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  • 1.
    Cowper, Patricia A.
    et al.
    Duke University, NC USA.
    Pan, Wenqin
    Duke University, NC USA.
    Anstrom, Kevin J.
    Duke University, NC USA.
    Kaul, Padma
    University of Alberta, Canada.
    Wallentin, Lars
    Uppsala University, Sweden.
    Davidson-Ray, Linda
    Duke University, NC USA.
    Lundborg, Elisabet
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Janzon, Magnus
    Linköping University, Department of Medical and Health Sciences, Division of Cardiovascular Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Heart and Medicine Center, Department of Cardiology in Linköping.
    Levin, Lars-Åke
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Cannon, Christopher P.
    Brigham and Womens Hospital, MA 02115 USA.
    Harrington, Robert A.
    Stanford University, CA 94305 USA.
    Mark, Daniel B.
    Duke University, NC USA.
    Economic Analysis of Ticagrelor Therapy From a US Perspective2015In: Journal of the American College of Cardiology, ISSN 0735-1097, E-ISSN 1558-3597, Vol. 65, no 5, p. 465-476Article in journal (Refereed)
    Abstract [en]

    BACKGROUND Based on results of the PLATO (Platelet Inhibition and Patient Outcomes) trial comparing ticagrelor with clopidogrel therapy, the U.S. Food and Drug Administration approved ticagrelor in 2011 for reducing thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) with the proviso that it be taken with low-dose aspirin. OBJECTIVES This study sought to assess the cost and cost effectiveness of ticagrelor therapy relative to clopidogrel in treating ACS patients from the perspective of the U.S. health care system. METHODS We estimated within-trial resource use and costs using U.S. low-dose aspirin patients in PLATO (n = 547). Quality-adjusted life expectancy was estimated using the total PLATO population (n = 18,624), combined with baseline risk and long-term survival data from an external ACS patient cohort. Study drugs were valued at current costs. Cost effectiveness was assessed, as was the sensitivity of results to sampling and methodological uncertainties. RESULTS One year of ticagrelor therapy, relative to that of generic clopidogrel, cost $29,665/quality-adjusted life-year gained, with 99% of bootstrap estimates falling under a $100,000 willingness-to-pay threshold. Results were robust to extensive sensitivity analyses, including variations in clopidogrel cost, exclusion of costs in extended years of life, and a recalibrated estimate of survival reflecting a lower underlying mortality risk in the United States. CONCLUSIONS For PLATO-eligible ACS patients, a U.S. perspective comparison of the current standard of dual antiplatelet therapy of aspirin with clopidogrel versus aspirin plus ticagrelor showed that the ticagrelor regimen increased life expectancy at an incremental cost well within accepted benchmarks of good value for money. (C) 2015 by the American College of Cardiology Foundation.

  • 2.
    Delgado-Ortega, L.
    et al.
    AstraZeneca Spain, Madrid.
    Lopez-Sendon, J. L
    Hospital Universitario de la Paz, Madrid, Spain.
    Heras Fortuny, M.
    Hospital Clinic, Barcelona, Spain.
    Alvarez Sanz, C.
    AstraZeneca Spain, Madrid.
    Nikolic, Elisabet
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Mellström, C.
    Astrazeneca R&D, Lomma, Sweden.
    Wallentin, L
    Uppsala University, Sweden.
    PCV45 Health Economic Evaluation of Ticagrelor in Patients with Acute Coronary Patients (ACS) Based on the Plato Study from A Spanish Health Care Perspective2011In: Value in Health, ISSN 1098-3015, E-ISSN 1524-4733, Vol. 14, no 7, p. A372-A372Article in journal (Other academic)
    Abstract [en]

    Objectives

    PLATO was a multi centered, double blind, randomized study that included 18,624 ACS patients from 43 countries, comparing ticagrelor + aspirin versus clopidogrel + aspirin. The PLATO demonstrated that ticagrelor was superior on the primary composite endpoint: myocardial infarction, stroke, cardiovascular death (HR 0.84, 95% CI: 0.77 to 0.92) without an increase in major bleedings compared to clopidogrel, and whether the strategy of choice was invasive or conservative. The aim of this analysis is to estimate direct health care costs from a Spanish health care perspective (excluding drug costs because ticagrelor price has not yet been established).

    Methods

    Resource utilization was pre specified in the PLATO trial and included hospitalization bed days, investigations, interventions and blood products. Direct health care costs per patient at 12 months were estimated by multiplying the resource use with Spanish unit costs derived from the Spanish database e-salud, the GRDs of the Ministry of Health, published literature, and the CMBD 2008.

    Results

    Ticagrelor resulted in numerically fewer bed days (mean difference per patient 0.21, 95% CI -0.16 to 0.59), PCIs (mean difference per patient 0.01, 95% CI -0.01 to 0.03) and CABGs (mean difference per patient 0.01, 95% CI: 0.00 to 0.01). Ticagrelor is associated with €341 reduction per patient (95% CI: 31 to 652) in healthcare costs at 12 months compared to clopidogrel. The reduction in healthcare costs was mainly due to fewer hospital days and cardiovascular interventions in the ticagrelor group. The reduction in cost increased over the 12-month treatment period consistent with the rate of clinical events over time in the PLATO study.

    Conclusions

    Treatment with ticagrelor is associated with cost savings in patients with ACS at 12 months compared with clopidogrel (excluding drug costs) from a Spanish health care perspective. However, the total cost savings will depend on drug price, data not available yet.

  • 3.
    Henriksson, M.
    et al.
    AstraZeneca Nord.
    Nikolic, Elisabet
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Janzon, Magnus
    Linköping University, Department of Medical and Health Sciences, Cardiology. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Heart and Medicine Centre, Department of Cardiology UHL.
    Hauch, O.
    AstraZeneca Pharmaceut LP.
    Levin, Lars-Åke
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Wallentin, L.
    Uppsala University.
    LONG-TERM COSTS AND HEALTH OUTCOMES OF TREATING ACUTE CORONARY SYNDROME PATIENTS WITH TICAGRELOR BASED ON THE EU LABEL - COST-EFFECTIVENESS ANALYSIS BASED ON THE PLATO STUDY in VALUE IN HEALTH, vol 14, issue 3, pp A40-A402011In: VALUE IN HEALTH, Wiley-Blackwell / Elsevier , 2011, Vol. 14, no 3, p. A40-A40Conference paper (Refereed)
    Abstract [en]

    n/a

  • 4.
    Henriksson, Martin
    et al.
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics.
    Janzon, Magnus
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medical and Health Sciences, Cardiology. Östergötlands Läns Landsting, Heart Centre, Department of Cardiology.
    Aasa, M.
    Lundborg (Nikolic), Elisabet
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics.
    Svensson, L.
    Herlitz, J.
    Grip, L.
    Levin, Lars-Åke
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics.
    Cost-effectiveness of very early treatment strategies for acute ST-elevation myocardial infarction based on the Swedish early decision (SWEDES) reperfusion trial (oral presentation)2008In: SMDM Europe,2008, 2008Conference paper (Other academic)
    Abstract [en]

       

  • 5.
    Henriksson, Martin
    et al.
    Linköping University, Center for Medical Image Science and Visualization (CMIV). Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences. Astra Zeneca Nordic-Baltic, Södertälje, Sweden.
    Nikolic, Elisabet
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Ohna, Audun
    Astra Zeneca Nordic-Baltic, Södertälje, Sweden.
    Wallentin, Lars
    Uppsala University, Sweden.
    Janzon, Magnus
    Linköping University, Department of Medical and Health Sciences, Division of Cardiovascular Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Heart and Medicine Center, Department of Cardiology in Linköping.
    Ticagrelor treatment in patients with acute coronary syndrome is cost-effective in Sweden and Denmark2014In: Scandinavian Cardiovascular Journal, ISSN 1401-7431, E-ISSN 1651-2006, Vol. 48, no 3, p. 138-147Article in journal (Refereed)
    Abstract [en]

    Objectives. To evaluate the cost-effectiveness of treating patients with acute coronary syndromes (ACS) for 12 months with ticagrelor compared with generic clopidogrel in Sweden and Denmark. Design. Decision-analytic model to estimate lifetime costs, life-expectancy, and quality-adjusted life years (QALYs) with ticagrelor and clopidogrel. Event rates, healthcare resource use, and health-related quality of life during 12 months of therapy were estimated from the PLATelet inhibition and patient Outcomes (PLATO) trial. Beyond 12 months, quality-adjusted survival and costs were estimated conditional on events occurring during the 12 months of therapy. When available, country-specific data were employed in the analysis. Incremental cost-effectiveness ratios are presented from a healthcare perspective and a broader societal perspective including costs falling outside the healthcare sector in 2010 local currency. Results. The cost per QALY with ticagrelor compared with generic clopidogrel was SEK 25 022 and DKK 26 892 for Sweden and Denmark, respectively, from a healthcare perspective. The cost per QALY from a broader societal perspective was SEK 24 290 and DKK 25 051 for Sweden and Denmark, respectively. Conclusion. The cost per QALY of treating ACS-patients with ticagrelor compared with generic clopidogrel is below the conventional thresholds of cost-effectiveness in Sweden and Denmark.

  • 6.
    Janzon, Magnus
    et al.
    Linköping University, Department of Medical and Health Sciences, Cardiology. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Heart and Medicine Centre, Department of Cardiology UHL.
    Nikolic, Elisabet
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Henriksson, Martin
    Department om Health Economics, AstraZeneca Södertälje.
    Levin, Lars-Åke
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Hauch, Ole
    AstraZeneca LP, Wilmington, DE, USA.
    Mark, DB
    Duke Clinical Research Institute, Duke University Medical Center, USA.
    Cowper, P.
    Duke Clinical Research Institute, Duke University Medical Center, USA.
    Kaul, P.
    Duke Clinical Research Institute, Duke University Medical Center, USA.
    Harrington, RA.
    Duke Clinical Research Institute, Duke University Medical Center, USA.
    Horrow, J.
    AstraZeneca LP, Wilmington, DE, USA.
    Wallentin, Lars
    Uppsala Clinical Research Centre, Uppsala University.
    Health Economics in the PLATelet Inhibition and Patient Outcomes (PLATO) Randomized Trial: Report on Within Trial Resource Use Patterns2010Conference paper (Refereed)
  • 7.
    Johansen, Kari
    et al.
    Smittskyddsinstitutet.
    Brytting, M.
    Smittskyddsinstitutet.
    Husberg, Magnus
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Lundborg (Nikolic), Elisabet
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Tran, A.N.
    Smittskyddsinstitutet.
    Bennet, R.
    Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset.
    Eriksson, M.
    Astrid Lindgrens Barnsjukhus, Karolinska Universitetssjukhuset.
    Carlsson, Per
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Estimates of Healthcare and Non-Healthcare Costs due to Severe Rotavirus Infections leading to Hospitalization in Swedish Children (<5 years)2011Conference paper (Refereed)
    Abstract [en]

    Introduction: Estimates of economic benefit of rotavirus vaccination depend on the accuracy of calculated country-specific costs related to rotavirus gastroenteritis (RVGE). Transmission of disease to family members adds to the economic burden through loss of caregiver productivity. The aim of this study was to assess costs related to severe RVGE.

    Material and methods: A prospective, observational study was conducted in a large hospital in the Stockholm region, serving a population of 66,222 children < 5 years. RVGE related health care resource use and time off work were collected from a sample of families with hospitalised children due to community- and nosocomially-derived RVGE (n=153). Health care related costs were calculated using 2008 DRG reimbursement for acute diarrhoea and productivity loss using self reported absence combined with 2008 Swedish average cost for a working hour (€28) from SCB/Statistics Sweden.

    Results: Median age of hospitalised children was 15 months. For caregivers, average workday loss due to children's, siblings or own disease was 4.2 days and 1.2 days, respectively. Estimated average total cost per child was €3227, €1949 (60%) for health -care related costs, €1186 (37%) productivity loss and €92 (3%) due to other indirect costs.

    Conclusions: Economic burden of RVGE is primarily driven by costs related to in-patient care, sensitive to unit cost used. However, loss of productivity is also significant in spite of generous parental allowance in Sweden, 12-18 months per child. A limitation of this study is that productivity loss from care for non-hospitalized children and its household members was not assessed.

  • 8.
    Nikolic, Elisabet
    et al.
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Janzon, Magnus
    Linköping University, Department of Medical and Health Sciences, Cardiology. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Heart and Medicine Centre, Department of Cardiology UHL.
    Hauch, Ole
    AstraZeneca LP, DE USA .
    Wallentin, Lars
    Uppsala University, Sweden .
    Henriksson, Martin
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Cost-effectiveness of treating acute coronary syndrome patients with ticagrelor for 12 months: results from the PLATO study2013In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 34, no 3, p. 220-228Article in journal (Refereed)
    Abstract [en]

    The efficacy and safety of ticagrelor vs. clopidogrel in patients with acute coronary syndromes (ACS) are well documented in the PLATelet inhibition and patient Outcomes trial (PLATO). The aim of this study was to assess the long-term cost-effectiveness of treating ACS patients for 12 months with ticagrelor compared with generic clopidogrel.less thanbrgreater thanless thanbrgreater thanEvent rates, health-care costs, and health-related quality of life during 12 months of therapy with either ticagrelor or generic clopidogrel were estimated from PLATO. Beyond 12 months, quality-adjusted survival and costs were estimated conditional on whether a non-fatal myocardial infarction (MI), a non-fatal stroke, or no MI or stroke occurred during the 12 months of therapy. Lifetime costs, life expectancy, and quality-adjusted life years (QALYs) were estimated for both treatment strategies. Incremental cost-effectiveness ratios were presented from a health-care perspective in 2010 Euros (Euro) applying unit costs and life tables from a Swedish setting in the base-case analysis. Treatment with ticagrelor was associated with increased health-care costs of Euro362 and a QALY gain of 0.13 compared with generic clopidogrel, yielding a cost per QALY gained with ticagrelor of Euro2753. The cost per life year gained was Euro2372. The results were consistent in major subgroups. Sensitivity analyses showed a cost per QALY gained with ticagrelor of approximate to Euro7300 under certain scenarios.less thanbrgreater thanless thanbrgreater thanBased on clinical and health-economic evidence from the PLATO study, treating ACS patients with ticagrelor for 12 months is associated with a cost per QALY below generally accepted thresholds for cost-effectiveness.less thanbrgreater thanless thanbrgreater thanClinicalTrials.gov Identifier: NCT00391872.

  • 9.
    Pulz, Matthias
    et al.
    Niedersachsisches Landesgesundheit, Hannover, Germany.
    Matussek, Andreas
    Cytonet GmbH & Co. Hannover Management KG, Germany.
    Monazahian, Masyar
    Niedersachsisches Landesgesundheit, Hannover, Germany.
    Tittel, Andreas
    Niedersachsisches Landesgesundheit, Hannover, Germany.
    Nikolic, Elisabet
    Linköping University, Department of Mathematics. Linköping University, The Institute of Technology.
    Hartmann, Maike
    Institute of Medical Microbiology, Hannover Medical School, Germany.
    Bellin, Tobias
    Institute of Medical Microbiology, Hannover Medical School, Germany.
    Buer, Jan
    German Research Centre for Biotechnology, Braunschweig, Germany .
    Gunzer, Florian
    Institute of Medical Microbiology, Hannover Medical School, Germany.
    Comparison of a Shiga Toxin Enzyme-Linked Immunosorbent Assay and Two Types of PCR for Detection of Shiga Toxin-Producing Escherichia coli in Human Stool Specimens2003In: Journal of Clinical Microbiology, ISSN 0095-1137, E-ISSN 1098-660X, Vol. 41, no 10, p. 4671-4675Article in journal (Refereed)
    Abstract [en]

    Shiga toxin (Stx)-producing Escherichia coli (STEC) is a major cause of sporadic cases of disease as well as serious outbreaks worldwide. The spectrum of illnesses includes mild nonbloody diarrhea, hemorrhagic colitis, and hemolytic-uremic syndrome. STEC produces one or more Stxs, which are subdivided into two major classes, Stx1 and Stx2. The ingestion of contaminated food or water, person-to-person spread, and contact with animals are the major transmission modes. The infective dose of STEC may be less than 100 organisms. Effective prevention of infection is dependent on rapid detection of the causative bacterial pathogen. In the present study, we examined 295 stool specimens for the presence of Stx-producing E. coli by three different methods: an Stx enzyme-linked immunosorbent assay, a conventional PCR assay, and a LightCycler PCR (LC-PCR) assay protocol recently developed by our laboratory at the Institute of Medical Microbiology at Hannover Medical School. Our intent was to compare these three methods and to examine the utility of the STEC LC-PCR protocol in a clinical laboratory. The addition of a control DNA to each sample to clearly discriminate inhibited specimens from negative ones enhanced the accuracy of the LC-PCR protocol. From our results, it can be concluded that LC-PCR is a very useful tool for the rapid and safe detection of STEC in clinical samples.

  • 10.
    Wahlberg, Jeanette
    et al.
    Linköping University, Department of Clinical and Experimental Medicine, Pediatrics. Linköping University, Faculty of Health Sciences.
    Fredriksson (Walldén), Jenny
    Linköping University, Department of Clinical and Experimental Medicine, Pediatrics. Linköping University, Faculty of Health Sciences.
    Nikolic, Elisabet
    Linköping University, Department of Clinical and Experimental Medicine, Pediatrics. Linköping University, Faculty of Health Sciences.
    Vaarala, Outi
    Linköping University, Department of Clinical and Experimental Medicine, Pediatrics. Linköping University, Faculty of Health Sciences.
    Ludvigsson, Johnny
    Linköping University, Department of Clinical and Experimental Medicine, Pediatrics. Linköping University, Faculty of Health Sciences.
    Environmental factors related to the induction of beta-cell autoantibodies in 1-yr-old healthy children2005In: Pediatric Diabetes, ISSN 1399-543X, E-ISSN 1399-5448, Vol. 6, no 4, p. 199-205Article in journal (Refereed)
    Abstract [en]

    We studied environmental risk factors which might contribute to the development of beta-cell autoantibodies in healthy children. Here, we investigated 6000 randomly selected children from the large All Babies in Southeast Sweden (ABIS) cohort, including 17 055 newborns recruited between 1997 and 1999. Questionnaires at birth and at 1 yr of age and the levels of autoantibodies to glutamic acid decarboxylase (GADA) and autoantibodies to tyrosine phosphatase (IA-2A) at 1 yr of age were analyzed. The 99th percentile cutoff for autoantibodies was proposed to identify children at risk of type 1 diabetes (T1D) and the 90th percentile cutoff to identify children in whom beta-cell autoimmunity has been induced. Using the 90th percentile cutoff level, 1156 children had either IA-2A (n = 574) or GADA (n = 582), while 126 children had both GADA and IA-2A. When the 99th percentile cutoff level was used, 114 children had either IA-2A (n = 57) or GADA (n = 57), and six children had both GADA and IA-2A. In logistic regression analysis, celiac disease in grandparents [odds ratio (OR) 2.2] and maternal gastrointestinal infection (OR 1.1) represented a risk for simultaneous occurrence of both IA-2A and GADA above the 90th percentile. Birth in spring (March to May) (OR 1.5) and male gender (OR 1.3) were risk factors for induction of IA-2A. Mother's low education represented a risk for induction of IA-2A (OR 1.5) and GADA (OR 1.4). T1D in first-degree relatives increased the risk for beta-cell autoimmunity above the 99th percentile (OR 2.6), whereas type 2 diabetes in grandparents was associated with GADA (OR 2.1). Exposure to cow's milk formulas <2 months of age implied an OR of 2.9 for IA-2A above the 99th percentile.

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