Development of an enhanced health-economic model and cost-effectiveness analysis of tiotropium + olodaterol Respimat® fixed-dose combination for chronic obstructive pulmonary disease patients in Italy

Background: The objective of this study was to compare the cost-effectiveness of the fixed-dose combination (FDC) of tiotropium + olodaterol Respimat® FDC with tiotropium alone for patients with chronic obstructive pulmonary disease (COPD) in the Italian health care setting using a newly developed patient-level Markov model that reflects the current understanding of the disease. Methods: While previously published models have largely been based around a cohort approach using a Markov structure and GOLD stage stratification, an individual-level Markov approach was selected for the new model. Using patient-level data from the twin TOnado trials assessing Tiotropium + olodaterol Respimat® FDC versus tiotropium, outcomes were modelled based on the trough forced expiratory volume (tFEV1) of over 1000 patients in each treatment arm, tracked individually at trial visits through the 52-week trial period, and after the trial period it was assumed to decline at a constant rate based on disease stage. Exacerbation risk was estimated based on a random-effects logistic regression analysis of exacerbations in UPLIFT. Mortality by age and disease stage was estimated from an analysis of TIOSPIR trial data. Cost of bronchodilators and other medications, routine management, and costs of treatment for moderate and severe exacerbations for the Italian setting were included. A cost-effectiveness analysis was conducted over a 15-year time horizon from the perspective of the Italian National Health Service. Results: Aggregating total costs and quality-adjusted life years (QALYs) for each treatment cohort over 15 years and comparing tiotropium + olodaterol Respimat® FDC with tiotropium alone, resulted in mean incremental co

Introspective self-narrative modulates the neuronal response during the emphatic process. An event-related potentials (ERPs) study

Empathy is the ability to perceive and understand others’ emotional states generating a similar mental state in the self. Previous behavioural studies have shown that self-reflection can enhance the empathic process. The present event-related potentials study aims to investigate whether self-reflection, elicited by an introspective self-narrative task, modulates the neuronal response to eye expressions and improves the accuracy of empathic process. The twenty-nine participants included in the final sample were divided into two groups: an introspection group (IG) (n=15), who received an introspective writing task, and a control group (CG) (n=14), who completed a not-introspective writing task. For both groups, the electroencephalographic and behavioural responses to images depicting eye expressions taken from the “Reading the Mind in the Eyes” Theory of Mind test were recorded pre- (T0) and post- (T1) seven days of writing. The main result showed that only the IG presented a different P300 amplitude in response to eye expressions at T1 compared to T0 on the left centre-frontal montage. No significant results on accuracy at T1 compared to T0 were found. These findings seem to suggest that the introspective writing task modulates attention and implicit evaluation of the socio-emotional stimuli. Results are discussed with reference to the hypothesis that such neuronal modulation is linked to an increase in the embodied simulation process underlying affective empathy

Does the Character-Based Dimension of Stories Impact Narrative Processing? An Event-Related Potentials (ERPs) study

This event-related potentials (ERPs) study investigated on-line processes of integration of information relating to characters in narrative comprehension. The final sample included twenty-nine participants who read short third-person stories in which the plausibility of the characters’ actions was manipulated. Stories were administered in three conditions: a character-based congruent condition including a target word that was consistent with the character’s job; a character-based incongruent condition with a target word inconsistent with the character’s job; a character-based neutral condition, narrating the action of a character presented by his/her proper name without information about his/her job. Results comparing the ERPs elicited by the experimental conditions revealed a greater negative amplitude of the N400 in the right temporal regions in response to the character-based incongruent compared to the character-based congruent narratives. This finding shows that implicit background character-based information affects the N400, with readers rapidly using this information to comprehend narratives

Narrative del disturbo da gioco d’azzardo e del disturbo da uso di sostanze. Una analisi multidimensionale per la caratterizzazione di possibili marcatori narrativi e linguistici delle dipendenze

Diversi studi hanno dimostrato che l’analisi della dimensione narrativa può rappresentare un valido strumento per far luce su alcuni aspetti psicologici critici; in questo senso, può essere utile per capire meglio il disturbo da dipendenza. Il presente articolo riporta tra l’altro alcuni tra i dati principali di una ricerca da noi condotta e pubblicata nella rivista Journal of Gambling Issues nel 2021. In tale ricerca abbiamo indagato gli aspetti psicologico-narrativi coinvolti nelle dipendenze, specificamente nel DUS e nel DGA, attraverso un’analisi quali-quantitativa multidimensionale di un’intervista semi-strutturata, che ha invitato due gruppi di soggetti dipendenti in trattamento (DGA e DUS) a raccontare le varie fasi della dipendenza. Le analisi narrative multidimensionali da noi condotte sembrano aver portato alla luce alcuni punti critici su cui focalizzare l’attenzione per la costruzione di un adeguato trattamento dei soggetti con dipendenza. Nello specifico, i risultati suggerirebbero la necessità di lavorare su aspetti dissociati del Sé al fine di: 1) favorire il processo di integrazione di motivazioni e azioni, aumentando la consapevolezza e il senso di autoefficacia, soprattutto con i giocatori d’azzardo; 2) migliorare la coerenza globale nella narrazione del desiderio al fine di diminuire la disregolazione emotiva tipica di questa fase; 3) migliorare la capacità di proiezione del Sé nel tempo. Quest’ultimo punto potrebbe essere particolarmente rilevante in una prospettiva di intervento riabilitativo, soprattutto per quanto riguarda gli strumenti di trattamento legati alla dimensione narrativa. Il rapporto circolare tra regolazione dell’impulsività, autocontrollo, integrità dell’Io, funzioni cognitive e dimensione narrativa trova nel fattore temporale uno dei principali perni comuni

Economic burden of patients affected by non-small cell lung cancer (NSCLC): the LIFE study

PURPOSE: Non-small cell lung cancer (NSCLC) is a condition with significant clinical burden for patients and relevant economic impact. Limited evidence exists on the management costs of NSCLC patients, especially in the late phases of the disease. The main objective of this analysis was to evaluate the economic impact of clinical management of NSCLC patients in the Italian population. METHODS: This evaluation was an economic analysis of the observational and multicentre study LIFE, which described the therapeutic approach in routine clinical practice for NSCLC patients, progressing after first-line treatment. This study evaluated resource consumption in different Italian hospitals, including specialist visits, hospitalizations, accesses to first aid, pharmacological treatment, laboratory tests and palliative care. The National Healthcare Service perspective was adopted. RESULTS: In this study, N = 191 patients enrolled in the LIFE study were included. Patients were aged 64.2 years and were predominantly males (66%). In the different line of treatments, monthly costs of patients ranged between \u20ac1471 (first line) and \u20ac1788 (third line). The overall healthcare cost over the average period of observation (16.4 months) was \u20ac25,859 per patient. Overall, oncology therapy was the cost driver, although the composition of medical costs changed across the different lines of treatment, with costs for concomitant medication and palliative care being predominant in late phase of the disease. CONCLUSIONS: The economic burden of NSCLC is extremely high during the overall period of treatment, and a significant level of care is required in each stage of the disease

Supplementary_Material – Supplemental material for Cost-description and multiple imputation of missing values: the SATisfaction and adherence to COPD treatment (SAT) study

<p>Supplemental material, Supplementary_Material for Cost-description and multiple imputation of missing values: the SATisfaction and adherence to COPD treatment (SAT) study by Carlo Lazzaro, Fabiano Di Marco, Nicola Scichilone, Fulvio Braido, Marco Contoli, Paola Rogliani, Pierachille Santus, Valentina Acciai, Carla Scognamillo, Irene Olivi and Angelo Guido Corsico in Global & Regional Health Technology Assessment</p

Drugs price and reimbursement regulation: comparators, endpoints and role of the cost-effectiveness

This document illustrates the results of a discussion of two multi-disciplinary expert panels on pricing and reimbursement of medicines. Experts work in different organizations. The discussion focused on comparator(s), endpoint(s), negotiation of prices of new medicines and/or indications to include in the List 648, as well as the role of cost-effectiveness in the price and reimbursement negotiation. The debate took place during the fourth edition of the Seminari di Mogliano, organized on the 30th of September/1st of October, 2021. The two panels agreed on a general need to enhance interaction among the different stakeholders, in the early assessment and negotiation phases, and to increase the transparency/reproducibility of the decisions taken. The experts have also emphasized the need (i) to improve clarity in the evaluation of additional therapeutic value and the place in therapy with respect to comparators and how comparators are identified; (ii) to create work groups to identify the most appropriate endpoint(s), for each therapeutic area and level of unmet needs; (iii) to provide for a systematic use of cost-effectiveness when an added therapeutic value is delivered by a new medicine. With regard to the 648 List, the experts advocated for an overall reorganization of the current rules governing the special uses of drugs