CONCLUSIONS:Even though each of the three considered corticosteroid-containing medicines are approved for marketing and included in clinical guidelines for treatment of macular edema, a high degree of heterogeneity in terms of quality of evidence has been noticed among them. This observation underlines the need to review the requirements for drug approval and their inclusion in clinical recommendations, as well as the importance of post-markeing monitoring to generate new evidence.

Introduction:In Italy, the central government sets the health benefit package (denominated “Livelli Essenziali di Assistenza” - LEAs) of the National Health System (NHS), which must be provided to all residents. In 2004, the Italian Ministry of Health established a new technical body, the National LEA Commission, responsible for updating LEAs.Methods:Recently, the Ministry has commissioned to the National Institute of Health (NIH) the development of a new value-based procedure for updating the health benefit package for the Italian NHS, supporting the National LEA Commission. A review and comparison of value frameworks and decisional models was performed in order to select a framework and a model that can be applied to the Italian context, design an administrative process for the update procedure, and propose approaches for: (i) the assessment of services currently included in the health benefit basket and of those planned to be incorporated, (ii) the process of appraisal and decision-making to be adopted by the Commission.Results:The NIH outlined an evidence and value-based three-step (i.e. priority setting, assessment and appraisal) administrative process that integrates roles and responsibilities of the different Italian healthcare institutions involved in LEA updating and HTA.Conclusions:The NIH is proposing to the Ministry of Health and to the National LEA Commission a new evidence and value-based procedure for updating the health benefit package for the Italian NHS. This procedure is entering a pilot phase in which potential gaps can be identified and minimized for its subsequent implementation.

Introduction:Acute myocardial infarction (AMI) is one of the leading causes of death and disability worldwide. The European Society of Cardiology Guidelines have established a new definition of myocardial infarction and have strengthened the central role of cardiac troponins in cardiology diagnostics for rule-in and rule-out of non ST-elevation myocardial infarction (NSTEMI). High-sensitivity cardiac troponin I assays (hsTnI) should increase diagnostic sensitivity, and a shorter interval for ruling-in and ruling-out AMI. This analysis aims to provide an overview of the clinical, economic, organizational and ethical impact of the use of hsTnI in clinical practice of Emergency Departments (ED) in Italy.Methods:HsTnl for rule-in and rule-out of AMI in the ED is being evaluated using the EUnetHTA Core Model® framework for health technology assessment. The hsTnI HTA assessment will be completed with real-world evidence derived from a multicenter observational study which has been designed to be conducted in 12 Italian EDs, enrolling 6000 patients with chest pain of suspected cardiac origin, aiming to provide data from the Italian context on clinical, organizational and economic aspects of the use of the test in the ED. Endpoints of the study include: time lapses related to diagnosis, admission, treatment and discharge of patients; number of tests performed; and number of patients diagnosed with AMI.Results:Initial results from a literature review confirm the usefulness of the hsTnI assay in diagnosing AMI. Generated real-world data will be collected, analyzed and integrated to existing evidence to assess the utility of the test in real contexts, providing details relevant for organizational aspects of the use of the test in the ED.Conclusions:The use of hsTnl could improve diagnosis of AMI by allowing a faster ruling-in or ruling-out, and reducing inappropriate hospitalizations. Furthermore, this technology could represent an opportunity to reduce overall costs for the healthcare system.