Stefania Lopatriello

Cost-effectiveness of 123I-FP-CIT SPECT in the differential diagnosis of essential tremor and Parkinson's disease in Italy.

Economic evaluation (Italian NHS perspective) modeling 123I‐FP‐CIT SPECT (DaTSCAN®) compared to clinical judgment alone for differentiating essential tremor (ET) from Parkinsons Disease (PD). A 5‐year Markov model was constructed to assess the cost‐effectiveness of 123I‐FP‐CIT SPECT to differentiate ET from PD in patients referred to a movement disorder specialist in Italy. Published data and a double‐round, Delphi panel of 12 specialists populated the model. Effectiveness was expressed as the projected Years on potentially beneficial therapy (PBTYs). Costs were expressed in Euros (2005 values). The model suggests that over 5 years, the “current” diagnostic pathway generated an average of 2.3 PBTYs/patient at an estimated cost of €8,864. 123I‐FP‐CIT SPECT generated an average of 4.1 PBTYs/patient at an estimated cost of €8,422, which represented an additional 1.8 PBTYs at a cost saving of €442/patient (€341 when discounted at 5%). The estimated cost‐effectiveness of 123I‐FP‐CIT SPECT is under €1,000 per PBTY gained when the underlying disease prevalence is high (55–70%), and cost‐saving at prevalence under 55%. 123I‐FP‐CIT SPECT is likely to be regarded as economically advantageous to differentiate ET from PD, increasing time on potentially beneficial therapy at a lower overall cost to the healthcare system.

The Pandora Project: Cost of Hypertension from a General Practitioner Database

Aim: The Pandora Project is a longitudinal database - implemented by general practitioners since June 1997 in the Ravenna area (Italy) - providing information on patients with hypertension. Data from 1651 patients were followed up for 1 year in order to investigate the cost of hypertension. Only direct medical costs were considered in the perspective of the National Healthcare System. Findings : At enrolment, 552 patients were classified as normotensive, 1099 as hypertensive. After 1 year, among normotensive group, 352 patients remained normotensive and 200 became hypertensive; among hypertensive group, 323 patients became normotensive and 776 remained hypertensive. The average total cost per patient at follow-up was 779.59 Euros. About 46% of total cost was due to anti-hypertensive therapy, irrespective of the evolution of blood pressure levels registered, whilst other direct costs represented 54% of total patient cost in all cohorts. It is possible that co-morbidities play a significant role in this situation. Patient aged 80-89 years generate higher costs. Even if further investigation is needed on the burden of comorbidity on a per-patient cost of hypertension, this work provides evidence that the average total cost per patient is likely to increase with age and co-morbidities.

Risedronate versus alendronate in older patients with osteoporosis at high risk of fracture: an Italian cost-effectiveness analysis.

Background and aims: This evaluation of the cost-effectiveness of risedronate vs generic alendronate is based on effectiveness data from a large real practice study. Applying a published cost-effectiveness model, we found that risedronate is cost-effective vs generic alendronate in an Italian population aged ≥65 years, and becomes dominant, saving costs and avoiding fractures, in patients aged ≥75 years. The aim of this work was to assess the cost-effectiveness and health utility of risedronate vs generic alendronate in clinical practice in Italy, using effectiveness data from the REAL study. Methods: A pre-existing model of osteoporosis was used to predict numbers of fractures, quality-adjusted life-years (QALYs), and costs associated with risedronate or alendronate treatment in post-menopausal (PMO) women aged ≥65 years with a previous vertebral fracture, within the Italian National Health System (NHS). Duration of treatment with risedronate or alendronate was assumed to occur for one year and patients were followed for an additional five years to capture long-term costs and outcomes, with a discount rate of 3% for costs and outcomes. Comprehensive sensitivity analyses were run. Results: The lower fracture rate among risedronate patients with respect to alendronate patients resulted in savings of € 19,083, a reduction of 8.91 hip fractures and an associated benefit of 7.46 QALYs, in an Italian cohort of 1,000 patients. Sensitivity analyses confirmed the robustness of these results. Conclusions: This economic analysis showed that risedronate is a cost-effective treatment in a population of Italian women aged 65 years and older at high risk of PMO-related fractures. Risedronate becomes dominant over generic alendronate in patients of 75 years or older and its cost-effectiveness even appears improved in patients with BMD score <—3 or <—3.5, with/without maternal history of fractures. Risedronate should be considered as a cost-effective option vs generic alendronate, in the Italian NHS’ perspective.

Different aspects of adherence to antihypertensive treatments

This review collects together data concerning the measurement of patient behavior towards antihypertensives, considering all its aspects – adherence, persistence and switching. The wide heterogeneity of terms, outcome definitions and methods of assessment (the multiplicity of approaches did not allow a full meta-analysis, but a qualitative description of the results) are demonstrated. The percentages of adherence/compliance from the studies discussed in this review range from 15 to 99% across different study designs, populations and methods. Large, observational studies are suggested as a reliable method to measure patient behavior. An emerging issue is the relevance of patient motivation and education, which could provide a higher level of compliance to treatment, thus allowing achievement of better clinical outcomes and improved use of resources for the healthcare system.

Long-term social costs of hypertension

According to published studies, much of the cost of hypertension is due to antihypertensive drug treatment. However, the cost of hypertension also includes the cost of an increased frequency of cardiovascular events when hypertension is not controlled. Although conceptually accepted by the scientific community, the achievement of appropriate blood pressure levels is less feasible than expected and studies demonstrate that only 13–27% of hypertensive patients are adequately informed, treated and controlled for their hypertension. This puts a tremendous burden on the healthcare system and society, since uncontrolled hypertension leads to higher rates of cardiovascular events and ultimately death. This paper demonstrates the paucity of reliable cost-of-illness estimates for the long-term consequences of uncontrolled hypertension and suggests that it is understandable that public and private payers focus on the immediate short-term costs of treating hypertension, paying less attention to potential cost savings of fewer cardiovascular events, as these costs are far less well defined. This paper also suggests that hypertension as a disease is an ideal candidate for disease management strategies and programs, as prevention of its long-term consequences should be the focus of medical treatment and could be better achieved through an integrated multispecialist and multisetting approach.

The costs of mobilisation and collection of peripheral blood stem cells in multiple myeloma and lymphoma in an European country: Results from The Gruppo Italiano Trapianto Midollo Osseo (GITMO) and Società Italiana di Emaferesi e Manipolazione Cellulare (SIdEM) survey

Scarce information is available about the cost of mobilisation/collection of peripheral blood stem cells for patients undergoing autologous transplant for relapsed Lymphoma or Multiple Myeloma. This paper reports the consumption of resources and costs collected through a survey among Italian Centres who adhere to the GITMO and SIdEM scientific societies. General transplant information was extracted from the European Promise database. Resources used alongside the phases of mobilisation/collection were retrieved. Resources for each of the process phases were quantified and averaged across centres and a unit cost value was attributed, based on administrative data from 3 centres, tariffs and market values. 25/89 Centres (34% of 2009 Promise transplants) provided data according to their standard practice. The mean cost/patient of the process of cell mobilisation/collection was € 6830 ± 1802 for Multiple Myeloma and € 7304 ± 1542 for Lymphoma. The organisational path for PBSC mobilisation/collection appears complex and cumbersome, spread amongst different treatment settings, with many different healthcare professionals being involved and considerable amounts of time and resources being currently dedicated to the management of patients requiring autologous transplantation.

Costo-efficacia di rituximab nella terapia di mantenimento in soggetti affetti da linfoma non-Hodgkin follicolare refrattario o recidivante

SummaryObjectives: Scope of this analysis was to estimate the cost-effectiveness of rituximab maintenance (r-maintenance) therapy vs. observation, in relapsed/refractory follicular lymphoma patients following response to induction therapy with or without rituximab, based on data from a large multicenter study, in the Italian public payer’s perspective. Methods: This study models the impact of r-maintenance vs. observation using a 15 years, health-state transition model. All patients entered the model following response to chemotherapy with or without rituximab as induction therapy (progression-free health state, PFHS). On the basis of probability estimates derived from the clinical trial, the model simulates transitions of patients from PFHS to either progressed health state (PHS) or death. Progression-free survival (PFS) and overall survival (OS) following r-maintenance are extrapolated from 2-year Kaplan-Meier curves from the study data (median trial follow-up 31 months) using a Weibull distribution (in the basecase PFS and OS clinical benefit is assumed to last 5 years). Quality of life utility values for the health states in the model were derived from a study of 165 patients using the EQ-5D questionnaire. Direct medical costs (including drug acquisition plus administration and management of adverse events) are reported in 2006 Euros and are derived from expert opinion and published sources. Costs and outcomes were discounted at a rate of 3.5%. In order to address uncertainty in point estimates, one-way and probabilistic sensitivity analyses were also performed. Results: The estimated lifetime incremental PFS is a 1.5 year increase for r-maintenance vs. observation (3.2 vs. 1.7 years). Overall survival analysis (based on 5 year extrapolation of the clinical benefit) yields an estimate of 5.9 life years (LY) for r-maintenance vs. 4.9 for observation (difference 0.99 LY gained). Total cost for r-maintenance is estimated as €26,027 vs. €16,146. R-maintenance results in a gain of 0.9 quality-adjusted life years (QALYs) [4.22 vs. 3.3] at an incremental cost of €9,881. The incremental cost-effectiveness ratio (ICER) of r-maintenance vs. observation is, therefore, estimated at €11,097/QALY gained. The ICER of r-maintenance is sensitive to the duration of treatment benefit and frequency of subsequent treatment; probabilistic sensitivity analysis shows that, over 2000 simulations, the cost/QALY never exceeds €14,000/QALY, a value well below commonly accepted cost-utility thresholds. Conclusions: In patients with partial or complete response to induction therapy, r-maintenance improves overall survival and progression-free survival and produces more QALYs compared with observation alone, at an acceptable cost/LY and cost/QALY ratio. Maintenance therapy with rituximab is a cost-effective approach for the management of patients with refractory/relapsed follicular lymphoma.

Efficacia clinica e costo-efficacia di atorvastatina a elevati dosaggi nella prevenzione degli eventi cardiocerebrovascolari

In the European Union cardiovascular diseases account for more than 2 million deaths per year, of which almost half are due to coronary artery disease, which has a significant impact on costs for health services. Nowdays one of the main cardiovascular risk factors is high cholesterol. Several randomized controlled trials have shown a beneficial role of statins in reducing cholesterol levels. The aim of this work is to summarize the efficacy data, the safety of use and cost-effectiveness of atorvastatin at high doses (80 mg/die) compared to the main treatment options available today.The efficacy and safety of atorvastatin were evaluated through a review of the scientific literature and clinical trials as well as post marketing and real world studies. Results of all available cost-effectiveness analysis are reported adopting a National Health Service (NHS) perspective. That is why only direct medical costs were identified and valued.The efficacy and safety of atorvastatin is high. Atorvastatin is effective in both primary and secondary prevention of coronary heart disease, and also in the secondary prevention in patients with acute coronary syndrome as well as patients undergoing coronary revascularization. Furthermore, atorvastatin is effective in preventing cardiovascular events in patients affected by diabetes or metabolic syndrome. Atorvastatin, at all prescribed doses, shows an excellent safety profile (the incidence of adverse events is not dose-dependent). With reference to the economic evaluation, atorvastatin (80 mg/die) has shown to be cost-effective or dominant versus placebo, simvastatin 20 mg, pravastatin 40 mg, PTCA, and versus lower doses of atorvastatin (10 mg/day and 20 mg/day).The effects of atorvastatin are beneficial both in the societal (improved patients’ quality of life) and in the NHS’ perspectives (monetary savings).