Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs.
Identifieur interne : 003703 ( PubMed/Checkpoint ); précédent : 003702; suivant : 003704Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs.
Auteurs : Brian Godman [Royaume-Uni] ; Rickard E. Malmström [Suède] ; Eduardo Diogene [Espagne] ; Sisira Jayathissa [Nouvelle-Zélande] ; Stuart Mctaggart [Royaume-Uni] ; Thomas Cars [Suède] ; Samantha Alvarez-Madrazo [Royaume-Uni] ; Christoph Baumg Rtel [Autriche] ; Anna Brzezinska [Pologne] ; Anna Bucsics [Autriche] ; Stephen Campbell [Royaume-Uni] ; Irene Eriksson [Suède] ; Alexander Finlayson [Royaume-Uni] ; Jurij Fürst [Slovénie] ; Kristina Garuoliene [Lituanie] ; I Aki Gutiérrez-Ibarluzea [Espagne] ; Krystyna Hviding [Norvège] ; Harald Herholz [Allemagne] ; Roberta Joppi [Italie] ; Marija Kalaba [Serbie] ; Ott Laius [Estonie] ; Kamila Malinowska [Pologne] ; Hanne B. Pedersen [Danemark] ; Vanda Markovic-Pekovic [Bosnie-Herzégovine] ; Jutta Piessnegger [Autriche] ; Gisbert Selke [Allemagne] ; Catherine Sermet [France] ; Susan Spillane [Irlande (pays)] ; Dominik Tomek [Slovaquie] ; Luka Von Ina [Croatie] ; Vera Vlahovi Pal Evski [Croatie] ; Janet Wale [Australie] ; Magdalena Wladysiuk [Pologne] ; Menno Van Woerkom [Pays-Bas] ; Corinne Zara [Espagne] ; Lars L. Gustafsson [Suède]Source :
- Frontiers in pharmacology [ 1663-9812 ] ; 2014.
Abstract
There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are effectiveness, safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies showed dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. These concerns resulted in extensive activities pre- to post-launch to manage its introduction.
DOI: 10.3389/fphar.2014.00109
PubMed: 24959145
Affiliations:
- Allemagne, Australie, Autriche, Bosnie-Herzégovine, Croatie, Danemark, Espagne, Estonie, France, Irlande (pays), Italie, Lituanie, Norvège, Nouvelle-Zélande, Pays-Bas, Pologne, Royaume-Uni, Serbie, Slovaquie, Slovénie, Suède
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Finance, Faculty of Business, Economics and Statistics, University of Vienna Vienna, Austria ; Hauptverband der Österreichischen Sozialversicherungsträger Vienna</wicri:regionArea><wicri:noRegion>Austria ; Hauptverband der Österreichischen Sozialversicherungsträger Vienna</wicri:noRegion></affiliation></author><author><name sortKey="Campbell, Stephen" sort="Campbell, Stephen" uniqKey="Campbell S" first="Stephen" last="Campbell">Stephen Campbell</name><affiliation wicri:level="1"><nlm:affiliation>Centre for Primary Care, Institute of Population Health, University of Manchester Manchester, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Centre for Primary Care, Institute of Population Health, University of Manchester Manchester</wicri:regionArea><wicri:noRegion>University of Manchester Manchester</wicri:noRegion></affiliation></author><author><name sortKey="Eriksson, Irene" sort="Eriksson, Irene" uniqKey="Eriksson I" first="Irene" last="Eriksson">Irene Eriksson</name><affiliation wicri:level="1"><nlm:affiliation>Department of Healthcare Development, Public Healthcare Services Committee, Stockholm County Council Stockholm, Sweden.</nlm:affiliation><country xml:lang="fr">Suède</country><wicri:regionArea>Department of Healthcare Development, Public Healthcare Services Committee, Stockholm County Council Stockholm</wicri:regionArea><wicri:noRegion>Stockholm County Council Stockholm</wicri:noRegion></affiliation></author><author><name sortKey="Finlayson, Alexander" sort="Finlayson, Alexander" uniqKey="Finlayson A" first="Alexander" last="Finlayson">Alexander Finlayson</name><affiliation wicri:level="1"><nlm:affiliation>Green Templeton College, University of Oxford Oxford, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Green Templeton College, University of Oxford Oxford</wicri:regionArea><wicri:noRegion>University of Oxford Oxford</wicri:noRegion></affiliation></author><author><name sortKey="Furst, Jurij" sort="Furst, Jurij" uniqKey="Furst J" first="Jurij" last="Fürst">Jurij Fürst</name><affiliation wicri:level="1"><nlm:affiliation>Health Insurance Institute Ljubljana, Slovenia.</nlm:affiliation><country xml:lang="fr">Slovénie</country><wicri:regionArea>Health Insurance Institute Ljubljana</wicri:regionArea></affiliation></author><author><name sortKey="Garuoliene, Kristina" sort="Garuoliene, Kristina" uniqKey="Garuoliene K" first="Kristina" last="Garuoliene">Kristina Garuoliene</name><affiliation wicri:level="1"><nlm:affiliation>Medicines Reimbursement Department, National Health Insurance Fund Vilnius, Lithuania.</nlm:affiliation><country xml:lang="fr">Lituanie</country><wicri:regionArea>Medicines Reimbursement Department, National Health Insurance Fund Vilnius</wicri:regionArea><wicri:noRegion>National Health Insurance Fund Vilnius</wicri:noRegion></affiliation></author><author><name sortKey="Gutierrez Ibarluzea, I Aki" sort="Gutierrez Ibarluzea, I Aki" uniqKey="Gutierrez 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wicri:level="1"><nlm:affiliation>Department of Medicines and Pharmacoeconomics, Republic Institute for Health Insurance Belgrade, Serbia.</nlm:affiliation><country xml:lang="fr">Serbie</country><wicri:regionArea>Department of Medicines and Pharmacoeconomics, Republic Institute for Health Insurance Belgrade</wicri:regionArea><wicri:noRegion>Republic Institute for Health Insurance Belgrade</wicri:noRegion></affiliation></author><author><name sortKey="Laius, Ott" sort="Laius, Ott" uniqKey="Laius O" first="Ott" last="Laius">Ott Laius</name><affiliation wicri:level="1"><nlm:affiliation>State Agency of Medicines Tartu, Estonia.</nlm:affiliation><country xml:lang="fr">Estonie</country><wicri:regionArea>State Agency of Medicines Tartu</wicri:regionArea></affiliation></author><author><name sortKey="Malinowska, Kamila" sort="Malinowska, Kamila" uniqKey="Malinowska K" first="Kamila" last="Malinowska">Kamila Malinowska</name><affiliation wicri:level="1"><nlm:affiliation>Department of Epidemiology and Health Promotion, Public Health School Warsaw, Poland ; Drug Management Department, National Health Fund Warsaw, Poland.</nlm:affiliation><country xml:lang="fr">Pologne</country><wicri:regionArea>Department of Epidemiology and Health Promotion, Public Health School Warsaw, Poland ; Drug Management Department, National Health Fund Warsaw</wicri:regionArea><wicri:noRegion>National Health Fund Warsaw</wicri:noRegion></affiliation></author><author><name sortKey="Pedersen, Hanne B" sort="Pedersen, Hanne B" uniqKey="Pedersen H" first="Hanne B" last="Pedersen">Hanne B. 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Medicine, University of Banja Luka Banja Luka, Bosnia and Herzegovina ; Ministry of Health and Social Welfare Banja Luka</wicri:regionArea><wicri:noRegion>Bosnia and Herzegovina ; Ministry of Health and Social Welfare Banja Luka</wicri:noRegion></affiliation></author><author><name sortKey="Piessnegger, Jutta" sort="Piessnegger, Jutta" uniqKey="Piessnegger J" first="Jutta" last="Piessnegger">Jutta Piessnegger</name><affiliation wicri:level="1"><nlm:affiliation>Hauptverband der Österreichischen Sozialversicherungsträger Vienna, Austria.</nlm:affiliation><country xml:lang="fr">Autriche</country><wicri:regionArea>Hauptverband der Österreichischen Sozialversicherungsträger Vienna</wicri:regionArea></affiliation></author><author><name sortKey="Selke, Gisbert" sort="Selke, Gisbert" uniqKey="Selke G" first="Gisbert" last="Selke">Gisbert Selke</name><affiliation wicri:level="1"><nlm:affiliation>Wissenschaftliches Institut der AOK (WidO) Berlin, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Wissenschaftliches Institut der AOK (WidO) Berlin</wicri:regionArea></affiliation></author><author><name sortKey="Sermet, Catherine" sort="Sermet, Catherine" uniqKey="Sermet C" first="Catherine" last="Sermet">Catherine Sermet</name><affiliation wicri:level="1"><nlm:affiliation>IRDES Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>IRDES Paris</wicri:regionArea></affiliation></author><author><name sortKey="Spillane, Susan" sort="Spillane, Susan" uniqKey="Spillane S" first="Susan" last="Spillane">Susan Spillane</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pharmacology and Therapeutics, Trinity College Dublin Dublin, Ireland.</nlm:affiliation><country xml:lang="fr">Irlande (pays)</country><wicri:regionArea>Department of Pharmacology and Therapeutics, Trinity College Dublin Dublin</wicri:regionArea><wicri:noRegion>Trinity College Dublin Dublin</wicri:noRegion></affiliation></author><author><name sortKey="Tomek, Dominik" sort="Tomek, Dominik" uniqKey="Tomek D" first="Dominik" last="Tomek">Dominik Tomek</name><affiliation wicri:level="1"><nlm:affiliation>Faculty of Pharmacy, Comenius University and Faculty of Medicine, Slovak Medical University Bratislava, Slovakia.</nlm:affiliation><country xml:lang="fr">Slovaquie</country><wicri:regionArea>Faculty of Pharmacy, Comenius University and Faculty of Medicine, Slovak Medical University Bratislava</wicri:regionArea><wicri:noRegion>Slovak Medical University Bratislava</wicri:noRegion></affiliation></author><author><name sortKey="Von Ina, Luka" sort="Von Ina, Luka" uniqKey="Von Ina L" first="Luka" last="Von Ina">Luka Von Ina</name><affiliation wicri:level="1"><nlm:affiliation>Ministry of Health Zagreb, Croatia.</nlm:affiliation><country xml:lang="fr">Croatie</country><wicri:regionArea>Ministry of Health Zagreb</wicri:regionArea></affiliation></author><author><name sortKey="Vlahovi Pal Evski, Vera" sort="Vlahovi Pal Evski, Vera" uniqKey="Vlahovi Pal Evski V" first="Vera" last="Vlahovi Pal Evski">Vera Vlahovi Pal Evski</name><affiliation wicri:level="1"><nlm:affiliation>Unit for Clinical Pharmacology, University Hospital Rijeka Rijeka, Croatia.</nlm:affiliation><country xml:lang="fr">Croatie</country><wicri:regionArea>Unit for Clinical Pharmacology, University Hospital Rijeka Rijeka</wicri:regionArea><wicri:noRegion>University Hospital Rijeka Rijeka</wicri:noRegion></affiliation></author><author><name sortKey="Wale, Janet" sort="Wale, Janet" uniqKey="Wale J" first="Janet" last="Wale">Janet Wale</name><affiliation wicri:level="1"><nlm:affiliation>Independent Consumer Advocate, VIC Melbourne, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Independent Consumer Advocate, VIC Melbourne</wicri:regionArea><wicri:noRegion>VIC Melbourne</wicri:noRegion></affiliation></author><author><name sortKey="Wladysiuk, Magdalena" sort="Wladysiuk, Magdalena" uniqKey="Wladysiuk M" first="Magdalena" last="Wladysiuk">Magdalena Wladysiuk</name><affiliation wicri:level="1"><nlm:affiliation>HTA Consulting Cracow, Poland.</nlm:affiliation><country xml:lang="fr">Pologne</country><wicri:regionArea>HTA Consulting Cracow</wicri:regionArea></affiliation></author><author><name sortKey="Van Woerkom, Menno" sort="Van Woerkom, Menno" uniqKey="Van Woerkom M" first="Menno" last="Van Woerkom">Menno Van Woerkom</name><affiliation wicri:level="1"><nlm:affiliation>Dutch Institute for Rational Use of Medicine Utrecht, Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Dutch Institute for Rational Use of Medicine Utrecht</wicri:regionArea></affiliation></author><author><name sortKey="Zara, Corinne" sort="Zara, Corinne" uniqKey="Zara C" first="Corinne" last="Zara">Corinne Zara</name><affiliation wicri:level="1"><nlm:affiliation>Barcelona Health Region, Catalan Health Service Barcelona, 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Malmström</name><affiliation wicri:level="1"><nlm:affiliation>Clinical Pharmacology Unit, Department of Medicine, Karolinska Institutet, Karolinska University Hospital Solna Stockholm, Sweden.</nlm:affiliation><country xml:lang="fr">Suède</country><wicri:regionArea>Clinical Pharmacology Unit, Department of Medicine, Karolinska Institutet, Karolinska University Hospital Solna Stockholm</wicri:regionArea><wicri:noRegion>Karolinska University Hospital Solna Stockholm</wicri:noRegion></affiliation></author><author><name sortKey="Diogene, Eduardo" sort="Diogene, Eduardo" uniqKey="Diogene E" first="Eduardo" last="Diogene">Eduardo Diogene</name><affiliation wicri:level="1"><nlm:affiliation>Clinical Pharmacology Service, Vall d'Hebron University Hospital, Fundació Institut Català de Farmacologia, Autonomous University of Barcelona Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Clinical Pharmacology Service, Vall d'Hebron University Hospital, Fundació Institut Català de Farmacologia, Autonomous University of Barcelona Barcelona</wicri:regionArea><wicri:noRegion>Autonomous University of Barcelona Barcelona</wicri:noRegion></affiliation></author><author><name sortKey="Jayathissa, Sisira" sort="Jayathissa, Sisira" uniqKey="Jayathissa S" first="Sisira" last="Jayathissa">Sisira Jayathissa</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, Hutt Valley DHB Lower Hutt, Wellington, New Zealand.</nlm:affiliation><country xml:lang="fr">Nouvelle-Zélande</country><wicri:regionArea>Department of Medicine, Hutt Valley DHB Lower Hutt, Wellington</wicri:regionArea><wicri:noRegion>Wellington</wicri:noRegion></affiliation></author><author><name sortKey="Mctaggart, Stuart" sort="Mctaggart, Stuart" uniqKey="Mctaggart S" first="Stuart" last="Mctaggart">Stuart Mctaggart</name><affiliation wicri:level="1"><nlm:affiliation>Public Health and Intelligence Business Unit, NHS National Services Scotland Edinburgh, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Public Health and Intelligence Business Unit, NHS National Services Scotland Edinburgh</wicri:regionArea><wicri:noRegion>NHS National Services Scotland Edinburgh</wicri:noRegion></affiliation></author><author><name sortKey="Cars, Thomas" sort="Cars, Thomas" uniqKey="Cars T" first="Thomas" last="Cars">Thomas Cars</name><affiliation wicri:level="1"><nlm:affiliation>Department of Healthcare Development, Public Healthcare Services Committee, Stockholm County Council Stockholm, Sweden ; Department of Medical Sciences, Uppsala University Uppsala, Sweden.</nlm:affiliation><country xml:lang="fr">Suède</country><wicri:regionArea>Department of Healthcare Development, Public Healthcare Services Committee, Stockholm County Council Stockholm, Sweden ; Department of Medical Sciences, Uppsala University Uppsala</wicri:regionArea><wicri:noRegion>Uppsala University Uppsala</wicri:noRegion></affiliation></author><author><name sortKey="Alvarez Madrazo, Samantha" sort="Alvarez Madrazo, Samantha" uniqKey="Alvarez Madrazo S" first="Samantha" last="Alvarez-Madrazo">Samantha Alvarez-Madrazo</name><affiliation wicri:level="1"><nlm:affiliation>Medicines Use and Health, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde Glasgow, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Medicines Use and Health, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde Glasgow</wicri:regionArea><wicri:noRegion>University of Strathclyde Glasgow</wicri:noRegion></affiliation></author><author><name sortKey="Baumg Rtel, Christoph" sort="Baumg Rtel, Christoph" uniqKey="Baumg Rtel C" first="Christoph" last="Baumg Rtel">Christoph Baumg Rtel</name><affiliation wicri:level="1"><nlm:affiliation>Austrian Medicines and Medical Devices Agency Wien, Austria.</nlm:affiliation><country xml:lang="fr">Autriche</country><wicri:regionArea>Austrian Medicines and Medical Devices Agency Wien</wicri:regionArea></affiliation></author><author><name sortKey="Brzezinska, Anna" sort="Brzezinska, Anna" uniqKey="Brzezinska A" first="Anna" last="Brzezinska">Anna Brzezinska</name><affiliation wicri:level="1"><nlm:affiliation>Agency for Health Technology Assessment Warsaw, Poland.</nlm:affiliation><country xml:lang="fr">Pologne</country><wicri:regionArea>Agency for Health Technology Assessment Warsaw</wicri:regionArea></affiliation></author><author><name sortKey="Bucsics, Anna" sort="Bucsics, Anna" uniqKey="Bucsics A" first="Anna" last="Bucsics">Anna Bucsics</name><affiliation wicri:level="1"><nlm:affiliation>Department of Finance, Faculty of Business, Economics and Statistics, University of Vienna Vienna, Austria ; Hauptverband der Österreichischen Sozialversicherungsträger Vienna, Austria.</nlm:affiliation><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of Finance, Faculty of Business, Economics and Statistics, University of Vienna Vienna, Austria ; Hauptverband der Österreichischen Sozialversicherungsträger Vienna</wicri:regionArea><wicri:noRegion>Austria ; Hauptverband der Österreichischen Sozialversicherungsträger Vienna</wicri:noRegion></affiliation></author><author><name sortKey="Campbell, Stephen" sort="Campbell, Stephen" uniqKey="Campbell S" first="Stephen" last="Campbell">Stephen Campbell</name><affiliation wicri:level="1"><nlm:affiliation>Centre for Primary Care, Institute of Population Health, University of Manchester Manchester, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Centre for Primary Care, Institute of Population Health, University of Manchester Manchester</wicri:regionArea><wicri:noRegion>University of Manchester Manchester</wicri:noRegion></affiliation></author><author><name sortKey="Eriksson, Irene" sort="Eriksson, Irene" uniqKey="Eriksson I" first="Irene" last="Eriksson">Irene Eriksson</name><affiliation wicri:level="1"><nlm:affiliation>Department of Healthcare Development, Public Healthcare Services Committee, Stockholm County Council Stockholm, Sweden.</nlm:affiliation><country xml:lang="fr">Suède</country><wicri:regionArea>Department of Healthcare Development, Public Healthcare Services Committee, Stockholm County Council Stockholm</wicri:regionArea><wicri:noRegion>Stockholm County Council Stockholm</wicri:noRegion></affiliation></author><author><name sortKey="Finlayson, Alexander" sort="Finlayson, Alexander" uniqKey="Finlayson A" first="Alexander" last="Finlayson">Alexander Finlayson</name><affiliation wicri:level="1"><nlm:affiliation>Green Templeton College, University of Oxford Oxford, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Green Templeton College, University of Oxford Oxford</wicri:regionArea><wicri:noRegion>University of Oxford Oxford</wicri:noRegion></affiliation></author><author><name sortKey="Furst, Jurij" sort="Furst, Jurij" uniqKey="Furst J" first="Jurij" last="Fürst">Jurij Fürst</name><affiliation wicri:level="1"><nlm:affiliation>Health Insurance Institute Ljubljana, Slovenia.</nlm:affiliation><country xml:lang="fr">Slovénie</country><wicri:regionArea>Health Insurance Institute Ljubljana</wicri:regionArea></affiliation></author><author><name sortKey="Garuoliene, Kristina" sort="Garuoliene, Kristina" uniqKey="Garuoliene K" first="Kristina" last="Garuoliene">Kristina Garuoliene</name><affiliation wicri:level="1"><nlm:affiliation>Medicines Reimbursement Department, National Health Insurance Fund Vilnius, Lithuania.</nlm:affiliation><country xml:lang="fr">Lituanie</country><wicri:regionArea>Medicines Reimbursement Department, National Health Insurance Fund Vilnius</wicri:regionArea><wicri:noRegion>National Health Insurance Fund Vilnius</wicri:noRegion></affiliation></author><author><name sortKey="Gutierrez Ibarluzea, I Aki" sort="Gutierrez Ibarluzea, I Aki" uniqKey="Gutierrez Ibarluzea I" first="I Aki" last="Gutiérrez-Ibarluzea">I Aki Gutiérrez-Ibarluzea</name><affiliation wicri:level="1"><nlm:affiliation>Basque Office for HTA, Ministry of Health and Consumer Affairs, Basque Government Basque Country, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Basque Office for HTA, Ministry of Health and Consumer Affairs, Basque Government Basque Country</wicri:regionArea><wicri:noRegion>Basque Government Basque Country</wicri:noRegion></affiliation></author><author><name sortKey="Hviding, Krystyna" sort="Hviding, Krystyna" uniqKey="Hviding K" first="Krystyna" last="Hviding">Krystyna Hviding</name><affiliation wicri:level="1"><nlm:affiliation>Norwegian Medicines Agency Oslo, Norway.</nlm:affiliation><country xml:lang="fr">Norvège</country><wicri:regionArea>Norwegian Medicines Agency Oslo</wicri:regionArea></affiliation></author><author><name sortKey="Herholz, Harald" sort="Herholz, Harald" uniqKey="Herholz H" first="Harald" last="Herholz">Harald Herholz</name><affiliation wicri:level="1"><nlm:affiliation>Kassenärztliche Vereinigung Hessen Frankfurt am Main, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Kassenärztliche Vereinigung Hessen Frankfurt am Main</wicri:regionArea></affiliation></author><author><name sortKey="Joppi, Roberta" sort="Joppi, Roberta" uniqKey="Joppi R" first="Roberta" last="Joppi">Roberta Joppi</name><affiliation wicri:level="1"><nlm:affiliation>Pharmaceutical Drug Department, Azienda Sanitaria Locale of Verona Verona, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Pharmaceutical Drug Department, Azienda Sanitaria Locale of Verona Verona</wicri:regionArea><wicri:noRegion>Azienda Sanitaria Locale of Verona Verona</wicri:noRegion></affiliation></author><author><name sortKey="Kalaba, Marija" sort="Kalaba, Marija" uniqKey="Kalaba M" first="Marija" last="Kalaba">Marija Kalaba</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicines and Pharmacoeconomics, Republic Institute for Health Insurance Belgrade, Serbia.</nlm:affiliation><country xml:lang="fr">Serbie</country><wicri:regionArea>Department of Medicines and Pharmacoeconomics, Republic Institute for Health Insurance Belgrade</wicri:regionArea><wicri:noRegion>Republic Institute for Health Insurance Belgrade</wicri:noRegion></affiliation></author><author><name sortKey="Laius, Ott" sort="Laius, Ott" uniqKey="Laius O" first="Ott" last="Laius">Ott Laius</name><affiliation wicri:level="1"><nlm:affiliation>State Agency of Medicines Tartu, Estonia.</nlm:affiliation><country xml:lang="fr">Estonie</country><wicri:regionArea>State Agency of Medicines Tartu</wicri:regionArea></affiliation></author><author><name sortKey="Malinowska, Kamila" sort="Malinowska, Kamila" uniqKey="Malinowska K" first="Kamila" last="Malinowska">Kamila Malinowska</name><affiliation wicri:level="1"><nlm:affiliation>Department of Epidemiology and Health Promotion, Public Health School Warsaw, Poland ; Drug Management Department, National Health Fund Warsaw, Poland.</nlm:affiliation><country xml:lang="fr">Pologne</country><wicri:regionArea>Department of Epidemiology and Health Promotion, Public Health School Warsaw, Poland ; Drug Management Department, National Health Fund Warsaw</wicri:regionArea><wicri:noRegion>National Health Fund Warsaw</wicri:noRegion></affiliation></author><author><name sortKey="Pedersen, Hanne B" sort="Pedersen, Hanne B" uniqKey="Pedersen H" first="Hanne B" last="Pedersen">Hanne B. Pedersen</name><affiliation wicri:level="1"><nlm:affiliation>Division of Health Systems and Public Health, Health Technologies and Pharmaceuticals, WHO Regional Office for Europe Copenhagen, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Division of Health Systems and Public Health, Health Technologies and Pharmaceuticals, WHO Regional Office for Europe Copenhagen</wicri:regionArea><wicri:noRegion>WHO Regional Office for Europe Copenhagen</wicri:noRegion></affiliation></author><author><name sortKey="Markovic Pekovic, Vanda" sort="Markovic Pekovic, Vanda" uniqKey="Markovic Pekovic V" first="Vanda" last="Markovic-Pekovic">Vanda Markovic-Pekovic</name><affiliation wicri:level="1"><nlm:affiliation>Faculty of Medicine, University of Banja Luka Banja Luka, Bosnia and Herzegovina ; Ministry of Health and Social Welfare Banja Luka, Bosnia and Herzegovina.</nlm:affiliation><country xml:lang="fr">Bosnie-Herzégovine</country><wicri:regionArea>Faculty of Medicine, University of Banja Luka Banja Luka, Bosnia and Herzegovina ; Ministry of Health and Social Welfare Banja Luka</wicri:regionArea><wicri:noRegion>Bosnia and Herzegovina ; Ministry of Health and Social Welfare Banja Luka</wicri:noRegion></affiliation></author><author><name sortKey="Piessnegger, Jutta" sort="Piessnegger, Jutta" uniqKey="Piessnegger J" first="Jutta" last="Piessnegger">Jutta Piessnegger</name><affiliation wicri:level="1"><nlm:affiliation>Hauptverband der Österreichischen Sozialversicherungsträger Vienna, Austria.</nlm:affiliation><country xml:lang="fr">Autriche</country><wicri:regionArea>Hauptverband der Österreichischen Sozialversicherungsträger Vienna</wicri:regionArea></affiliation></author><author><name sortKey="Selke, Gisbert" sort="Selke, Gisbert" uniqKey="Selke G" first="Gisbert" last="Selke">Gisbert Selke</name><affiliation wicri:level="1"><nlm:affiliation>Wissenschaftliches Institut der AOK (WidO) Berlin, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Wissenschaftliches Institut der AOK (WidO) Berlin</wicri:regionArea></affiliation></author><author><name sortKey="Sermet, Catherine" sort="Sermet, Catherine" uniqKey="Sermet C" first="Catherine" last="Sermet">Catherine Sermet</name><affiliation wicri:level="1"><nlm:affiliation>IRDES Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>IRDES Paris</wicri:regionArea></affiliation></author><author><name sortKey="Spillane, Susan" sort="Spillane, Susan" uniqKey="Spillane S" first="Susan" last="Spillane">Susan Spillane</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pharmacology and Therapeutics, Trinity College Dublin Dublin, Ireland.</nlm:affiliation><country xml:lang="fr">Irlande (pays)</country><wicri:regionArea>Department of Pharmacology and Therapeutics, Trinity College Dublin Dublin</wicri:regionArea><wicri:noRegion>Trinity College Dublin Dublin</wicri:noRegion></affiliation></author><author><name sortKey="Tomek, Dominik" sort="Tomek, Dominik" uniqKey="Tomek D" first="Dominik" last="Tomek">Dominik Tomek</name><affiliation wicri:level="1"><nlm:affiliation>Faculty of Pharmacy, Comenius University and Faculty of Medicine, Slovak Medical University Bratislava, Slovakia.</nlm:affiliation><country xml:lang="fr">Slovaquie</country><wicri:regionArea>Faculty of Pharmacy, Comenius University and Faculty of Medicine, Slovak Medical University Bratislava</wicri:regionArea><wicri:noRegion>Slovak Medical University Bratislava</wicri:noRegion></affiliation></author><author><name sortKey="Von Ina, Luka" sort="Von Ina, Luka" uniqKey="Von Ina L" first="Luka" last="Von Ina">Luka Von Ina</name><affiliation wicri:level="1"><nlm:affiliation>Ministry of Health Zagreb, Croatia.</nlm:affiliation><country xml:lang="fr">Croatie</country><wicri:regionArea>Ministry of Health Zagreb</wicri:regionArea></affiliation></author><author><name sortKey="Vlahovi Pal Evski, Vera" sort="Vlahovi Pal Evski, Vera" uniqKey="Vlahovi Pal Evski V" first="Vera" last="Vlahovi Pal Evski">Vera Vlahovi Pal Evski</name><affiliation wicri:level="1"><nlm:affiliation>Unit for Clinical Pharmacology, University Hospital Rijeka Rijeka, Croatia.</nlm:affiliation><country xml:lang="fr">Croatie</country><wicri:regionArea>Unit for Clinical Pharmacology, University Hospital Rijeka Rijeka</wicri:regionArea><wicri:noRegion>University Hospital Rijeka Rijeka</wicri:noRegion></affiliation></author><author><name sortKey="Wale, Janet" sort="Wale, Janet" uniqKey="Wale J" first="Janet" last="Wale">Janet Wale</name><affiliation wicri:level="1"><nlm:affiliation>Independent Consumer Advocate, VIC Melbourne, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Independent Consumer Advocate, VIC Melbourne</wicri:regionArea><wicri:noRegion>VIC Melbourne</wicri:noRegion></affiliation></author><author><name sortKey="Wladysiuk, Magdalena" sort="Wladysiuk, Magdalena" uniqKey="Wladysiuk M" first="Magdalena" last="Wladysiuk">Magdalena Wladysiuk</name><affiliation wicri:level="1"><nlm:affiliation>HTA Consulting Cracow, Poland.</nlm:affiliation><country xml:lang="fr">Pologne</country><wicri:regionArea>HTA Consulting Cracow</wicri:regionArea></affiliation></author><author><name sortKey="Van Woerkom, Menno" sort="Van Woerkom, Menno" uniqKey="Van Woerkom M" first="Menno" last="Van Woerkom">Menno Van Woerkom</name><affiliation wicri:level="1"><nlm:affiliation>Dutch Institute for Rational Use of Medicine Utrecht, Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Dutch Institute for Rational Use of Medicine Utrecht</wicri:regionArea></affiliation></author><author><name sortKey="Zara, Corinne" sort="Zara, Corinne" uniqKey="Zara C" first="Corinne" last="Zara">Corinne Zara</name><affiliation wicri:level="1"><nlm:affiliation>Barcelona Health Region, Catalan Health Service Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Barcelona Health Region, Catalan Health Service Barcelona</wicri:regionArea><wicri:noRegion>Catalan Health Service Barcelona</wicri:noRegion></affiliation></author><author><name sortKey="Gustafsson, Lars L" sort="Gustafsson, Lars L" uniqKey="Gustafsson L" first="Lars L" last="Gustafsson">Lars L. Gustafsson</name><affiliation wicri:level="1"><nlm:affiliation>Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge Stockholm, Sweden.</nlm:affiliation><country xml:lang="fr">Suède</country><wicri:regionArea>Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge Stockholm</wicri:regionArea><wicri:noRegion>Karolinska University Hospital Huddinge Stockholm</wicri:noRegion></affiliation></author></analytic><series><title level="j">Frontiers in pharmacology</title><idno type="ISSN">1663-9812</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are effectiveness, safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies showed dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. These concerns resulted in extensive activities pre- to post-launch to manage its introduction.</div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">24959145</PMID><DateCreated><Year>2014</Year><Month>06</Month><Day>24</Day></DateCreated><DateCompleted><Year>2014</Year><Month>06</Month><Day>24</Day></DateCompleted><DateRevised><Year>2017</Year><Month>09</Month><Day>22</Day></DateRevised><Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Print">1663-9812</ISSN><JournalIssue CitedMedium="Print"><Volume>5</Volume><PubDate><Year>2014</Year></PubDate></JournalIssue><Title>Frontiers in pharmacology</Title><ISOAbbreviation>Front Pharmacol</ISOAbbreviation></Journal><ArticleTitle>Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs.</ArticleTitle><Pagination><MedlinePgn>109</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.3389/fphar.2014.00109</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are effectiveness, safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies showed dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. These concerns resulted in extensive activities pre- to post-launch to manage its introduction.</AbstractText><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To (i) review authority activities across countries, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications based on post-launch activities.</AbstractText><AbstractText Label="METHODOLOGY" NlmCategory="METHODS">(i) Descriptive review and appraisal of activities regarding dabigatran, (ii) development of guidance for key stakeholder groups through an iterative process, (iii) refining guidance following post launch studies.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Plethora of activities to manage dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions and monitoring of prescribing post launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities. Post-launch activities include increasing use of patient registries to monitor the safety and effectiveness of new drugs in clinical practice.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">Models for introducing new drugs are essential to optimize their prescribing especially where concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Godman</LastName><ForeName>Brian</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge Stockholm, Sweden ; Medicines Use and Health, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde Glasgow, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Malmström</LastName><ForeName>Rickard E</ForeName><Initials>RE</Initials><AffiliationInfo><Affiliation>Clinical Pharmacology Unit, Department of Medicine, Karolinska Institutet, Karolinska University Hospital Solna Stockholm, Sweden.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Diogene</LastName><ForeName>Eduardo</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Clinical Pharmacology Service, Vall d'Hebron University Hospital, Fundació Institut Català de Farmacologia, Autonomous University of Barcelona Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jayathissa</LastName><ForeName>Sisira</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Medicine, Hutt Valley DHB Lower Hutt, Wellington, New Zealand.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>McTaggart</LastName><ForeName>Stuart</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Public Health and Intelligence Business Unit, NHS National Services Scotland Edinburgh, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cars</LastName><ForeName>Thomas</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Department of Healthcare Development, Public Healthcare Services Committee, Stockholm County Council Stockholm, Sweden ; Department of Medical Sciences, Uppsala University Uppsala, Sweden.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Alvarez-Madrazo</LastName><ForeName>Samantha</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Medicines Use and Health, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde Glasgow, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Baumgärtel</LastName><ForeName>Christoph</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Austrian Medicines and Medical Devices Agency Wien, Austria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Brzezinska</LastName><ForeName>Anna</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Agency for Health Technology Assessment Warsaw, Poland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bucsics</LastName><ForeName>Anna</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Finance, Faculty of Business, Economics and Statistics, University of Vienna Vienna, Austria ; Hauptverband der Österreichischen Sozialversicherungsträger Vienna, Austria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Campbell</LastName><ForeName>Stephen</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Centre for Primary Care, Institute of Population Health, University of Manchester Manchester, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Eriksson</LastName><ForeName>Irene</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Department of Healthcare Development, Public Healthcare Services Committee, Stockholm County Council Stockholm, Sweden.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Finlayson</LastName><ForeName>Alexander</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Green Templeton College, University of Oxford Oxford, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fürst</LastName><ForeName>Jurij</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Health Insurance Institute Ljubljana, Slovenia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Garuoliene</LastName><ForeName>Kristina</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Medicines Reimbursement Department, National Health Insurance Fund Vilnius, Lithuania.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gutiérrez-Ibarluzea</LastName><ForeName>Iñaki</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Basque Office for HTA, Ministry of Health and Consumer Affairs, Basque Government Basque Country, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hviding</LastName><ForeName>Krystyna</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Norwegian Medicines Agency Oslo, Norway.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Herholz</LastName><ForeName>Harald</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Kassenärztliche Vereinigung Hessen Frankfurt am Main, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Joppi</LastName><ForeName>Roberta</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Pharmaceutical Drug Department, Azienda Sanitaria Locale of Verona Verona, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kalaba</LastName><ForeName>Marija</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Medicines and Pharmacoeconomics, Republic Institute for Health Insurance Belgrade, Serbia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Laius</LastName><ForeName>Ott</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>State Agency of Medicines Tartu, Estonia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Malinowska</LastName><ForeName>Kamila</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Department of Epidemiology and Health Promotion, Public Health School Warsaw, Poland ; Drug Management Department, National Health Fund Warsaw, Poland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pedersen</LastName><ForeName>Hanne B</ForeName><Initials>HB</Initials><AffiliationInfo><Affiliation>Division of Health Systems and Public Health, Health Technologies and Pharmaceuticals, WHO Regional Office for Europe Copenhagen, Denmark.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Markovic-Pekovic</LastName><ForeName>Vanda</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Faculty of Medicine, University of Banja Luka Banja Luka, Bosnia and Herzegovina ; Ministry of Health and Social Welfare Banja Luka, Bosnia and Herzegovina.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Piessnegger</LastName><ForeName>Jutta</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Hauptverband der Österreichischen Sozialversicherungsträger Vienna, Austria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Selke</LastName><ForeName>Gisbert</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Wissenschaftliches Institut der AOK (WidO) Berlin, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sermet</LastName><ForeName>Catherine</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>IRDES Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Spillane</LastName><ForeName>Susan</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Pharmacology and Therapeutics, Trinity College Dublin Dublin, Ireland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tomek</LastName><ForeName>Dominik</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Faculty of Pharmacy, Comenius University and Faculty of Medicine, Slovak Medical University Bratislava, Slovakia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vončina</LastName><ForeName>Luka</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Ministry of Health Zagreb, Croatia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vlahović-Palčevski</LastName><ForeName>Vera</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Unit for Clinical Pharmacology, University Hospital Rijeka Rijeka, Croatia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wale</LastName><ForeName>Janet</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Independent Consumer Advocate, VIC Melbourne, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wladysiuk</LastName><ForeName>Magdalena</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>HTA Consulting Cracow, Poland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>van Woerkom</LastName><ForeName>Menno</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Dutch Institute for Rational Use of Medicine Utrecht, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zara</LastName><ForeName>Corinne</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Barcelona Health Region, Catalan Health Service Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gustafsson</LastName><ForeName>Lars L</ForeName><Initials>LL</Initials><AffiliationInfo><Affiliation>Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge Stockholm, Sweden.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>001</GrantID><Agency>World Health Organization</Agency><Country>International</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016454">Review</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>06</Month><Day>10</Day></ArticleDate></Article><MedlineJournalInfo><Country>Switzerland</Country><MedlineTA>Front Pharmacol</MedlineTA><NlmUniqueID>101548923</NlmUniqueID><ISSNLinking>1663-9812</ISSNLinking></MedlineJournalInfo><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Eur Heart J. 2013 Jan;34(3):177-83</RefSource><PMID Version="1">22733833</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Science. 2012 Feb 10;335(6069):645</RefSource><PMID 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Version="1">22971029</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Eur J Clin Pharmacol. 2014 Feb;70(2):249-50</RefSource><PMID Version="1">24132558</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>CMAJ Open. 2013 Oct 16;1(3):E115-9</RefSource><PMID Version="1">25077110</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Orthop Sports Phys Ther. 2003 Apr;33(4):163-5</RefSource><PMID Version="1">12723672</PMID></CommentsCorrections></CommentsCorrectionsList><OtherID Source="NLM">PMC4050532</OtherID><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">critical drug evaluation</Keyword><Keyword MajorTopicYN="N">dabigatran</Keyword><Keyword MajorTopicYN="N">demand-side measures</Keyword><Keyword MajorTopicYN="N">managed introduction new medicines</Keyword><Keyword MajorTopicYN="N">registries</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2014</Year><Month>02</Month><Day>19</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2014</Year><Month>04</Month><Day>23</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2014</Year><Month>6</Month><Day>25</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2014</Year><Month>6</Month><Day>25</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2014</Year><Month>6</Month><Day>25</Day><Hour>6</Hour><Minute>1</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">24959145</ArticleId><ArticleId IdType="doi">10.3389/fphar.2014.00109</ArticleId><ArticleId IdType="pmc">PMC4050532</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Autriche</li><li>Bosnie-Herzégovine</li><li>Croatie</li><li>Danemark</li><li>Espagne</li><li>Estonie</li><li>France</li><li>Irlande (pays)</li><li>Italie</li><li>Lituanie</li><li>Norvège</li><li>Nouvelle-Zélande</li><li>Pays-Bas</li><li>Pologne</li><li>Royaume-Uni</li><li>Serbie</li><li>Slovaquie</li><li>Slovénie</li><li>Suède</li></country></list><tree><country name="Royaume-Uni"><noRegion><name sortKey="Godman, Brian" sort="Godman, Brian" uniqKey="Godman B" first="Brian" last="Godman">Brian Godman</name></noRegion><name sortKey="Alvarez Madrazo, Samantha" sort="Alvarez Madrazo, Samantha" uniqKey="Alvarez Madrazo S" first="Samantha" last="Alvarez-Madrazo">Samantha Alvarez-Madrazo</name><name sortKey="Campbell, Stephen" sort="Campbell, Stephen" uniqKey="Campbell S" first="Stephen" last="Campbell">Stephen Campbell</name><name sortKey="Finlayson, Alexander" sort="Finlayson, Alexander" uniqKey="Finlayson A" first="Alexander" last="Finlayson">Alexander Finlayson</name><name sortKey="Mctaggart, Stuart" sort="Mctaggart, Stuart" uniqKey="Mctaggart S" first="Stuart" last="Mctaggart">Stuart Mctaggart</name></country><country name="Suède"><noRegion><name sortKey="Malmstrom, Rickard E" sort="Malmstrom, Rickard E" uniqKey="Malmstrom R" first="Rickard E" last="Malmström">Rickard E. Malmström</name></noRegion><name sortKey="Cars, Thomas" sort="Cars, Thomas" uniqKey="Cars T" first="Thomas" last="Cars">Thomas Cars</name><name sortKey="Eriksson, Irene" sort="Eriksson, Irene" uniqKey="Eriksson I" first="Irene" last="Eriksson">Irene Eriksson</name><name sortKey="Gustafsson, Lars L" sort="Gustafsson, Lars L" uniqKey="Gustafsson L" first="Lars L" last="Gustafsson">Lars L. Gustafsson</name></country><country name="Espagne"><noRegion><name sortKey="Diogene, Eduardo" sort="Diogene, Eduardo" uniqKey="Diogene E" first="Eduardo" last="Diogene">Eduardo Diogene</name></noRegion><name sortKey="Gutierrez Ibarluzea, I Aki" sort="Gutierrez Ibarluzea, I Aki" uniqKey="Gutierrez Ibarluzea I" first="I Aki" last="Gutiérrez-Ibarluzea">I Aki Gutiérrez-Ibarluzea</name><name sortKey="Zara, Corinne" sort="Zara, Corinne" uniqKey="Zara C" first="Corinne" last="Zara">Corinne Zara</name></country><country name="Nouvelle-Zélande"><noRegion><name sortKey="Jayathissa, Sisira" sort="Jayathissa, Sisira" uniqKey="Jayathissa S" first="Sisira" last="Jayathissa">Sisira Jayathissa</name></noRegion></country><country name="Autriche"><noRegion><name sortKey="Baumg Rtel, Christoph" sort="Baumg Rtel, Christoph" uniqKey="Baumg Rtel C" first="Christoph" last="Baumg Rtel">Christoph Baumg Rtel</name></noRegion><name sortKey="Bucsics, Anna" sort="Bucsics, Anna" uniqKey="Bucsics A" first="Anna" last="Bucsics">Anna Bucsics</name><name sortKey="Piessnegger, Jutta" sort="Piessnegger, Jutta" uniqKey="Piessnegger J" first="Jutta" last="Piessnegger">Jutta Piessnegger</name></country><country name="Pologne"><noRegion><name sortKey="Brzezinska, Anna" sort="Brzezinska, Anna" uniqKey="Brzezinska A" first="Anna" last="Brzezinska">Anna Brzezinska</name></noRegion><name sortKey="Malinowska, Kamila" sort="Malinowska, Kamila" uniqKey="Malinowska K" first="Kamila" last="Malinowska">Kamila Malinowska</name><name sortKey="Wladysiuk, Magdalena" sort="Wladysiuk, Magdalena" uniqKey="Wladysiuk M" first="Magdalena" last="Wladysiuk">Magdalena Wladysiuk</name></country><country name="Slovénie"><noRegion><name sortKey="Furst, Jurij" sort="Furst, Jurij" uniqKey="Furst J" first="Jurij" last="Fürst">Jurij Fürst</name></noRegion></country><country name="Lituanie"><noRegion><name sortKey="Garuoliene, Kristina" sort="Garuoliene, Kristina" uniqKey="Garuoliene K" first="Kristina" last="Garuoliene">Kristina Garuoliene</name></noRegion></country><country name="Norvège"><noRegion><name sortKey="Hviding, Krystyna" sort="Hviding, Krystyna" uniqKey="Hviding K" first="Krystyna" last="Hviding">Krystyna Hviding</name></noRegion></country><country name="Allemagne"><noRegion><name sortKey="Herholz, Harald" sort="Herholz, Harald" uniqKey="Herholz H" first="Harald" last="Herholz">Harald Herholz</name></noRegion><name sortKey="Selke, Gisbert" sort="Selke, Gisbert" uniqKey="Selke G" first="Gisbert" last="Selke">Gisbert Selke</name></country><country name="Italie"><noRegion><name sortKey="Joppi, Roberta" sort="Joppi, Roberta" uniqKey="Joppi R" first="Roberta" last="Joppi">Roberta Joppi</name></noRegion></country><country name="Serbie"><noRegion><name sortKey="Kalaba, Marija" sort="Kalaba, Marija" uniqKey="Kalaba M" first="Marija" last="Kalaba">Marija Kalaba</name></noRegion></country><country name="Estonie"><noRegion><name sortKey="Laius, Ott" sort="Laius, Ott" uniqKey="Laius O" first="Ott" last="Laius">Ott Laius</name></noRegion></country><country name="Danemark"><noRegion><name sortKey="Pedersen, Hanne B" sort="Pedersen, Hanne B" uniqKey="Pedersen H" first="Hanne B" last="Pedersen">Hanne B. Pedersen</name></noRegion></country><country name="Bosnie-Herzégovine"><noRegion><name sortKey="Markovic Pekovic, Vanda" sort="Markovic Pekovic, Vanda" uniqKey="Markovic Pekovic V" first="Vanda" last="Markovic-Pekovic">Vanda Markovic-Pekovic</name></noRegion></country><country name="France"><noRegion><name sortKey="Sermet, Catherine" sort="Sermet, Catherine" uniqKey="Sermet C" first="Catherine" last="Sermet">Catherine Sermet</name></noRegion></country><country name="Irlande (pays)"><noRegion><name sortKey="Spillane, Susan" sort="Spillane, Susan" uniqKey="Spillane S" first="Susan" last="Spillane">Susan Spillane</name></noRegion></country><country name="Slovaquie"><noRegion><name sortKey="Tomek, Dominik" sort="Tomek, Dominik" uniqKey="Tomek D" first="Dominik" last="Tomek">Dominik Tomek</name></noRegion></country><country name="Croatie"><noRegion><name sortKey="Von Ina, Luka" sort="Von Ina, Luka" uniqKey="Von Ina L" first="Luka" last="Von Ina">Luka Von Ina</name></noRegion><name sortKey="Vlahovi Pal Evski, Vera" sort="Vlahovi Pal Evski, Vera" uniqKey="Vlahovi Pal Evski V" first="Vera" last="Vlahovi Pal Evski">Vera Vlahovi Pal Evski</name></country><country name="Australie"><noRegion><name sortKey="Wale, Janet" sort="Wale, Janet" uniqKey="Wale J" first="Janet" last="Wale">Janet Wale</name></noRegion></country><country name="Pays-Bas"><noRegion><name sortKey="Van Woerkom, Menno" sort="Van Woerkom, Menno" uniqKey="Van Woerkom M" first="Menno" last="Van Woerkom">Menno Van Woerkom</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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