Publications by authors named "Giorgio L Colombo"

Background: Icodec, once-weekly basal insulin, aims to simplify therapy management by reducing injection frequency for diabetic patients. The efficacy and safety of icodec were evaluated in the ONWARDS clinical development program. This study evaluates icodec economic and quality of life impact from the Italian National Healthcare System (NHS) perspective.

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  • Metabolic dysfunction-associated steatotic liver disease (MASLD) is a rising health issue in Italy, with the study evaluating its economic burden on the National Healthcare Service.
  • Utilizing an Excel model, researchers compared healthcare costs and complications associated with MASLD against a similar population without it, revealing significant financial and mortality impacts.
  • The study estimates that MASLD could cost the Italian healthcare system over €12 billion annually and result in approximately 13,438 extra deaths, highlighting the need for lifestyle changes and future pharmaceutical interventions.
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Introduction: The underdiagnosis of chronic kidney disease (CKD) remains a significant public health concern. The Early chroNic kiDney disease pOint of caRe Screening (ENDORSE) project aimed to evaluate the clinical and economic implications of a targeted training intervention for general practitioners (GPs) to enhance CKD awareness and early diagnosis.

Methods: Data on estimated Glomerular Filtration Rate (eGFR) and Urinary Albumin-Creatinine Ratio (uACR) were collected by 53 Italian GPs from 112,178 patients at baseline and after six months.

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  • Paroxysmal nocturnal hemoglobinuria (PNH) is a rare disease leading to hemolysis, with C5 inhibitors improving treatment but having limited effects on some hemolysis types.
  • The newly approved C3 inhibitor, pegcetacoplan, effectively reduces both intravascular and extravascular hemolysis, enhancing hemoglobin levels and quality of life for patients.
  • A cost-utility analysis showed pegcetacoplan is less expensive over 5 years (€1,483,454) compared to C5 inhibitors and provides greater increases in quality-adjusted life years (QALYs) while reducing management costs associated with complications.
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Introduction: Advanced urothelial carcinoma remains aggressive and very hard to cure, while new treatments will pose a challenge for clinicians and healthcare funding policymakers alike. The U-CHANGE Project aimed to redesign the current model of care for advanced urothelial carcinoma patients to identify limitations ("as is" scenario) and recommend future actions ("to be" scenario).

Methods: Twenty-three subject-matter experts, divided into three groups, analyzed the two scenarios as part of a multidimensional consensus process, developing statements for specific domains of the disease, and a simplified Delphi methodology was used to establish consensus among the experts.

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  • The study aimed to determine the most cost-effective sequence of anti-IL17 treatments for moderate-to-severe plaque psoriasis in Italy and Germany over five years.
  • Researchers adapted a treatment model to include real-world data on drug discontinuation rates and specific costs for the four available anti-IL17 biologics, using long-term efficacy measures to evaluate effectiveness.
  • The findings indicated that the best treatment sequence is starting with brodalumab, followed by bimekizumab, ixekizumab, and finally secukinumab, resulting in a total cost-per-responder of €128,200 in Italy and €138,212 in Germany.
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  • The study looks at how different types of medications, called biological drugs and biosimilars, affect health care costs for patients with certain diseases, especially in rheumatology.
  • Researchers examined 145 patients and found that most were using the original biological drugs instead of the biosimilars, even though patients using biosimilars showed better adherence to treatment.
  • The total health costs for these patients over one year was quite high, with a large portion going toward medications, and the study suggests that better communication among health professionals could help more people use biosimilars.
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Background: To date, no study evaluated the cost-effectiveness of palbociclib (PAL) plus fulvestrant (FUL) vs ribociclib (RIB) plus FUL and abemaciclib (ABM) plus FUL in Italy. Cost-effectiveness analysis comparing the three cyclin-dependent 4/6 kinase inhibitors in combination with endocrine therapies for the management of postmenopausal women with HR+, HER2- advanced or metastatic breast cancer in Italy was developed.

Material And Methods: To assess the cost-effectiveness of PAL plus FUL vs RIB plus FUL and ABM plus FUL, a cost-minimization has been carried out with a conservative scenario considering three CDK4/6 inhibitors with equal effectiveness in terms of overall survival (OS) (MAIC, Rugo et al 2021).

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Background: Aim of our study is to evaluate the economic impact of NASH among diabetic population in Italy and potential benefits of treatments that can slow the disease progression.

Methods: A Markov model was conducted from the Italian National Healthcare System perspective reporting results at 3, 5, 10 and 15 years. The model included NASH and T2DM patients with all stages of fibrosis (F0-F3), compensated cirrhosis (CC), decompensated cirrhosis (DCC), hepatocellular carcinoma (HCC), liver transplant (LT), post-LT and death.

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Importance: Previous systematic reviews and meta-analyses have concluded that given data paucity, a comparison of reflectance confocal microscopy (RCM) with dermoscopy is complex. They recommend comparative prospective studies in a real-world setting of suspect lesions.

Objective: To test the hypothesis that RCM reduces unnecessary lesion excision by more than 30% and identifies all melanoma lesions thicker than 0.

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Purpose: Platelet transfusions (PT) are commonly used as prophylaxis in patients with chronic liver disease (CLD) and severe thrombocytopenia (TCP) before invasive procedures, in order to reduce risk of bleeding. The aim of this cost analysis was to generate a comprehensive estimate of costs of platelet transfusions in Italy, focusing on patients with severe TCP due to CLD undergoing an elective procedure.

Methods: The research was conducted in different phases: 1) assessment of a pre-specified framework for the identification of processes related to PT; 2) estimation of resource consumption through Delphi technique and collection of unit costs through literature; 3) development of a cost analysis to estimate the overall average costs per PT, focusing on a representative patient with CLD and severe TCP.

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Background: Gonadotropins represent an important component of IVF costs. In order to reduce costs, much attention was given to the type of gonadotropins (recombinant versus urinary) and the daily dose. In this study, we decided to focus on gonadotropin wastage, a neglected aspect that may harbor a relevant source of useless economic expenditure.

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  • The COVID-19 lockdown in Italy led to a significant reduction in outpatient visits, especially among diabetic patients, raising concerns about their health outcomes.
  • Diabetic individuals experienced a 28% drop in access to healthcare and a mortality rate of 20.4%, double that of the general population, highlighting the pandemic's severe impact on this group.
  • The study estimated a financial burden on the National Health Service of €26.6 million and a significant loss in quality of life, indicating the negative consequences of delayed treatment and reduced access to innovative therapies.
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Purpose: Understand the demographics and clinical features of patients with osteoarthritis (OA), quantify healthcare resource utilization by OA patients, and estimate the annual direct medical costs per OA patient from a National Health Service (NHS) perspective in Italy.

Patients And Methods: Retrospective observational cohort analysis using data from electronic medical records captured by the Italian IQVIA Longitudinal Patient Database (LPD). Only direct medical costs reimbursed by the NHS were considered.

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Objectives/purpose: The costs attributable to antimicrobial resistance (AMR) remain theoretical and largely unspecified. Current figures fail to capture the full health and economic burden caused by AMR across human, animal, and environmental health; historically many studies have considered only direct costs associated with human infection from a hospital perspective, primarily from high-income countries. The Global Antimicrobial Resistance Platform for ONE-Burden Estimates (GAP-ON€) network has developed a framework to help guide AMR costing exercises in any part of the world as a first step towards more comprehensive analyses for comparing AMR interventions at the local level as well as more harmonized analyses for quantifying the full economic burden attributable to AMR at the global level.

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Diabetes treatment cost represents an ever-growing problem. The adoption of new drugs in therapy, although they can guarantee an improvement in patient's quality of life, can meet obstacles when it involves an increase in costs. We decided to compare the costs and benefits of the new saxagliptin and dapagliflozin combination versus traditional therapies.

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  • Diabetes is a global public health issue, leading to serious complications and increased treatment costs, prompting a study on the economic impact of dulaglutide as a diabetes treatment alternative.
  • The study utilized a cost-utility analysis to compare the total costs of dulaglutide versus gliclazide (a sulfonylurea) and basal insulin, with a focus on their effectiveness alongside metformin in type II diabetic patients.
  • Results indicated that while dulaglutide is more expensive upfront than gliclazide and basal insulin, it may lead to lower overall costs in terms of self-monitoring and hypoglycemia-related expenses.
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Introduction: Inadequately controlled severe asthma patients require additional therapy accounting for significant clinical and economic burden. Our analysis aims to determine the cost-effectiveness of omalizumab in the management of severe allergic asthma in Italy based on observational data from the PROXIMA study.

Methods: Observational data on efficacy, healthcare resource utilization and changes in quality of life at 12 months after the initiation of omalizumab were examined to estimate the cost-effectiveness compared to pre-omalizumab period and results were expressed with Incremental Cost-Effectiveness Ratio (ICER).

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  • Asthma is a chronic inflammatory disease affecting quality of life, and the Asthma Quality of Life Questionnaire (AQLQ) is a key tool for measuring patient-reported outcomes (PROs).
  • A systematic review was conducted following PRISMA guidelines to assess long-term QoL outcomes related to omalizumab therapy in patients with moderate-to-severe allergic asthma, reviewing studies published until February 2018.
  • Results from eight selected studies highlighted that omalizumab significantly improves both subjective and objective measures of asthma control over time, although the observational nature of these studies may introduce selection bias concerns.
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Background: Asthma is one of the most common non-communicable respiratory diseases, affecting about 6% of the general population. Severe asthma, even if afflicts a minority of asthmatics, drives the majority of costs of the disease. The aim of this study is to create a pharmacoeconomic model to predict the costs of corticosteroid-related adverse events in severe asthmatics and applying it to the first published epidemiologic data from the Severe Asthma Network in Italy (SANI) registry.

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  • Secukinumab is a monoclonal antibody approved in Europe for treating moderate-to-severe psoriasis, psoriatic arthritis, and ankylosing spondylitis since 2015, with a budget impact assessment conducted for its introduction into the Italian market.
  • A budget impact model projected the number of patients treated with secukinumab to increase from 6,648 in the first year to 12,001 by the third year, estimating a total savings of €66.1 million over three years, largely due to savings in ankylosing spondylitis treatment.
  • The analysis confirmed that introducing secukinumab would lead to a -5% cumulative budget impact over three years, indicating cost-effectiveness compared to scenarios
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