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1. The global patient-reported outcomes for multiple sclerosis initiative: bridging the gap between clinical research and care – updates at the 2023 plenary event

Author

Paola Zaratin, Sara Samadzadeh, Meral Seferoğlu, Vito Ricigliano, Jonadab dos Santos Silva, Abdulkadir Tunc, Giampaolo Brichetto, Timothy Coetzee, Anne Helme, Usman Khan, Robert McBurney, Guy Peryer, Helga Weiland, Peer Baneke, Mario Alberto Battaglia, Valerie Block, Luca Capezzuto, Loïc Carment, Paolo Angelo Cortesi, Gary Cutter, Letizia Leocani, Hans-Peter Hartung, Jan Hillert, Jeremy Hobart, Kaisa Immonen, Paul Kamudoni, Rod Middleton, Patricia Moghames, Xavier Montalban, Liesbet Peeters, Maria Pia Sormani, Susanna van Tonder, Angela White, Giancarlo Comi, and Patrick Vermersch

Subjects
multiple sclerosis progression, patient reported outcomes, patient engagement, personalized medicine, digital health, Neurology. Diseases of the nervous system, RC346-429
Abstract

Significant advancements have been achieved in delineating the progress of the Global PROMS (PROMS) Initiative. The PROMS Initiative, a collaborative endeavor by the European Charcot Foundation and the Multiple Sclerosis International Federation, strives to amplify the influence of patient input on MS care and establish a cohesive perspective on Patient-Reported Outcomes (PROs) for diverse stakeholders. This initiative has established an expansive, participatory governance framework launching four dedicated working groups that have made substantive contributions to research, clinical management, eHealth, and healthcare system reform. The initiative prioritizes the global integration of patient (For the purposes of the Global PROMS Initiative, the term “patient” refers to the people with the disease (aka People with Multiple Sclerosis – pwMS): any individual with lived experience of the disease. People affected by the disease/Multiple Sclerosis: any individual or group that is affected by the disease: E.g., family members, caregivers will be also engaged as the other stakeholders in the initiative). insights into the management of MS care. It merges subjective PROs with objective clinical metrics, thereby addressing the complex variability of disease presentation and progression. Following the completion of its second phase, the initiative aims to help increasing the uptake of eHealth tools and passive PROs within research and clinical settings, affirming its unwavering dedication to the progressive refinement of MS care. Looking forward, the initiative is poised to continue enhancing global surveys, rethinking to the relevant statistical approaches in clinical trials, and cultivating a unified stance among ‘industry’, regulatory bodies and health policy making regarding the application of PROs in MS healthcare strategies.

Published
2024
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2. Health Technology Assessment of Vaccines in Italy: History and Review of Applications

Author

Sara Boccalini, Rosalia Ragusa, Donatella Panatto, Giovanna Elisa Calabrò, Paolo Angelo Cortesi, Gabriele Giorgianni, Carlo Favaretti, Paolo Bonanni, Walter Ricciardi, and Chiara de Waure

Subjects
HTA, vaccination, immunization, recommendation, NITAG, decision-making process, Medicine
Abstract

Background/Objectives. Many vaccines have been developed in recent decades, and many more will be available in the future. When new safe and effective vaccines are available, decision-makers must extensively assess them before including them in the national immunization plan and issuing recommendations. The Health Technology Assessment (HTA) could be an objective, transparent, and comprehensive approach to guiding the decision-making process for the use of vaccines. Objectives and Methods. The aim of this study was to review the indications for HTA use contained in Italian institutional documents on vaccination, namely the National Immunization Plans (NIPs) and available full Italian HTA reports on vaccines, assessing their availability at the time of national recommendations’ introductions. Results. HTA has been recognised as an eligible approach to deciding upon the introduction of vaccines through the NIPs of 2012–2014 and 2017–2019, and the last NIP, of 2023–2025, highlights the lack of funding dedicated to the production of independent HTA reports that can be used for issuing recommendations. In 2007–2023, twenty full HTA reports on vaccines were published in Italy: eight reports on influenza vaccines, five on Human Papilloma Virus (HPV), three each on meningococcal and pneumococcal vaccines, and one on rotavirus vaccine. HTA was applied with different purposes, namely the evaluation of new vaccines or their re-assessment, but it was not always timely with respect to both the marketing authorisation and the issuing of national recommendations for use. Conclusions. As HTA can be considered the best tool to disentangle the overall value of vaccines, it would be desirable for it to be used more and more to provide the evidence for efficient resource use. This calls for action to improve the transfer of HTA results to decision-makers, to try to fill the gap between research and decision and foster evidence-based recommendations.

Published
2024
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3. A cost-consequence analysis of adding pertuzumab to the neoadjuvant combination therapy in HER2-positive high-risk early breast cancer in Italy

Author

Alberto Zambelli, Marina Cazzaniga, Nicla La Verde, Elisabetta Munzone, Ippazio Cosimo Antonazzo, Lorenzo Giovanni Mantovani, Serena Di Cosimo, Anna Mancuso, Daniele Generali, and Paolo Angelo Cortesi

Subjects
Breast cancer, Pertuzumab, Neoadjuvant, Italy, Cost-consequence analysis, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Introduction: Clinical trials confirmed the beneficial effects of adding pertuzumab (P) to the combination of trastuzumab-chemotherapy (TC) in the (neo)adjuvant setting of high-risk HER2-positive early breast cancer (HER2+BC). We evaluated the clinical, economic and societal impact of adding pertuzumab to neoadjuvant TC combination (TPC) in Italy. Methods: A cost-consequence analysis comparing TPC vs. TC was performed developing a cohort-based multi-state Markov model to estimate the clinical, societal and economic impact of the neoadjuvant therapy of TPC versus TC in HER2+BC at high-risk of recurrence. The model works on a cycle length of 1 month and 5-years-time horizon. Literature review-based data were used to populate the model. The following clinical and economic outcomes were estimated: cumulative incidence of loco-regional/distant recurrences, life of years and QALY and both direct and indirect costs (€). Finally, sensitivity analyses were performed. Results: TPC was associated with a 75,630 € saved of direct costs. Specifically, it was associated with an initial increase of treatment costs (+4.8%) followed by reduction of recurrence management cost (−20.4%). TPC was also associated with an indirect cost reduction of 1.40%, as well as decreased incidence of distant recurrence (−20.14%), days of work lost (−1.53%) and days lived with disability (−0.50%). Furthermore, TPC reported 10,47 QALY gained (+2.77%) compared to TC. The probability to achieve the pathological complete response (pCR) was the parameter that mostly affected the results in the sensitivity analysis. Conclusion: Our findings suggested that TPC combination could be a cost-saving option in patients with HER2+BC at high-risk of recurrence.

Published
2023
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4. Personalized Prophylaxis with myPKFiTCE: A Real-World Cost-Effectiveness Analysis in Haemophilia A Patients

Author

Ippazio Cosimo Antonazzo, Paolo Angelo Cortesi, Ezio Zanon, Samantha Pasca, Massimo Morfini, Cristina Santoro, Raimondo De Cristofaro, Giovanni Di Minno, Paolo Cozzolino, and Lorenzo Giovanni Mantovani

Subjects
hemophilia A, health economics, pharmacokinetics-guided, prophylaxis, Medicine (General), R5-920
Abstract

Background and Objectives: This study aimed to assess the effectiveness and costs associated with pharmacokinetics-driven (PK) prophylaxis based on the myPKFiT® device in patients affected by hemophilia A (HA) in Italy. Materials and Methods: An observational retrospective study was conducted in three Italian hemophilia centers. All patients with moderate or severe HA, aged ≥ 18 years, capable of having PK estimated using the myPKFiT device, and who had had a clinical visit between 1 November 2019 and 31 March 2022 were included. Differences in clinical, treatment, health resources, and cost data were assessed comparing post-PK prophylaxis with pre-PK. The incremental cost-effectiveness ratio (ICER) was estimated as cost (EUR) per bleed avoided. Results: The study enrolled 13 patients with HA. The mean annual bleeding rate decreased by −1.45 (−63.80%, p = 0.0055) after the use of myPKFiT®. Overall, the consumption of FVIII IU increased by 1.73% during follow-up compared to the period prior the use of the myPKFiT. Prophylaxis based on the myPKFiT resulted in an ICER of EUR 5099.89 per bleed avoided. Conclusions: The results of our study support the idea that the use of PK data in clinical practice can be associated with an improvement in the management of patients, as well as clinical outcomes, with a reasonable increase in costs.

Published
2023
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5. Cost-Effectiveness of Dimethyl Fumarate Compared to Teriflunomide for Relapsing Remitting Multiple Sclerosis Patients in Italy

Author

Lorenzo Giovanni Mantovani, Paolo Angelo Cortesi, Alessandra Cardillo, Laura Santoni, and Luca Prosperini

Subjects
dimethyl fumarate, teriflunomide, relapsing-remitting multiple sclerosis, cost-effectiveness, quality-adjusted survival, Medicine (General), R5-920
Abstract

BACKGROUND: The objective of this economic analysis was to compare the cost-effectiveness of dimethyl fumarate vs teriflunomide for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) in the Italian setting. Additionally, the cost-effectiveness analysis was used to predict some patient-relevant outcomes such as burden of relapses and survival with disability over time. METHODS: A Markov model was used to conduct the cost-effectiveness analysis. The model measured health outcomes and costs of RRMS patients treated with either dimethyl fumarate or teriflunomide. Data from a published mixed treatment comparison were used for efficacy and safety input. Local economic data were used to calculate costs. A supplementary analysis was carried out to assess ICER variability over time from the Italian National Healthcare Service (NHS) and societal perspectives. Further analyses were conducted to compare clinical effectiveness of the alternatives over time, in terms of incidence of relapses, proportion of patients with EDSS (Expanded Disability Status Scale) score ≤3 and EDSS score ≥6. RESULTS: In the base-case analysis (lifetime horizon; societal perspective) dimethyl fumarate was dominant over teriflunomide (6.526 vs 5.953 QALYs – quality-adjusted life-years; € 1.01 M vs € 1.03 M). The most relevant cost savings (per-patient) with dimethyl fumarate were related to relapses (-€ 5,096), inpatient care (-€ 5,767), informal care (-€ 9,603), long-term absence/early retirement (-€ 14,187). The additional analysis of ICER by time horizon shows that dimethyl fumarate is cost-effective vs teriflunomide (i.e., ICER

Published
2022
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6. Cost-effectiveness and budget impact analysis of siponimod in the treatment of secondary progressive multiple sclerosis in Italy

Author

Paolo Angelo Cortesi, Ippazio Cosimo Antonazzo, Claudio Gasperini, Mihaela Nica, Daniela Ritrovato, and Lorenzo Giovanni Mantovani

Subjects
Medicine, Science
Abstract

Background Siponimod is an effective treatment for patients with secondary progressive multiple sclerosis (SPMS), with active disease evidenced by relapses or imaging features characteristic of multiple sclerosis inflammatory activity, however there is a need to evaluate its economic value and sustainability compared to other disease modifying-therapies (DMTs). Objective To estimate the siponimod cost-effectiveness profile and its relative budget impact compared with other DMTs, by using the Italian National Healthcare System perspective. Methods We performed: 1) a cost-effectiveness analysis (CEA) vs interferon beta-1b using an analytical Markov model and a life time-horizon, and 2) a budget impact analysis by using 3-years time-horizon. The results were reported as incremental cost-effectiveness ratio (ICER) and net-monetary benefit (NMB) for CEA, using a willingness to pay threshold of €40,000 per QALY gained, and as difference in the overall budget (Euro) between the scenario with and without siponimod for budget impact. Results In the base case scenario siponimod resulted cost-effective compared with interferon beta-1b 28,891€ per QALY. Overall, the market access of siponimod was associated to an increased budget of about 3€ millions (+0.9%) in the next 3 years simulated. Conclusion Compared to interferon beta-1b, siponimod seems to be cost-effective in SPMS patients and sustainable, with less than 1% overall budget increased in the next 3 years. Future studies need to confirm our results in the real word setting and in other countries.

Published
2022

7. Health Technology Assessment on the use of the Wearable Cardioverter Defibrillator in Patients with Myocardial Infarction and with ICD Explant

Author

Paolo Angelo Cortesi, Giovanni Luca Botto, Lucia D'Angiolella, Luciana Scalone, Roberto De Ponti, Giuseppe Boriani, and Lorenzo Giovanni Mantovani

Subjects
health technology assessment, cardioverter defibrillator, myocardial infarction, Medicine (General), R5-920
Abstract

The objective of the present work is to conduct a Health Technology Assessment (HTA) on the use of the Wearable Cardioverter Defibrillator (WCD) in patients at risk of Sudden Cardiac Arrest (SCA) following Myocardial Infarction (MI) or with an explanted Implantable Cardioverter Defibrillator (ICD).

Published
2021
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8. The Economic Burden of Different Multiple Sclerosis Courses: Analysis from Italian Administrative and Clinical Databases

Author

Paolo Angelo Cortesi, Paolo Cozzolino, Ruggero Capra, Giancarlo Cesana, and Lorenzo Giovanni Mantovani

Subjects
multiple sclerosis, burden of disease, direct costs, italy, Medicine (General), R5-920
Abstract

INTRODUCTION: Poor specific economic information are available for the different Multiple Sclerosis (MS) courses: relapsing remitting (RRMS), secondary progressive (SPMS) and primary progressive (PPMS). This study aims to fill this gap. METHODS: A cost of illness study was conducted. Clinical information of patients treated in a major MS Center located in Lombardy, in the period 2004-2010, were linked with administrative data of Lombardy Healthcare System. We assessed the mean cost per patient-year and its association with different MS characteristics. RESULTS: The study identified 869 patients (83.9% RRMS, 8.5% SPMS, 7.2% PPMS). RRMS reported the highest cost per patient-year with a mean of € 5,623 in Expanded Disability Status Scale (EDSS) 0-3, € 8,675 in EDSS 3.5-6.5, and € 7,451 in EDSS 7-9. The PPMS patients reported the lower annual mean cost per patient in all EDSS categories. The mul-tivariate analysis reported a significant association between cost per patient-year and EDSS categories, relapse and use of Disease Modifying Therapies but not to MS courses, age and sex. CONCLUSION: This study provides a complete picture of MS courses direct costs at the different disability levels. The results can help to better understand the burden of each MS courses and the cost-effectiveness of different interventions.

Published
2020
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9. Critical Review of the Pivotal Studies of Four rFVIII Products for the Treatment of Hemophilia A Patients: The Role of Octocog Alfa

Author

Matteo Nicola Dario Di Minno, Lucia D'Angiolella, Paolo Angelo Cortesi, Angelo Claudio Molinari, and Lorenzo Giovanni Mantovani

Subjects
hemophilia, recombinant factor viii, kovaltry®, critical review, Medicine (General), R5-920
Abstract

INTRODUCTION: Hemophilia A is a rare congenital bleeding disorder caused by a deficiency of clotting factor VIII (FVIII). The severe form of the disease is characterized by spontaneous bleeds, especially into the joints. Prophylaxis, based on regularly intravenous administration of the missing factor to avoid hemorrhages, represents the gold standard of treatment. In recent years, new products that significantly improve the treatment management options for patients with hemophilia have become available in the market. OBJECTIVE: To critically evaluate the pivotal studies of recombinant FVIII (rFVIII) products, approved in Europe within the first half of 2018 having obtained the indication for a prophylaxis dosing regimen based also on a twice weekly infusion frequency or even less, highlighting their limitations or strengths. METHODS: A systematic literature search was conducted, and several databases (PubMed and Embase) were consulted. RESULTS: Nine clinical trials involving patients with severe hemophilia A without inhibitor were included in this analysis. Four rFVIII products (Elocta®, Biogen, Cambridge, MA, USA; Kovaltry®, Bayer HealthCare Pharmaceuticals, Germany; Afstyla®, CSL Behring GmbH, Germany; Adynovi®, Baxalta Innovation GmbH, Austria) with different pharmacokinetic profiles were evaluated. The trials included in this analysis had different designs and heterogeneous methods were utilized to assess the study outcomes. The baseline characteristics of the patients enrolled in the studies were also often different and sometimes not adequately described. LEOPOLD II, a trial to compare prophylaxis to on-demand therapy with an unmodified rFVIII product (Kovaltry®, octocog alfa), was the only completely randomized trial that enrolled a more critical patient population in terms of compromised joint condition than the other studies. Based on these side-by-side comparison, Octocog alfa reported similar efficacy, in terms of annualized bleeding rate, to the other rFVIII products, including extended half-life. CONCLUSIONS: Even without structural modifications, octocog alfa may be considered a useful treatment option for two times a week prophylaxis in a selected population of haemophilia patients.

Published
2020
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10. Italy's health performance, 1990–2017: findings from the Global Burden of Disease Study 2017

Author

Lorenzo Monasta, Cristiana Abbafati, Giancarlo Logroscino, Giuseppe Remuzzi, Norberto Perico, Boris Bikbov, Giorgio Tamburlini, Ettore Beghi, Eugenio Traini, Sofia Boston Redford, Filippo Ariani, Antonio M Borzì, Cristina Bosetti, Giulia Carreras, Valeria Caso, Giulio Castelpietra, Massimo Cirillo, Sara Conti, Paolo Angelo Cortesi, Giovanni Damiani, Lucia Sara D'Angiolella, Jessica Fanzo, Carla Fornari, Silvano Gallus, Giorgia Giussani, Giuseppe Gorini, Giuseppe Grosso, Davide Guido, Carlo La Vecchia, Paolo Lauriola, Matilde Leonardi, Miriam Levi, Fabiana Madotto, Stefania Mondello, Luigi Naldi, Stefano Olgiati, Raffaele Palladino, Cristiano Piccinelli, Marco Piccininni, Elisabetta Pupillo, Alberto Raggi, Salvatore Rubino, Paola Santalucia, Marco Vacante, Simone Vidale, Francesco S Violante, Mohsen Naghavi, and Luca Ronfani

Subjects
Public aspects of medicine, RA1-1270
Abstract

Summary: Background: Through a comprehensive analysis of Italy's estimates from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2017, we aimed to understand the patterns of health loss and response of the health-care system, and offer evidence-based policy indications in light of the demographic transition and government health spending in the country. Methods: Estimates for Italy were extracted from GBD 2017. Data on Italy are presented for 1990 and 2017, on prevalence, causes of death, years of life lost, years lived with disability, disability-adjusted life-years (DALYs), life expectancy at birth and at age 65 years, healthy life expectancy, and Healthcare Access and Quality (HAQ) Index. We compared the estimates for Italy with those of 15 other western European countries. Findings: The quality of the universal health system and healthy behaviours contribute to favourable overall health, even in comparison with other western European countries. In 2017, life expectancy and HAQ Index score in Italy were among the highest globally, with life expectancy at birth reaching 85·3 years for females and 80·8 for males in 2017, ranking Italy eighth globally for females and sixth for males, and an HAQ Index score of 94·9 in 2016 compared with 81·54 in 1990, keeping Italy ranked as ninth globally. Between 1990 and 2017 age-standardised death rates for cardiovascular diseases decreased by 53·7% (95% uncertainty interval −56·1 to −51·4), for neoplasms decreased by 28·2% (−32·3 to −24·6), and for transport injuries decreased by 62·1% (−64·6 to −59·2). However, population ageing is causing an increase in the burden of specific diseases, such as Alzheimer's disease and other dementias (DALYs increased by 77·9% [68·4 to 87·2]) and pancreatic (DALYs increased by 39·7% [28·4 to 51·7]) and uterine cancers (DALYs increased by 164·7% [129·7 to 202·5]). Behavioural risk factors, which are potentially modifiable, still have a strong effect, particularly on cardiovascular diseases and neoplasms. For instance, in 2017, 44 400 (41 200 to 47 800) cancer deaths were attributed to smoking, 12 000 (9600 to 14 800) to alcohol use, and 9500 (5400 to 14 200) to high body-mass index, while 47 000 (31 100 to 65 700) deaths due to cardiovascular diseases could be attributed to high LDL cholesterol, 28 700 (19 700 to 38 500) to diets low in whole grains, and 15 900 (8500 to 24 900) to low physical activity. Interpretation: Italy provides an interesting example of the results that can be achieved by a mix of relatively healthy lifestyles and a universal health system. Two main issues require attention, population ageing and gradual decrease of public health financing, which both pose several challenges to the future of Italy's health status. Our findings should be useful to Italy's policy makers and health system experts elsewhere. Funding: Bill & Melinda Gates Foundation.

Published
2019
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11. Cost-Utility Analysis of Bariatric Surgery in Italy: Results of Decision-Analytic Modelling

Author

Marcello Lucchese, Oleg Borisenko, Lorenzo Giovanni Mantovani, Paolo Angelo Cortesi, Giancarlo Cesana, Daniel Adam, Elisabeth Burdukova, Vasily Lukyanov, and Nicola Di Lorenzo

Subjects
Bariatric surgery, Cost-Benefit analysis, Italy, Nutrition. Foods and food supply, TX341-641, Nutritional diseases. Deficiency diseases, RC620-627
Abstract

Objective: To evaluate the cost-effectiveness of bariatric surgery in Italy from a third-party payer perspective over a medium-term (10 years) and a long-term (lifetime) horizon. Methods: A state-transition Markov model was developed, in which patients may experience surgery, post-surgery complications, diabetes mellitus type 2, cardiovascular diseases or die. Transition probabilities, costs, and utilities were obtained from the Italian and international literature. Three types of surgeries were considered: gastric bypass, sleeve gastrectomy, and adjustable gastric banding. A base-case analysis was performed for the population, the characteristics of which were obtained from surgery candidates in Italy. Results: In the base-case analysis, over 10 years, bariatric surgery led to cost increment of EUR 2,661 and generated additional 1.1 quality-adjusted life years (QALYs). Over a lifetime, surgery led to savings of EUR 8,649, additional 0.5 life years and 3.2 QALYs. Bariatric surgery was cost-effective at 10 years with an incremental cost-effectiveness ratio of EUR 2,412/QALY and dominant over conservative management over a lifetime. Conclusion: In a comprehensive decision analytic model, a current mix of surgical methods for bariatric surgery was cost-effective at 10 years and cost-saving over the lifetime of the Italian patient cohort considered in this analysis.

Published
2017
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12. The Value and Sustainability of Ocrelizumab in Relapsing Multiple Sclerosis: A Cost-Effectiveness and Budget Impact Analysis

Author

Paolo Angelo Cortesi, Damiano Paolicelli, Marco Capobianco, Paolo Cozzolino, and Lorenzo Giovanni Mantovani

Subjects
disease modifying therapies, relapsing multiple sclerosis, cost-effectiveness, Medicine (General), R5-920
Abstract

INTRODUCTION: The availability of ocrelizumab for the relapsing forms of multiple sclerosis (MS) in the Italian markets raised some questions about its economic impact and value compared to the alternative treatment options available. AIM: To assess the cost-effectiveness and budget impact of ocrelizumab compared to the most used second line disease modifying therapies (DMTs) in Italy. METHODS: The study was divided in two phases: Phase 1 – based on the development of a decision analytical Markov model to assess the cost-effectiveness of ocrelizumab compared to natalizumab and fingolimod, and Phase 2 – based on the development of a budget impact model to assess the economic impact of ocrelizumab in Italy. Both models used the National Health System perspective; a lifetime horizon was applied in the cost-effectiveness analysis and a 3-year time horizon in the budget impact. The cost-effectiveness analysis results were reported as incremental cost-effectiveness ratio (ICER) expressed as € per Quality Adjusted Life Year (QALY) gained, the budget impact analysis results were reported as difference in the overall budget (€) between a scenario with and without ocrelizumab. RESULTS: The two analyses reported ocrelizumab as a cost-effective option compared to natalizumab and fingolimod with a positive impact on the overall NHS budget. In the base-case analysis, the ICER was € 2,023 for ocrelizumab compared to fingolimod; while ocrelizumab resulted cost-saving compared to natalizumab. The sensitivity analysis confirmed the base-case analysis results. Further, the use of ocrelizumab was associated to a budget decrease of € 21 million (-2.6%) in a 3-year time horizon. CONCLUSION: The results of our cost-effectiveness and budget impact models reported ocrelizumab as an effective and efficient treatment in patients with relapsing forms of MS who failed a first line DMTs from the Italian NHS perspective.

Published
2019
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13. [Cost-effectiveness analysis of delayed-release dimethyl-fumarate in the treatment of relapsing-remitting multiple sclerosis in Italy]

Author

Gianluca Furneri, Laura Santoni, Chiara Marchesi, Sergio Iannazzo, Paolo Angelo Cortesi, Achille Patrizio Caputi, and Lorenzo Giovanni Mantovani

Subjects
disease modifying therapies, multiple sclerosis, cost-effectiveness, Medicine (General), R5-920
Abstract

INTRODUCTION: Disease Modifying Therapies (DMTs) have significantly improved clinical conditions of Relapsing Remitting Multiple Sclerosis (RRMS) patients. However, several unmet needs are still relevant in RRMS. Recently, a new therapy, delayed-release dimethyl-fumarate (DMF; also known as gastro-resistant DMF), has been approved and reimbursed by the Italian Drug Agency (AIFA) for the treatment of RRMS. OBJECTIVE: To compare the cost-effectiveness of DMF vs. pharmacological alternatives indicated for the first-line treatment of RRMS in Italy. METHODS: The analysis was conducted from the perspective of the Italian National Healthcare Service (NHS) and outcomes and costs were evaluated over a 50-year time horizon (equivalent to a lifetime horizon). Both outcomes and costs were discounted at 3.5%. The Markov model estimates the clinical and economic consequences of treating RRMS patients with the following therapeutic options: DMF, interferon (IFN) beta-1a intramuscular (IM); IFN beta-1a subcutaneous (SC) at two different doses, 22 mcg and 44 mcg; IFN beta-1b SC; glatiramer acetate (GA) SC 20 mg; oral teriflunomide. Clinical efficacy data used in this analysis came from an elaboration of the mixed treatment comparison (MTC) already published. According to the Italian NHS perspective, only the following direct costs were considered: pharmacological treatment acquisition, treatment monitoring, relapse management, direct costs associated with disability, adverse event management. Administration costs were assumed equal to €0, because every treatment included in the economic analysis can be self-administered. One-way and probabilistic sensitivity analyses were developed and cost effectiveness acceptability curves generated. RESULTS: In the base-case analysis, DMF was more efficacious than alternatives, in terms of both survival (19.496 vs. 19.297-19.461 discounted LYs, respectively), and QALYs (6.548 vs. 5.172- 6.212 discounted QALYs, respectively). Per-patient lifetime costs with DMF amounted to € 276,500, similarly to the other options. DMF was the drug with the largest effect of disability cost reduction. DMF was dominant vs. IFN beta-1a 44 mcg and cost-effective vs. all other IFNs, GA and teriflunomide, with incremental cost-effectiveness ratio (ICERs) between € 11,272 and € 23,409. All ICER values were lower than the € 50,000 per QALY threshold. One-way sensitivity analysis showed that, for all tested scenarios, ICER of DMF vs. therapeutic alternatives remained favourable (≤ 50.000 €/QALY gained) and the results of probabilistic sensitivity analysis showed that the probability for DMF of being favourable (≤ 50.000 €/QALY gained) was between around 70% and 93%, thus ensuring robustness of the results. CONCLUSIONS: The results of this economic analysis show that, at the current price and the described assumptions, DMF represents a cost-effective option vs. other available first-line treatments indicated in RRMS in the perspective of the Italian NHS. [Article in Italian]

Published
2016
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14. [Tecfidera® (delayed-release dimethylfumarate) in the treatment of relapsing-remitting multiple sclerosis]

Author

Lorenzo Giovanni Mantovani, Gianluca Furneri, Paolo Angelo Cortesi, Maria Pia Amato, Achille Patrizio Caputi, Patrizio Piacentini, Alessandra Solari, Carlo Pozzilli, and Giancarlo Comi

Subjects
delayed-release dimethylfumarate, health technology assessment, relapsing-remitting multiple sclerosis, italy, Medicine (General), R5-920
Abstract

The present health technology assessment (HTA) evaluates the clinical and economic profile of delayed-release dimethylfumarate (DMF, also known as gastro-resistant DMF) in the treatment of relapsing-remitting multiple sclerosis (RRMS) in Italy. Chapter 1 briefly introduces the condition (multiple sclerosis and, more specifically, the relapsing-remitting form) and provides an overall description of the main therapeutic options for physicians, in terms of clinical evidence, regulatory status in Europe and approval status and reimbursement (refunding) criteria in Italy. In the next sections (Chapters 2-5), key-topics regarding RRMS are analysed: epidemiology, clinical burden, quality of life/social impact and the economic implications for healthcare services, patients and society. In Chapter 6, the clinical evidence supporting the use of DMF in RRMS is summarized. Data from phase III randomized clinical trials (DEFINE, CONFIRM), plus the pooled post-hoc analysis of the two studies, were evaluated to assess the level of clinical benefit provided by DMF. Finally, in Chapter 7, a review of the health economic evidence assessing DMF is performed, with a specific focus on Italy. Overall, the methodological quality of registration studies, together with the robustness and consistency of the study results, support the conclusion that DMF is an effective and safe treatment for RRMS. The economic assessment of DMF in Italy, based on cost-effectiveness and budget impact analyses (adopting clinical input data from a mixed treatment comparison and economic input data relative to the Italian healthcare setting), confirm that DMF is a cost-effective and economically sustainable treatment for the Italian National Healthcare Service. These findings are in line with the results of most international publications and the assessments from well-recognized HTA agencies (e.g. NICE/SMC). In summary, both the clinical and economic evidence analyzed in this HTA substantiate DMF as an important therapeutic option for the treatment of RRMS.

Published
2017
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15. [Nintedanib for the treatment of idiopathic pulmonary fibrosis in Italy]

Author

Andrea Belisari, Daria Bettoni, Paolo Angelo Cortesi, Lucia Sara D'Angiolella, Lorenzo Giovanni Mantovani, Gerardo Miceli Sopo, and Marino Nonis

Subjects
nintedanib, idiopathic pulmonary fibrosis, health technology assessment, cost-utility analysisology assessment, cost-utility analysis, Medicine (General), R5-920
Abstract

To date, there are few therapeutic answers for Idiopathic pulmonary fibrosis (IPF) and only two pharmacological treatments have a marketing authorization for this disease. Recently nintedanib (Ofev®) has been authorized as a new therapeutic option and its economic profile has been evaluated by international Health Technology Assessment (HTA) bodies. IPF has important implications for everyday life of patients and their carers, negatively influencing their quality of life and bringing heavy economic burden to the NHS and to the entire society. It is, therefore important to consider these aspects for the Italian environment and to perform a pharmacoeconomic evaluation to define the efficiency of nintedanib in IPF by means of a Cost-Utility Analysis (CUA). As IPF is a chronic and progressive disease, a lifetime Markov model has been therefore developed with health states describing the patient’s condition as a combination of lung function and exacerbation history. The cohort entered in the model at different Forced Vital Capacity (FVC%) predicted health states, without exacerbation. The Clinical data used to perform this CUA were derived from clinical trials and the relative efficacy of nintedanib versus the comparator (pirfenidone) was then obtained from a Network Meta-Analysis (NMA) combining data reported in each primary study (INPULSIS 1-2 and TOMORROW trials for nintedanib, and CAPACITY and ASCEND trials for pirfenidone, respectively). At base-case, treatment with nintedanib resulted in a slightly lower estimated total cost vs pirfenidone, better safety profile and lower risk of acute exacerbations with an advantage in Quality Adjusted Life years (QALYs) gained. These results were confirmed by the sensitivity analysis. Although nintedanib appears to be a valuable option for the NHS to treat IPF patients, future data evidence, as long-term or real-life data, will help to confirm these results. [In Italian]

Published
2017
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17. Cost-effectiveness analysis of oral fentanyl formulations for breakthrough cancer pain treatment.

Author

Paolo Angelo Cortesi, Lucia Sara D'Angiolella, Renato Vellucci, Massimo Allegri, Giuseppe Casale, Carlo Favaretti, Flavia Kheiraoui, Giancarlo Cesana, and Lorenzo Giovanni Mantovani

Subjects
Medicine, Science
Abstract

Breakthrough cancer Pain (BTcP) has a high prevalence in cancer population. Patients with BTcP reported relevant health care costs and poor quality of life. The study assessed the cost-effectiveness of the available Oral Fentanyl Formulations (OFFs) for BTcP in Italy. A decision-analytical model was developed to estimate costs and benefits associated with treatments, from the Italian NHS perspective. Expected reductions in pain intensity per BTcP episodes were translated into, percentage of BTcP reduction, resource use and Quality-Adjusted-Life-Years (QALYs). Relative efficacy, resources used and unit costs data were derived from the literature and validated by clinical experts. Probabilistic and deterministic sensitivity analyses were performed. At base-case analysis, Sublingual Fentanyl Citrate (FCSL) compared to other oral formulations reported a lower patient's cost (€1,960.8) and a higher efficacy (18.7% of BTcP avoided and 0.0507 QALYs gained). The sensitivity analyses confirmed the main results in all tested scenarios, with the highest impact reported by BTcP duration and health care resources consumption parameters. Between OFFs, FCSL is the cost-effective option due to faster reduction of pain intensity. However, new research is needed to better understand the economic and epidemiologic impact of BTcP, and to collect more robust data on economic and quality of life impact of the different fentanyl formulations. Different fentanyl formulations are available to manage BTcP in cancer population. The study is the first that assesses the different impact in terms of cost and effectiveness of OFFs, providing new information to better allocate the resources available to treat BTcP and highlighting the need of better data.

Published
2017
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18. Abstract P6-08-01: A cost-consequence analysis of pertuzumab in the neoadjuvant treatment of high-risk HER2+ Early-Stage Breast Cancer (EBC): health-economic considerations for drug availability in Italy

Author

Alberto Zambelli, Marina Elena Cazzaniga, Nicla La Verde, Elisabetta Munzone, Ippazio Cosimo Antonazzo, Lorenzo Giovanni Mantovani, Anna Mancuso, Daniele G. Generali, and Paolo Angelo Cortesi

Subjects
Cancer Research, Oncology
Abstract

Introduction: Neoadjuvant pertuzumab+trastuzumab+chemotherapy (TPC) combo is a well established treatment for HER2+ high-risk (EBC) as recommended by International and National guidelines. However, notwithstanding EMA approval, in some European countries (i.e Italy and France) pertuzumab drug-access is prevented by the NHS decision not to reimburse the drug in a value-driven sustainability balance. This study aims to estimate the cost and consequences of TPC vs. the same combo w/o pertuzumab (TC) in the neaodjuvant treatment of high-risk HER2+ eBC to better understand the value of TPC regimen. Methods: With a Markov model, we simulated the costs and consequences associated to TPC or TC neoadjuvant treatments, using 5 years time horizon and Italian Lombardy region Health System point of view. The model includes nine health states: Neoadjuvant treatment; Surgery; Invasive disease-free Survival (IDFS) with pathological complete response (pCR), IDFS with residual disease (RD), non-metastatic recurrence, remission, first-line treatment and subsequent-lines for metastatic cancer, and death. Transition probabilities and utilities were derived from relevant clinical trials and literature. For each neoadjuvant treatment, the model estimates: direct (drug, administration, hospitalization, disease management), indirect (patients’ loss of productivity), total costs and different outcomes, as cumulative incidence of metastatic recurrence, days of work lost, days with activity impairment, IDFS life years, and quality adjusted life years (QALY). Costs and outcomes were estimated per 100-treated patients. An alternative scenario analysis with a 10-year time horizon and a deterministic sensitivity analysis was performed to assess the impact of model time horizon and parameters value. Results: The estimated costs and outcomes for TPC and TC are reported in Table 1. TPC produces a total direct cost reduction of €75,630 per 100-treated patients, a small increase of TPC neoadjuvant treatment costs (+4.8%) is offset by the lower cost of metastatic treatment and management (-20.4%). Considering also the indirect costs, TPC is associated to a cost reduction of €124,956 per 100-treated patients. The cost saving is associated to a reduction of 5-year cumulative incidence metastatic recurrence (8.32% vs 10.42%, -20.14%), a reduction of days of work loss (-548 days) and days with activity impairment (-283 days) and a 10.5 QALY gained per 100-treated patients. Using a 10-year time horizon, the value of TPC compared to TC increases. Probabilities of pCR with TPC and TC were the parameter with the higher impact on model results. Conclusion: Use of TC instead of TPC in high-risk HER2+ EBC derives a marginal savings (4.8%) according to the first year of our cost-consequence analysis. However, this negligible savings comes with the need for a heavily and long-lasting adjuvant cytotoxic therapy escalation because of a lower clinical activity of TC vs TPC. Moreover, according to medium-term cost-consequence analysis (5 years) the early negligible savings is overwhelmed by the subsequent increase in costs for the patients’ management, because of the lower clinical efficacy of TC vs. TPC. In Italy, the lack of pertuzumab in the neoadjuvant setting of high-risk HER2+ eBC is questionable; our results support the opportunity to reconsider the pertuzumab availability in Italy and reduce inequalities within Europe. Cost and consequences of neoadjuvant treatments for high-risk HER2-Positive Early-Stage Breast Cancer: trastuzuamb+pertuzumab+chemotheraphy (TPC) vs trastuzumab+chemotheraphy (TC) IDFS, Invasive disease-free Survival; QALY, quality adjusted life years. Citation Format: Alberto Zambelli, Marina Elena Cazzaniga, Nicla La Verde, Elisabetta Munzone, Ippazio Cosimo Antonazzo, Lorenzo Giovanni Mantovani, Anna Mancuso, Daniele G. Generali, Paolo Angelo Cortesi. A cost-consequence analysis of pertuzumab in the neoadjuvant treatment of high-risk HER2+ Early-Stage Breast Cancer (EBC): health-economic considerations for drug availability in Italy [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-08-01.

Published
2023

19. The value of wearable cardioverter defibrillator in adult patients with recent myocardial infarction: Economic and clinical implications from a health technology assessment perspective

Author

Giovanni Luca Botto, Lorenzo Giovanni Mantovani, Paolo Angelo Cortesi, Roberto De Ponti, Antonio D'Onofrio, Mauro Biffi, Alessandro Capucci, Gavino Casu, Pasquale Notarstefano, Marco Scaglione, Gabriele Zanotto, Giuseppe Boriani, Botto, G, Mantovani, L, Cortesi, P, De Ponti, R, D'Onofrio, A, Biffi, M, Capucci, A, Casu, G, Notarstefano, P, Scaglione, M, Zanotto, G, and Boriani, G

Subjects
Adult, Quality of life, Technology Assessment, Biomedical, MED/42 - IGIENE GENERALE E APPLICATA, Electric Countershock, Defibrillators, Implantable, Wearable Electronic Devices, Myocardial infarction, Sudden cardiac death, Death, Sudden, Cardiac, Cost-effectivene, Humans, Cost-effectiveness, Health technology assessment, Wearable cardioverter defibrillator, Cardiology and Cardiovascular Medicine, Defibrillators
Abstract

Aims: Sudden cardiac death (SCD) causes high mortality and substantial societal burdens for healthcare systems (HSs). The risk of SCD is significantly increased in patients with reduced left ventricular ejection fraction after myocardial infarction (MI). Current guidelines recommend re-evaluation of cardioverter-defibrillator implantation 40 days post-MI, earliest. Medical therapy alone does not provide sufficient protection against SCD, especially in the first month post-MI, and needs time. Consequently, there is a gap in care of high-risk patients upon hospital discharge. The wearable cardioverter defibrillator (WCD) is a proven safe, effective therapy, which temporarily protects from SCD. Little information on WCD cost-effectiveness exists. We conducted this research to demonstrate the medical need of the device in the post-MI setting defining WCD cost-effectiveness. Methods & results: Based on a randomized clinical trials (RCTs) and Italian and international data, we developed a Markov-model comparing costs, patient survival, and quality-of-life, and calculated the Incremental Cost-Effectiveness Ratio (ICER) of a WCD vs. current standard of care in post-MI patients. The rather conservative base case analysis – based on the RCT intention-to-treat results - produced an ICER of €47,709 per Quality Adjusted Life Year (QALY) gained, which is far lower than the accepted threshold of €60,000 in the Italian National HS. The ICER per Life Year (LY) gained was €38,276. Conclusion: WCD utilization in post-MI patients is clinically beneficial and cost-effective. While improving guideline directed patient care, the WCD can also contribute to a more efficient use of resources in the Italian HS, and potentially other HSs as well.

Published
2022

20. Statins Use in Patients with Cardiovascular Diseases and COVID-19 Outcomes: An Italian Population-Based Cohort Study

Author

Ippazio Cosimo Antonazzo, Carla Fornari, Davide Rozza, Sara Conti, Raffaella Di Pasquale, Paolo Angelo Cortesi, Shaniko Kaleci, Pietro Ferrara, Alberto Zucchi, Giovanni Maifredi, Andrea Silenzi, Giancarlo Cesana, Lorenzo Giovanni Mantovani, Giampiero Mazzaglia, Antonazzo, I, Fornari, C, Rozza, D, Conti, S, Di Pasquale, R, Cortesi, P, Kaleci, S, Ferrara, P, Zucchi, A, Maifredi, G, Silenzi, A, Cesana, G, Mantovani, L, and Mazzaglia, G

Subjects
pharmacoepidemiology, ICU acce, public health, statin, COVID-19, General Medicine, mechanical ventilation, mortality, statins, ICU access
Abstract

Background: The role of statins among patients with established cardiovascular diseases (CVDs) who are hospitalized with COVID-19 is still debated. This study aimed at assessing whether the prior use of statins was associated with a less severe COVID-19 prognosis. Methods: Subjects with CVDs infected with SARS-CoV-2 and hospitalized between 20 February 2020 and 31 December 2020 were selected. These were classified into two mutually exclusive groups: statins-users and non-users of lipid-lowering therapies (non-LLT users). The relationship between statins exposure and the risk of Mechanical Ventilation (MV), Intensive Care Unit (ICU) access and death were evaluated by using logistic and Cox regressions models. Results: Of 1127 selected patients, 571 were statins-users whereas 556 were non-LLT users. The previous use of statins was not associated with a variation in the risk of need of MV (Odds Ratio [OR]: 1.00; 95% Confidence Intervals [CI]: 0.38–2.67), ICU access (OR: 0.54; 95% CI: 0.22–1.32) and mortality at 14 days (Hazard Ratio [HR]: 0.42; 95% CI: 0.16–1.10). However, a decreased risk of mortality at 30 days (HR: 0.39; 95% CI: 0.18–0.85) was observed in statins-users compared with non-LLT users. Conclusions: These findings support the clinical advice for patients CVDs to continue their treatment with statins during SARS-CoV-2 infection.

Published
2022

22. Real-World Clinical Outcomes and Replacement Factor VIII Consumption in Patients with Haemophilia A in Italy: A Comparison between Prophylaxis Pre and Post Octocog Alfa (BAY 81-8973)

Author

Paolo Angelo Cortesi, Giovanni Di Minno, Ezio Zanon, Gaetano Giuffrida, Rita Carlotta Santoro, Renato Marino, Lucia Sara D’Angiolella, Ippazio Cosimo Antonazzo, Ginevra Squassabia, Francesco Clemente, Danilo Di Laura, Ernesto Cimino, Samantha Pasca, Daniela Nicolosi, Lorenzo Giovanni Mantovani, Cortesi, P, Di Minno, G, Zanon, E, Giuffrida, G, Santoro, R, Marino, R, D'Angiolella, L, Antonazzo, I, Squassabia, G, Clemente, F, Di Laura, D, Cimino, E, Pasca, S, Nicolosi, D, and Mantovani, L

Subjects
haemophilia A, treatment burden, cost-effectiveness, infusion frequency, cost-effectivene, General Medicine
Abstract

(1) Background: new generations of rFVIII products offered the possibility to improve personalized therapeutic approaches, reducing the number of infusions or increasing the protection against bleeding risk. The aim of this study was to assess the effectiveness of prophylaxis with BAY 81-8973 (octocog alfa, Kovaltry®, Bayer Pharma AG) in the real-world setting and its impact on FVIII consumption compared to previous standard half-life treatments. (2) Methods: a retrospective observational study was conducted in five Italian Haemophilia Centers. Patients with haemophilia A under prophylactic treatment with BAY 81-8973 for at least one year, and previously on prophylaxis with a different product were included in the study. Annual bleeding rate (ABR) and annual FVIII consumption were compared. (3) Results: forty-four patients were included in the study. After switching to BAY 81-8973, ABR was significantly reduced (1.76 vs. 0.23; p = 0.015), the percentage of patients with zero bleeds increased from 54.6% to 84.1% (p = 0.003), and the overall FVIII consumption decreased by 25,542 (−7.2%, p = 0.046) IU per patient-year. Patients treated every 3 days or 2 times per week increased from 0% to 27.3%. (4) Conclusion: our results suggest that prophylaxis with BAY 81-8973 can improve clinical outcomes and reduce FVIII consumption, in the real-world practice, compared with the previous prophylaxis regimen with standard half-life products.

Published
2022

23. Haemophilia management and treatment: An Italian survey on patients', caregivers' and clinicians' point of view

Author

Paolo Angelo Cortesi, Angiola Rocino, Daniele Preti, Anna Fragomeno, Francesco Cucuzza, Nicola Ceresi, Cristina Santoro, Antonietta Ferretti, Arianna Fornari, Ippazio Cosimo Antonazzo, Rita Facchetti, Paolo Cozzolino, Chiara Biasoli, Cristina Cassone, Antonio Coppola, Lorenzo G. Mantovani, Cortesi, P, Rocino, A, Preti, D, Fragomeno, A, Cucuzza, F, Ceresi, N, Santoro, C, Ferretti, A, Fornari, A, Antonazzo, I, Facchetti, R, Cozzolino, P, Biasoli, C, Cassone, C, Coppola, A, and Mantovani, L

Subjects
Adult, treatment, prophylaxi, haemophilia, Hematology, General Medicine, Hemophilia A, acce, Caregivers, Italy, comprehensive care, Surveys and Questionnaires, Quality of Life, Humans, survey, Child, Genetics (clinical)
Abstract

Introduction: Haemophilia management and patients’ quality of life significantly improved. However, data on current patients’, caregivers’ and clinicians’ satisfaction and limitations of treatments and haemophilia management are limited. Aim: Assessing the management satisfaction and unmet needs from the perspective of Italian patients with haemophilia (PWH) without inhibitors (or caregivers if children) and of specialist physicians. Methods: Surveys (for patients≥18 years, caregivers of children and haemophilia specialists) were developed by a multidisciplinary working group and conducted from November 2019 to June 2020. Results: Among 275 participants, 120 (43.6%) were PWH without inhibitors, 79 (28.7%) caregivers and 37 (13.4%) clinicians. Patients and caregivers perceived a higher control of the disease compared to clinicians. However, more than 40% of patients and caregivers reported to feel significantly conditioned by the risk of bleeding during their daily life. PWH reported a 6-month mean/median (range) of bleeds 2.3/.0 (0-24) and caregivers 1.3/.0 (0-16) in children. The treatment burden (frequency of administration) was not satisfactory for more than half adults and caregivers of children treated with prophylaxis. A good access to treatment, haemophilia centres and medical service was reported, with issues associated to the multidisciplinary approach and treatment at emergency department. Conclusions: This large national study provides an updated overview of haemophilia care in Italy from different points of views, highlighting positive aspects and unmet needs. This information can guide future interventions to improve haemophilia management and the assessment of impact of new treatment options.

Published
2022

24. Global, regional, and national burden of hepatitis B, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019

Author

Brittney S Sheena, Lindsey Hiebert, Hannah Han, Helen Ippolito, Mohsen Abbasi-Kangevari, Zeinab Abbasi-Kangevari, Hedayat Abbastabar, Amir Abdoli, Hiwa Abubaker Ali, Mesafint Molla Adane, Oyelola A Adegboye, Qorinah Estiningtyas Sakilah Adnani, Shailesh M Advani, Muhammad Sohail Afzal, Saira Afzal, Mohamad Aghaie Meybodi, Bahman Ahadinezhad, Bright Opoku Ahinkorah, Sajjad Ahmad, Tauseef Ahmad, Sepideh Ahmadi, Haroon Ahmed, Muktar Beshir Ahmed, Tarik Ahmed Rashid, Gizachew Taddesse Akalu, Addis Aklilu, Tayyaba Akram, Hanadi Al Hamad, Fares Alahdab, Adugnaw Zeleke Alem, Dejene Tsegaye Alem, Fadwa Alhalaiqa Naji Alhalaiqa, Robert Kaba Alhassan, Liaqat Ali, Muhammad Ashar Ali, Yousef Alimohamadi, Vahid Alipour, Motasem Alkhayyat, Sami Almustanyir, Rajaa M Al-Raddadi, Haya Altawalah, Saeed Amini, Hubert Amu, Robert Ancuceanu, Catalina Liliana Andrei, Tudorel Andrei, Amir Anoushiravani, Adnan Ansar, Anayochukwu Edward Anyasodor, Jalal Arabloo, Morteza Arab-Zozani, Ayele Mamo Argaw, Zeleke Gebru Argaw, Muhammad Arshad, Anton A Artamonov, Tahira Ashraf, Daniel Atlaw, Floriane Ausloos, Marcel Ausloos, Sina Azadnajafabad, Mohammadreza Azangou-Khyavy, Amirhossein Azari Jafari, Ghasem Azarian, Sayna Bagheri, Saeed Bahadory, Atif Amin Baig, Maciej Banach, Nastaran Barati, Amadou Barrow, Abdul-Monim Mohammad Batiha, Diana Fernanda Bejarano Ramirez, Uzma Iqbal Belgaumi, Alemshet Yirga Berhie, Devidas S Bhagat, Nikha Bhardwaj, Pankaj Bhardwaj, Krittika Bhattacharyya, Vijayalakshmi S Bhojaraja, Ali Bijani, Antonio Biondi, Belay Boda Abule Bodicha, Hunduma Amensisa Bojia, Archith Boloor, Cristina Bosetti, Dejana Braithwaite, Nikolay Ivanovich Briko, Zahid A Butt, Luis Alberto Cámera, Raja Chandra Chakinala, Promit Ananyo Chakraborty, Jaykaran Charan, Shu Chen, Jee-Young Jasmine Choi, Sonali Gajanan Choudhari, Fazle Rabbi Chowdhury, Dinh-Toi Chu, Sheng-Chia Chung, Paolo Angelo Cortesi, Benjamin C Cowie, Garland T Culbreth, Omid Dadras, Xiaochen Dai, Lalit Dandona, Rakhi Dandona, Fernando Pio De la Hoz, Sisay Abebe Debela, Mohammed Gebre Dedefo, Feleke Mekonnen Demeke, Takele Gezahegn G Demie, Getu Debalkie Demissie, Meseret Derbew Molla, Abebaw Alemayehu Desta, Deepak Dhamnetiya, Mandira Lamichhane Dhimal, Meghnath Dhimal, Mojtaba Didehdar, Linh Phuong Doan, Fariba Dorostkar, Thomas M Drake, Fatemeh Eghbalian, Michael Ekholuenetale, Iman El Sayed, Maysaa El Sayed Zaki, Muhammed Elhadi, Mohamed A Elmonem, Aisha Elsharkawy, Shymaa Enany, Daniel Berhanie Enyew, Ryenchindorj Erkhembayar, Sharareh Eskandarieh, Firooz Esmaeilzadeh, Sayeh Ezzikouri, Hossein Farrokhpour, Getahun Fetensa, Florian Fischer, Masoud Foroutan, Mohamed M Gad, Abhay Motiramji Gaidhane, Shilpa Gaidhane, Natalie C Galles, Silvano Gallus, Teferi Gebru Gebremeskel, Eyob Alemayehu Gebreyohannes, Keyghobad Ghadiri, Kazem Ghaffari, Mansour Ghafourifard, Seyyed-Hadi Ghamari, Ahmad Ghashghaee, Ali Gholami, Abdolmajid Gholizadeh, Aima Gilani, Amit Goel, Mahaveer Golechha, Pouya Goleij, Davide Golinelli, Giuseppe Gorini, Yitayal Ayalew Goshu, Max G Griswold, Mohammed Ibrahim Mohialdeen Gubari, Bhawna Gupta, Sapna Gupta, Veer Bala Gupta, Vivek Kumar Gupta, Rasool Haddadi, Rabih Halwani, Saeed S Hamid, Samer Hamidi, Asif Hanif, Shafiul Haque, Harapan Harapan, Arief Hargono, Sanam Hariri, Ahmed I Hasaballah, S M Mahmudul Hasan, Soheil Hassanipour, Hadi Hassankhani, Simon I Hay, Khezar Hayat, Golnaz Heidari, Claudiu Herteliu, Demisu Zenbaba Heyi, Kamal Hezam, Ramesh Holla, Mohammad-Salar Hosseini, Mostafa Hosseini, Mehdi Hosseinzadeh, Mihaela Hostiuc, Mowafa Househ, Junjie Huang, Nawfal R Hussein, Ivo Iavicoli, Segun Emmanuel Ibitoye, Olayinka Stephen Ilesanmi, Irena M Ilic, Milena D Ilic, Lalu Muhammad Irham, Jessica Y Islam, Nahlah Elkudssiah Ismail, Kathryn H Jacobsen, Farhad Jadidi-Niaragh, Amirreza Javadi Mamaghani, Shubha Jayaram, Ranil Jayawardena, Rime Jebai, Ravi Prakash Jha, Nitin Joseph, Farahnaz Joukar, Billingsley Kaambwa, Ali Kabir, Zubair Kabir, Rohollah Kalhor, Himal Kandel, Tesfaye K Tesfaye Kanko, Rami S Kantar, Ibraheem M Karaye, Bekalu Getnet Kassa, Phillip M Kemp Bohan, Mohammad Keykhaei, Yousef Saleh Khader, Himanshu Khajuria, Gulfaraz Khan, Imteyaz A Khan, Junaid Khan, Moien AB Khan, Javad Khanali, Amir M Khater, Mahalaqua Nazli Khatib, Mahmoud Khodadost, Abdullah T Khoja, Omid Khosravizadeh, Jagdish Khubchandani, Gyu Ri Kim, Hanna Kim, Min Seo Kim, Yun Jin Kim, Jonathan M Kocarnik, Ali-Asghar Kolahi, Rajasekaran Koteeswaran, G Anil Kumar, Carlo La Vecchia, Dharmesh Kumar Lal, Iván Landires, Savita Lasrado, Jeffrey V Lazarus, Caterina Ledda, Doo Woong Lee, Sang-woong Lee, Yeong Yeh Lee, Miriam Levi, Jiarui Li, Stephen S Lim, Stany W Lobo, Platon D Lopukhov, Joana A Loureiro, Jennifer H MacLachlan, Hassan Magdy Abd El Razek, Muhammed Magdy Abd El Razek, Azeem Majeed, Alaa Makki, Mohammad-Reza Malekpour, Reza Malekzadeh, Ahmad Azam Malik, Fariborz Mansour-Ghanaei, Mohammad Ali Mansournia, Francisco Rogerlândio Martins-Melo, Philippa C Matthews, Walter Mendoza, Ritesh G Menezes, Tuomo J Meretoja, Amanual Getnet Mersha, Tomislav Mestrovic, Ted R Miller, Le Huu Nhat Minh, Andreea Mirica, Seyyedmohammadsadeq Mirmoeeni, Erkin M Mirrakhimov, Sanjeev Misra, Prasanna Mithra, Babak Moazen, Ashraf Mohamadkhani, Mokhtar Mohammadi, Shafiu Mohammed, Nagabhishek Moka, Ali H Mokdad, Jalal Moludi, Sara Momtazmanesh, Lorenzo Monasta, Ghobad Moradi, Maliheh Moradzadeh, Rahmatollah Moradzadeh, Paula Moraga, Ebrahim Mostafavi, Sumaira Mubarik, Malaisamy Muniyandi, Christopher J L Murray, Mohsen Naghavi, Mukhammad David Naimzada, Sreenivas Narasimha Swamy, Zuhair S Natto, Biswa Prakash Nayak, Javad Nazari, Ionut Negoi, Serban Mircea Negru, Seyed Aria Nejadghaderi, Sandhya Neupane Kandel, Huong Lan Thi Nguyen, Che Henry Ngwa, Robina Khan Niazi, Chukwudi A Nnaji, Jean Jacques Noubiap, Ali Nowroozi, Virginia Nuñez-Samudio, Bogdan Oancea, Chimedsuren Ochir, Oluwakemi Ololade Odukoya, In-Hwan Oh, Andrew T Olagunju, Babayemi Oluwaseun Olakunde, Ahmed Omar Bali, Emad Omer, Stanislav S Otstavnov, Bilcha Oumer, Jagadish Rao Padubidri, Adrian Pana, Anamika Pandey, Eun-Cheol Park, Fatemeh Pashazadeh Kan, Urvish K Patel, Uttam Paudel, Ionela-Roxana Petcu, Zahra Zahid Piracha, Richard Charles G Pollok, Maarten J Postma, Akram Pourshams, Hossein Poustchi, Mohammad Rabiee, Navid Rabiee, Alireza Rafiei, Sima Rafiei, Pavan Manibettu Raghuram, Mosiur Rahman, Amir Masoud Rahmani, Setyaningrum Rahmawaty, Aashish Rajesh, Priyanga Ranasinghe, Chythra R Rao, Sowmya J Rao, Mahsa Rashidi, Mohammad-Mahdi Rashidi, David Laith Rawaf, Salman Rawaf, Reza Rawassizadeh, Negar Rezaei, Aziz Rezapour, Sahba Rezazadeh-Khadem, Jefferson Antonio Buendia Rodriguez, Godfrey M Rwegerera, Siamak Sabour, Basema Saddik, Mohammad Reza Saeb, Umar Saeed, Amirhossein Sahebkar, KM Saif-Ur-Rahman, Sarvenaz Salahi, Hamideh Salimzadeh, Chethan Sampath, Abdallah M Samy, Juan Sanabria, Francesco Sanmarchi, Milena M Santric-Milicevic, Arash Sarveazad, Brijesh Sathian, Monika Sawhney, Abdul-Aziz Seidu, Sadaf G Sepanlou, Allen Seylani, Saeed Shahabi, Masood Ali Shaikh, Elaheh Shaker, Murad Ziyaudinovich Shakhmardanov, Mohammed Shannawaz, Suchitra M Shenoy, Jeevan K Shetty, Pavanchand H Shetty, Kenji Shibuya, Jae Il Shin, Parnian Shobeiri, Migbar Mekonnen Sibhat, Achintya Dinesh Singh, Jasvinder A Singh, Surjit Singh, Valentin Yurievich Skryabin, Anna Aleksandrovna Skryabina, Amir Ali Sohrabpour, Suhang Song, Seidamir Pasha Tabaeian, Eyayou Girma Tadesse, Majid Taheri, Mircea Tampa, Ker-Kan Tan, Ahmad Tavakoli, Abdelghani Tbakhi, Belay Negash Tefera, Arash Tehrani-Banihashemi, Habtamu Molla Tesfaw, Rekha Thapar, Aravind Thavamani, Seyed Abolfazl Tohidast, Daniel Nigusse Tollosa, Maria Elena Tosti, Marcos Roberto Tovani-Palone, Eugenio Traini, Mai Thi Ngoc Tran, Indang Trihandini, Biruk Shalmeno Tusa, Irfan Ullah, Marco Vacante, Sahel Valadan Tahbaz, Pascual R Valdez, Shoban Babu Varthya, Bay Vo, Yasir Waheed, Adisu Birhanu Weldesenbet, Melat Woldemariam, Suowen Xu, Seyed Hossein Yahyazadeh Jabbari, Mehdi Yaseri, Yigizie Yeshaw, Vahit Yiğit, Birhanu Wubale Yirdaw, Naohiro Yonemoto, Chuanhua Yu, Ismaeel Yunusa, Mazyar Zahir, Leila Zaki, Mohammad Zamani, Maryam Zamanian, Mikhail Sergeevich Zastrozhin, Theo Vos, John W Ward, M Ashworth Dirac, Value, Affordability and Sustainability (VALUE), Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), Microbes in Health and Disease (MHD), Sheena, Brittney S, Hiebert, Lindsey, Han, Hannah, Ippolito, Helen, Abbasi-Kangevari, Mohsen, Abbasi-Kangevari, Zeinab, Abbastabar, Hedayat, Abdoli, Amir, Abubaker Ali, Hiwa, Adane, Mesafint Molla, Adegboye, Oyelola A, Adnani, Qorinah Estiningtyas Sakilah, Advani, Shailesh M, Afzal, Muhammad Sohail, Afzal, Saira, Aghaie Meybodi, Mohamad, Ahadinezhad, Bahman, Ahinkorah, Bright Opoku, Ahmad, Sajjad, Ahmad, Tauseef, Ahmadi, Sepideh, Ahmed, Haroon, Ahmed, Muktar Beshir, Ahmed Rashid, Tarik, Akalu, Gizachew Taddesse, Aklilu, Addi, Akram, Tayyaba, Al Hamad, Hanadi, Alahdab, Fare, Alem, Adugnaw Zeleke, Alem, Dejene Tsegaye, Alhalaiqa, Fadwa Alhalaiqa Naji, Alhassan, Robert Kaba, Ali, Liaqat, Ali, Muhammad Ashar, Alimohamadi, Yousef, Alipour, Vahid, Alkhayyat, Motasem, Almustanyir, Sami, Al-Raddadi, Rajaa M, Altawalah, Haya, Amini, Saeed, Amu, Hubert, Ancuceanu, Robert, Andrei, Catalina Liliana, Andrei, Tudorel, Anoushiravani, Amir, Ansar, Adnan, Anyasodor, Anayochukwu Edward, Arabloo, Jalal, Arab-Zozani, Morteza, Argaw, Ayele Mamo, Argaw, Zeleke Gebru, Arshad, Muhammad, Artamonov, Anton A, Ashraf, Tahira, Atlaw, Daniel, Ausloos, Floriane, Ausloos, Marcel, Azadnajafabad, Sina, Azangou-Khyavy, Mohammadreza, Azari Jafari, Amirhossein, Azarian, Ghasem, Bagheri, Sayna, Bahadory, Saeed, Baig, Atif Amin, Banach, Maciej, Barati, Nastaran, Barrow, Amadou, Batiha, Abdul-Monim Mohammad, Bejarano Ramirez, Diana Fernanda, Belgaumi, Uzma Iqbal, Berhie, Alemshet Yirga, Bhagat, Devidas S, Bhardwaj, Nikha, Bhardwaj, 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Y., Ismail, N. E., Jacobsen, K. H., Jadidi-Niaragh, F., Javadi Mamaghani, A., Jayaram, S., Jayawardena, R., Jebai, R., Jha, R. P., Joseph, N., Joukar, F., Kaambwa, B., Kabir, A., Kabir, Z., Kalhor, R., Kandel, H., Kanko, T. K. T., Kantar, R. S., Karaye, I. M., Kassa, B. G., Kemp Bohan, P. M., Keykhaei, M., Khader, Y. S., Khajuria, H., Khan, G., Khan, I. A., Khan, J., Khan, M. A., Khanali, J., Khater, A. M., Khatib, M. N., Khodadost, M., Khoja, A. T., Khosravizadeh, O., Khubchandani, J., Kim, G. R., Kim, H., Kim, M. S., Kim, Y. J., Kocarnik, J. M., Kolahi, A. -A., Koteeswaran, R., Kumar, G. A., La Vecchia, C., Lal, D. K., Landires, I., Lasrado, S., Lazarus, J. V., Ledda, C., Lee, D. W., Lee, S. -W., Lee, Y. Y., Levi, M., Li, J., Lim, S. S., Lobo, S. W., Lopukhov, P. D., Loureiro, J. A., Maclachlan, J. H., Magdy Abd El Razek, H., Magdy Abd El Razek, M., Majeed, A., Makki, A., Malekpour, M. -R., Malekzadeh, R., Malik, A. A., Mansour-Ghanaei, F., Mansournia, M. A., Martins-Melo, F. 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Subjects
Liver Cirrhosis, Hepatology, Seroepidemiologic Studies, 3121 General medicine, internal medicine and other clinical medicine, Liver Neoplasms, Gastroenterology, Humans, Bayes Theorem, HBV, Global burden of diseases, HCC, Cirrhosis, Child, Hepatitis B, Global Burden of Disease
Abstract

Publisher Copyright: © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Background: Combating viral hepatitis is part of the UN Sustainable Development Goals (SDGs), and WHO has put forth hepatitis B elimination targets in its Global Health Sector Strategy on Viral Hepatitis (WHO-GHSS) and Interim Guidance for Country Validation of Viral Hepatitis Elimination (WHO Interim Guidance). We estimated the global, regional, and national prevalence of hepatitis B virus (HBV), as well as mortality and disability-adjusted life-years (DALYs) due to HBV, as part of the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019. This included estimates for 194 WHO member states, for which we compared our estimates to WHO elimination targets. Methods: The primary data sources were population-based serosurveys, claims and hospital discharges, cancer registries, vital registration systems, and published case series. We estimated chronic HBV infection and the burden of HBV-related diseases, defined as an aggregate of cirrhosis due to hepatitis B, liver cancer due to hepatitis B, and acute hepatitis B. We used DisMod-MR 2.1, a Bayesian mixed-effects meta-regression tool, to estimate the prevalence of chronic HBV infection, cirrhosis, and aetiological proportions of cirrhosis. We used mortality-to-incidence ratios modelled with spatiotemporal Gaussian process regression to estimate the incidence of liver cancer. We used the Cause of Death Ensemble modelling (CODEm) model, a tool that selects models and covariates on the basis of out-of-sample performance, to estimate mortality due to cirrhosis, liver cancer, and acute hepatitis B. Findings: In 2019, the estimated global, all-age prevalence of chronic HBV infection was 4·1% (95% uncertainty interval [UI] 3·7 to 4·5), corresponding to 316 million (284 to 351) infected people. There was a 31·3% (29·0 to 33·9) decline in all-age prevalence between 1990 and 2019, with a more marked decline of 76·8% (76·2 to 77·5) in prevalence in children younger than 5 years. HBV-related diseases resulted in 555 000 global deaths (487 000 to 630 000) in 2019. The number of HBV-related deaths increased between 1990 and 2019 (by 5·9% [–5·6 to 19·2]) and between 2015 and 2019 (by 2·9% [–5·9 to 11·3]). By contrast, all-age and age-standardised death rates due to HBV-related diseases decreased during these periods. We compared estimates for 2019 in 194 WHO locations to WHO-GHSS 2020 targets, and found that four countries achieved a 10% reduction in deaths, 15 countries achieved a 30% reduction in new cases, and 147 countries achieved a 1% prevalence in children younger than 5 years. As of 2019, 68 of 194 countries had already achieved the 2030 target proposed in WHO Interim Guidance of an all-age HBV-related death rate of four per 100 000. Interpretation: The prevalence of chronic HBV infection declined over time, particularly in children younger than 5 years, since the introduction of hepatitis B vaccination. HBV-related death rates also decreased, but HBV-related death counts increased as a result of population growth, ageing, and cohort effects. By 2019, many countries had met the interim seroprevalence target for children younger than 5 years, but few countries had met the WHO-GHSS interim targets for deaths and new cases. Progress according to all indicators must be accelerated to meet 2030 targets, and there are marked disparities in burden and progress across the world. HBV interventions, such as vaccination, testing, and treatment, must be strategically supported and scaled up to achieve elimination. Funding: Bill & Melinda Gates Foundation.

Published
2022

25. The Value of Tucatinib in Metastatic HER2-Positive Breast Cancer Patients: An Italian Cost-Effectiveness Analysis

Author

Ippazio Cosimo Antonazzo, Paolo Angelo Cortesi, Gerardo Miceli Sopo, Giampiero Mazzaglia, Pierfranco Conte, Lorenzo Giovanni Mantovani, Antonazzo, I, Cortesi, P, Miceli Sopo, G, Mazzaglia, G, Conte, P, and Mantovani, L

Subjects
Cancer Research, breast cancer, Italy, Oncology, TDM-1, cost-effectiveness analysis, tucatinib, cost-effectiveness analysi
Abstract

Background: This study was aimed at estimating the appropriate price of tucatinib plus trastuzumab and capecitabine (TXC), as third-line treatment, in HER2+ breast cancer (BC) patients from the Italian National Health System (NHS) perspective. Methods: A partitioned survival model with three mutually exclusive health states (i.e., progression-free survival (PFS), progressive disease (PD), and death) was used to estimate the price of tucatinib vs trastuzumab emtansine (TDM-1), considering a willingness to pay (WTP) of 60,000 EUR. Data from the HER2CLIMB trial, the Italian population, and the literature were used as input. The model also estimated the total costs and the life-years (LY) of TXC and TDM1. Deterministic and probabilistic (PSA) sensitivity analyses were conducted to evaluate the robustness of the model. Results: In the base case scenario, the appropriate price of tucatinib was 4828.44 EUR per cycle. The TXC resulted in +0.28 LYs and +16,628 EUR compared with TDM-1. Results were mainly sensitive to therapy intensity variation. In PSA analysis, TXC resulted cost-effective in 53% of the simulations. Assuming a WTP ranging 20,000–80,000 EUR, the tucatinib price ranged from 4090.60 to 5197.41 EUR. Conclusions: This study estimated the appropriate price for tucatinib according to different WTP in order to help healthcare decision makers to better understand the treatment value.

Published
2023

26. Impact of COVID-19 Lockdown, during the Two Waves, on Drug Use and Emergency Department Access in People with Epilepsy: An Interrupted Time-Series Analysis

Author

Ippazio Cosimo Antonazzo, Carla Fornari, Sandy Maumus-Robert, Eleonora Cei, Olga Paoletti, Sara Conti, Paolo Angelo Cortesi, Lorenzo Giovanni Mantovani, Rosa Gini, Giampiero Mazzaglia, Antonazzo, I, Fornari, C, Maumus-Robert, S, Cei, E, Paoletti, O, Conti, S, Cortesi, P, Mantovani, L, Gini, R, and Mazzaglia, G

Subjects
Emergency department acce, Epilepsy, SARS-CoV-2, Health, Toxicology and Mutagenesis, Time-series analysi, COVID-19, Italy, epilepsy, anti-seizure medication, emergency department access, time-series analysis, Public Health, Environmental and Occupational Health, Article, Pharmaceutical Preparations, Communicable Disease Control, Medicine, Humans, Emergency Service, Hospital, Pandemics
Abstract

Background: In 2020, during the COVID-19 pandemic, Italy implemented two national lockdowns aimed at reducing virus transmission. We assessed whether these lockdowns affected anti-seizure medication (ASM) use and epilepsy-related access to emergency departments (ED) in the general population. Methods: We performed a population-based study using the healthcare administrative database of Tuscany. We defined the weekly time series of prevalence and incidence of ASM, along with the incidence of epilepsy-related ED access from 1 January 2018 to 27 December 2020 in the general population. An interrupted time-series analysis was used to assess the effect of lockdowns on the observed outcomes. Results: Compared to pre-lockdown, we observed a relevant reduction of ASM incidence (0.65; 95% Confidence Intervals: 0.59–0.72) and ED access (0.72; 0.64–0.82), and a slight decrease of ASM prevalence (0.95; 0.94–0.96). During the post-lockdown the ASM incidence reported higher values compared to pre-lockdown, whereas ASM prevalence and ED access remained lower. Results also indicate a lower impact of the second lockdown for both ASM prevalence (0.97; 0.96–0.98) and incidence (0.89; 0.80–0.99). Conclusion: The lockdowns implemented during the COVID-19 outbreaks significantly affected ASM use and epilepsy-related ED access. The potential consequences of these phenomenon are still unknown, although an increased incidence of epilepsy-related symptoms after the first lockdown has been observed. These findings emphasize the need of ensuring continuous care of epileptic patients in stressful conditions such as the COVID-19 pandemic.

Published
2021

27. Cost-effectiveness and budget impact analysis of siponimod in the treatment of secondary progressive multiple sclerosis in Italy

Author

Paolo Angelo Cortesi, Ippazio Cosimo Antonazzo, Claudio Gasperini, Mihaela Nica, Daniela Ritrovato, Lorenzo Giovanni Mantovani, Cortesi, P, Antonazzo, I, Gasperini, C, Nica, M, Ritrovato, D, and Mantovani, L

Subjects
Multidisciplinary, Multiple Sclerosis, multiple sclerosi, Cost-Benefit Analysis, Benzyl Compounds, Azetidines, Humans, Quality-Adjusted Life Years, Multiple Sclerosis, Chronic Progressive, Interferon beta-1b
Abstract

Background Siponimod is an effective treatment for patients with secondary progressive multiple sclerosis (SPMS), with active disease evidenced by relapses or imaging features characteristic of multiple sclerosis inflammatory activity, however there is a need to evaluate its economic value and sustainability compared to other disease modifying-therapies (DMTs). Objective To estimate the siponimod cost-effectiveness profile and its relative budget impact compared with other DMTs, by using the Italian National Healthcare System perspective. Methods We performed: 1) a cost-effectiveness analysis (CEA) vs interferon beta-1b using an analytical Markov model and a life time-horizon, and 2) a budget impact analysis by using 3-years time-horizon. The results were reported as incremental cost-effectiveness ratio (ICER) and net-monetary benefit (NMB) for CEA, using a willingness to pay threshold of €40,000 per QALY gained, and as difference in the overall budget (Euro) between the scenario with and without siponimod for budget impact. Results In the base case scenario siponimod resulted cost-effective compared with interferon beta-1b 28,891€ per QALY. Overall, the market access of siponimod was associated to an increased budget of about 3€ millions (+0.9%) in the next 3 years simulated. Conclusion Compared to interferon beta-1b, siponimod seems to be cost-effective in SPMS patients and sustainable, with less than 1% overall budget increased in the next 3 years. Future studies need to confirm our results in the real word setting and in other countries.

Published
2021

28. Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980–2017: a systematic analysis for the Global Burden of Disease Study 2017

Author

Gregory A Roth, Degu Abate, Kalkidan Hassen Abate, Solomon M Abay, Cristiana Abbafati, Nooshin Abbasi, Hedayat Abbastabar, Foad Abd-Allah, Jemal Abdela, Ahmed Abdelalim, Ibrahim Abdollahpour, Rizwan Suliankatchi Abdulkader, Haftom Temesgen Abebe, Molla Abebe, Zegeye Abebe, Ayenew Negesse Abejie, Semaw F Abera, Olifan Zewdie Abil, Haftom Niguse Abraha, Aklilu Roba Abrham, Laith Jamal Abu-Raddad, Manfred Mario Kokou Accrombessi, Dilaram Acharya, Abdu A Adamu, Oladimeji M Adebayo, Rufus Adesoji Adedoyin, Victor Adekanmbi, Olatunji O Adetokunboh, Beyene Meressa Adhena, Mina G Adib, Amha Admasie, Ashkan Afshin, Gina Agarwal, Kareha M Agesa, Anurag Agrawal, Sutapa Agrawal, Alireza Ahmadi, Mehdi Ahmadi, Muktar Beshir Ahmed, Sayem Ahmed, Amani Nidhal Aichour, Ibtihel Aichour, Miloud Taki Eddine Aichour, Mohammad Esmaeil Akbari, Rufus Olusola Akinyemi, Nadia Akseer, Ziyad Al-Aly, Ayman Al-Eyadhy, Rajaa M Al-Raddadi, Fares Alahdab, Khurshid Alam, Tahiya Alam, Animut Alebel, Kefyalew Addis Alene, Mehran Alijanzadeh, Reza Alizadeh-Navaei, Syed Mohamed Aljunid, Ala'a Alkerwi, François Alla, Peter Allebeck, Jordi Alonso, Khalid Altirkawi, Nelson Alvis-Guzman, Azmeraw T Amare, Leopold N Aminde, Erfan Amini, Walid Ammar, Yaw Ampem Amoako, Nahla Hamed Anber, Catalina Liliana Andrei, Sofia Androudi, Megbaru Debalkie Animut, Mina Anjomshoa, Hossein Ansari, Mustafa Geleto Ansha, Carl Abelardo T Antonio, Palwasha Anwari, Olatunde Aremu, Johan Ärnlöv, Amit Arora, Monika Arora, Al Artaman, Krishna K Aryal, Hamid Asayesh, Ephrem Tsegay Asfaw, Zerihun Ataro, Suleman Atique, Sachin R Atre, Marcel Ausloos, Euripide F G A Avokpaho, Ashish Awasthi, Beatriz Paulina Ayala Quintanilla, Yohanes Ayele, Rakesh Ayer, Peter S Azzopardi, Arefeh Babazadeh, Umar Bacha, Hamid Badali, Alaa Badawi, Ayele Geleto Bali, Katherine E Ballesteros, Maciej Banach, Kajori Banerjee, Marlena S Bannick, Joseph Adel Mattar Banoub, Miguel A Barboza, Suzanne Lyn Barker-Collo, Till Winfried Bärnighausen, Simon Barquera, Lope H Barrero, Quique Bassat, Sanjay Basu, Bernhard T Baune, Habtamu Wondifraw Baynes, Shahrzad Bazargan-Hejazi, Neeraj Bedi, Ettore Beghi, Masoud Behzadifar, Meysam Behzadifar, Yannick Béjot, Bayu Begashaw Bekele, Abate Bekele Belachew, Ezra Belay, Yihalem Abebe Belay, Michelle L Bell, Aminu K Bello, Derrick A Bennett, Isabela M Bensenor, Adam E Berman, Eduardo Bernabe, Robert S Bernstein, Gregory J Bertolacci, Mircea Beuran, Tina Beyranvand, Ashish Bhalla, Suraj Bhattarai, Soumyadeeep Bhaumik, Zulfiqar A Bhutta, Belete Biadgo, Molly H Biehl, Ali Bijani, Boris Bikbov, Ver Bilano, Nigus Bililign, Muhammad Shahdaat Bin Sayeed, Donal Bisanzio, Tuhin Biswas, Brigette F Blacker, Berrak Bora Basara, Rohan Borschmann, Cristina Bosetti, Kayvan Bozorgmehr, Oliver J Brady, Luisa C Brant, Carol Brayne, Alexandra Brazinova, Nicholas J K Breitborde, Hermann Brenner, Paul Svitil Briant, Gabrielle Britton, Traolach Brugha, Reinhard Busse, Zahid A Butt, Charlton S K H Callender, Ismael R Campos-Nonato, Julio Cesar Campuzano Rincon, Jorge Cano, Mate Car, Rosario Cárdenas, Giulia Carreras, Juan J Carrero, Austin Carter, Félix Carvalho, Carlos A Castañeda-Orjuela, Jacqueline Castillo Rivas, Chris D Castle, Clara Castro, Franz Castro, Ferrán Catalá-López, Ester Cerin, Yazan Chaiah, Jung-Chen Chang, Fiona J Charlson, Pankaj Chaturvedi, Peggy Pei-Chia Chiang, Odgerel Chimed-Ochir, Vesper Hichilombwe Chisumpa, Abdulaal Chitheer, Rajiv Chowdhury, Hanne Christensen, Devasahayam J Christopher, Sheng-Chia Chung, Flavia M Cicuttini, Liliana G Ciobanu, Massimo Cirillo, Aaron J Cohen, Leslie Trumbull Cooper, Paolo Angelo Cortesi, Monica Cortinovis, Ewerton Cousin, Benjamin C Cowie, Michael H Criqui, Elizabeth A Cromwell, Christopher Stephen Crowe, John A Crump, Matthew Cunningham, Alemneh Kabeta Daba, Abel Fekadu Dadi, Lalit Dandona, Rakhi Dandona, Anh Kim Dang, Paul I Dargan, Ahmad Daryani, Siddharth K Das, Rajat Das Gupta, José Das Neves, Tamirat Tesfaye Dasa, Aditya Prasad Dash, Adrian C Davis, Nicole Davis Weaver, Dragos Virgil Davitoiu, Kairat Davletov, Fernando Pio De La Hoz, Jan-Walter De Neve, Meaza Girma Degefa, Louisa Degenhardt, Tizta T Degfie, Selina Deiparine, Gebre Teklemariam Demoz, Balem Betsu Demtsu, Edgar Denova-Gutiérrez, Kebede Deribe, Nikolaos Dervenis, Don C Des Jarlais, Getenet Ayalew Dessie, Subhojit Dey, Samath D Dharmaratne, Daniel Dicker, Mesfin Tadese Dinberu, Eric L Ding, M Ashworth Dirac, Shirin Djalalinia, Klara Dokova, David Teye Doku, Christl A Donnelly, E Ray Dorsey, Pratik P Doshi, Dirk Douwes-Schultz, Kerrie E Doyle, Tim R Driscoll, Manisha Dubey, Eleonora Dubljanin, Eyasu Ejeta Duken, Bruce B Duncan, Andre R Duraes, Hedyeh Ebrahimi, Soheil Ebrahimpour, Dumessa Edessa, David Edvardsson, Anne Elise Eggen, Charbel El Bcheraoui, Maysaa El Sayed Zaki, Ziad El-Khatib, Hajer Elkout, Christian Lycke Ellingsen, Matthias Endres, Aman Yesuf Endries, Benjamin Er, Holly E Erskine, Babak Eshrati, Sharareh Eskandarieh, Reza Esmaeili, Alireza Esteghamati, Mahdi Fakhar, Hamed Fakhim, Mahbobeh Faramarzi, Mohammad Fareed, Farzaneh Farhadi, Carla Sofia E sá Farinha, Andre Faro, Maryam S Farvid, Farshad Farzadfar, Mohammad Hosein Farzaei, Valery L Feigin, Andrea B Feigl, Netsanet Fentahun, Seyed-Mohammad Fereshtehnejad, Eduarda Fernandes, Joao C Fernandes, Alize J Ferrari, Garumma Tolu Feyissa, Irina Filip, Samuel Finegold, Florian Fischer, Christina Fitzmaurice, Nataliya A Foigt, Kyle J Foreman, Carla Fornari, Tahvi D Frank, Takeshi Fukumoto, John E Fuller, Nancy Fullman, Thomas Fürst, João M Furtado, Neal D Futran, Silvano Gallus, Alberto L Garcia-Basteiro, Miguel A Garcia-Gordillo, William M Gardner, Abadi Kahsu Gebre, Tsegaye Tewelde Gebrehiwot, Amanuel Tesfay Gebremedhin, Bereket Gebremichael, Teklu Gebrehiwo Gebremichael, Tilayie Feto Gelano, Johanna M Geleijnse, Ricard Genova-Maleras, Yilma Chisha Dea Geramo, Peter W Gething, Kebede Embaye Gezae, Mohammad Rasoul Ghadami, Reza Ghadimi, Khalil Ghasemi Falavarjani, Maryam Ghasemi-Kasman, Mamata Ghimire, Katherine B Gibney, Paramjit Singh Gill, Tiffany K Gill, Richard F Gillum, Ibrahim Abdelmageed Ginawi, Maurice Giroud, Giorgia Giussani, Shifalika Goenka, Ellen M Goldberg, Srinivas Goli, Hector Gómez-Dantés, Philimon N Gona, Sameer Vali Gopalani, Taren M Gorman, Atsushi Goto, Alessandra C Goulart, Elena V Gnedovskaya, Ayman Grada, Giuseppe Grosso, Harish Chander Gugnani, Andre Luiz Sena Guimaraes, Yuming Guo, Prakash C Gupta, Rahul Gupta, Rajeev Gupta, Tanush Gupta, Reyna Alma Gutiérrez, Bishal Gyawali, Juanita A Haagsma, Nima Hafezi-Nejad, Tekleberhan B Hagos, Tewodros Tesfa Hailegiyorgis, Gessessew Bugssa Hailu, Arvin Haj-Mirzaian, Arya Haj-Mirzaian, Randah R Hamadeh, Samer Hamidi, Alexis J Handal, Graeme J Hankey, Hilda L Harb, Sivadasanpillai Harikrishnan, Josep Maria Haro, Mehedi Hasan, Hadi Hassankhani, Hamid Yimam Hassen, Rasmus Havmoeller, Roderick J Hay, Simon I Hay, Yihua He, Akbar Hedayatizadeh-Omran, Mohamed I Hegazy, Behzad Heibati, Mohsen Heidari, Delia Hendrie, Andualem Henok, Nathaniel J Henry, Claudiu Herteliu, Fatemeh Heydarpour, Pouria Heydarpour, Sousan Heydarpour, Desalegn Tsegaw Hibstu, Hans W Hoek, Michael K Hole, Enayatollah Homaie Rad, Praveen Hoogar, H Dean Hosgood, Seyed Mostafa Hosseini, Mehdi Hosseinzadeh, Mihaela Hostiuc, Sorin Hostiuc, Peter J Hotez, Damian G Hoy, Thomas Hsiao, Guoqing Hu, John J Huang, Abdullatif Husseini, Mohammedaman Mama Hussen, Susan Hutfless, Bulat Idrisov, Olayinka Stephen Ilesanmi, Usman Iqbal, Seyed Sina Naghibi Irvani, Caleb Mackay Salpeter Irvine, Nazrul Islam, Sheikh Mohammed Shariful Islam, Farhad Islami, Kathryn H Jacobsen, Leila Jahangiry, Nader Jahanmehr, Sudhir Kumar Jain, Mihajlo Jakovljevic, Moti Tolera Jalu, Spencer L James, Mehdi Javanbakht, Achala Upendra Jayatilleke, Panniyammakal Jeemon, Kathy J Jenkins, Ravi Prakash Jha, Vivekanand Jha, Catherine O Johnson, Sarah C Johnson, Jost B Jonas, Ankur Joshi, Jacek Jerzy Jozwiak, Suresh Banayya Jungari, Mikk Jürisson, Zubair Kabir, 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Subjects
Overview, Disease, Territory, Causes of death, humanities
Abstract

Global development goals increasingly rely on country-specific estimates for benchmarking a nation's progress. To meet this need, the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2016 estimated global, regional, national, and, for selected locations, subnational cause-specific mortality beginning in the year 1980. Here we report an update to that study, making use of newly available data and improved methods. GBD 2017 provides a comprehensive assessment of cause-specific mortality for 282 causes in 195 countries and territories from 1980 to 2017. The Lancet Publishing Group

Published
2019

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