Giorgio Colombo - Academia.edu (original) (raw)

Papers by Giorgio Colombo

Therapeutics and Clinical Risk Management

Background: To date, no study evaluated the cost-effectiveness of palbociclib (PAL) plus fulvestr... more 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 costminimization 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). Adverse events (AEs) associated with all therapies were obtained from clinical trials. Ad-hoc analysis was performed to estimate the cost-effectiveness considering the quality-of-life (QoL) data (Lloyd et al 2006). Results: Cost-minimization inputs were drugs, visits and exams, AE monitoring and best supportive care (BSC) before the progression state, active and BSC in the progression and terminal phase of the last two weeks of life. Given the comparability of PAL, RIB and ABM in terms of efficacy, this analysis demonstrated slight economic savings over a lifetime for PAL. Results showed saving per patient of €305 (lifetime) when PAL is compared with RIB; for PAL vs ABM a saving of €243 (lifetime) in a conservative scenario. Results of a budget impact analysis showed a potential savings of €319,563 for PAL vs RIB and €297,544 for PAL vs ABM. When QoL data were considered, results may favor PAL due to the lower impact of AE with savings and improvement in the QoL related to fewer AE. Conclusion: From the Italian perspective, a cost-saving profile associated with the use of PAL+FUL for the management of advanced/metastatic HR+/HER2-breast cancer compared to RIB+FUL and ABM+FUL emerged.

ClinicoEconomics and Outcomes Research

Background: Aim of our study is to evaluate the economic impact of NASH among diabetic population... more 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. A 1-year model cycle length was considered, with each patient passing through the stages and exiting the model when reached one of mortality states. Transition probabilities and annual cost related to health states were derived from published literature. Moreover, the model made it possible to develop a scenario analysis to simulate the impact of treatments capable of slowing the disease progression in phases F0-F4 (CC). Results: The results highlighted an economic burden of NASH in T2DM patients of approximately € 1.4 billion, € 3.1 billion, and € 9.4 billion, respectively, after 3, 5 and 10 years, reaching about € 17.3 billion after 15 years. The slowing down of the progression in the early stages of the disease (fibrosis F0-CC) has led to significant savings corresponding to € 2.3 billion at 15 years. These savings were generated by the reduction of the patients in the advanced stages of the disease, which is linked to a reduction in deaths, equal to 92,208 deaths avoided over a 15-year time horizon. Conclusion: Patients with NASH and T2DM reported an important burden in Italy. It is important to investigate the potential clinical and economic benefits of antidiabetic drugs that have been shown to be effective in preventing the transition to advanced disease, simultaneously acting on the therapeutic goals of diabetic disease.

ClinicoEconomics and Outcomes Research

Platelet transfusions (PT) are commonly used as prophylaxis in patients with chronic liver diseas... more 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. Robustness of results was tested in a sensitivity analysis. Results: Despite the lack of some cost components estimation and uncertainty related to event probability, the analysis showed a total cost of 5297 € for each PT in patients with CLD and severe TCP. The total cost was largely driven by direct costs (4863 €) associated with platelet collection, transfusion, and management of refractoriness, which accounted for 92% of total. Conclusion: In an environment of limited resources, it is crucial for the healthcare service to have accurate and inclusive information on transfusion costs, incorporating not only the cost of blood products but also those related to collection and management. The analysis showed that platelet collection and administration costs add substantially to the cost of platelet products themselves. As expected, the highest cost was the transfusion process itself (44% of total), followed by refractoriness (43% of total). Since limited literature exists concerning these cost estimates, this analysis represents a step forward in understanding the economic burden of patients with CLD and severe TCP scheduled to undergo an invasive procedure.

ClinicoEconomics and Outcomes Research, 2021

Background: In Italy, the adoption of a total lockdown has generated almost total suspension of o... more Background: In Italy, the adoption of a total lockdown has generated almost total suspension of outpatient visits except for emergencies. Even after lockdown, the pandemic fear created additional barriers to access the health services. The aim of our study is to evaluate the economic impact of the lockdown for COVID-19 on public health in Italy, focusing on its effects on diabetic population. Materials and Methods: We analyzed the impact of the lockdown on excess mortality and morbidity in the Italian diabetic population during 2020. The analysis was divided into several steps: a quantification of specialist visit reduction, the calculation of excess mortality in the diabetic population, the economic evaluation of the slowdown in the use of innovative diabetic therapies. Furthermore, the impact of the lockdown on the reduction of procedures and follow-up visits in diabetic population was evaluated. The overall impact of the pandemic and lockdown effects on costs and quality of life was then calculated. Results: During 2020, a drop of 28% in patient access has been observed. Diabetic patients recorded a twice higher mortality value compared to general population (20.4% vs 10.2%). The analysis of market data revealed a slowdown in consumption of new antidiabetic therapies (−14%, 27% vs 41%). We estimated an expense of €26.6 million for NHS and a loss of 257 utilities in diabetic population due to the missed benefits related to slowdown in innovative antidiabetic drugs use and non-optimal follow-up and control of diabetes complications. In simulation scenarios, we also estimated an overall expenditure ranging from €38.7 to 94.0 million and a loss of 294-836 utilities. Conclusion: Diabetic population paid a high tribute to pandemic and lockdown, both in terms of number of deaths and burden of diabetic complications, together with an overall deterioration of quality of life.

R e V i e w open access to scientific and medical research Open Access Full Text Article

ClinicoEconomics and Outcomes Research, 2018

Background: Anas barbariae hepatis et cordis extractum 200K (Oscillococcinum ®) is used to treat ... more Background: Anas barbariae hepatis et cordis extractum 200K (Oscillococcinum ®) is used to treat and prevent seasonal colds and airway inflammatory affections, improve symptom control, and reduce the frequency of respiratory tract infection (RTI) episodes. The objective of this controlled observational study is to investigate, from the Italian National Health Service (NHS) point of view, the role of Anas barbariae hepatis et cordis extractum 200K in preventing RTIs and estimate the annual average cost per patient due to visits and medicines in a real-world setting, investigating whether this method of treatment can bring savings for the NHS. Methods: Data from a single center from 2002 to 2011 were used. The analysis examined 455 patients who suffered from respiratory diseases. Of the total number of patients, 246 were treated with Anas barbariae hepatis et cordis extractum 200K while 209 were not treated (Control group). All the data concerning RTI episodes, pharmacological treatments, and pneumological visits were extracted from the database. Results: It was found that, regardless of the diagnosis, the frequency of RTI episodes was always lower in patients treated with Anas barbariae hepatis et cordis extractum 200K; the difference between the numbers of events occurring was statistically significant in every class of patients (p<0.001). The costs that the NHS had to incur were significantly lower in the classes of patients treated (p<0.001). Discussion: The results indicate that Anas barbariae hepatis et cordis extractum 200K has a preventive effect on the onset of RTI episodes. The analysis shows that treating patients with Anas barbariae hepatis et cordis extractum 200K lowers costs for the NHS; this is primarily due to the fact that the medication causes fewer episodes of RTI to develop. This study suggests that the treatment with Anas barbariae hepatis et cordis extractum 200K could be helpful in preventing RTIs and improving the health status of patients who suffer from respiratory diseases, and it could lead to savings to the Italian NHS.

Health Services Insights, 2020

Diabetes treatment cost represents an ever-growing problem. The adoption of new drugs in therapy,... more 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. Bodyweight loss and the sharp reduction in hypoglycemic episodes were the 2 main clinical outcomes that emerged from registered studies of saxagliptin and dapagliflozin compared with the sulfonylureas. These results, combined with the good cardiovascular risk profile, led to develop a cost-utility analysis. We aimed to show the economic value of this new association therapy. We carried out a cost-utility analysis from the Italian National Healthcare System (NHS) perspective, focused on direct costs related to the treatment and management of main diabetes complications. Utility scores adopted have been measured based on the patient’s...

ClinicoEconomics and Outcomes Research, 2020

Background: Diabetes represents a relevant public health problem worldwide due to its growing pre... more Background: Diabetes represents a relevant public health problem worldwide due to its growing prevalence and socioeconomic burden, principally due to the development of macrovascular and microvascular complications as well as to the continuous launch of new and even more expensive drugs. The aim of our study is to evaluate the economic impact of dulaglutide, a weekly GLP-1 receptor agonist, on the treatment of diabetic patients as an alternative to both high dose sulphonylureas and insulin basalization at the failure of oral therapies alone. We carried out a cost-effectiveness analysis developed considering the economic implications of recent clinical studies regarding cardiovascular risk drug effects and especially of REWIND studies outcomes, focusing on the impact of weight changes on HRQoL. Material and Method: In our analysis, we have applied the cost-utility technique to the above reported clinical outcomes and compared the global costs of dulaglutide versus sulfonylurea or basal insulin, all in add-on with metformin. We have chosen gliclazide, as a sulfonylurea and Abasaglar ® , the less expensive among basal insulin analogues. Abasaglar was titrated to 20 IU, corresponding to the mean dosage used in the treatment of type II diabetic patients. The model aims to estimate total direct costs related to the above-reported treatments and find out the real gap in costs between dulaglutide, the apparently cheaper gliclazide and basal insulin glargine (IGlargine) based on the Italian National Healthcare System (INHS). Results: The total cost of dulaglutide has resulted in €859.66 higher than gliclazide (€1,579.73 vs €720.07) and basal insulin, although less significantly, reporting a difference of €396.54 (€1,579.73 vs 1,183.19). Except for the purchase cost, dulaglutide has reported reduced costs compared to insulin IGlargine and gliclazide. Dulaglutide showed lower selfmonitoring blood glucose and hypoglycaemia costs, a significant reduction in costs related to cardiovascular complications, as well as savings in costs in other drugs. Dulaglutide can be considered a cost-effective antidiabetic therapy, due to the positive impact on the quality of life induced by weight reduction, despite the higher annual cost per patient, mainly influenced by drug purchase cost. Discussion and Conclusion: In this cost-utility analysis, dulaglutide has shown to be a cost-effective treatment option from the Italian healthcare system perspective as add-on therapy to metformin in patients with inadequately controlled type 2 diabetes mellitus. Study findings can provide stakeholders valuable evidence to support the adoption of this costeffective second-or third-line therapy compared to gliclazide or basal insulin glargine. Dulaglutide cost-effectiveness has been particularly evident in the comparison with basal insulin glargine, indicating that, in patients who have treatment indication, this therapy may be preferred to basalization avoiding related complications and costs.

ClinicoEconomics and Outcomes Research, 2018

Objective: Secukinumab, a fully human monoclonal IgG1 antibody that selectively neutralizes the p... more Objective: Secukinumab, a fully human monoclonal IgG1 antibody that selectively neutralizes the proinflammatory cytokine IL-17A, has been approved in Europe in 2015 for the treatment of adult patients with moderate-to-severe plaque psoriasis, psoriatic arthritis (PsA), and ankylosing spondylitis (AS). This analysis assessed the budget impact of introduction of secukinumab to the Italian market for all three indications from the perspective of the Italian National Health Service. Materials and methods: A cross-indication budget impact model was developed and included biologic-treated adult patients diagnosed with psoriasis, PsA, and AS. The analyses were conducted over a 3-year time horizon and included direct costs (drug therapy costs, administration costs, diseases-related costs, and adverse events costs). Model input parameters (epidemiology, market share projections, resource use, and costs) were obtained from the published literature and other Italian sources. The robustness of the results was tested via one-way sensitivity analyses: secukinumab cost, secukinumab market share, intravenous administration costs, and adverse events costs were varied by ±10%. Results: The total patient population for secukinumab over the 3-year timeframe was projected to be 6,648 in the first year, increasing to 12,001 in the third year, for all three indications combined (psoriasis, PsA, and AS). Compared to a scenario without secukinumab in the market, the introduction of secukinumab in the market for the treatment of psoriasis, PsA, and AS showed a cumulative 3-year incremental budget impact of-5%, corresponding to savings of €66.1 million and per patient savings of about €1,855. The majority of the cost savings came from the adoption of secukinumab in AS (58%), followed by PsA (29%) and psoriasis (13%). Sensitivity analyses confirmed the robustness of the results. Conclusion: Results from this cross-indication budget impact model show that secukinumab is a cost-saving option for the treatment of PsA, AS, and psoriasis patients in Italy.

ClinicoEconomics and outcomes research : CEOR, 2018

Diabetes represents a relevant public health problem worldwide due to its increasing prevalence a... more Diabetes represents a relevant public health problem worldwide due to its increasing prevalence and socioeconomic burden. There is no doubt that tight glycemic control reduces the development of diabetic complications such as the long-term costs related to the disease. The aim of our model was to calculate total direct costs associated with the two treatments considered in DUAL VII study, and hence evaluate the potential economic benefits for the National Health System (NHS) deriving from the use of insulin degludec plus liraglutide (IDegLira) in a once-daily fixed combination. We applied the cost-minimization technique adopting the NHS point of view to the DUAL VII trial outcomes. In the model, developed in Microsoft Excel, we calculated and compared annual costs per patient of the two therapeutic options for type 2 diabetes (T2D) patients not achieving glycemic control on basal insulin and metformin described in the trial, including costs of therapy management and side effects, bo...

Pragmatic and observational research, 2017

The source and significance of residual low-level viremia (LLV) during combinational antiretrovir... more The source and significance of residual low-level viremia (LLV) during combinational antiretroviral therapy (cART) remain a matter of controversy. It is unclear whether residual viremia depends on ongoing release of HIV from the latent reservoir or if viral replication contributes to LLV. We examined the relationship between adherence and LLV. Adherence was estimated by pharmacy refill and dichotomized as ≥95% or <95%. Plasma HIV-RNA was determined, with an ultrasensitive test having a limit of detection of 3 copies/mL at least 2 times over the follow-up period. Patients were grouped according to HIV-RNA over time as K<3: constantly <3 copies/mL; V<3: sometimes below or above the cutoff limit but always <50 copies/mL; K>3: constantly between 3 and 50 copies/mL; and V>50: a measure of >50 copies/mL minimum. Overall, 2789 patients were included. At each time point approximately 92% of the patients presented an HIV-RNA <50 copies/mL and two-thirds of those &l...

Patient Preference and Adherence, 2017

Medication adherence is an important challenge while treating chronic illnesses, such as ulcerati... more Medication adherence is an important challenge while treating chronic illnesses, such as ulcerative colitis (UC), that require a long-term management to induce and maintain clinical remission. This review provides an overview of the role that medication adherence plays in the routine management of UC, with a focus on the results of a recent Italian study reporting the perception of patients with UC regarding adherence to treatment. A literature analysis was conducted on topics, such as measurement of adherence in real practice, causes, risk factors and consequences of non-adherence and strategies, to raise patients' adherence. Most of the data refer to adherence to 5-aminosalicylic acid, and standard of care for the induction and maintenance of remission in UC. The adherence rate to 5-aminosalicylic acid is low in clinical practice, thus resulting in fivefold higher risk of relapse, likely increased risk of colorectal cancer, reduced quality of life and higher health care costs for in-and outpatient settings. There are various causes affecting non-adherence to therapy: forgetfulness, high cost of drugs, lack of understanding of the drug regimen-which are sometimes due to insufficient explanation by the specialist-anxiety created by possible adverse events, lack of confidence in physicians' judgment and complex dosing regimen. The last aspect negatively influences adherence to medication both in clinical trial settings and in real-world practice. Regarding this feature, mesalamine in once-daily dosage may be preferable to medications with multiple doses per day because the simplification of treatment regimens improves adherence.

Therapeutics and Clinical Risk Management, 2008

Psoriasis is a chronic infl ammatory, immune-mediated skin disorder that affects 1.5-1.8 million ... more Psoriasis is a chronic infl ammatory, immune-mediated skin disorder that affects 1.5-1.8 million people in Italy. The most common form of the disease is chronic plaque psoriasis, affecting about 90% of psoriasis patients, with about 20%-30% of them suffering from a moderate or severe condition. Little information is available about the economic impact of psoriasis in European countries. The primary objective of this study was to perform a cost-ofillness analysis of patients with moderate and severe plaque psoriasis in Italy. Therefore, direct, indirect costs, and intangible costs (quality of life-QoL) were assessed. In this national, multicenter, prospective, 3-month cost-of-illness study of moderate and severe plaque psoriasis, direct and indirect costs were assessed from the patient, third-party payer (National Health Service, NHS), and societal perspectives. From November 2003 to October 2004 consecutive patients were enrolled over a 1-year period, in order to minimize seasonal fl uctuations in disease severity. 150 patients enrolled in 6 investigational sites in Italy, completed the study, and were eligible to be analyzed according to the study protocol. Intangible costs (QoL) were measured using SF36 and DLQI questionnaires. The mean total cost for psoriasis (average Psoriasis Area Severity Index [PASI] score 21.4), including direct and indirect items, was 8,371.61 per patient per year. The mean cost for patients with moderate disease (PASI Յ 20) was 5,226.04, while the mean cost for patients with more severe disease (PASI Ͼ 20) was 11,434.40 per year. Disease heavily affected QoL measured using SF36, and the impairment was greater in patients affected by a more severe form of disease. Moderate and severe plaque psoriasis is associated with extremely high costs, which are related to disease severity. Data from this study show that the more severe plaque psoriasis, the higher the direct and indirect costs for its management. Direct costs are higher than indirect costs; hospitalization represents the most signifi cant item, accounting for 30% of the total expenses. QoL in moderate and severe plaque psoriasis is low compared with the population at large, confi rming the high impact of plaque psoriasis on QoL. The relatively high average annual costs per patient point to the need for a more effi cient and long-term control of psoriasis.

Risk Management and Healthcare Policy, 2015

Despite the awareness about the increasing rates of Clostridium difficile infection (CDI) and the... more Despite the awareness about the increasing rates of Clostridium difficile infection (CDI) and the economic burden arising from its management (prolonged hospitalization, laboratory tests, visits, surgical treatment, environmental sanitation), few studies are available in Italy on the economic costs directly attributable to the CDI. The Florence health care system has designed a study with the aim of describing the costs attributable to the CDI and defines the incremental economic burden associated with the management of this complication. Methods: We conducted a retrospective study in five hospitals of the Florence health care system. The enrolled population included all patients who were hospitalized during the year 2013 with a diagnosis of CDI. Of the 187 total cases reported in 2013, 69 patients were enrolled, for whom the main cause of hospitalization was directly attributable to CDI. Results: We enrolled 69 patients (19 males and 50 females), with a mean age of 82.16 years (minimum 46 to maximum 98). The total number of hospitalization days observed was 886 (12.8 per patient on average). The data from this study show that the mean total incremental cost for a patient with CDI was €3,270.52 per year. The hospital stay length is the most significant cost parameter, having the largest influence on the overall costs, with an impact of 87% on the total cost. The results confirm the costs for the management of CDI in five hospitals of the Florence health care system are in line with data from the international literature. Conclusion: The economic impact of CDI is most evident in the extension of the duration of hospitalization and emergency recurrences requiring new therapeutic options with the need to develop and implement new diagnostic and therapeutic algorithms in clinical practice.

Therapeutics and Clinical Risk Management, 2015

Background: Hepatocellular carcinoma (HCC) is a severe health condition associated with high hosp... more Background: Hepatocellular carcinoma (HCC) is a severe health condition associated with high hospitalizations and mortality rates, which also imposes a relevant economic burden. Purpose: The aim of the present survey is to investigate treatment strategies and related costs for HCC in the intermediate and advanced stages of the disease. Patients and methods: The survey was conducted in four Italian centers through structured interviews with physicians. Information regarding the stage of disease, treatments performed, and related health care resource consumption was included in the questionnaire. Direct health care cost per patient associated with the most relevant treatments such as sorafenib, transarterial chemoembolization (TACE), and transarterial radioembolization (TARE) was evaluated. Results: Between 2013 and 2014, 285 patients with HCC were treated in the four participating centers; of these, 80 were in intermediate stage HCC (Barcelona Clinic Liver Cancer Classification [BCLC] B), and 57 were in the advanced stage of the disease (BCLC C). In intermediate stage HCC, the most frequent first-line treatment was TACE (63%) followed by sorafenib (15%), radiofrequency ablation (14%), and TARE (1.3%). In the advanced stage of HCC, the most frequently used first-line therapy was sorafenib (56%), followed by best supportive care (21%), TACE (18%), and TARE (3.5%). The total costs of treatment per patient amounted to €12,214.54 with sorafenib, €13,418.49 with TACE, and €26,106.08 with TARE. Both in the intermediate and in the advanced stage of the disease, variability in treatment patterns among centers was observed. Conclusion: The present analysis raises for the first time the awareness of the overall costs incurred by the Italian National Healthcare System for different treatments used in intermediate and advanced HCC. Further investigations would be important to better understand the effective health care resource usage.

Patient Related Outcome Measures, 2015

Costs may play a role in deciding how and when to start highly active antiretroviral therapy (HAA... more Costs may play a role in deciding how and when to start highly active antiretroviral therapy (HAART) in a naïve patient. The aim of the present study was to assess the costeffectiveness of treatment with HAART in a large clinical cohort of naïve adults to determine the potential role of single-tablet regimens in the management of patients with human immunodeficiency virus (HIV). An incremental cost-effectiveness ratio analysis was performed, including a quality-adjusted life year approach. Results: In total, 741 patients (females comprising 25.5%) were retrospectively included. The mean age was 39 years, the mean CD4 cell count was 266 cells/µL, and the mean viral load was 192,821 copies/mL. The most commonly used backbone was tenofovir + emtricitabine (77.6%); zidovudine + lamivudine was used in 10%, lamivudine + abacavir in 3%, and other nucleoside reverse transcriptase inhibitor (NRTI) or NRTI-free regimens in 9.4% of patients. NNRTIs were used in 52.8% of cases, boosted protease inhibitors in 44.1%, and unboosted protease inhibitors and integrase inhibitors in 0.7% and 2.4%, respectively. Starting therapy at CD4 .500 cells/µL and CD4 351-500 cells/µL rather than at ,201 cells/µL was the more cost-effective approach. The same consideration was not true comparing current indications with the possibility to start HAART at any CD4 value (eg, .500 cells per µL); in this case, the incremental cost-effectiveness ratio value was €199,130 per quality-adjusted life year gained, a higher value than the one suggested in guidelines. The single-tablet regimen (STR) invariably dominated any other therapeutic approach. Sensitivity analysis was performed, and starting right away with an STR was cost-effective even when compared with therapeutic strategies contemplating STR as simplification. Conclusion: By integrating clinical data with economic variables, our study offers an estimate of the cost-effectiveness of the various first-line treatment strategies for patients infected with HIV and provides significant evidence to be used in future prospective pharmacoeconomic evaluations.

Farmeconomia. Health economics and therapeutic pathways, 2014

Chronic hepatitis B (CHB) is a complex disease with significant social impact both on the patient... more Chronic hepatitis B (CHB) is a complex disease with significant social impact both on the patients’ quality of life of and the economic resources involved. Its chronicity affects considerably not only the clinical management of the disease (for the need for drugs with proven long-term safety and low rate of resistance), but also the economic impact (for the high costs of treatment, the management of complications, and the constant monitoring of therapy).Since, as is well known, the main problem of modern health care systems is the general scarcity of available resources in the face of growing demand for health, the issue of economic evaluation of therapies for the treatment of chronic hepatitis B has been addressed in numerous national and international studies. In fact, clinicians find a strong support for the choice of the most suitable therapeutic pathway in the major scientific societies’ guidelines (European Association for the Study of The Liver – EASL, American Association fo...

Therapeutics and clinical risk management, 2014

Hypogonadotropic hypogonadal women are characterized by ovarian functionality deficiency, caused ... more Hypogonadotropic hypogonadal women are characterized by ovarian functionality deficiency, caused by low concentrations of follicle-stimulating hormone (FSH) and luteinizing hormone (LH). To recover reproduction functionality, recommended therapies for ovarian induction involve injections of FSH and LH medications. Since important differences exist between recombinant and urinary gonadotropin therapies in terms of efficacy and cost, the objective of this study was to develop a cost-effectiveness model to compare recombinant FSH (rFSH) + recombinant LH (rLH) and highly purified human menopausal gonadotropin (HP-HMG). A Markov model was developed, considering three cycles of therapy; probability of pregnancy and miscarriage were considered, and the efficacy was evaluated in terms of pregnancy occurrence. The perspective of the model was that of the Italian Health Service, so only direct cost (drugs, specialist visits, patient examinations, and hospitalizations) were included. rFSH + rL...

Journal of the International AIDS Society, 2014

IntroductionTDF/FTC/RPV has been shown effective in both naïve and PI‐pre‐treated patients. Less ... more IntroductionTDF/FTC/RPV has been shown effective in both naïve and PI‐pre‐treated patients. Less is known about a switch strategy in subjects receiving EFV.Materials and MethodsWe evaluated viro‐immunologic outcomes, Quality of Life (QoL) and costs of an unselected cohort of patients switching from a TDF/FTC/EFV STR (≥6 months duration) to a TDF/FTC/RPV STR. The considered outcome measures were quality‐adjusted life years (QALYs) as measured with the EQ5D questionnaire and the overall direct health costs. 64 patients with a baseline viral load<50 copies/mL were randomized to immediately switch therapy or to continue TDF/FTC/EFV for four months and then switch to TDF/FTC/RPV. Six patients in the deferred switch group did not actually change cART.ResultsPatients were mostly males (73.4%) with a mean age of 46 years, a baseline mean HIV‐RNA of 6.4 copies/mL and a mean baseline CD4 count of 588 cells/µL. For the considered follow‐up period, the mean cost per patient resulted 2,563 fo...

Therapeutics and Clinical Risk Management, 2012

We carried out an economic analysis to assess the cost-effectiveness of highly active antiretrovi... more We carried out an economic analysis to assess the cost-effectiveness of highly active antiretroviral therapy (HAART) regimens in Italy for the management of human immunodeficiency virus (HIV)-infected patients according to clinical practice in the Infectious Diseases

Therapeutics and Clinical Risk Management

ClinicoEconomics and Outcomes Research

ClinicoEconomics and Outcomes Research, 2021

R e V i e w open access to scientific and medical research Open Access Full Text Article

ClinicoEconomics and Outcomes Research, 2018

Health Services Insights, 2020

ClinicoEconomics and Outcomes Research, 2020

ClinicoEconomics and Outcomes Research, 2018

ClinicoEconomics and outcomes research : CEOR, 2018

Pragmatic and observational research, 2017

Patient Preference and Adherence, 2017

Therapeutics and Clinical Risk Management, 2008

Risk Management and Healthcare Policy, 2015

Therapeutics and Clinical Risk Management, 2015

Patient Related Outcome Measures, 2015

Farmeconomia. Health economics and therapeutic pathways, 2014

Therapeutics and clinical risk management, 2014

Journal of the International AIDS Society, 2014

Therapeutics and Clinical Risk Management, 2012