Role of economic evaluations on pricing of medicines reimbursed by the Italian National Health Service

Objective The main objective of this study was to explore the extent to which the incremental cost-effectiveness ratio (ICER), alongside other factors, predicts the final outcome of medicine price negotiation in Italy. The second objective was to depict the mean ICER of medicines obtained after negotiation. Methods Data were extracted from company dossiers submitted to the Italian Medicines Agency (AIFA) from October 2016 to January 2021 and AIFA’s internal database. Beta-based regression analyses were used to test the effect of ICER and other variables on the outcome of price negotiation (ΔP), defined as the percentage difference between the list price requested by manufacturers and the final price paid by the Italian National Health Service (INHS). Results In our dataset of 48 pricing and reimbursement procedures, the ICER before negotiation was one of the variables with a major impact on the outcome of negotiation when ≥ 40,000€/QALY. As resulting from multiple regression analyses, the effect of the ICER on ΔP seemed driven by medicines for non-onco-immunological and non-rare diseases. Overall, the negotiation process granted mean incremental costs of €64,688 and mean incremental QALYs of 1.96, yielding an average ICER of €33,004/QALY. Conclusions This study provides support on the influence of cost-effectiveness analysis on price negotiation in the Italian context, providing an estimate of the mean ICER of reimbursed medicines, calculated using net confidential prices charged by the INHS. The role and use of economic evaluations in medicines pricing should be further improved to get the best value for money

COVID-19 in rheumatic diseases in Italy: first results from the Italian registry of the Italian Society for Rheumatology (CONTROL-19)

OBJECTIVES: Italy was one of the first countries significantly affected by the coronavirus disease 2019 (COVID-19) epidemic. The Italian Society for Rheumatology promptly launched a retrospective and anonymised data collection to monitor COVID-19 in patients with rheumatic and musculoskeletal diseases (RMDs), the CONTROL-19 surveillance database, which is part of the COVID-19 Global Rheumatology Alliance. METHODS: CONTROL-19 includes patients with RMDs and proven severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) updated until May 3rd 2020. In this analysis, only molecular diagnoses were included. The data collection covered demographic data, medical history (general and RMD-related), treatments and COVID-19 related features, treatments, and outcome. In this paper, we report the first descriptive data from the CONTROL-19 registry. RESULTS: The population of the first 232 patients (36% males) consisted mainly of elderly patients (mean age 62.2 years), who used corticosteroids (51.7%), and suffered from multi-morbidity (median comorbidities 2). Rheumatoid arthritis was the most frequent disease (34.1%), followed by spondyloarthritis (26.3%), connective tissue disease (21.1%) and vasculitis (11.2%). Most cases had an active disease (69.4%). Clinical presentation of COVID-19 was typical, with systemic symptoms (fever and asthenia) and respiratory symptoms. The overall outcome was severe, with high frequencies of hospitalisation (69.8%), respiratory support oxygen (55.7%), non-invasive ventilation (20.9%) or mechanical ventilation (7.5%), and 19% of deaths. Male patients typically manifested a worse prognosis. Immunomodulatory treatments were not significantly associated with an increased risk of intensive care unit admission/mechanical ventilation/death. CONCLUSIONS: Although the report mainly includes the most severe cases, its temporal and spatial trend supports the validity of the national surveillance system. More complete data are being acquired in order to both test the hypothesis that RMD patients may have a different outcome from that of the general population and determine the safety of immunomodulatory treatments

Il ruolo degli Stakeholder nel processo di HTA: l\u2019esperienza dell\u2019Health Policy Forum SIHTA

L'articolo presenta sinteticamente i risultati delle prime quattro edizioni dell'Health Policy Foru

Valutazione economica della tossina botulinica per la profilassi dell\u2019emicrania cronica

Aim: we investigated about the cost effectiveness of BOTOX treatment for chronic migraine. Results showed the treatment is highly cost effective

LA DEFINIZIONE DELLE PRIORITÀ NEL PROCESSO DI HTA TRA ESIGENZE CENTRALI E REGIONALI

La definizione delle priorità deve avvenire in modo diverso a seconda che il processo avvenga a livello nazionale o regionale. I criteri di prioritizzazione, conseguentemente, possono essere adattati a tutti i livelli decisionali mediante l’attribuzione di punteggi atti a definirne il peso relativo di ogni criterio. Tutti gli stakeholder devono partecipare alla definizione delle priorità di valutazione con ruoli strategici e responsabilità diverse, che possono essere individuate mediante la definizione di un peso, una pertinenza e una rilevanza. Si è trovata una condivisione sui criteri per l’identificazione delle priorità, classificandoli in criteri oggettivi e soggettivi. A. I criteri oggettivi individuati sono: 1. Prevalenza della condizione clinica. 2. Burden of disease. 3. Evidenze scientifiche disponibili. 4. Costo della tecnologia utilizzata. 5. Costo della malattia. 6. Variazione nell’uso della tecnologia. 7. Presenza di alternative terapeutiche. 8. Sicurezza della tecnologia. B. I criteri soggettivi individuati sono: 1. Potenziali cambiamenti sui risultati di salute. 2. Potenziali cambiamenti sui costi. 3. Impatto etico, legale e sociale della tecnologia. 4. potenziale impatto sullo sviluppo economico (es. impatto economico sulla produzione industriale, sugli investimenti in R&D, sull’occupazione). 5. Variazione nell’uso della tecnologia Interesse delle parti. Lo sviluppo di un sistema di definizione delle priorità, realmente utile, viene ritenuto fondamentale in considerazione dei vincoli economici che rendono “critico” l’uso responsabile delle risorse e la diffusione della cultura della valutazione a tutti i livelli decisionali