Seasonal influenza is caused by two subtypes of influenza A and two lineages of influenza B. Although trivalent influenza vaccines (TIVs) contain both circulating A strains, they contain only a ...single B-lineage strain. This can lead to mismatches between the vaccine and predominant circulating B lineages, a concern especially for at-risk populations. Quadrivalent influenza vaccines (QIVs) containing a strain from both B lineages have been developed to improve protection against influenza. Here, we used a cost-utility model to examine whether switching from TIV to QIV would be cost-effective for the at-risk population in Italy. Costs were estimated from the payer and societal perspectives. The discount rate for outcomes was 3.0%. Univariate and probabilistic sensitivity analyses were performed to examine the effects of variations in parameters. Switching from TIV to QIV in Italy was estimated to increase quality-adjusted life-years (QALYs) and produce cost savings, including €1.6 million for hospitalization and approximately €2 million in productivity. The incremental cost-effectiveness ratio was €23,426 per QALY from a payer perspective and €21,096 per QALY from a societal perspective. Switching to QIV was most cost-effective for individuals ≥ 65 years of age (€19,170 per QALY). Probabilistic sensitivity analysis showed that the switching from TIV to QIV would be cost-effective for > 91% of simulation at a maximum willingness-to-pay threshold of €40,000 per QALY gained. Although the model did not take herd protection into account, it predicted that the switch from TIV to QIV would be cost-effective for the at-risk population in Italy.
Objective: To estimate the economic impact of the introduction of a new care system based on apomorphine and Patient Support Program for motor fluctuations (“on-off” phenomena) in patients with ...Parkinson’s disease which are not sufficiently controlled by oral anti-Parkinson medication in Italy.
Method: A Budget Impact model was developed to evaluate the new care system in patients with Parkinson’s disease over a 3-years’ time horizon. The comparator treatments included in the analysis were treatments based on apomorphine and levodopa + carbidopa. The analysis was conducted from a National Health Service (NHS) perspective. Costs included in the analysis were acquisition costs and device costs. A deterministic sensitivity analysis was carried out to evaluate the uncertainty of the parameters used. A break-even analysis was conducted to identify the minimum number of subjects that would need to be treated with the new care system to obtain a positive Budget Impact (World With – World Without = 0).
Results: The analysis shows that the introduction of the new care system based on apomorphine could generate a cost saving incurred by the NHS of over € 5.7 million in 3 years. Break-even analysis shows that if it were possible to intercept with the new treatment at least 9 patients treated with apomorphine, there would not be an increase in costs for the NHS.
Conclusion: The new care system would respond to the unmet needs of patients with Parkinson’s disease by generating a reduction in the expenditure incurred by NHS.
Objective. To assess the cost-effectiveness and economic sustainability of treosulfan plus fludarabine compared with busulfan plus fludarabine as a conditioning treatment for malignant disease prior ...to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients in Italy.
Method. The two theoretical cohorts of patients aged ≥ 60 years with acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) were pooled and followed over time using a partitioned survival model with cycles of 28 days. Patients can transition between a post-HSCT recovery/remission state (Event-Free Survival state, EFS state), a relapsed/progressed disease state, and a death state. A lifetime horizon for cost-effectiveness analysis and a 5-years’ time horizon for budget impact analysis were used. The perspective of the Italian National Health Service was adopted. Utility values were obtained from published sources. Costs included: drug acquisition, HSCT procedure, management and treatment of adverse reactions, graft-versus-host disease (GvHD) and health states, end of life treatment. Discounting of 3% per year was applied for both costs and outcomes according to Italian guidelines. Sensitivity was tested through both one-way and probabilistic analyses.
Results. Cost-effectiveness analysis showed that treosulfan is both more effective and less expensive compared with busulfan (+1.11 life-years, +0.96 quality-adjusted life-years per patient and -€ 41,784 per patient). On the side of economic sustainability, the introduction of treosulfan in the market could generate a cumulative decrement of the expense incurred by NHS of about -€ 179,174 over five years.
Conclusion. Treosulfan could represent a cost-effective and sustainable treatment alternative from the perspective of the NHS.
Obiettivo: Questo studio ha lo scopo di valutare il rapporto costo-efficacia di ceftolozano/tazobactam rispetto a meropenem per il trattamento di pazienti con polmonite acquisita in ospedale (HABP) o ...polmonite associata a ventilazione meccanica (VABP) sia secondo la prospettiva del Servizio Sanitario Nazionale (SSN), sia secondo la prospettiva sociale. Metodo: L’analisi è stata condotta mediante lo sviluppo di un albero decisionale e di un modello di Markov al fine di catturare rispettivamente gli effetti di breve e di lungo periodo. Una popolazione target ipotetica di 1.000 pazienti con vHABP/VABP è stata seguita per un orizzonte temporale lifetime (40 anni). In particolare, con riferimento all’albero decisionale di breve termine, sono stati sviluppati due diversi setting al fine di valutare il valore della terapia empirica rispetto all’avvio del trattamento dopo la conferma dell’antibiogramma. I pazienti trattati e guariti entrano nel modello di Markov di lungo termine seguendo la mortalità della popolazione generale. Risultati: L’analisi ha evidenziato come ceftozolano/tazobactam, in entrambi i setting di trattamento (empirico e confermato), possa risultare un’opzione costo-efficace rispetto a meropenem sia nella prospettiva del SSN sia nella prospettiva sociale (ICER per QALY rispettivamente pari a € 1.913 e pari a € 2.203 per il setting di trattamento empirico e rispettivamente pari a € 6.163 e pari a € 6.597 per il setting di trattamento confermato). Conclusioni: Alla luce dei risultati emersi dall’analisi, è possibile notare come l’introduzione di ceftolozano/tazobactam all’interno del contesto sanitario italiano possa rappresentare una soluzione terapeutica valida sia sotto il profilo economico sia sotto il profilo di efficacia.
Objective: To assess, from an epidemiological and economic point of view, the consequences of the reduction in the supply of antiretroviral drugs due to the COVID-19 pandemic.
Method: The analysis ...was conducted by adapting a Markov model previously published in literature. The simulations were conducted considering the possibility of continuous treatment for patients already diagnosed (no therapeutic interruptions are expected) and an immediate start of patients with new diagnosis during 2021. This analysis was compared with a scenario involving a therapeutic interruption or diagnostic delay caused by COVID-19.
Results: The analysis showed that the scenario characterized by a treatment delay, compared to the scenario of early resumption of therapy, could generate an increase in the number of patients with CD4 < 200 equal to 1,719 subjects (+16%) and a reduction in the number of patients with CD4 500 equal to 6,751 (−9%). A timely resumption of treatment for HIV+ patients could prevent 296, 454 and 687 deaths in the third, fifth and tenth years of analysis respectively with a potential cost reduction equal to 78,9 million at a 10 year time horizon.
Conclusions: These findings show that it is essential, especially in a pandemic situation such as the present one, to introduce technological, digital and organizational solutions, aimed at promoting timely diagnosis and at accelerating the therapeutic switch for patients who are no longer targeted.
Objectives: The aim of this study was to estimate the total annual direct costs incurred by the National Health Service for the management and treatment of CSCC and advanced CSCC patients in Italy.
...Methods: An incidence-based cost of illness (COI) model was developed to estimate direct costs associated with the treatment and management of CSCC patients in Italy. The identified treatment pathway was validated with a team of clinical experts and was distinguished between resectable CSCC and locally advanced CSCC or metastatic CSCC. Treatments costs were obtained through the analysis of the National Hospital Discharge Database (HDD) for the years 2015-2018; monitoring and terminal care costs were obtained from national tariffs of outpatient care service and from the literature respectively.
Results: Associating the estimated costs for each phase of the treatment pathway with the proportion of patients present in each phase, the COI model estimated an annual economic burden of about € 25.9 million for the management and treatment of patients with CSCC in Italy, € 2.7 million of which were associated to patients with advanced CSCC. The average cost per patient with advanced CSCC was higher compared to that of patient with resectable CSCC (€ 4,490 vs € 2,236 respectively).
Conclusions: Our analysis showed that advanced CSCC patients are associated with a higher average cost than patients with resectable CSCC.
OBJECTIVES: Cytomegalovirus (CMV) infection represents a serious post-transplantation complication, particularly among transplant recipients with resistant or refractory (R/R) infection. Despite the ...improvement made in CMV prevention and treatment, remains a need for new therapies that are better tolerated and safer for patients, especially for refractory or resistant (R/R) infections. This analysis investigates the cost-effectiveness of maribavir versus investigator-assigned therapy (IAT) for treatment of post-transplant R/R CMV in the Italian context. METHODS: The analysis was conducted from the National Health Service (NHS) perspective using a Markov model previously developed in Excel® to evaluate the cost-effectiveness of maribavir versus IAT for the treatment of post-transplant R/R CMV. Health event rates and transition probabilities were informed by data from observational studies and from SOLSTICE clinical trial, which compared maribavir to conventional antiviral treatments for transplant patients with R/R CMV infections. Utilities were from SOLSTICE and a utility vignette study. Costs inputs were derived from published literature and Italian national tariffs for outpatient and hospital services. Costs and outcomes were discounted by 3%. RESULTS: Maribavir compared to the IAT used for the treatment of post-transplant R/R CMV achieved an incremental cost of € 11,455 for an incremental quality adjusted life year (QALY) gain of 0.313. This resulted in an incremental cost-effectiveness ratio of € 36,626/QALY, for maribavir compared to IAT, which is below the generally accepted, national willingness-to-pay threshold for orphan drugs (€ 37,000/QALY). CONCLUSIONS: This analysis showed that maribavir, an orphan drug treatment, is cost-effective compared to the current antiviral treatments used for treatment of post-transplant R/R CMV.
Cellular prion protein (PrPc) is a ubiquitous glycoprotein, whose physiological role is poorly characterized. It has been suggested that PrPc participates in neuritogenesis, neuroprotection, copper ...metabolism, and signal transduction. In this study we detailed the intracellular events induced by PrPc antibody-mediated cross-linking in PC12 cells. We found a Fyn-dependent activation of the Ras-Raf pathway, which leads to a rapid and transient phosphorylation of extracellular regulated kinases. In addition, this activation cascade relies on the engagement of integrins, and involves focal adhesion kinase activation. We demonstrated the tyrosine phosphorylation of caveolin-1 as a consequence of PrPc stimulation, and showed that phosphocaveolin-1 scaffolds and coordinates protein complexes involved in PrPc-dependent signaling. Moreover, we found that caveolin-1 phosphorylation, is a mechanism for recruiting the C-terminal Src kinase and inactivating Fyn, so as to terminate cell signaling. Furthermore our data support a significant role for PrPc as a response mediator in neuritogenesis and cell differentiation.
OBJECTIVE: The Short Bowel Syndrome (SBS) is the most common cause of chronic intestinal failure (CIF) due to benign disease. The prevalence in Europe was estimated about 1.4 cases per million and ...few information are available for Italy. Home parenteral nutrition (HPN) is the primary and lifesaving treatment for patients with CIF. The parenteral nutrition (PN) has a great impact on the quality of life (QoL) of patients and the role of the caregiver is crucial for the disease management. The aim of this study was to evaluate the economic burden of SBS in Italy and to assess the impact of the disease and the parenteral nutrition on the quality of life of patients. METHODS: The total burden of SBS in Italy was assessed both in terms of costs and QoL using different tools. A prevalence-based cost of illness (COI) model was developed to estimate direct costs (PN cost, central venous catheter insertion cost, monitoring cost, hospitalization cost) and indirect costs (absenteeism, presenteeism, unemployment, abandonment of work due to the disease and economic benefits granted by the National Social Security Institute) associated with patient with SBS in Italy. The total annual costs were calculated considering a micro-costing approach, thus associating the average costs per patient with the prevalence of the disease. A systematic literature review (SLR) was conducted to collect epidemiological and direct cost data related to the patients with SBS. Hospital costs were estimated using the national Hospital Information System. Indirect costs were estimated using a human capital approach; therefore, the productivity loss was estimated both for patients and caregivers. A survey was conducted to obtain data about productivity loss and quality of life of patients and caregivers. The questionnaires were completed by clinicians, who were asked to indirectly report the experience of patients with SBS in parenteral nutrition currently being treated at their referral center. In a subsequent phase, a focus group was conducted to collect further information on QoL for patients and caregivers based on the experience of the KOLs involved. The QoL was evaluated considering a Likert scale. RESULTS: The prevalence of patients with gastrointestinal disease in HPN was estimated equal to 9.4 and 2.3 patients per million inhabitants for adults (age >18) and pediatric (age 0-18 years) patients, respectively. Knowing that SBS is the main cause of CIF due to benign disease, constituting 75% among adults and 56% among children, the number of adults with SBS in HPN present in Italy were 420, while the number of children with SBS in HPN were 77. Regarding direct costs, the mean total annual cost associated with adult and pediatric patient with SBS in Italy was estimated equal to € 36,434 and € 46,682, respectively. Parenteral nutrition accounted for 91% of the mean total cost estimated for the adult and for 87% of the mean total cost estimated for pediatric patient. Concerning indirect costs, the mean total annual cost per adult patient was estimated equal to € 51,093 (81% related to the productivity loss because of the abandonment of work due to the disease), while the mean total cost per pediatric patient was estimated equal to € 3,201 (60% related to caregiver’s presenteeism and 40% attributable to caregiver’s absenteeism). Finally, the average total annual cost per adult SBS patient in Italy was estimated at € 87,527 (42% of direct costs and 58% of indirect costs), whereas for pediatric patients it was estimated at € 49,882 (94% of direct costs and 6% of indirect costs). Overall, the weighted average cost for an SBS patient in Italy was estimated at € 81,712 (47% of direct costs and 53% of indirect costs). The analysis conducted on the QoL of patients with SBS in PN has shown that QoL was perceived as low (mean value equal to 5). The greatest impact on QoL was due to the disease (mean value equal to 9), while PN appeared to have less impact (mean value equal to 6). CONCLUSIONS: The analysis provides an estimate of the total burden associated with patients with SBS in Italy both in terms of cost and QoL. The cost associated with parenteral nutrition and indirect costs represent the main drivers of the total cost estimated for a patient with SBS in Italy. Based on the experience of the KOL involved in this study it was also found that the disease has a great impact on the QoL of these patients.
Introduction: Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) include all complicated skin and soft tissue infections. The aim of this study was to conduct a cost-utility analysis to ...compare dalbavancin with standard antibiotic therapies for the management of non-severe ABSSSIs from the National Health Service (NHS) perspective. Methods: A probabilistic decision tree model was developed considering a 30-days follow-up to simulate the therapeutic pathway of a patient treated with dalbavancin or Standard of Care (SoC). The model considered three mutually exclusive health states: a) discharge of patients from the emergency department, b) discharge of patients after one night from admission, c) discharge after 24 or 36 hours from admission. A one-way deterministic sensitivity analysis and a probabilistic sensitivity analysis were conducted. Results: The analysis showed that the use of dalbavancin in patients with non-severe ABSSSI compared to SoC could generate a reduction in costs (– € 291.6 per patient treated) and an increase in QALYs (+0.0018 per patient treated). In 99.7% of the simulations carried out, dalbavancin was dominant compared to the SoC. Considering a threshold for the willingness to pay of € 30,000 for QALY gained, the minimum level of efficacy of dalbavancin so that the treatment can be considered cost-effective compared to the SoC was equal to 69.4%. Conclusions: The analysis showed that dalbavancin may represent a cost-effective option compared to SoC for the treatment of patients with non-severe ABSSSI.
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