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Purpose: Diabetic macular edema (DME) is a leading cause of vision loss and blindness. The aim of this study was to evaluate the economic benefits of introducing additional alternative technologies (Dexamethasone intravitreal implant – DEX – and Aflibercept injections), compared with the historical scenario of Ranibizumab intravitreal injections. Methods: A 3‐year budget impact model was developed, taking into consideration the perspective of the Lombardy Region Healthcare Service (LRHS). Total administration costs (real‐life data retrieved from clinical practice at three Departments of Ophthalmology) as well as costs related to the management of potential adverse events (information collected from the literature) were analysed. Results: Over a 36‐month horizon, the results showed that a higher consumption of DEX could lead to significant economic savings for the Regional Healthcare Service, ranging from a minimum of −4.35% (if DEX were used only in the second‐line of treatment) to a maximum of −12.97% (if DEX were used in both the first‐line and second‐line), including the potential impact of adverse events. Therapy costs with Aflibercept and Ranibizumab were similar. Conclusions: This study demonstrates that concentrating all eligible patients within the Ranibizumab regimen is unlikely to represent a cost‐effective strategy. Indeed, significant economic advantages would be achieved by introducing the other licensed alternatives, Dexamethasone implant and Aflibercept, thus optimising DME Italian healthcare expenditure. The results demonstrate DEX as an advantageous technological alternative for the target population affected by DME, both as a first‐ and second‐line treatment option, reducing the economic burden of the pathology for the Regional/National Health Service. [ABSTRACT FROM AUTHOR]

INTRODUCTION:Health Technology Assessment (HTA) aims at providing decision makers with relevant data, matching different perspectives, with an evidence-based approach. The most common framework used is the European Network for Health Technology Assessment (EUnetHTA) Core Model (1): HTA may be further supported by a Multi-Criteria Decision Analysis (MCDA) (2,3), leading to a final quantitative synthesis, facilitating the appraisal phase.This project presents a multi-dimensional comparison of the technologies available for the treatment of diabetic macular edema (Ranibizumab, Aflibercept, Dexamethasone implant and off-label Bevacizumab), comparing three Italian Regions: Lombardy, Liguria and Veneto.METHODS:The nine EUnetHTA dimensions were first prioritized by seventeen multidisciplinary evaluators. Thereafter a further nine professionals attributed a 3-level rating score (from “1” not performant, to “3” most performant) to each dimension and sub-dimension, after carefully assessing the three HTA reports. In conclusion, the investigation of statistically significant differences between the attributed scores of the evaluators was conducted, using a multi-variate analysis.RESULTS:No statistically significant differences were reported in the prioritization of each dimension, except for the equity (more important in Liguria and in Lombardy) and the economic financial dimensions (more relevant in Veneto and in Lombardy).Notwithstanding the evaluators’ different professional titles, job roles, center size, and various Regional contexts, they attributed similar scores to the HTA dimensions during the appraisal phase (even though conducted in different years, in 2015 and 2016). This finding demonstrates the robustness of both the evaluations and the final MCDA results: i) no statistically inter-regional significant differences emerged regarding Ranibizumab and Aflibercept (p-value >.05); ii) no statistically significant inter-regional differences emerged regarding Dexamethasone, except for the assessments in the clinical dimensions (p-value = .026), since in Lombardy Region the evaluation was carried out earlier in the technology's life-cycle.CONCLUSIONS:Dexamethasone was consistently attributed a higher total score, considering the final normalised weight derived from the MCDA approach (p-value =.001). [ABSTRACT FROM PUBLISHER]

Background: We evaluated the frequency of naturally occurring resistance associated substitutions (RASs) and their characteristic of polymorphic or non-polymorphic amino acid change to direct acting antivirals (DAAs) in NS5b HCV subtypes 1a and 1b according to different geographic origin of isolates. Methods: Using a public database we retrieved 738 worldwide NS5b sequences (for which was available the geographic origin) from HCV genotype (G)1 infected patients naive to DAAs. NS5b sequences clustering with G1a were more conserved in regard of RASs than G1b isolates, (14% vs 57% RASs, P < 0.0001). Results: In G1a, RASs were differently distributed between isolates from Europe (24%) and USA, (12%) P = 0.0186. In particular, 421 V associated with resistance to non-nucleoside inhibitor beclabuvir was polymorphic in Europe and USA, being detected in 24% and 11% of sequences, respectively, P = 0.0140. In G1b, RASs were found in 45% of sequences from Europe, in 54% of isolates from USA and in 70% of sequences from Asia (P = 0.0051). The 316 N polymorphism was detected in 54% of Asian isolates and at lower frequency, in 28% of isolates from USA and in 20% of European sequences (P < 0.0001). Conclusions: In conclusion, a higher prevalence of RASs in G1b respect to G1a was found and a geographical distribution of RASs and polymorphic aa changes was observed in G1a as well in G1b. The clinical and therapeutic impact of the geographic distribution of RASs to polymerase inhibitors remains to be established, particularly in patients with virologic failure to DAAs and/or advanced liver disease. [ABSTRACT FROM AUTHOR]