Farmeconomia. Health economics and therapeutic pathways
Not a member yet
496 research outputs found
Sort by
[Horizon Scanning Of Therapeutic Alternatives For Generalized Myasthenia Gravis And Five-Year Healthcare Expenditure Forecast Model]
No full textOBJECTIVE: The objective of the analysis was to assess and quantify the economic impact of generalized Myasthenia Gravis (gMG) in Italy over the next five years (2025—2029) using Horizon Scanning and expenditure forecasting methodologies.METHODS: The analysis is characterized by conducting Horizon Scanning of therapies for gMG that will be reimbursed in the Italian market over the next five years (2025—2029), followed by the development of a disease expenditure model for the same time frame. The Horizon Scanning methodology for gMG included research on ClinicalTrials.gov to identify relevant Phase 2 or 3 studies. A forecasting model was developed to evaluate the impact of new therapies for gMG from the perspective of the Italian National Health Service, considering total patient management costs. The analysis included acquisition and administration costs of treatments, as well as costs for managing exacerbations and myasthenic crises. The assumptions were validated by an expert panel.RESULTS: Horizon Scanning identified 14 new drugs for gMG in clinical development, with 7 of these expected to enter the Italian market between 2025 and 2029. The expenditure forecast analysis results indicate a slight increase in gMG treatment costs, stable administration costs and a slight reduction in costs for managing exacerbations and myasthenic crises. Total expenditure is projected to rise by 10.3%, from approximately €126 million in 2025 to €139 million in 2029.CONCLUSIONS: Through the Horizon Scanning and expenditure forecasting, it was estimated that, with the arrival of new therapeutic alternatives for gMG on the market, despite the high initial cost of these new treatments, their greater effectiveness could reduce the costs for managing exacerbations and myasthenic crises. This analysis provides essential information to improve the clinical management of the disease, optimize the allocation of healthcare resources and ultimately enhance the quality of life of patients with gMG
Therapeutic Journey and Economic Burden of Patients with Myasthenia Gravis in Italy: Results of a Real-World Analysis
Full text linkAIM: This analysis investigated the population with Myasthenia Gravis (MG) in Italy, to describe epidemiology, mortality, patients’ characteristics, comorbidity profile, therapeutic management, and healthcare consumption and related costs.METHODS: From 2012 to 2021, MG patients were identified in administrative flows of healthcare entities through hospitalization discharge diagnosis or exemption code for MG or a pyridostigmine prescription. Medications and comorbidities were searched before inclusion and healthcare costs were analysed at 1-year follow-up. Epidemiology estimates were reported as cases/100,000 people, and mortality rates, stratified by age classes and gender, were assessed during 2019. MG patients were compared with age- and gender-matched subjects without MG.RESULTS: At the end of 2021, MG prevalence was 35.1/100,000 and incidence 4.7/100,000 people. Mortality in 2019 was 3.2% in overall MG sample, and tended to rise in males and elderly patients. About 90% received MG-related treatments, namely pyridostigmine, corticosteroids and immunosuppressants (81.3%, 76.9% and 26.1% of patients respectively). Unsurprisingly, the yearly healthcare resource consumption/patient was higher in MG patients than in non-MG subjects (p<0.001), resulting in increased annual direct costs for MG patients (€5,495 vs €823, p<0.001), related to expenses for hospitalizations (mostly related to nervous system and respiratory system), drugs and outpatient services.CONCLUSIONS: In this study, incidence and prevalence of MG estimated in Italy were similar to other European countries and mortality rates were from 2 to 3-times higher than general population. Despite the current treatment options and adherence to guidelines for MG management, the clinical and economic burden of the disease remains high
[Enhanced Influenza Vaccines Under Review by the ECDC and the Latest Scientific Literature]
No full textDecatecholaminization of Septic Shock Patients in Intensive Care Unit: an Economic Assessment in the Italian Setting
Full text linkINTRODUCTION: Prolonged administration of norepinephrine to critically ill patients can lead to serious adverse events. In this context, the concept of “decatecholaminization” has emerged over the past decade, involving the association of vasopressin with norepinephrine to reduce catecholamines need. Additionally, beta-blockers can help prevent increased heart rate resulting from sepsis treatments. This study presents an economic analysis evaluating the economic implications of the decatecholaminization use in patients with septic shock treated in intensive care unit (ICU) from the Italian National Health Service (NHS) perspective.METHODS: Two analyses were conducted: (1) a patient-level comparison of costs between two real-world cases, one treated with decatecholaminization and one without this approach, and (2) a cohort-level analysis using a pharmacoeconomic model to project cost differences for the Italian National Health Service (NHS) before and after implementing decatecholaminization.RESULTS: In the patient-level analysis, the use of decatecholaminization results in increased pharmacological expenses (+€210), and cost reduction in resource utilization (-€30,412). Similarly, the cohort-level shows higher pharmacological costs (+€192 per patient) and lower cost for other resources (-€1,264 per patient) in the future vs current scenario, resulting in a cumulative cost reduction of -€1,072 per patient. Considering an eligible population of 39,207 patients, decatecholaminization results in a total cost reduction of approximately €42.4 million.CONCLUSION: This analysis supports the economic viability of decatecholaminization as an effective treatment for comprehensive management of septic shock. Further evaluation in real-world settings is needed to validate these findings and optimize clinical application
[Implantation of Reveal LINQ in Different Italian Scenarios: How to Further Improve?]
Full text linkINTRODUCTION: The manuscript describes the long-term cardiac rhythm monitoring system, known as Reveal LINQ, along with an analysis of the evolution in the Italian cardiology practice that its introduction has brought and may still bring given the smaller size and the implantable procedure, performed even by nursing personnel.METHODS: The project was articulated, firstly, to understand how the Reveal LINQ implantation is organized in 4 different Italian hospital facilities and to estimate the associated costs. For each of the involved facilities, data on the operating room type, length of hospital stay, resource consumption, and unit costs associated with the implantation procedure were collected. Direct costs for the hospital were calculated, including personnel work, materials used, and overhead. After that, we identified the ideal pathway (IP) that may enhance and optimize efficiency and resources consumption, without compromising the quality of care. The hypothetical cost savings resulting from the adoption of IP were estimated.RESULTS: According to our analysis, total cost per procedure ranges between 2,500 and 3,100 Euros, depending on the hospital facility. The IP is based on the use of an outpatient setting in which trained nursing personnel performs the implantation procedure. The shift from current clinical practice to ideal setting has the potential to decrease administrative costs, overhead expenses, and working time, leading to an average cost saving of 333 euros per procedure. It varies between 115 and 650 Euros, according to the starting background of each facility.CONCLUSIONS: The article concludes by emphasizing the introduction of a dedicated outpatient tariff as key incentive for the transition toward the ideal pathway and, consequently, for enhancing the overall efficiency of the Health Service
Optimizing Treatment of Schizophrenia: Clinical and Economical Potential for Patient Switching to Long‑Acting Injectables
Full text linkINTRODUCTION: Long-acting injectable antipsychotics (LAIs), due to a lower frequency of administration, could address the well-established challenge of non-adherence to oral ones. We conducted a Network Meta-Analysis (NMA) to assess the relationship between administration frequency and effectiveness. The recent introduction of a semi-annual paliperidone palmitate formulation, along with the arrival of monthly paliperidone generics, could emphasize LAI’s advantages. Aim of this paper is to present the results derived from an updated version of our previous NMA. These results are used to fuel a budget impact model built to evaluate the economic implications of optimizing dosing intervals.METHODS: We compare the current distribution of patients among available LAI active substances and dosing frequencies with an optimized scenario. In this scenario, 20% of patients are switched to the next permitted regimen with a longer inter-dosing interval. Drug acquisition costs and relapse management costs are taken into account over a one-year simulation period; these last items are estimated by means of the event rates obtained from the updated meta-analysis. The optimized scenario incorporates the reduced cost resulting from the expiration of patents.RESULTS: Throughout the analysis, a total of 11,600 patients were able to switch from shorter to longer dosing intervals, leading to an overall optimization of quality of care. The greater expenditure incurred by the Italian National Health Service (NHS) in the acquisition of newer and longer-lasting drugs is offset by savings associated with the arrival of generics of monthly paliperidone palmitate and the shift toward less-relapsing regimens. The net impact on the NHS budget is a saving of more than 19 million Euros.CONCLUSION: This economic saving has the potential to initiate a virtuous process: it could be reinvested to fund a further shift from oral daily therapies, which are less expensive but marked by poor compliance, to LAIs. According to our simulation, nearly 40 thousand patients could undergo this transition, without additional expenses for the NHS
Cost-Effectiveness of Dimethyl Fumarate Compared to Teriflunomide for Relapsing Remitting Multiple Sclerosis Patients in Italy: Results of an Updated Analysis
Full text link[Cost per Responder Analysis of Filgotinib in Patients Suffering from Ulcerative Colitis]
Full text linkOBJECTIVE: To evaluate the costs and benefits associated with the use of biologics and Janus kinase inhibitors (JAKi) for the treatment of bio-experienced patients suffering from ulcerative colitis in Italy.METHODS: This pharmacoeconomic analysis compared JAKi (filgotinib, tofacitinib and upadacitinib) and biologics (vedolizumab and ustekinumab). A decision tree model with a 1-year time horizon was built in MS Excel in order to estimate treatment cost and clinical efficacy expressed in terms of clinical response (CR), clinical remission (CRe) and mucosal healing (MH). Efficacy of each treatment was estimated using relative risks elaborated from a recent network meta-analysis of 17 RCTs. The investigated population concerned patients previously treated with biologic drugs (bio-experienced). Both induction and maintenance phases were considered and dose escalation (when allowed) was planned for patients not reaching an appropriate response after induction. Outcomes included total treatment cost (acquisition and administration), overall response rate, and cost per responder at one year.RESULTS: According to the model results, the treatment associated with the best clinical response at 1 year was vedolizumab (69.6%) followed by filgotinib (60.9%) and upadacitinib (60.1%). Despite differences in efficacy, filgotinib resulted in the lowest cost per responder, in every outcome, compared with all the other alternatives. The same trend applies when observing results at the end of the induction phase only. Results were robust to probabilistic sensitivity analyses, filgotinib has a posterior probability to be better than the other alternatives higher than 96% according to all the three response definitions (CR, CRe, and MH).CONCLUSIONS: Generally, JAKis and vedolizumab were associated with higher treatment response. Among the alternatives included in the analysis, filgotinib has the lowest cost per responder for all the outcomes included. These findings could help deliver more effective and efficient healthcare in the NHS.
The Importance of the Pharmacoeconomic Analyses in Drug Negotiation. A Farewell Editorial
Full text linkHTA dei dispositivi di controllo urinario artificiale per il trattamento dell’incontinenza urinaria maschile grave post-prostatectomia
Full text linkL’incontinenza urinaria (IU) è un sintomo frequente a seguito di prostatectomia radicale per carcinoma della prostata, dal momento che interessa quote elevate di pazienti, che variano a seconda della definizione, delle tempistiche di valutazione, dell’approccio chirurgico e di chi effettua la rilevazione e che possono anche superare l’80% dei pazienti [1]. Nella maggior parte dei casi, il problema si risolve a distanza di un anno. Tuttavia, l’incontinenza permane anche dopo 12 mesi in una quota non trascurabile di pazienti, che varia a seconda delle statistiche e che si attesta intorno a percentuali pari al 10% [1]. L’IU, oltre a rappresentare un problema di tipo igienico e sociale, compromette fortemente la qualità della vita del soggetto che, dopo aver superato il trauma e la paura della patologia oncologica, vive sentimenti di perdita di autostima, associati ad alterazioni nelle relazioni familiari, sociali e nel rapporto col partner, che interessano anche la vita lavorativa [2,3]. Il tavolo tecnico sull’incontinenza – istituito presso il Ministero della Salute – ha definito un percorso basato su evidenze cliniche, che risponde alla necessità di prendersi cura del paziente con IU dopo chirurgia prostatica [4]. Tra le diverse criticità rilevate sul territorio nazionale, emerge il mancato accesso alla terapia chirurgica dell’IU, che non viene proposta perché non effettuata nel centro di cura oncologica, per la limitata proposta di soluzioni terapeutiche offerte al paziente dal chirurgo e per la limitata disponibilità di presidi chirurgici, anche in relazione ai costi. Nel caso dell’IU da sforzo da incompetenza sfinterica dopo prostatectomia radicale, l’opzione dello sfintere urinario artificiale (AUS) rimane il gold standard per l’IU moderata-grave (raccomandazione B ICI, livello di evidenza 2b EAU). Tale giudizio è confermato anche dalla Regione Veneto che, con il Decreto del Direttore generale dell’Area Sanità e Sociale n. 58 del 15.06.2016, ha emanato le “Linee di indirizzo regionali per l’utilizzo di sfinteri urinari artificiali, sling e neurostimolatori sacrali nell’incontinenza urinaria e fecale”, con cui si stabilisce che «Lo sfintere urinario artificiale deve essere offerto agli uomini con incontinenza da sforzo (SUI) post-prostatectomia da moderata a severa, a seguito di fallimento della terapia conservativa» [5]. Il paradosso dell’impianto di AUS è che, pur essendo una soluzione terapeutica eccellente e costo-efficace per i pazienti con incontinenza urinaria da moderata a grave, la maggioranza dei candidati non ne ha accesso. Come evidenziato dalla analisi delle Schede di Dimissione Ospedaliera (SDO) 2016 [6], in Italia vengono effettuati non più di 240 impianti all’anno a fronte di una stima media di circa 1.000 pazienti/anno che vivono con incontinenza non risolta con terapia conservativa. Tali numeri dimostrano un evidente sottoutilizzo della tecnologia di elezione per questi pazienti. Le barriere all’adozione della soluzione chirurgica sono diverse; tra di esse si annoverano la scarsità di informazione adeguata ai pazienti e la mancata allocazione di risorse – economiche e professionali – adeguate a garantire la procedura: spesso gli ospedali hanno pochissime unità/professionalità disponibili, con lunghe liste d’attesa, e un rimborso inadeguato a coprire i costi della procedura da parte del Servizio Sanitario Regionale/Nazionale (SSR/SSN) [7]. Questi fattori disincentivano il ricorso all’impianto dell’AUS anche laddove clinicamente appropriato, determinando un trattamento insufficiente e inadeguato della popolazione eleggibile. Alla luce dell’analisi HTA condotta, sarebbe auspicabile un intervento normativo che riconosca dignità e valore all’impianto dell’AUS post-prostatectomia radicale, laddove la terapia farmacologica si rivelasse insufficiente alla soluzione del problema. L’analisi ha dimostrato come incrementando il numero di soggetti trattati con AUS (+29 pazienti trattati con il gold standard AMS 800TM [8]) rispetto alla terapia conservativa si verifichi un importante incremento della qualità di vita dei pazienti (rapporto di costo-efficacia altamente positivo e in alcuni casi dominante) accompagnato da una consistente riduzione del costo legato alla terapia conservativa (pannoloni). Si tratterebbe di un numero limitato di procedure, che consentirebbe, però, di migliorare notevolmente la qualità della vita dei pazienti interessati da questa condizione