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Dabigatran - a case...
Dabigatran - a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs
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- Malmström, Rickard E. (author)
- Karolinska Institutet,Karolinska University Hospital Solna, Sweden
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- Godman, Brian B. (author)
- Karolinska University Hospital Huddinge, Sweden; University of Liverpool, England; University of Strathclyde, Scotland
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- Diogene, Eduard (author)
- Catalan Institute Heatlh, Spain
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- Baumgartel, Christoph (author)
- Austrian Medical and Medical Dev Agency, Austria
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- Bennie, Marion (author)
- University of Strathclyde, Scotland; NHS National Serv Scotland, Scotland
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- Bishop, Iain (author)
- NHS National Serv Scotland, Scotland
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- Brzezinska, Anna (author)
- Agency Health Technology Assessment, Poland
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- Bucsics, Anna (author)
- Hauptverband Osterreichischen Sozialversicherung, Austria
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- Campbell, Stephen (author)
- University of Manchester, England
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- Ferrario, Alessandra (author)
- LSEHealth, England
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- Finlayson, Alexander E. (author)
- Weston Educat Centre, England
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- Furst, Jurij (author)
- Health Insurance Institute, Slovenia
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- Garuoliene, Kristina (author)
- National Health Insurance Fund, Lithuania
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- Gomes, Miguel (author)
- Institute Nacl Farmacia and Med, Portugal
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- Gutierrez-Ibarluzea, Inaki (author)
- Ministry Health Basque Country, Spain
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- Haycox, Alan (author)
- University of Liverpool, England
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- Hviding, Krystyna (author)
- Norwegian Medical Agency, Norway
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- Herholz, Harald (author)
- Kassenarztliche Vereinigung Hessen, Germany
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- Hoffmann, Mikael (author)
- Linköpings universitet,Avdelningen för läkemedelsforskning,Medicinska fakulteten
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- Jan, Saira (author)
- Horizon Blue Cross Blue Shield New Jersey, NJ USA
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- Jones, Jan (author)
- NHS Tayside, Scotland
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- Joppi, Roberta (author)
- Local Health Unit Verona, Italy
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- Kalaba, Marija (author)
- Republ Institute Health Insurance, Serbia
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- Kvalheim, Christina (author)
- Norwegian Medical Agency, Norway
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- Laius, Ott (author)
- State Agency Med, Estonia
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- Langner, Irene (author)
- Wissenschaftliches Institute AOK, Germany
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- Lonsdale, Julie (author)
- Lancashire Commissioning Support Unit, England
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- Lööv, Sven-Åke (author)
- Stockholm County Council, Sweden
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- Malinowska, Kamila (author)
- HTA Consulting, Poland; Medical Centre Postgrad Educat, Poland
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- McCullagh, Laura (author)
- St James Hospital, Ireland
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- Paterson, Ken (author)
- Scottish Medical Consortium, Scotland
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- Markovic-Pekovic, Vanda (author)
- University of Banja Luka, Bosnia and Herceg; Ministry Health and Social Welfare, Bosnia and Herceg
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- Martin, Andrew (author)
- NHS Bury, England
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- Piessnegger, Jutta (author)
- Hauptverband Osterreichischen Sozialversicherung, Austria
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- Selke, Gisbert (author)
- State Agency Med, Estonia
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- Sermet, Catherine (author)
- Institute Rech and Documentat Econ St, France
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- Simoens, Steven (author)
- Katholieke University of Leuven, Belgium
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- Tulunay, Cankat (author)
- President Turkish Rational Drug Use Platform, Turkey
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- Tomek, Dominik (author)
- Comenius University, Slovakia; Slovak Medical University, Slovakia
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- Voncina, Luka (author)
- Minist Heatlh, Croatia
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- Vlahovic-Palcevski, Vera (author)
- University Hospital Rijeka, Croatia
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- Wale, Janet (author)
- Independent Consumer Advocate, Australia
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- Wilcock, Michael (author)
- Royal Cornwall Hospital NHS Trust, England
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- Wladysiuk, Magdalena (author)
- HTA Consulting, Poland
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- van Woerkom, Menno (author)
- Dutch Institute Rational Use Med, Netherlands
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- Zara, Corrine (author)
- Catalan Health Serv, Spain
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- Gustafsson, Lars L. (author)
- Karolinska Institutet,Karolinska University Hospital Huddinge, Sweden
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(creator_code:org_t)
- 2013
- 2013
- English.
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In: Frontiers in Pharmacology. - : FRONTIERS RESEARCH FOUNDATION. - 1663-9812. ; 4
- Related links:
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https://liu.diva-por... (primary) (Raw object)
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https://www.frontier...
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https://urn.kb.se/re...
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https://doi.org/10.3...
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http://kipublication...
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Abstract
Subject headings
Close
- Background: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are 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 have shown dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. There are also issues with potentially re-designing anticoagulant services. This has resulted in activities across countries to better manage its use. Objective: To (i) review authority activities in over 30 countries and regions, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications for all major stakeholder groups. Methodology: Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process. Results: There has been a plethora of activities among authorities to manage the prescribing of 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-, pen-, and post-launch activities. Conclusion: Models for introducing new drugs are essential to optimize their prescribing especially where there are concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmakologi och toxikologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmacology and Toxicology (hsv//eng)
Keyword
- critical drug evaluation; dabigatran; demand-side measures; drug and therapeutics committees; managed introduction new medicines; pharmacovigilance; registries; risk sharing
Publication and Content Type
- ref (subject category)
- art (subject category)
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To the university's database
- By the author/editor
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Malmström, Ricka ...
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Godman, Brian B.
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Diogene, Eduard
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Baumgartel, Chri ...
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Bennie, Marion
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Bishop, Iain
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show more...
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Brzezinska, Anna
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Bucsics, Anna
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Campbell, Stephe ...
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Ferrario, Alessa ...
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Finlayson, Alexa ...
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Furst, Jurij
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Garuoliene, Kris ...
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Gomes, Miguel
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Gutierrez-Ibarlu ...
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Haycox, Alan
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Hviding, Krystyn ...
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Herholz, Harald
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Hoffmann, Mikael
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Jan, Saira
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Jones, Jan
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Joppi, Roberta
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Kalaba, Marija
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Kvalheim, Christ ...
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Laius, Ott
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Langner, Irene
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Lonsdale, Julie
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Lööv, Sven-Åke
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Malinowska, Kami ...
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McCullagh, Laura
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Paterson, Ken
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Markovic-Pekovic ...
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Martin, Andrew
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Piessnegger, Jut ...
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Selke, Gisbert
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Sermet, Catherin ...
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Simoens, Steven
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Tulunay, Cankat
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Tomek, Dominik
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Voncina, Luka
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Vlahovic-Palcevs ...
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Wale, Janet
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Wilcock, Michael
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Wladysiuk, Magda ...
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van Woerkom, Men ...
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Zara, Corrine
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Gustafsson, Lars ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Pharmacology and ...
- Articles in the publication
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Frontiers in Pha ...
- By the university
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Linköping University
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Karolinska Institutet