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Background: Dapagliflozin, approved in the treatment of patients with chronic kidney disease (CKD), has demonstrated attenuation of CKD progression and a reduced risk of cardio-renal outcomes and all-cause mortality (ACM) versus placebo, in addition to standard of care (SoC). The aim of this economic evaluation was to assess the potential medical care cost offsets associated with reduced rates of cardio-renal outcomes in Italy. Methods: A comparative micro-simulation model estimated the outcome-related costs of dapagliflozin plus SoC versus SoC alone over a 3-year horizon based on the DAPA-CKD trial. Incidence rates of end-stage kidney disease (ESKD), hospitalizations for heart failure (hHF), acute kidney injury (AKI) and ACM were estimated for a treated population of 90,564 patients. Associated direct medical costs for non-fatal events (ESKD, hHF and AKI) were calculated using available literature and national tariffs. The analysis was restricted to outcome-associated costs and did not consider the cost of drug treatments and disease management. Results: Patients treated with dapagliflozin plus SoC experienced fewer incident events of ESKD (6,540 vs 9,751), hHF (2,146 vs 4,242), AKI (3,772 vs. 5,271) and ACM (5,780 vs 8,037) per 90,564 treated patients versus those treated with SoC alone. Reductions (–35,6%) in clinical events (ESKD, hHF and AKI) were associated with a 34.4% reduction in total costs (€ 170 million) over 3 years. The clinical effect of dapagliflozin on ESKD management accounted for a € 134.5 million reduction in total costs. Conclusion: Based on the DAPA-CKD trial, dapagliflozin may prevent cardio-renal event incidence with a positive effect upon the Italian National Healthcare Service (NHS). Over three years, we estimated that dapagliflozin can reduce the Italian NHS expenditure associated with the management of ESKD, hHF and AKI events by 34.4% (€ 170 million).

Objective: The aim of this study was to evaluate the economic consequences of the introduction of roxadustat on the market as treatment for chronic kidney disease (CKD)-related anaemia in Italy. Method: A budget impact model was developed to assess the economic impact of the introduction of roxadustat for the management of patient with CKD-related anaemia. The analysis was conducted considering National Health Service (NHS) perspective and three years’ time horizon. Eligible population for the treatment with roxadustat was estimated through published literature and clinicians’ support. Direct healthcare costs included drug acquisition (list prices for base case) and administration costs, monitoring costs, cost per blood transfusion, costs related to the management of adverse events and dialysis costs. Results: The model estimated a three years expenditure associated with the management of patients with CKD-related incident anaemia in Italy of about € 260 and € 44.6 million for non-dialysis dependent (NDD) and dialysis-dependent (DD) patients respectively. The introduction of roxadustat on the market could generate a reduction in the expenditure related to the iron supplementation both for NDD and for DD patients (−€ 397,305 and −€ 50,135 over three years of the analysis, respectively) and a reduction in the pharmaceutical expenditure for NDD patients (−€ 2.3 million, −€ 7.5 million and −€ 13 million at first, second and third year of the analysis). Overall, the introduction of roxadustat could generate a saving for NHS approximately equal to € 2.3, € 7.5 and € 13 million at first, second and third year of the analysis. Conclusion: The introduction of roxadustat could generate a reduction in the expenditure for the management of patients with CKD anaemia. A scenario analysis which used tender prices for ESAs and hypothesis of confidential discount for roxadustat showed that the saving for NHS will be kept if roxadustat’s discount is greater than 60.3%.

Gliomas are a group of heterogeneous tumors that account for substantial morbidity, mortality, and costs to patients and healthcare systems globally. Survival varies considerably by grade, histology, biomarkers, and genetic alterations such as IDH mutations and MGMT promoter methylation, and treatment, but is poor for some grades and histologies, with many patients with glioblastoma surviving less than a year from diagnosis. The present review provides an introduction to glioma, including its classification, epidemiology, economic and humanistic burden, as well as treatment options. Another focus is on treatment recommendations for IDH-mutant astrocytoma, IDH-mutant oligodendroglioma, and glioblastoma, which were synthesized from recent guidelines. While recommendations are nuanced and reflect the complexity of the disease, maximum safe resection is typically the first step in treatment, followed by radiotherapy and/or chemotherapy using temozolomide or procarbazine, lomustine, and vincristine. Immunotherapies and targeted therapies currently have only a limited role due to disappointing clinical trial results, including in recurrent glioblastoma, for which the nitrosourea lomustine remains the de facto standard of care. The lack of treatment options is compounded by frequently suboptimal clinical practice, in which patients do not receive adequate therapy after resection, including delayed, shortened, or discontinued radiotherapy and chemotherapy courses due to treatment side effects. These unmet needs will require significant efforts to address, including a continued search for novel treatment options, increased awareness of clinical guidelines, improved toxicity management for chemotherapy, and the generation of additional and more robust clinical and health economic evidence.

Competing Interests: Conflict of interest: LDN reported serving as an advisory board member for Astellas, AstraZeneca, Bayer e Novo Nordisk. The other Authors reported no conflict of interest.