Percutaneous cryoablation vs. open partial nephrectomy in small kidney cancers: the Italian experience.

INTRODUCTION: The aim of the present work was to analyze the economic impact of PCA (percutaneous cryoablation) vs. OPN (open partial nephrectomy), as it represents the most common standard of care for SRMs (small renal masses), namely T1a renal cancers (<4 cm), in Italy. EVIDENCE ACQUISITION: A cost analysis was performed to compare the difference of the total perioperative costs between PCA and OPN, both from the perspective of the National Healthcare System and the hospital. Clinical and resources consumption inputs were retrieved by a non-systematic literature search on scientific databases, complemented by a grey literature research, and validated by expert opinion. Costs calculation for the NHS perspective were based on reference tariffs published by the National Ministry of Health, while for the hospital perspective, unit costs published in the grey literature were used to compare the two alternatives. EVIDENCE SYNTHESIS: Assuming the NHS perspective, the cost analysis shows there is an economic advantage in using PCA vs. OPN (€4080 vs. €7541) for the treatment of SRMs. Hospitalization time is the driver of the total costs, while the costs of complications are quite negligible in both groups. From the hospital perspective the costs of PCA is slightly higher (+€737) than OPN, with cryoprobes contributing as the greatest cost component. However, this increase is quite restrained and is offset by an inferior use of healthcare resources (surgery room, healthcare personnel, length of stay in the hospital). CONCLUSIONS: According to our analysis, PCA results an advantageous technique compared to OPN respectively in terms of costs and resource consumption from both the NHS and the hospital perspective.

The burden of atopic dermatitis in adults in Italy.

BACKGROUND: Moderate-to-severe atopic dermatitis (AD) generates a considerable consumption of healthcare resources and significant economic consequences for the patients and their families, healthcare systems (NHS) and society. Several studies on the burden of AD in paediatric patients are available in literature, while data in adults is scant. The purpose of this study was to estimate the direct and indirect costs of moderate to severe AD in adult patients in Italy. METHODS: Patients with Eczema Area and Severity Index (EASI) Score >20 were included in a multicentre, observational study conducted in six outpatient dermatology clinics throughout the national territory. Data were retrospectively gathered through a case report form investigating healthcare resources consumption, out-of-pocket expenses and patients' and caregivers' productivity loss. Descriptive statistics was used to illustrate data. Univariate generalized linear model with gamma distribution and identity function link was used to describe association between costs and disease severity. RESULTS: A total of 50 patients with a diagnosis of moderate-to-severe DA (EASI Score ≥20), equal to 89% of the total, were included in the analysis. The total annual burden of the disease, direct and indirect costs, amounted to € 4284 per patient; 19.3% accounted for direct medical costs, 19.9% for direct non-medical and 60.8% for indirect costs due to productivity loss. CONCLUSIONS: Moderate-to-severe AD in adults represents an important cost for the society imposing a high financial burden for the NHS, but even more for patients and caregivers. Results from this study may support identification of potential factors impacting on the choice of new therapeutic options to improve the clinical and economic management of this devastating disease.

Cost-effectiveness analysis of ibrutinib in patients with Waldenström macroglobulinemia in Italy.

Background and Objective: Ibrutinib has recently been approved in Europe for Waldenström Macroglobulinemia (WM) in symptomatic patients who have received at least one prior therapy, or in first-line treatment for patients unsuitable for chemo-immunotherapy. The aim of the study is to estimate the incremental cost-effectiveness ratio (ICER) of ibrutinib in relapse/refractory WM, compared with the Italian current therapeutic pathways (CTP). Methods: A Markov model was adapted for Italy considering the National Health System perspective. Input data from literature as well as global trials were used. The percentage use of therapies, and healthcare resources consumption were estimated according to expert panel advice. Drugs ex-factory prices and national tariffs were used for estimating costs. The model had a 15-year time horizon, with a 3.0% discount rate for both clinical and economic data. Deterministic and probabilistic sensitivity analyses were performed to test the results strength. Results: Ibrutinib resulted in increased Life Years Gained (LYGs) and increased costs compared to CTP, with an ICER of €52,698/LYG. Sensitivity analyses confirmed the results of the BaseCase. Specifically, in the probabilistic analysis, at a willingness to pay threshold of €60,000/LYG ibrutinib was cost-effective in 84% of simulations. Conclusions: Ibrutinib has demonstrated a positive cost-effectiveness profile in Italy.

Cost-effectiveness of bedaquiline in MDR and XDR tuberculosis in Italy.

Objective: To evaluate the cost-effectiveness of bedaquiline plus background drug regimens (BR) for multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB) in Italy. Methods: A Markov model was adapted to the Italian setting to estimate the incremental cost-effectiveness ratio (ICER) of bedaquiline plus BR (BBR) versus BR in the treatment of MDR-TB and XDR-TB over 10 years, from both the National Health Service (NHS) and societal perspective. Cost-effectiveness was evaluated in terms of life-years gained (LYG). Clinical data were sourced from trials; resource consumption for compared treatments was modelled according to advice from an expert clinicians panel. NHS tariffs for inpatient and outpatient resource consumption were retrieved from published Italian sources. Drug costs were provided by reference centres for disease treatment in Italy. A 3% annual discount was applied to both cost and effectiveness. Deterministic and probabilistic sensitivity analyses were conducted. Results: Over 10 years, BBR vs. BR alone is cost-effective, with ICERs of €16,639/LYG and €4081/LYG for the NHS and society, respectively. The sensitivity analyses confirmed the robustness of the results from both considered perspectives. Conclusion: In Italy, BBR vs. BR alone has proven to be cost-effective in the treatment of MDR-TB and XDR-TB under a range of scenarios.

Sacral neuromodulation and Botulinum toxin A for refractory idiopathic overactive bladder: a cost-utility analysis in the perspective of Italian Healthcare System.

OBJECTIVES: To assess the relative cost-effectiveness of two therapeutic strategies: one starting with sacral neuromodulation (SNM) versus one starting with Botulinum toxin A (BTX-A) for the management of refractory incontinent idiopathic overactive bladder (OAB) patients, from the perspective of the Italian National Health Service (INHS). METHODS: Direct medical costs (2011) and benefits (quality-adjusted life years-QALYs) were assessed over a ten-year time frame adapting to the Italian practice a published Markov model. Clinical inputs were based on the published literature and on the expert opinion. Resource consumption rates were provided by clinical experts; unit costs were collected from a single hospital accounting and from standard tariff lists and public prices. Interventional procedures and management of adverse events were costed through a micro-costing approach. The primary outcome was incremental costs per QALYs gained (i.e. differential costs divided by differential benefits). Deterministic (DSA) and probabilistic (PSA) sensitivity analyses were conducted to assess the robustness of the model. RESULTS: Starting with SNM appears to be cost effective (i.e. under 40.000/QALY) from year three (21,259/QALY) onwards and becomes dominant (i.e. more effective and less costly) at year ten: cumulative costs were 32,975 for early SNM and 33,309 for early BTX-A, while cumulative QALYs were 7.52 and 6.93, respectively. At year ten, DSA suggests the results robustness and 99.8 % of the PSA iterations fell within the cost-effectiveness threshold. CONCLUSIONS: A therapeutic strategy starting with SNM may be considered cost effective in the midterm and cost saving in the long-term treatment of idiopathic OAB from the INHS perspective.

[Health Technology Assessment to evaluate the economic advantage of offering of low-protein diet to pre-dialysis patients in Campania (Italy)]. / Un modello HTA a sostegno dell'offerta della dieta ipoproteica ai nefropatici della Campania.

A low-protein diet is well known to slow the progression of chronic renal failure, delay initiation of dialysis, while achieving significant economic benefits. In the context of a Health Technology Assessment (HTA), a budget impact analysis model was implemented to evaluate the economic advantage of offering of low-protein diet to nephropathic patients in Campania (Italy). The implemented model takes into account only the direct costs to the national healthcare system. In particular, costs related to supplying low-protein foods are compared to dialysis costs avoided, in a scenario that evaluates different indices of Numbers Needed to Treat and compliance to treatment. Results indicate that when compliance to treatment is at least 50% and NNT is £ 50, supplying a low-protein diet to all kidney disease patients in the pre-dialysis phase, namely with an estimated Glomerular filtration rate > 45, in Campania (which in the year 2009 were equal to 25,000 subjects), is economically advantageous. In this perspective, the authors argue that distribution of low-protein foods by local pharmacies could be an appropriate choice as it would allow the products to be offered at a discounted price and create a favorable setting for increasing adherence to treatment.

[Cost analysis in Italy of various strategies for the treatment of Parkinson disease in the advanced phase]. / Analisi dei costi, in Italia, di diverse strategie per il trattamento della malattia di Parkinson in fase avanzata.

OBJECTIVE: To perform a comparative economic evaluation of therapies--L-dopa drugs, subcutaneous infusion of apomorphine and surgical intervention of Deep Brain Stimulation (DBS)--for the treatment of advanced Parkinson's disease (APD) and to verify the level of assistance guaranteed in Italy to patients affected by APD. METHODS: Literature review and Delphi Panel to collect data about the efficacy of the therapies for the treatment of APD and the use of healthcare resources for such therapies. Field survey to investigate financing mechanisms of the therapeutical alternatives in the Italian regions; cost-analysis over five years (NHS perspective); cost-analysis (hospital perspective) for the initial administration of therapeutic alternatives. RESULTS: Literature review shows that the reduction of the "off-periods" is 62% for Apomorphine and 80-90% for DBS compared to traditional therapy. The 5-years economic analysis from the NHS perspective shows that the cost of a patients with APD is [symbol: see text] 58.065 if treated with traditional therapy, [symbol: see text] 36.423 (including infusional pump and the drug) with subcutaneous apomorphine and respectively [symbol: see text] 56.489 and [symbol: see text] 41.379 (depending on reimbursement of electrodes and neurostimulator on top of the DRG tariff) with DBS. The field survey, highlighted that Regions which currently reimburse the infusion pump for apomorphine and the electrodes and neurostimulator for DBS--on top of the DRG tariff--are a very limited number. CONCLUSIONS: Apomorphine and DBS in the treatment of APD show higher efficacy and lower costs compared to traditional therapy.