Farmeconomia. Health economics and therapeutic pathways
Not a member yet
496 research outputs found
Sort by
The Importance of Real-World Evidence in Understanding Influenza Vaccine Effectiveness
Full text linkOsteoarthritis in Italy: Impact on Health-Related Quality of Life and Health Care Resources
Full text linkOBJECTIVE: To determine how osteoarthritis (OA) severity correlates with self-reported outcomes relevant from the patient’s perspective in the Italian clinical setting.METHODS: Data were drawn from the 2017-18 Adelphi OA Disease Specific ProgrammeTM (DSP). Data were collected in the Italian clinical practice settings by primary care physicians, rheumatologists, orthopedists, and their patients with OA, during their regular office visits. Physicians completed information about OA-related visits to healthcare professionals (HCPs), tests/scans conducted, emergency room (ER) visits, surgeries, and OA-related treatment. Physicians also rated patients’ functioning on a 0 to 10 scale (0 = fully functional; 10 = completely impaired). Outcomes included Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, functional limitations, treatment needs, EuroQoL-5 Dimension (EQ-5D) visual analogue scale (VAS), the work productivity and activity impairment. Descriptive statistics (numbers and percent for categorical variables; means with standard deviations [SD] for continuous variables) were used to evaluate the different variables as appropriate.RESULTS: The study population comprised 900 patients from Italy with knee (40.9%), back (38.7%), hip (27.9%), and/or shoulder (20.3%) OA. Mean age was 66.6 years with a prevalence of female (63%) patients. Patients had mild (26%), moderate (54%), severe (20%) disease severity. Patients with severe disease reported higher functional limitations, greater use of treatments, reduced quality of life, and impaired work productivity and activity. The burdens were higher among elderly and obese patients and in patients with highest pain severity score.CONCLUSIONS: The results from this cross-sectional study show the impact of OA disease severity on all dimensions of health-related quality of life (HRQoL), as well as in OA-related health care resource use
Cost-Effectiveness Analysis of Alirocumab in High Cardiovascular-Risk Patients in Italy
Full text linkOBJECTIVE: Dyslipidemia, in particular elevated total and low-density lipoprotein cholesterol (LDL-C), results in atherosclerosis and increases the risk of cardiovascular (CV) events. Despite treatment with statins, many patients fail to reduce their LDL-C enough to optimally minimize their risk. Novel therapy alirocumab, on top of background statin therapy, resulted efficacious in lowering CV risk by reducing LDL-C levels. Aim of the present paper is to evaluate the cost-effectiveness of alirocumab in high cardiovascular-risk patients in ItalyMETHODS: A 1-year cycles Markov model was developed to evaluate the cost-effectiveness of statins at maximum dose tolerated plus ezetimibe (MDTS+E) with or without alirocumab. Target population consisted of patients with high baseline risk of CV events. Patients entered the model in stable disease and could experience a non- fatal CV event (acute coronary syndrome, elective revascularization or ischemic stroke) or die. Results from the ODYSSEY trial were used to evaluate CV risk reduction due to alirocumab add-on. Pharmaceutical, CV events, and LDL-C levels’ detection costs are considered in the analysis from the perspective of Italian National Health Service.RESULTS: Simulated cohort was 75 years old on average, 66% male, 42% diabetes mellitus and baseline LDL-C level equal to 121mg/dl. Furthermore, 96% of subjects were hospitalized in the last 12 months. Alirocumab used as an add-on to MDTS+E was more costly (€ 45,358 vs € 13,208) but more effective (8.01LY vs 6.33LY) than MDTS+E, leading to an incremental cost effectiveness ratio of € 19,158 per LY. At a willingness to pay threshold of € 30,000 per LY, alirocumab had 96% probability to be cost effective vs. MDTS+E alone. Results were relatively more favorable in the patient subset with recent CV event (<12 months from index).CONCLUSION: The results indicate that alirocumab in addition to MDTS+E is cost-effective versus MDTS+E alone in a representative cohort of high CV risk patients in Italy
A Budget Impact Analysis of the VENTANA PD-L1 SP142 Immunohistochemistry Assay Versus the Dako PD-L1 IHC 22C3 Assay in Patients With Advanced or Metastatic Triple-Negative Breast Cancer Treated With Atezolizumab in Combination With Nab-Paclitaxel
Full text linkOBJECTIVE: To estimate the budget impact determined by the adoption of two different diagnostic strategies, SP142 assay or 22C3 assay, in the identification (in terms of PD-L1 status) of patients with mTNBC eligible for treatment with atezolizumab in combination with nab-paclitaxel.METHODS: The budget impact analysis (BIA) was conducted using a budget impact model (BIM) considering the Italian National Health Service’s (iNHS) perspective. The analysis assessed only the direct medical cost (tissue biopsy, PD-L1 assay, specialist visit, pharmacological treatment with atezolizumab in combination with nab-paclitaxel) of patients with PD-L1 positive mTNBC, and management of the adverse events associated with the pharmacological treatment administered. The BIM also considered the clinical benefits (progression free survival, PFS) resulting from the drug therapy administered on the basis of the results of the post-hoc analysis of the IMpassion130 clinical trial. The BIA was conducted over a 1-year time horizon. The median cost per patient in the progression-free state was also calculated. The costs were calculated using the net ex-factory prices (cancer drugs) and regional or national tariffs (tissue biopsy, PD-L1 assay, specialist visit and adverse events management). A sensitivity analysis was conducted to evaluate the base case result.RESULTS: The SP142 assay diagnostic pathway would result in a reduction of the iNHS expenditure of approximately 5.6 million euros (-12%). Almost all of the reduction in iNHS expenditure would be determined by the lower number of patients treated (SP142: 689 patients vs 22C3: 786 patients) with immunotherapy (-€ 5,530,871). Compared with 22C3 assay, the SP142 assay shows a cost per PFS month reduction of € 736 (€ 7,010 vs € 7,746).CONCLUSIONS: The use of the SP142 assay proved to be cost-effective compared to the 22C3 assay; the SP142 assay can support the choice of the most appropriate cancer drug, maximizing the effectiveness and minimizing the waste of healthcare resources
[The Multidisciplinary Management of Type 2 Diabetes: an Integrated Care Model]
No full textOver the past 20 years, the prevalence of diabetes in Italy has been growing, up to the current estimated proportion of about 8.5%, which accounts also for undiagnosed patients. As most of these subjects are >65 years of age, the probability of having comorbidities is high. In addition, diabetes itself exposes patients to a wide spectrum of complications, that cover several therapeutic areas. This is why the optimal management of diabetes necessarily involves a multidisciplinary team.Several models of integrated care of chronic diseases may be set: for instance, the role assigned to GPs and specialists may differ among models. Indeed, a disequilibrium between GPs and specialists is deemed to be the main cause of the low patients’ participation in Progetto Cronicità (chronic diseases project), which started in Lombardia (a Northern region in Italy) in 2018.A help to understand how to build a proper integrated care model in diabetes comes from the experience of the Authors, that describe in detail their experience in IRCCS MultiMedica (Sesto San Giovanni, MI, Italy).This Supplement ends with a review of the evidence found in literature about the advantages of a multidisciplinary management of diabetes in terms of outcomes, costs, and patients’ satisfaction
Health Technology Assessment on the use of the Wearable Cardioverter Defibrillator in Patients with Myocardial Infarction and with ICD Explant
Full text linkThe objective of the present work is to conduct a Health Technology Assessment (HTA) on the use of the Wearable Cardioverter Defibrillator (WCD) in patients at risk of Sudden Cardiac Arrest (SCA) following Myocardial Infarction (MI) or with an explanted Implantable Cardioverter Defibrillator (ICD)
Critical Review of the Pivotal Studies of Four rFVIII Products for the Treatment of Hemophilia A Patients: The Role of Octocog Alfa
Full text linkINTRODUCTION: Hemophilia A is a rare congenital bleeding disorder caused by a deficiency of clotting factor VIII (FVIII). The severe form of the disease is characterized by spontaneous bleeds, especially into the joints. Prophylaxis, based on regularly intravenous administration of the missing factor to avoid hemorrhages, represents the gold standard of treatment. In recent years, new products that significantly improve the treatment management options for patients with hemophilia have become available in the market.OBJECTIVE: To critically evaluate the pivotal studies of recombinant FVIII (rFVIII) products, approved in Europe within the first half of 2018 having obtained the indication for a prophylaxis dosing regimen based also on a twice weekly infusion frequency or even less, highlighting their limitations or strengths.METHODS: A systematic literature search was conducted, and several databases (PubMed and Embase) were consulted.RESULTS: Nine clinical trials involving patients with severe hemophilia A without inhibitor were included in this analysis. Four rFVIII products (Elocta®, Biogen, Cambridge, MA, USA; Kovaltry®, Bayer HealthCare Pharmaceuticals, Germany; Afstyla®, CSL Behring GmbH, Germany; Adynovi®, Baxalta Innovation GmbH, Austria) with different pharmacokinetic profiles were evaluated. The trials included in this analysis had different designs and heterogeneous methods were utilized to assess the study outcomes. The baseline characteristics of the patients enrolled in the studies were also often different and sometimes not adequately described. LEOPOLD II, a trial to compare prophylaxis to on-demand therapy with an unmodified rFVIII product (Kovaltry®, octocog alfa), was the only completely randomized trial that enrolled a more critical patient population in terms of compromised joint condition than the other studies. Based on these side-by-side comparison, Octocog alfa reported similar efficacy, in terms of annualized bleeding rate, to the other rFVIII products, including extended half-life.CONCLUSIONS: Even without structural modifications, octocog alfa may be considered a useful treatment option for two times a week prophylaxis in a selected population of haemophilia patients
Extended Half-life rFVIII for the Treatment of Hemophilia A: Drugs Consumption and Patients’ Perspective
Full text linkProphylaxis is recognized as the most effective treatment regimen for patients with severe hemophilia A. Prophylaxis with standard half-life (SHL) FVIII products requires frequent intravenous administrations, at least two-three times per week. Frequency of injections is reported as one of the major obstacles to adherence to treatment and caused impairment in quality of life (QoL) and possible clinical implications. The extended half-life (EHL) rFVIII products recently reimbursed by Italian National Health Service (NHS), give the possibility of prophylactic dosage regimens characterized by reduced administration frequency with the potential to increase adherence to therapy and to improve QoL and clinical outcomes. Based on the approved dosing regimens the minimum and maximum number of administrations per year and the annual consumption for the marketed EHL rFVIII products were estimated. Compared to Adynovi® and Elocta®, Jivi® is the drug associated with the lowest number of administrations per year while versus Esperoct® is associated to a slightly higher maximum number of administrations per year. Furthermore, Jivi® has an annual mean consumption per kg lower than Adynovi®, Elocta® and Esperoct® (-24%, -27% and -22%, respectively). The contemporary reduction of number of injections per year and the lower annual mean consumption (IU) represent important benefits for the patient. From the economic point of view, at the prices published in Italian Official Journal, Jivi® weighted average annual expenditure per patient is 26% lower than Adynovi® and 29% lower than Elocta® and a saving is possible even considering a 10% increase in Jivi®’s price per IU versus comparators. Among the EHL rFVIII concentrates Jivi® appears to be more suitable to cover patients’ needs due to the possibility to adopt different dosage regimens (up to every 7 days) and is associated with the lowest average annual consumption per patient allowing a more predictable budget forecast and overall reducing the NHS expenditure
Clinical Impact of two Different Diagnostic Strategies in the First- and Second-Line Treatment of Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
Full text linkBACKGROUND: A histopathological and mutational diagnosis has become a priority in the correct choice of the most appropriate cancer therapy for NSCLC. In the absence of a molecular analysis, the therapeutic choice will be directed towards platinum-based chemotherapy, thus preventing, in the presence of a specific mutation, the benefits deriving from the administration of a target therapies (TT).AIM: the present analysis was carried out with the aim of estimating the clinical impact, expressed in terms of progression free survival (PFS), associated with the use of the combined strategy (tissue biopsy and liquid biopsy) or the tissue strategy in the EGFR+ mNSCLC population.METHODS: A pre-existing cost-consequence model was adapted to estimate the annual number of mNSCLC patients with or without the EGFR mutation in order to decide the oncological treatment to be administered in first (1L) or second line (2L). In 1L, against the presence of the EGFR mutation, the administration of a Tyrosine Kinase Inhibitor (TKI), such as osimertinib, gefitinib, erlotinib or afatinib, was considered; in the absence of the EGFR mutation, the administration ofstandard platinum-based chemotherapy was instead considered. With reference to 2L, in the presence of the EGFR T790M mutation, only osimertinib was considered. In the absence of the EGFR T790M mutation, the administration of the standard platinum-based chemotherapy was also considered. The PFS data associated with each of the drugs considered were extrapolated from the respective clinical studies. Key variables were tested in the sensitivity analysis.RESULTS: The adoption of the combined strategy (tissue biopsy and liquid biopsy), by virtue of a greater number of patients treated with TKIs, would make it possible to increase the average PFS in the range of 1.1-3,7 months in the 1L and by 1.4 months in the 2L.CONCLUSION: These results show how the adoption of a correct diagnostic strategy is critical in order to optimize the choice of the therapeutic path in the 1L and 2L of mNSCLC. The addition of the liquid biopsy to the classic diagnostic path (tissue biopsy) would in fact allow to obtain an increase in therapeutic efficacy (average PFS)
Corrigendum: An Integrated Management Model of Patients With Atrial Fibrillation: The Experience of the Local Health Unit Tuscany North-West/1
Full text linkThere was an error in the description of GLORIA-AF registry program at page 10 in this Supplement by Casolo et al. [Farmeconomia. Health economics and therapeutic pathways 2019; 20(Suppl 1): 3-16; https://doi.org/10.7175/fe.v20i1S.1454]. The online version has been corrected on February 12, 2020