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..

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..

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 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..

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 in base allo studio NAVoTRIAL01 con riferimento al contesto sanitario italiano: Vinorelbine orale e Cisplatino o Pemetrexed e Cisplatino seguiti da mantenimento rispettivamente con Vinorelbine orale e Pemetrexed nel trattamento del Carcinoma Polmonare Non a Piccole Cellule Non Squamoso (NS-NSCLC) in stadio avanzato

Background Vinorelbine and Cisplatin is a standard treatment in non small cell lung cancer; oral Vinorelbine is registered in 45 countries. Pemetrexed and Cisplatin are recommended in front-line chemotherapy of non-squamous non small cell lung cancer (NS-NSCLC). An economic evaluation of oral Vinorelbine plus Cisplatin and Pemetrexed plus Cisplatin was implemented in NS-NSCLC patients, adopting specific costs and clinical settings reflecting the Italian practice

Intravenous methylprednisolone pulses in hospitalised patients with severe COVID-19 pneumonia, A double-blind, randomised, placebo-controlled trial

Rationale: Pulse glucocorticoid therapy is used in hyperinflammation related to coronavirus 2019 (COVID-19). We evaluated the efficacy and safety of pulse intravenous methylprednisolone in addition to standard treatment in COVID-19 pneumonia. Methods: In this multicenter, randomised, double-blind, placebo-controlled trial, 304 hospitalised patients with Covid-19 pneumonia were randomised to receive 1 g of methylprednisolone intravenously for 3 consecutive days or placebo in addition to standard dexamethasone. The primary outcome was the duration of the patient hospitalisation, calculated as the time interval between randomisation and hospital discharge without the need of supplementary oxygen. The key secondary outcomes were survival free from invasive ventilation with orotracheal intubation and overall survival. Results: Overall, 112 of 151 (75.4%) patients in the pulse methylprednisolone arm and 111 of 150 (75.2%) in the placebo arm were discharged from hospital without oxygen within 30 days from randomisation. Median time to discharge was similar in both groups [15 days (95% confidence interval (CI), 13.0 to 17.0) and 16 days (95%CI, 13.8 to 18.2); hazard ratio (HR), 0.92; 95% CI 0.71-1.20; p=0.528]. No significant differences between pulse methylprednisolone and placebo arms were observed in terms of admission to Intensive Care Unit with orotracheal intubation or death (20.0% versus 16.1%; HR, 1.26; 95%CI, 0.74-2.16; p=0.176), or overall mortality (10.0% versus 12.2%; HR, 0.83; 95%CI, 0.42-1.64; p=0.584). Serious adverse events occurred with similar frequency in the two groups. Conclusions: Methylprenisolone pulse therapy added to dexamethasone was not of benefit in patients with COVID-19 pneumonia. Message of the study: Pulse glucocorticoid therapy is used for severe and/or life threatening immuno-inflammatory diseases. The addition of pulse glucocorticoid therapy to the standard low dose of dexamethasone scheme was not of benefit in patients with COVID-19 pneumonia

Cost of an Outbreak of Hepatitis A in Puglia, Italy

In total, 5889 cases of hepatitis A virus infection were reported during an outbreak in Puglia, a region of Southern Italy, in 1996. The primary cause of the outbreak was consumption of contaminated food (raw shellfish, vegetables, etc.), with a contributory risk factor of person-to-person transmission. A detailed questionnaire was completed by 250 randomly selected patients to obtain information sufficient to calculate the direct and indirect costs of the outbreak for the individual patient, the National Health Service (NHS) and society as a whole. A conversion rate of $US1 = 1530 Italian lire (L) has been used throughout the study since this was the average exchange rate in 1996. For the individual patient with hepatitis A virus infection, the mean cost was L1.013 million ($US662), which was equivalent to 6.6% of the mean annual income of the employed patients. The total cost of the outbreak to the NHS was L23.98 billion ($US15.67 million), which was equivalent to 0.4$US24.45 million), corresponding to 0.04% of the gross domestic product of the entire region in 1996, with a mean cost per patient of L6.35 million ($US4150) from a societal perspective. The majority of patients (86.3%) were 11 to 30 years of age, reflecting the increasing susceptibility of younger patients to hepatitis A virus infection in recent decades. These economic and demographic data provide important information for the evaluation of preventive strategies including public education, sanitation and immunisation, so as to optimise the use of local health resources.Pharmacoeconomics, Hepatitis-A, Cost-of-illness, Antivirals