Publications by authors named "Paolo A Cortesi"

31 Publications

Trends in cardiovascular diseases burden and vascular risk factors in Italy: The Global Burden of Disease study 1990-2017.

Eur J Prev Cardiol 2021 May;28(4):385-396

School of Medicine and Surgery, Research Centre on Public Health (CESP), University of Milano-Bicocca, Italy.

Aims: An exhaustive and updated estimation of cardiovascular disease burden and vascular risk factors is still lacking in European countries. This study aims to fill this gap assessing the global Italian cardiovascular disease burden and its changes from 1990 to 2017 and comparing the Italian situation with European countries.

Methods: All accessible data sources from the 2017 Global Burden of Disease study were used to estimate the cardiovascular disease prevalence, mortality and disability-adjusted life years and cardiovascular disease attributable risk factors burden in Italy from 1990 to 2017. Furthermore, we compared the cardiovascular disease burden within the 28 European Union countries.

Results: Since 1990, we observed a significant decrease of cardiovascular disease burden, particularly in the age-standardised prevalence (-12.7%), mortality rate (-53.8%), and disability-adjusted life years rate (-55.5%). Similar improvements were observed in the majority of European countries. However, we found an increase in all-ages prevalence of cardiovascular diseases from 5.75 m to 7.49 m Italian residents. Cardiovascular diseases still remain the first cause of death (34.8% of total mortality). More than 80% of the cardiovascular disease burden could be attributed to known modifiable risk factors such as high systolic blood pressure, dietary risks, high low density lipoprotein cholesterol, and impaired kidney function.

Conclusions: Our study shows a decline in cardiovascular mortality and disability-adjusted life years, which reflects the success in reducing disability, premature death and early incidence of cardiovascular diseases. However, the burden of cardiovascular diseases is still high. An approach that includes the cooperation and coordination of all stakeholders of the Italian National Health System is required to further reduce this burden.
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http://dx.doi.org/10.1177/2047487320949414DOI Listing
May 2021

Liver transplantation for patients with acute-on-chronic liver failure (ACLF) in Europe: results of the ELITA/EF-CLIF collaborative study (ECLIS).

J Hepatol 2021 Apr 24. Epub 2021 Apr 24.

Department of hepatogastroenterology, Hepatology and Liver Transplantation Unit, HCL Hopital de la Croix-Rousse, Lyon, France.

Background And Aims: Liver transplantation (LT) has been proposed to be an effective salvage therapy even for the sickest patients with acute-on-chronic liver failure (ACLF). This large collaborative study was designed to address the current clinical practice and outcomes of ACLF patients wait listed (WL) for LT in Europe.

Methods: Retrospective study including 308 consecutive ACLF patients, listed in 20 centres across 8 European countries, from January 2018 to June 2019.

Results: 2677 patients received a LT, 1216 (45.4%) for decompensated cirrhosis (DC). Of these, 234 (19.2%) had ACLF at LT: ACLF-1, 58 (4.8%); ACLF-2, 78 (6.4%); and ACLF-3, 98 (8.1%). Wide variations were observed amongst countries: France and Germany had high rates of ACLF-2/3 (27-41%); Italy, Switzerland, Poland and Netherlands had medium rates (9-15%); and United Kingdom and Spain had low rates (3-5%) (p <.0001). One-year probability of survival after LT for patients with ACLF was 81% (95% CI 74-87). Pre-LT arterial lactate levels >4 mmol/L (HR 3.14, 95% CI 1.37-7.19), recent infection from multi-drug resistant organisms (HR 3.67, 95% CI 1.63-8.28), and renal replacement therapy (HR 2.74, 95% CI 1.37-5.51) were independent predictors of post-LT mortality. During the same period, 74 patients with ACLF died on the WL. In an intention-to-treat analysis, one-year survival of ACLF patients on the LT WL was 73% for ACLF-1 or -2 and 50% for ACLF-3.

Conclusion: The results reveal wide variations in listing patients with ACLF in Europe despite favorable post-LT survival. Risk factors for mortality were identified, allowing a more precise prognostic assessment of ACLF patients for potential LT.

Lay Summary: Acute on chronic liver failure (ACLF) is a severe clinical condition for which liver transplantation is an effective therapeutic option. This study has demonstrated that in Europe, referral and access to liver transplantation (LT) for patients with ACLF needs to be harmonized to avoid inequities. Post-LT survival for patients with ACLF was >80% after 1 year and some factors have been identified for selecting patients with favorable outcomes.
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http://dx.doi.org/10.1016/j.jhep.2021.03.030DOI Listing
April 2021

Cost-Effectiveness Analysis of Rivaroxaban Plus Aspirin Compared with Aspirin Alone in Patients with Coronary and Peripheral Artery Diseases in Italy.

Clin Drug Investig 2021 May 16;41(5):459-468. Epub 2021 Mar 16.

Center for Public Health Research, University of Milano-Bicocca, Via Cadore 48, 20900, Monza, Italy.

Background: Rivaroxaban is a selective inhibitor of coagulation factor Xa and its combination with aspirin showed better outcomes in the prevention of recurrent cardiovascular disease than aspirin alone.

Objective: This analysis aimed to economically compare the cost effectiveness of rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily) with aspirin alone in patients with coronary artery disease (CAD) or peripheral artery disease (PAD) and related subgroups.

Methods: The analysis simulates the perspective of the Italian National Healthcare Service and used a state-transition decision Markov model. Clinical efficacy data and health events risks were gathered from the COMPASS trial. Health outcomes and costs (in Euros) were evaluated over a lifetime horizon and were discounted at 3.5% per annum. Direct healthcare costs entered the analysis. Results were expressed in terms of incremental cost-effectiveness ratio (ICER), defined as cost per quality-adjusted life-year (QALY) gained. One-way deterministic and probabilistic sensitivity analyses were performed.

Results: For the CAD or PAD population, rivaroxaban plus aspirin was more effective and costly compared with aspirin alone. Incremental costs and efficacy produced an ICER of €16,522 per QALY gained. Analyses found similar trends for the PAD and CAD groups, with respective ICERs of €8003 and €18,599, while ICERs for the other groups were lower than €13,000 per QALY. Sensitivity analyses confirmed these findings.

Conclusion: Compared with aspirin alone, rivaroxaban plus aspirin is cost effective in preventing recurrent cardiovascular events in all patients with CAD or PAD, from the Italian perspective. These results could help clinicians and decision makers to develop improved strategies for cardiovascular disease prevention.
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http://dx.doi.org/10.1007/s40261-021-01023-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8149345PMC
May 2021

Protective Role of Tacrolimus, Deleterious Role of Age and Comorbidities in Liver Transplant Recipients With Covid-19: Results From the ELITA/ELTR Multi-center European Study.

Gastroenterology 2021 03 9;160(4):1151-1163.e3. Epub 2020 Dec 9.

Liver and Multi-organ Transplantation, Sant'Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.

Background And Aims: Despite concerns that liver transplant (LT) recipients may be at increased risk of unfavorable outcomes from COVID-19 due the high prevalence of co-morbidities, immunosuppression and ageing, a detailed analysis of their effects in large studies is lacking.

Methods: Data from adult LT recipients with laboratory confirmed SARS-CoV2 infection were collected across Europe. All consecutive patients with symptoms were included in the analysis.

Results: Between March 1 and June 27, 2020, data from 243 adult symptomatic cases from 36 centers and 9 countries were collected. Thirty-nine (16%) were managed as outpatients while 204 (84%) required hospitalization including admission to the ICU (39 of 204, 19.1%). Forty-nine (20.2%) patients died after a median of 13.5 (10-23) days, respiratory failure was the major cause. After multivariable Cox regression analysis, age >70 (HR, 4.16; 95% CI, 1.78-9.73) had a negative effect and tacrolimus (TAC) use (HR, 0.55; 95% CI, 0.31-0.99) had a positive independent effect on survival. The role of co-morbidities was strongly influenced by the dominant effect of age where comorbidities increased with the increasing age of the recipients. In a second model excluding age, both diabetes (HR, 1.95; 95% CI, 1.06-3.58) and chronic kidney disease (HR, 1.97; 95% CI, 1.05-3.67) emerged as associated with death CONCLUSIONS: Twenty-five percent of patients requiring hospitalization for COVID-19 died, the risk being higher in patients older than 70 and with medical co-morbidities, such as impaired renal function and diabetes. Conversely, the use of TAC was associated with a better survival thus encouraging clinicians to keep TAC at the usual dose.
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http://dx.doi.org/10.1053/j.gastro.2020.11.045DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7724463PMC
March 2021

Health related quality of life in chronic liver diseases.

Liver Int 2020 11;40(11):2630-2642

Research Centre on Public Health (CESP), University of Milan-Bicocca, Milan, Italy.

Background & Aims: The impact of chronic liver diseases (CLDs) on health-related quality of life (HRQoL) is relevant to understand the burden of these conditions and inform decision-making processes related to their care. Studies simultaneously comparing the HRQoL of patients affected by the major CLDs to that of the general population are still lacking and are the subject of this study.

Methods: Using the EQ-5D-3L questionnaire, we analysed and compared HRQoL data from 2962 Italian patients affected by CLDs and forming a representative sample of the general Italian population (6800 individuals). Exploratory analyses were conducted to investigate the effects of each CLD on HRQoL, using the general population as reference and adjusting for possible confounders.

Results: Patients with CLDs (HBV, HCV, PSC, PBC, AIH, NAFLD/NASH) in the chronic hepatitis stage and with compensated cirrhosis (CC) showed HRQoL similar to the general population. However, AIH were more likely to report problems in self-care and lower EQ-5D VAS score, while NAFLD/NASH and HCV showed an increased risk of anxiety/depression. On the other hand, with progression to more advanced stages of liver disease (DC or HCC), HRQoL decreased significantly with higher risk of reporting problems in the physical domains, and significant reductions in the VAS and utility index scores.

Conclusions: Different subtypes of CLD affected different QoL domains. This study therefore provides a real estimate of the impact of CLDs on patients' HRQoL, and represents a much needed tool to inform decision-making while assessing the effectiveness and cost-effectiveness of the care of these patients.
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http://dx.doi.org/10.1111/liv.14647DOI Listing
November 2020

Trends in cardiovascular diseases burden and vascular risk factors in Italy: The Global Burden of Disease study 1990-2017.

Eur J Prev Cardiol 2020 Aug 24:2047487320949414. Epub 2020 Aug 24.

School of Medicine and Surgery, Research Centre on Public Health (CESP), University of Milano-Bicocca, Italy.

Aims: An exhaustive and updated estimation of cardiovascular disease burden and vascular risk factors is still lacking in European countries. This study aims to fill this gap assessing the global Italian cardiovascular disease burden and its changes from 1990 to 2017 and comparing the Italian situation with European countries.

Methods: All accessible data sources from the 2017 Global Burden of Disease study were used to estimate the cardiovascular disease prevalence, mortality and disability-adjusted life years and cardiovascular disease attributable risk factors burden in Italy from 1990 to 2017. Furthermore, we compared the cardiovascular disease burden within the 28 European Union countries.

Results: Since 1990, we observed a significant decrease of cardiovascular disease burden, particularly in the age-standardised prevalence (-12.7%), mortality rate (-53.8%), and disability-adjusted life years rate (-55.5%). Similar improvements were observed in the majority of European countries. However, we found an increase in all-ages prevalence of cardiovascular diseases from 5.75 m to 7.49 m Italian residents. Cardiovascular diseases still remain the first cause of death (34.8% of total mortality). More than 80% of the cardiovascular disease burden could be attributed to known modifiable risk factors such as high systolic blood pressure, dietary risks, high low density lipoprotein cholesterol, and impaired kidney function.

Conclusions: Our study shows a decline in cardiovascular mortality and disability-adjusted life years, which reflects the success in reducing disability, premature death and early incidence of cardiovascular diseases. However, the burden of cardiovascular diseases is still high. An approach that includes the cooperation and coordination of all stakeholders of the Italian National Health System is required to further reduce this burden.
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http://dx.doi.org/10.1177/2047487320949414DOI Listing
August 2020

Cost-Effectiveness Analysis of Cannabinoid Oromucosal Spray Use for the Management of Spasticity in Subjects with Multiple Sclerosis.

Clin Drug Investig 2020 Apr;40(4):319-326

Department of Medical, Surgical Science and Advanced Technology "GF Ingrassia", University of Catania, Catania, Italy.

Introduction: Multiple sclerosis (MS) is a highly symptomatic disease, with a wide range of disabilities affecting many bodily functions, even in younger persons with a short disease history. The availability of a cannabinoid oromucosal spray (Sativex) for the management of treatment-resistant MS spasticity has provided a new opportunity for many patients.

Objective: Our study aimed to assess the cost effectiveness of Sativex in Italian patients with treatment-resistant MS spasticity. The analysis was based on the real-world data of a large registry of Italian patients.

Methods: A cost-utility analysis was conducted using data collected prospectively from an electronic registry of all patients who began to use Sativex for MS-resistant spasticity between January 2014 and February 2015 in 30 specialized MS units across Italy and were followed up for ≤ 6 months. Data on drug consumption and spasticity/utility were used to estimate the incremental cost-effectiveness ratio (ICER) of Sativex, as compared with no intervention. No costs or spasticity/utility changes were assumed for no treatment intervention. The ICER was expressed as quality-adjusted life-years (QALYs) gained, using the Italian NHS perspective and a 6-month time horizon.

Results: Sativex effectiveness and consumption was estimated analyzing data of 1350 patients from the registry. These patients reported a mean (SD) utility increment of 0.087 (0.069) after 1 month of treatment, 0.118 (0.073) after 3 months' treatment and 0.127 (0.080) after 6 months' treatment. The 6-month cost of treating the entire population with Sativex was €1,361,266, with a €1008 cost and 0.0284 QALYs gained per patient. The estimated ICER was €35,516 per QALY gained, with little variability around the central estimate of cost-effectiveness, as shown by the cost-effectiveness acceptability curve.

Conclusion: The use of Sativex could improve the quality of life of patients with a reasonable incremental cost resulting as a cost-effective option for patients with MS-resistant spasticity. These results could help clinicians and decision makers to develop improved management strategies for spasticity in patients with MS, optimizing the use of available resources.
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http://dx.doi.org/10.1007/s40261-020-00895-6DOI Listing
April 2020

Clinical outcome indicators in chronic hepatitis B and C: A primer for value-based medicine in hepatology.

Liver Int 2020 01 12;40(1):60-73. Epub 2019 Nov 12.

International Center for Digestive Health, University of Milan-Bicocca, Milan, Italy.

Background & Aims: Chronic liver diseases (CLDs) are major health problems that require complex and costly treatments. Liver-specific clinical outcome indicators (COIs) able to assist both clinicians and administrators in improving the value of care are presently lacking. The Value-Based Medicine in Hepatology (VBMH) study aims to fill this gap, devising and testing a set of COIs for CLD, that could be easily collected during clinical practice. Here we report the COIs generated and recorded for patients with HBV or HCV infection at different stages of the disease.

Methods/results: In the first phase of VBMH study, COIs were identified, based on current international guidelines and literature, using a modified Delphi method and a RAND 9-point appropriateness scale. In the second phase, COIs were tested in an observational, longitudinal, prospective, multicentre study based in Lombardy, Italy. Eighteen COIs were identified for HBV and HCV patients. Patients with CLD secondary to HBV (547) or HCV (1391) were enrolled over an 18-month period and followed for a median of 4 years. The estimation of the proposed COIs was feasible in the real-word clinical practice and COI values compared well with literature data. Further, the COIs were able to capture the impact of new effective treatments like direct-acting antivirals (DAAs) in the clinical practice.

Conclusions: The COIs efficiently measured clinical outcomes at different stages of CLDs. While specific clinical practice settings and related healthcare systems may modify their implementation, these indicators will represent an important component of the tools for a value-based approach in hepatology and will positively affect care delivery.
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http://dx.doi.org/10.1111/liv.14285DOI Listing
January 2020

Impact of DAAs on liver transplantation: Major effects on the evolution of indications and results. An ELITA study based on the ELTR registry.

J Hepatol 2018 10 27;69(4):810-817. Epub 2018 Jun 27.

Department of Hepatology and Liver Transplant Unit, Henri Mondor Hospital, AssistancePublique-Hôpitaux de Paris, Paris-Est University, Creteil, France.

Background & Aims: Direct-acting antivirals (DAAs) have dramatically improved the outcome of patients with hepatitis C virus (HCV) infection including those with decompensated cirrhosis (DC). We analyzed the evolution of indications and results of liver transplantation (LT) in the past 10 years in Europe, focusing on the changes induced by the advent of DAAs.

Methods: This is a cohort study based on data from the European Liver Transplant Registry (ELTR). Data of adult LTs performed between January 2007 to June 2017 for HCV, hepatitis B virus (HBV), alcohol (EtOH) and non-alcoholic steatohepatitis (NASH) were analyzed. The period was divided into different eras: interferon (IFN/RBV; 2007-2010), protease inhibitor (PI; 2011-2013) and second generation DAA (DAA; 2014-June 2017).

Results: Out of a total number of 60,527 LTs, 36,382 were performed in patients with HCV, HBV, EtOH and NASH. The percentage of LTs due to HCV-related liver disease varied significantly over time (p <0.0001), decreasing from 22.8% in the IFN/RBV era to 17.4% in the DAA era, while those performed for NASH increased significantly (p <0.0001). In the DAA era, the percentage of LTs for HCV decreased significantly (p <0.0001) from 21.1% (first semester 2014) to 10.6% (first semester 2017). This decline was more evident in patients with DC (HCV-DC, -58.0%) than in those with hepatocellular carcinoma (HCC) associated with HCV (HCV-HCC, -41.2%). Conversely, three-year survival of LT recipients with HCV-related liver disease improved from 65.1% in the IFN/RBV era to 76.9% in the DAA era, and is now comparable to the survival of recipients with HBV infection (p = 0.3807).

Conclusions: In Europe, the number of LTs due to HCV infection is rapidly declining for both HCV-DC and HCV-HCC indications and post-LT survival has dramatically improved over the last three years. This is the first comprehensive study of the overall impact of DAA treatment for HCV on liver transplantation in Europe.

Lay Summary: After the advent of direct-acting antivirals in 2014, a dramatic decline was observed in the number of liver transplants performed both in patients with decompensated cirrhosis due to hepatitis C virus (HCV), minus 60%, and in those with hepatocellular carcinoma associated with HCV, minus 41%. Furthermore, this is the first large-scale study demonstrating that the survival of liver transplant recipients with HCV-related liver disease has dramatically improved over the last three years and is now comparable to the survival of recipients with hepatitis B virus infection. The reduction in HCV-related indications for LT means that there is a greater availability of livers, at least 600 every year, which can be allocated to patients with indications other than HCV.
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http://dx.doi.org/10.1016/j.jhep.2018.06.010DOI Listing
October 2018

The socioeconomic burden of patients affected by hemophilia with inhibitors.

Eur J Haematol 2018 Oct 27;101(4):435-456. Epub 2018 Jul 27.

Research Centre on Public Health (CESP), University of Milano Bicocca, Monza, Italy.

Hemophilia is associated with a high financial burden on individuals, healthcare systems, and society. The development of inhibitors significantly increases the socioeconomic burden of the diseases. This study aimed to review and describe the burden of hemophilia with inhibitors, providing a reference scenario to assess the impact of new products in the real word. Two systematic literature reviews were performed to collect data on (i) health economics and (ii) health-related quality of life evidences in hemophilic patients with inhibitors. The costs associated with patients with hemophilia and inhibitors are more than 3 times greater than the costs incurred in those without inhibitors, with an annual cost per patient that can be higher than €1 000 000. The costs of bypassing agents account for the large majority of the total healthcare direct costs for hemophilia treatment. The quality of life is more compromised in patients with hemophilia and inhibitors compared to those without inhibitors, in particular the physical domains, whereas mental domains were comparable to that of the general population. The development of an inhibitor has a high impact on costs and quality of life. New treatments have the potential to change positively the management and socioeconomic burden of hemophilia with inhibitors.
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http://dx.doi.org/10.1111/ejh.13108DOI Listing
October 2018

Delisting HCV-infected liver transplant candidates who improved after viral eradication: Outcome 2 years after delisting.

Liver Int 2018 12 25;38(12):2170-2177. Epub 2018 May 25.

Gastroenterology and Hepatology Unit, Liver Unit, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.

Backgrounds & Aims: Treating patients with decompensated cirrhosis with direct-acting antiviral (DAA) therapy while on the waiting list for liver transplantation results in substantial improvement of liver function allowing 1 in 4 patients to be removed from the waiting list or delisted, as reported in a previous study promoted by the European Liver and Intestine Transplant Association (ELITA). The aim of this study was to report on clinical outcomes of delisted patients, including mortality risk, hepatocellular carcinoma development and clinical decompensation requiring relisting.

Methods: One hundred and forty-two HCV-positive patients on the liver transplant waiting list for decompensated cirrhosis, negative for hepatocellular carcinoma, between February 2014 and June 2015 were treated with DAA therapy and were prospectively followed up.

Results: Forty-four patients (30.9%) were delisted following clinical improvement. This percentage was higher than in the original study because of a number of patients being delisted long after starting DAAs. The median Child-Pugh and MELD score of delisted patients was 5.5 and 9 respectively. Four patients were relisted, because of HCC diagnosis in 1 case and 3 patients developed ascites. One further patient died (2.4%) because of rapidly progressing hepatocellular carcinoma twenty-two months after delisting. Of the 70 patients who received a liver graft, 9 died (13%).

Conclusions: Antiviral therapy allows for a long-term improvement of liver function and the delisting of one-third of treated patients with risk of liver-related complications after delisting being very low.
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http://dx.doi.org/10.1111/liv.13878DOI Listing
December 2018

Benefits in pain perception, ability function and health-related quality of life in patients with failed back surgery syndrome undergoing spinal cord stimulation in a clinical practice setting.

Health Qual Life Outcomes 2018 04 19;16(1):68. Epub 2018 Apr 19.

Research Centre on Public Health (CESP), University of Milano Bicocca, Via Cadore 48, I-20900, Monza, Italy.

Background: Failed back surgery syndrome (FBSS) represents one main cause of chronic neuropathic or mixed pain, functional disability and reduced Health Related Quality of Life (HRQoL). Spinal Cord Stimulation (SCS) can be a value for money option to treat patients refractory to conventional medical management (CMM). We estimated from real-world data: 1) the amount of reduced levels of HRQoL of target patients compared to general population, 2) the relationship between pain intensity, functional disability, and overall HRQoL, and 3) the improvement of patients’ health from SCS intervention, and 4) we give some insights and make some suggestions on the selection of a battery of patients’ reported health instruments for use in routine clinical practice.

Methods: At recruitment (before SCS) and every 6 months for 2 years after SCS a battery of questionnaires/tests were completed: the generic EQ-5D and SF-36 for HRQoL, the specific Numerical Rating Scale (NRS) to measure pain intensity, and Oswestry Disability Index (ODI) to measure functional disability. We conducted multilevel regression analyses to investigate the association of HRQoL with the NRS and ODI indexes; multiple regression analyses to compare EQ-5D data with those of the general population adjusted for age, sex and education, and statistical tests to compare the changes of HRQoL, NRS and ODI estimates at baseline with those measured during the follow-up.

Results: Eighty patients (40% male, mean age = 58 years) participated. HRQoL was significantly worse in the patients than in the corresponding general population. Pain, functional disability and HRQoL significantly related each other during follow-up, Significant improvements (p < 0.001) in pain intensity, functional capability and HRQoL were reached after 6 months from SCS and generally remained stable during follow-up. Specific instruments provided detailed information on disability and pain, while generic instruments assessed the overall HRQoL and allowed a comparison with the general population’s one.

Conclusions: SCS + CMM treatment reaches a statistically significant and probably a clinically relevant improvement in pain perception, functional disability and HRQoL in patients with FBSS refractory to CMM. An appropriate selection of instruments for use in clinical practice is crucial for a routine assessment of health perception in patients, aimed to guide decisions for optimal treatment.
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http://dx.doi.org/10.1186/s12955-018-0887-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5909225PMC
April 2018

Thromboembolic event rate in patients exposed to anti-inhibitor coagulant complex: a meta-analysis of 40-year published data.

Blood Adv 2017 Dec 12;1(26):2637-2642. Epub 2017 Dec 12.

Research Centre on Public Health, University of Milan-Bicocca, Monza, Italy.

Anti-inhibitor coagulant complex (AICC), an activated prothrombin complex concentrate, has been available for the treatment of patients with inhibitors since 1977, and thromboembolic events (TEEs) have been reported after infusion of AICC in patients with congenital or acquired hemophilia. With the aim of estimating the TEE incidence rate (IR) related to AICC exposure in these patients, a systematic review of the literature was carried out in Medline, according to PRISMA guidelines, from inception date to March 2017. The IR of TEEs was estimated through a meta-analytic approach by using a generalized linear mixed model based on a Poisson distribution. Thirty-nine studies were included (1980-2016). Overall, 46 TEEs were reported; of these, 13 were reported as disseminated intravascular coagulations, 11 as myocardial infarctions, and 3 as thrombotic cerebrovascular accidents. The pooled TEE IR was 2.87 (95% confidence interval [CI], 0.32-25.40) per 100 000 AICC infusions (5.42 in retrospective studies [95% CI, 0.92-31.82]; 1.09 in prospective studies [95% CI, 0.01-238.77]). The TEE rate was 5.09 (95% CI, 0.01-1795.60) per 100 000 AICC infusions administered on demand, whereas no TEEs were reported with prophylaxis. Interestingly, the estimated IR in patients with congenital hemophilia was <0.01 per 100 000 infusions. These findings provide robust evidence of safety of AICC over almost 40 years of published studies.
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http://dx.doi.org/10.1182/bloodadvances.2017011536DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5728640PMC
December 2017

Modern Treatments of Haemophilia: Review of Cost-Effectiveness Analyses and Future Directions.

Pharmacoeconomics 2018 03;36(3):263-284

Research Centre on Public Health (CESP), University of Milan-Bicocca, Via G. Pergolesi 33, Monza, 20900, Italy.

Background: Cost is currently one of the most important aspects in haemophilia care. Factor concentrates absorb more than 90% of healthcare direct costs of haemophilia care, and the debate regarding the high cost of haemophilia treatments and their different use across different countries is increasing.

Objective: The objective of this study was to review cost-effectiveness analyses conducted on treatment options in haemophilia, focusing on their results and their strengths and limitations; to highlight the possible issues associated with economic evaluations of new treatment options.

Methods: Electronic searches in PubMed and EMBASE were performed to retrieve papers published between November 2015 and September 2017 to update the previous review of economic evaluations of haemophilia treatments by Drummond et al. Reference lists of included articles and reviews were examined for relevant studies, which were assessed for their quality and their empirical results.

Results: Twenty-six relevant economic analyses were identified; 15 (57.7%) were conducted in patients with haemophilia with inhibitors while 11 (42.3%) involved patients without inhibitors. There were methodological variations among the included studies, and differences in the treatment schemes make a comparative assessment of interventions for patients with haemophilia difficult. Only immune tolerance induction showed consistent results in its cost-saving profile compared with the treatment with bypassing agents.

Conclusions: Economic evaluations of haemophilia treatments are increasing, but the identification of general cost-effectiveness trends is still difficult in these studies. We are now facing a new era in haemophilia management with a soaring need for high-quality economic evaluations, performed through proactive collaboration between clinical experts, budget holders and health economists.
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http://dx.doi.org/10.1007/s40273-017-0588-zDOI Listing
March 2018

Sacubitril/valsartan in heart failure with reduced ejection fraction: cost and effectiveness in the Italian context.

Eur J Heart Fail 2017 11 28;19(11):1551-1553. Epub 2017 Aug 28.

Cardiology Division, Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo, Italy.

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http://dx.doi.org/10.1002/ejhf.919DOI Listing
November 2017

Meta-analysis on incidence of inhibitors in patients with haemophilia A treated with recombinant factor VIII products.

Blood Coagul Fibrinolysis 2017 Dec;28(8):627-637

aResearch Centre on Public Health (CESP), University of Milan-Bicocca, MonzabFondazione Charta, Milano, ItalycShire, Vienna, AustriadSobi, Stockholm, Sweden.

: Recent cohort studies showed differences in inhibitor incidence in previously untreated patients (PUPs) with haemophilia A treated with recombinant factor VIII (rFVIII) concentrates. We carried out a systematic literature search and meta-analysis for all randomized clinical trials and observational studies published from 1 January 1988 to 31 August 2015, to assess the incidence of inhibitor development and the relationship with rFVIII product used in PUPs and minimally treated patients (MTPs, ≤5 previous exposure days), with severe haemophilia. The primary outcome measure was development of all inhibitors and high-titre inhibitors. We computed pooled meta-analytic estimates according to the rFVIII product used with the inverse-variance method, assuming a fixed, or a random-effects model if significant between-studies heterogeneity was present. Out of 781 articles, 16 published between 1998 and 2015 were included in the meta-analysis, involving a total of 2094 haemophilia A PUPs or MTPs. The pooled estimate of all inhibitors was 0.27 (95% confidence interval 0.23-0.31). No significant difference in pooled inhibitor incidence across products was found (P = 0.72). Meta-analysis of studies reporting inhibitor hazard ratios with different rFVIII products, adjusted to different risk factors, showed that PUPs/MTPs treated with Advate had a pooled inhibitor hazard ratio estimate of 0.63 (95% confidence interval 0.48-0.83) as compared with Kogenate FS. The overall inhibitor incidence in PUPs/MTPs was 27%. Differences between products were found considering hazard ratios in which potential confounders were taken into account.
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http://dx.doi.org/10.1097/MBC.0000000000000647DOI Listing
December 2017

Epidemiologic and Economic Burden Attributable to First Spinal Fusion Surgery: Analysis From an Italian Administrative Database.

Spine (Phila Pa 1976) 2017 Sep;42(18):1398-1404

Research Center on Public Health, University of Milan-Bicocca, Monza, Italy.

Study Design: Retrospective large population based-study.

Objective: Assessment of the epidemiologic trends and economic burden of first spinal fusions.

Summary Of Background Data: No adequate data are available regarding the epidemiology of spinal fusion surgery and its economic impact in Europe.

Methods: The study population was identified through a data warehouse (DENALI), which matches clinical and economic data of different Healthcare Administrative databases of the Italian Lombardy Region. The study population consisted of all subjects, resident in Lombardy, who, during the period January 2001 to December 2010, underwent spinal fusion surgery (ICD-9-CM codes: 81.04, 81.05, 81.06, 81.07, and 81.08). The first procedure was used as the index event. We estimated the incidence of first spinal fusion surgery, the population and surgery characteristics and the healthcare costs from the National Health Service's perspective. The analysis was performed for the entire population and divided into the main groups of diagnosis.

Results: The analysis identified 17,772 [mean age (SD): 54.6 (14.5) years, 55.3% females] spinal fusion surgeries. Almost 67% of the patients suffered from a lumbar degenerative disease. The incidence rate of interventions increased from 11.5 to 18.5 per 100,000 person-year between 2001 and 2006, and was above 20.0 per 100,000 person-year in the last 4 years. The patients' mean age increased during the observational time period from 48.1 to 55.9 years; whereas the median hospital length of stay reported for the index event decreased. The average cost of the spinal fusion surgery increased during the observational period, from &OV0556; 4726 up to &OV0556; 9388.

Conclusion: The study showed an increasing incidence of spinal fusion surgery and costs from 2001 to 2010. These results can be used to better understand the epidemiological and economic burden of these interventions, and help to optimize the resources available considering the different clinical approaches accessible today.

Level Of Evidence: 4.
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http://dx.doi.org/10.1097/BRS.0000000000002118DOI Listing
September 2017

Direct-acting antivirals combination for elderly patients with chronic hepatitis C: A cost-effectiveness analysis.

Liver Int 2017 07 2;37(7):982-994. Epub 2017 Mar 2.

Department of Medicine and Surgery, Center for Digestive Health, University of Milano-Bicocca, Monza, Italy.

Background: Chronic hepatitis C (CHC) has been undertreated among elderly patients. Interferon-free treatment represents an opportunity for these patients. The aim of this study was to assess the cost-effectiveness of directly acting antivirals (DAAs) in CHC elderly patients.

Methods: A Markov model of CHC natural history was built. This study focuses on CHC patients older than 65 years, stratified according to genotype (1/4, 2 and 3), liver fibrosis (METAVIR F1 to F4), age and frailty phenotype (robust, pre-frail and frail). DAAs combination vs no treatment was simulated for each theoretical population, assessing life years, quality-adjusted life years (QALYs), costs, incremental cost-effectiveness ratios (ICERs) in a lifetime time horizon and by the Healthcare System perspective.

Results: Incremental cost-effectiveness ratio increased with age and frailty status in all fibrosis stages. For robust F3 and F4 patients ICERs remained below the willingness-to-pay threshold (WTP) of 40 000€/QALY up to age 75 and 86 years, respectively, depending on drug price and sustained virological response probability (sensitivity analysis). Notably, in F4 and frail subjects older than 75 years, ICER was more sensitive to non-liver-related mortality rate. In elderly F1 and F2 patients, ICERs were below WTP only up to 77 years old, with wide variability among frailty phenotypes.

Conclusions: Cost-effectiveness of DAAs treatment of elderly CHC patients is solid in those with advanced fibrosis, but it depends strongly on frailty status and age, particularly in patients with milder fibrosis stages. Accurate assessment of clinical variables, including frailty, is necessary to allocate limited resources to this special population.
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http://dx.doi.org/10.1111/liv.13339DOI Listing
July 2017

Cost-effectiveness analysis of pharmacokinetic-driven prophylaxis vs. standard prophylaxis in patients with severe haemophilia A.

Blood Coagul Fibrinolysis 2017 Sep;28(6):425-430

aFondazione Charta, Milano bResearch Centre on Public Health (CESP), University of Milan-Bicocca, Monza, Italy cBaxalta Innovations GmbH, Vienna, Austria.

: The objective of this study was to assess the cost-effectiveness of pharmacokinetic-driven prophylaxis in severe haemophilia A patients. A microsimulation model was developed to evaluate the cost-effectiveness of pharmacokinetic-driven prophylaxis vs. standard prophylaxis and estimate cost, annual joint bleed rate (AJBR), and incremental cost-effectiveness ratio over a 1-year time horizon for a hypothetical population of 10 000 severe haemophilia A patients. A dose of 30 IU/kg per 48 h was assumed for standard prophylaxis. Pharmacokinetic prophylaxis was individually adjusted to maintain trough levels at least 1 and 5 IU/dl or less. AJBR was estimated on the relationship between factor VIII (FVIII) levels and bleeding rate reported in the literature. Sensitivity analyses were performed to assess the stability of the model and the reliability of results. The FVIII dose was reduced in the 27.8% of patients with a trough level more than 5 IU/dl on standard prophylaxis, with a negligible impact on AJBR (+0.1 bleed/year). The FVIII dose was increased in the 10.6% of patients with trough levels less than 1 IU/dl on standard prophylaxis, with a significant reduction of AJBR (-1.9 bleeds/year). On average, overall, pharmacokinetic-driven prophylaxis was shown to decrease the AJBR from 1.012 to 0.845 with a slight reduction of the infusion dose of 0.36 IU/kg, with total saving of 5 197&OV0556; per patient-year. Pharmacokinetic-driven prophylaxis was preferable (i.e. more effective and less costly) compared with standard prophylaxis, with savings of 31 205&OV0556; per bleed avoided. Pharmacokinetic-driven prophylaxis, accounting for patients' individual pharmacokinetic variability, appears to be a promising strategy to improve outcomes with efficient use of available resources in severe haemophilia A patients.
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http://dx.doi.org/10.1097/MBC.0000000000000610DOI Listing
September 2017

About the Reliability of the Critical Review to Investigate the Generalizability of Economic Evaluations Conducted in Italy.

Value Health 2016 Jul-Aug;19(5):697. Epub 2016 Apr 26.

CHARTA Foundation, Milan, Italy.

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http://dx.doi.org/10.1016/j.jval.2016.03.1833DOI Listing
February 2018

Long-term costs and outcomes in psoriatic arthritis patients not responding to conventional therapy treated with tumour necrosis factor inhibitors: the extension of the Psoriatic Arthritis Cost Evaluation (PACE) study.

Clin Exp Rheumatol 2016 Jan-Feb;34(1):68-75. Epub 2015 Dec 3.

Researh Centre on Public Health (CESP), University of Milan-Bicocca, and Fondazione Charta, Milan, Italy.

Objectives: Poor information on long-term outcomes and costs on tumour necrosis factor (TNF) inhibitors in psoriatic arthritis (PsA) are available. Our aim was to evaluate long-term costs and benefits of TNF- inhibitors in PsA patients with inadequate response to conventional treatment with traditional disease-modifying anti-rheumatic drugs (tDMARDs).

Methods: Fifty-five out of 107 enrolled patients included in the study at one year, completed the 5-year follow-up period. These patients were enrolled in 8 of 9 centres included in the study at one year. Patients aged older than 18 years, with different forms of PsA and failure or intolerance to tDMARDs therapy were treated with anti-TNF agents. Information on resource use, health-related quality of life (HRQoL), disease activity, function and laboratory values were collected at baseline and through the 5 years of therapy. Costs (expressed in Euro 2011) and utility (measured by EQ-5D instrument) before TNF inhibitor therapy and after 1 and 5 years were compared.

Results: The majority of patients (46 out of 55; 83.6%) had a predominant or exclusive peripheral arthritis and 16.4% had predominant or exclusive axial involvement. There was a statistically significant improvement of the most important clinical variables after 1 year of follow-up. These improvements were maintained also after 5 years. The direct costs increased by approximately €800 per patient-month after 1 year, the indirect costs decreased by €100 and the overall costs increased by more than €700 per patient-month due to the cost of TNF inhibitor therapy. Costs at 5 year were similar to the costs at 1 year. The HRQoL parameters showed the same trends of the clinical variables. EQ-5D VAS, EQ-5D utility and SF-36 PCS score showed a significant improvement after 1 year, maintained at 5 years. SF-36 MCS showed an improvement only at 5 years.

Conclusions: The results of our study suggest that TNF blockers have long-term efficacy. The higher cost of TNF inhibitor therapy was balanced by a significant improvement of HRQoL, stable at 5 years of follow-up. Our results need to be confirmed in larger samples of patients.
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April 2016

Health economic models in hemophilia A and utility assumptions from a clinician's perspective.

Pediatr Blood Cancer 2015 Oct 14;62(10):1826-31. Epub 2015 May 14.

Department of Biomedical Science and Human Oncology-Pediatric Unit, University of Bari "Aldo Moro,", Bari, Italy.

Background: The clinical benefits of prophylaxis in patients with hemophilia are well-established and include the following: reduced bleeding episodes, prevention of joint damage, decreased inhibitor development, and improved health-related quality of life. However, the cost-effectiveness of prophylaxis is still not clear.

Procedures: We reviewed the published hemophilia prophylaxis economic models focusing on utility assumptions.

Results: We found six cost-utility studies that compared prophylaxis and on-demand regimens. These studies reported remarkably different results, using utility values based on different assumptions and data sources.

Conclusions: We suggest that cooperation among key stakeholders (clinicians, patient organizations and health-care decision makers) as a means of collecting evidence-based and experiential data to represent both the utility and the quality of life changes for patients with Hemophilia A who are treated with prophylaxis or receive on-demand treatments may represent a winning strategy with which to resolve the outstanding issues related to health technology assessments in the care of patients with hemophilia.
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http://dx.doi.org/10.1002/pbc.25543DOI Listing
October 2015

Cost-utility analysis of biologic therapies to treat chronic plaque psoriasis in Italy: the importance of using updated and adequate social tariffs to calculate quality-adjusted life-years.

BioDrugs 2015 Feb;29(1):69

Research Centre on Public Health (CESP), Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Villa Serena, Via Pergolesi 33, 20052, Monza, Italy,

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http://dx.doi.org/10.1007/s40259-015-0117-6DOI Listing
February 2015

Cost-effectiveness analysis of new drugs for chronic hepatitis C: the importance of updating utility values.

Hepatology 2015 Mar 20;61(3):1096-7. Epub 2015 Jan 20.

Research Center on Public Health, University of Milan-Bicocca, Monza, Italy; CHARTA Foundation, Milan, Italy.

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http://dx.doi.org/10.1002/hep.27316DOI Listing
March 2015

Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids.

Contact Dermatitis 2014 Mar 19;70(3):158-68. Epub 2013 Sep 19.

Research Centre on Public Health (CESP), University of Milan-Bicocca, 20052, Monza, Italy; CHARTA Foundation, 20122 Milano, Italy.

Background: Little is known about the socio-economic burden of severe chronic hand eczema in patients refractory to treatment with potent corticosteroids.

Objectives: To estimate the socio-economic burden of severe chronic hand eczema refractory to potent topical corticosteroids, and to establish an algorithm for the estimation of the health-related quality of life EuroQol five-dimensional (EQ-5D) utility index from the Dermatology Life Quality Index (DLQI) summary score.

Methods: A multicentre cost of illness study was conducted, adopting the societal perspective. Adult patients with severe and refractory chronic hand eczema were enrolled. Direct (e.g. drug treatment and travel) and indirect (i.e. loss of productivity) mean costs/patient-month were estimated. Health-related quality of life was assessed with the EQ-5D and DLQI questionnaires. An ordinary least square regression model was used to investigate relationships between health-related quality of life scores.

Results: One hundred and four valid patients (mean age 44.5 years, 39.4% male) participated. Overall mean costs were €418.3/patient-month: loss of productivity contributed 43.7%, followed by hospitalization (16.1%) and travel (10.3%). Health-related quality of life scores were, on average, 0.50 (EQ-5D utility) and 11.3 (DLQI). Utility and DLQI summary were significantly related to each other.

Conclusions: Wellbeing and loss of productivity are the most important consequences in these patients. Appropriate treatment is necessary to improve patient health and productivity, which will contribute to reducing societal costs.
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http://dx.doi.org/10.1111/cod.12130DOI Listing
March 2014

Italian population-based values of EQ-5D health states.

Value Health 2013 Jul-Aug;16(5):814-22. Epub 2013 Jun 19.

CHARTA Foundation, Milan, Italy.

Objective: To estimate a value set for the calculation of Italian-specific quality-adjusted life years (QALYs), based on preferences elicited on EuroQol five-dimensional (EQ-5D) questionnaire health states using the time trade-off technique.

Methods: The revised standard Measurement and Valuation of Health protocol was followed. Twenty-five health states, divided into three groups and given to 450 subjects, were selected to obtain 300 observations per state. Subjects aged 18 to 75 years were recruited to be representative of the Italian general adult population for age, sex, and geographical distribution. To improve efficiency, face-to-face interviews were conducted by using the Computer Assisted Personal Interviewing approach. Several random effects regression models were tested to predict the full set of EQ-5D questionnaire health states. Model selection was based on logical consistency of the estimates, sign and magnitude of the regression coefficients, goodness of fit, and parsimony.

Results: The model that satisfied the criteria of logical consistency and was more efficient includes 10 main effect dummy variables for the EQ-5D questionnaire domain levels and the D1 interaction term, which accounts for the number of dimensions at levels 2 or 3 beyond the first. This model has an R(2) of 0.389 and a mean absolute error of 0.03, which are comparable to or better than those of models used in other countries. The utility estimates after state 11111 range from 0.92 (21111) to -0.38 (33333). Italian utility estimates are higher than those estimated in the United Kingdom and Spain and used so far to assess QALYs and conduct cost-utility evaluations in Italy.

Conclusions: A specific value set is now available to calculate QALYs for the conduction of health economic studies targeted at the Italian health care system.
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http://dx.doi.org/10.1016/j.jval.2013.04.008DOI Listing
November 2013

Compliance, persistence, costs and quality of life in young patients treated with antipsychotic drugs: results from the COMETA study.

BMC Psychiatry 2013 Mar 22;13:98. Epub 2013 Mar 22.

Research Centre on Public Health (CeSP), Univeristy of Milan-Bicocca, Monza, Italy.

Background: Little data is available on the real-world socio-economic burden and outcomes in schizophrenia. This study aimed to assess persistence, compliance, costs and Health-Related Quality-of-Life (HRQoL) in young patients undergoing antipsychotic treatment according to clinical practice.

Methods: A naturalistic, longitudinal, multicentre cohort study was conducted: we involved 637 patients aged 18-40 years, with schizophrenia or schizophreniform disorder diagnosed ≤10 years before, enrolled in 86 Italian Mental Health Centres and followed-up for 1 year. Comparisons were conducted between naïve (i.e., patients visiting the centre for the first time and starting a new treatment regimen) and non naïve patients.

Results: At enrolment, 84% of patients were taking atypical drugs, 3.7% typical, 10% a combination of the two classes, and 2% were untreated. During follow-up, 23% of patients switched at least once to a different class of treatment, a combination or no treatment. The mean Drug-Attitude-Inventory score was 43.4, with 94.3% of the patients considered compliant by the clinicians. On average, medical costs at baseline were 390.93€/patient-month, mostly for drug treatment (29.5%), psychotherapy (29.2%), and hospitalizations (27.1%). Patients and caregivers lost 3.5 days/patient-month of productivity. During follow-up, attitude toward treatment remained fairly similar, medical costs were generally stable, while productivity, clinical statusand HRQoL significantly improved. While no significantly different overall direct costs trends were found between naïve and non naïve patients, naïve patients showed generally a significant mean higher improvement of clinical outcomes, HRQoL and indirect costs, compared to the others.

Conclusions: Our results suggest how tailoring the treatment strategy according to the complex and specific patient needs make it possible to achieve benefits and to allocate more efficiently resources. This study can also provide information on the most relevant items to be considered when conducting cost-effectiveness studies comparing specific alternatives for the treatment of target patients.
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http://dx.doi.org/10.1186/1471-244X-13-98DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3621844PMC
March 2013

A systematic literature review of the economic impact of ankylosing spondylitis.

Clin Exp Rheumatol 2012 Jul-Aug;30(4 Suppl 73):S136-41. Epub 2012 Oct 16.

Istituto di Management, Scuola Superiore Sant'Anna, Pisa, Italy.

This article reviews the last decade studies on the economic impact of ankylosing spondylitis (AS). Interestingly, a common observation is that in AS indirect costs are higher than the use of direct healthcare resources. Country, age, gender, and severity of the diseases impact on per patient annual costs AS related. Different payment and reimbursement regimes may impact on the amount and distribution of indirect costs. The differences observed among countries on absolute and relative (compared with direct costs) amounts of indirect costs can be explained with the capability of a country of actually measure productivity losses and indirect costs. Low indirect costs without other indicators should not be considered as a sign of efficiency in AS care, but may be due to an underestimation of AS-related costs; as a consequence, indirect costs may be a net loss for patients that nobody can repay. A private insurance reimbursement regime has the highest capability of inducing players to define, select and actually identify indirect costs better than in different reimbursement regimes. Therefore indirect costs may become very high in case of private insurance regimes because of their more detailed identification.
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March 2013

The rationale of pharmacoeconomic analysis in rheumatologic indications.

Clin Exp Rheumatol 2012 Jul-Aug;30(4 Suppl 73):S64-71. Epub 2012 Oct 18.

Istituto di Management, Scuola Superiore Sant'Anna, Pisa, Italy.

Pharmacoeconomic analysis is aimed at supporting choices between alternatives available for the efficient management of specific conditions. Aim of the paper is to provide an overview of the main features of pharmacoeconomic evaluations, with the objective of providing the reader with the basic tools necessary to read and interpret or to design and conduct a pharmacoeconomic analysis in RA and in other rheumatic diseases. The paragraphs will cover in detail the definition of health economic evaluation and pharmacoeconomics, the alternatives to be compared, the perspective of the analysis, costs and effects (presenting in detail direct costs and effects, indirect costs and effects, intangible costs and effects and source of data), and pharmacoeconomic techniques. Pharmacoeconomic analyses have to be conducted accurately to provide valuable information to guide the choice of options representing the best value for money without compromising the quality of care delivered. For this reason, as these analyses generally present some limitations, a very close and strong relationship between pharmacoeconomists and clinicians is crucial both in the design of pharmacoeconomic studies and in the interpretation of their results, and also in the development of more satisfactory methods and indicators.
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March 2013

Systematic literature review on economic implications and pharmacoeconomic issues of psoriatic arthritis.

Clin Exp Rheumatol 2012 Jul-Aug;30(4 Suppl 73):S126-31. Epub 2012 Oct 18.

CESP, Research Centre on Public Health, University of Milano-Bicocca, Monza, Italy.

The introduction of anti tumour necrosis factors-α (TNF-α) agents has greatly advanced the management of psoriatic arthritis (PsA). Functional disability in patients with PsA may result in significant impairment of Quality of Life (QoL), psychosocial disability and productivity loss. Although many patients respond adequately to methotrexate and other therapies, in patients who have incomplete responses, anti TNF-α agents reduce inflammation and minimise joints damage, increasing functional capacity and QoL, and decreasing the progression rate of structural damage in peripheral joints. Because of the high costs associated to anti TNF-α agents therapy, an increasing number of economic evaluations have been performed over the last few years, and several cost-of-illness and cost-effectiveness studies have been published concerning use of anti TNF-α agents in management of PsA. We performed a systematic literature review to better understand the pharmacoeconomic perspective of PsA. The pharmacoeconomic studies analysed have demonstrated the high socioeconomic burden of PsA and that TNF-α blockers treatment options provide value for money in the musculoskeletal and cutaneous manifestations of psoriatic disease.
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March 2013