Budget impact analysis of infliximab biosimilar: the Italian scenery

Chronic inflammatory diseases, while seriously impairing patients' quality of life, are a heavy financial cost to the National Health Service (NHS) and to society. The availability of biological drugs – among which infliximab (Remicade®) – greatly improved treatment efficacy. On the other hand, these drugs are an expensive resource. Infliximab patent protection is going to expire, and a biosimilar has been recently approved.A budget impact (BI) analysis was conducted to evaluate the favourable consequences – for the Italian NHS – of the biosimilar availability in terms of cost containment (savings), thanks to its lower price compared to the originator's. The analysis model expects that some patients in treatment with the originator will switch (according to a prudent assumption of the market uptake rate) to the biosimilar and that many naive patients will directly start treatment with the biosimilar (according to a bolder uptake rate assumed). Separately considering all the different diseases for which in..

Social cost of chronic pain in Italy

Chronic pain negatively impacts on sick people's daily life and their working ability, and it is a heavy financial burden on the health systems. This article is aimed at evaluating the social costs of chronic pain in Italy.The analysis is based on national tariffs and prices and on epidemiologic, health resource consumption, and absence from work published data; when no information specifically related to Italy was available, results from studies carried out in other European Countries were used as appropriate.The average annual cost per patient amounts to €4,556, 31% of which (€1,400) is charged on the National Health Service. Of this share, 51% is due to hospitalisation and 6% to analgesic drug (mostly NSAIDs) costs. Indirect costs (€3,157) are caused by sickness leaves (31%) and retirements.Based on an estimated prevalence of 8 million people with pain in Italy, the impact of chronic pain direct costs on public health expenditure results 9.6%, whereas the impact of total costs on gross domestic product..

cost effectiveness evaluation of oncological drugs newly marketed in italy

In a previous publication, the incremental overall survival (OS gain vs current therapy) was estimated for the 32 new cancer therapies authorized in Italy between 2010 and 2013.The objective of this article was to quantify the respective incremental costs (including possible regulatory agreements) in order to build incremental cost-effectiveness ratios (ICERs) to be used for economic evaluation.In a first group of 12 therapies, where OS gains were statistically significant (p < 0.05), the ICERs' median value was €53,273 per year gained (range: 3,945 - 179,098) and the mean value was €64,181 (95% CI: 29,302 - 99,060). In the other group, excluding four therapies with negative OS gains, ICERs were calculated for the remaining 16 drugs. The median ICER resulted in €69,568 (range: 3,406 - 308,928) and the mean value was €87,330 (95% CI: 37,024 - 137,636).Assuming a threshold of €5,000 per life-month gained, a total of 14 new cancer therapies met this criterion of economic acceptability (eight out of 12 in the..

Cost-effectiveness of ponatinib in chronic myeloid leukemia in Italy:

An area-under-the-curve Markov model was designed to evaluate the cost-effectiveness of ponatinib as a third line treatment of Chronic Myeloid Leukemia-Chronic Phase (CML-CP) with reference to Italy. As for current guidelines, comparators were dasatinib, nilotinib, bosutinib, allogeneic stem cell transplantation (SCT), hydroxyurea. The economic perspective was the Italian National Health Service's (NHS), where costs for treatment drugs, monitoring and follow-up, adverse events, SCT procedure were considered on a lifetime span. Costs (mainly based on current tariffs in Italy) and benefits (QALYs) were discounted at a 3.5% annual rate. Ponatinib resulted dominant versus SCT. The lowest ICER was €13,090 (ponatinib vs hydroxyurea); the highest was €22,529 (ponatinib vs dasatinib). Sensitivity analysis – both deterministic (one way) and probabilistic – was focused on the comparison between ponatinib and dasatinib. The deterministic analysis showed that the most critical parameter in the model was ponatinib pri..

Health Technology Assessment and vaccinations in Italy

Vaccines are a basic investment in the long term, both for Countries and the whole world – where they are estimated to save 2.5 million lives among children each year. In this perspective vaccine r..

Il trattamento di pazienti con sepsi grave mediante drotrecogin alfa: una valutazione economica con riferimento all’Italia

Sepsis can be defined as a spectrum of clinical conditions caused by the immune response of a host to infection or trauma and characterized by systemic inflammation and coagulation. Particularly in elderly, immunocompromised and critically ill patients, sepsis is a major cause of morbidity and mortality in intensive care units (ICUs) worldwide. In the US, sepsis is the leading cause of death in noncoronary ICU patients. Drotrecogin alfa, or recombinant human activated protein C, has antithrombotic, antiinflammatory, and profibrinolytic properties. Recently in a phase III trial (PROWESS), Drotrecogin alfa demonstrated significantly reduced mortality in severe sepsis patients at 28 days. In this trial important value factors for the assessment of costs and outcomes of severe sepsis were also considered. The purpose of the present study is to determine the economic burden of the treatment with Drotrecogin alfa, according to a cost-effectiveness analysis based on the data of the PROWESS trial. The study has been adapted to the italian health environment. As regards to the costs per surviving patient and costs per QALY (Quality Adjusted Life Year), the predicted cost-effectiveness ratio of drotrecogin alfa in severe sepsis patients is much lower than the standard values considered as acceptable in the international litterature

Valutazione economica dei costi associati al trattamento di pazienti in ossigenoterapia a lungo termine, con o senza monitoraggio telemetrico domiciliare

Long term oxygen treatment (LTOT) represents an helpful, even though costly, therapeutic strategy for managing severe chronic respiratory diseases at home. The aim of the present study was to assess the economic impact of adding the home telemetric monitoring of some vital signs to the traditional domiciliary LTOT in this kind of patients. Two samples of severe chronic respiratory patients (COPD patients in 89% of cases, managed at home without, n=20, and with, n= 61, telemetric home monitoring) were compared for a 24-month period, and the corresponding outcomes measured. In the tele-monitored group of subjects, both the mean number and the mean duration of hospitalisations dropped along the two-year study, together with the n. exacerbations/ patient/year. The mean annual cost for the tele-monitored group of patients was lower by 28% in the first year, and by 33% in the second year of the study. The home tele-LTOT management of patients with severe chronic respiratory disease, mostly COPD, allows a better clinical control of the disease, with a corresponding 50% reduction of exacerbations leading to hospitalisation. Finally, the home tele-LTOT contributes substantially in minimizing the economic impact of these severe chronic respiratory diseases

Il costo sociale del morbillo in età pediatrica. L’epidemia a Palermo nel 1996-97

Objective To determine the direct and indirect costs associated with a measles epidemic occurring between September 1996 and August 1997 in Palermo (Italy) in paediatric-aged patients. Design A total of 2,029 cases of measles in a paediatric patient population were identified from a total of 38 paediatricians databases (24% of total). An extrapolation to the general population was then performed to estimate a total of 9,059 cases. Patient information obtained from the database such as patient age, risk factors, complications, vaccination history, as well as caretaker’s profession were included in a questionnaire compiled for each patient. Setting Inpatient and outpatient clinics in Palermo, Italy. Patients and participants Participants were paediatric-aged patients who had been diagnosed with measles. Included in the study was a group of previously vaccinated patients (6%). Main outcome measures and results The average cost of care was 464.000 Italian lire (Lit.) per case with a total cost of Lit. 4,2 billion for the entire epidemic. The direct costs comprehended 46.6% (Lit. 217.000 per case) of the total costs related to the measles epidemic and were subdivided according to in-patient care (55.4%), paediatric outpatient visits (33.5%) and drugs (9.7%). The average health-care cost associated to previously vaccinated patients (6%) was lower than for non-vaccinated patients, Lit. 110.000 vs Lit. 223.000 per case, respectively. Conclusion The demographic and economic data obtained highlights not only the social and economic impact of the epidemic, but also provides relevant information useful for cost-effectiveness analysis