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Dabigatran - a case...
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Malmström, Rickard E.Karolinska Institutet,Karolinska University Hospital Solna, Sweden
(author)
Dabigatran - a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs
- Article/chapterEnglish2013
Publisher, publication year, extent ...
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2013
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FRONTIERS RESEARCH FOUNDATION,2013
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electronicrdacarrier
Numbers
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LIBRIS-ID:oai:DiVA.org:liu-141008
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https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-141008URI
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https://doi.org/10.3389/fphar.2013.00039DOI
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http://kipublications.ki.se/Default.aspx?queryparsed=id:130396101URI
Supplementary language notes
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Language:English
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Summary in:English
Part of subdatabase
Classification
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
Notes
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Funding Agencies|Karolinska Institutet, Sweden
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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 and genre
Added entries (persons, corporate bodies, meetings, titles ...)
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Godman, Brian B.Karolinska University Hospital Huddinge, Sweden; University of Liverpool, England; University of Strathclyde, Scotland
(author)
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Diogene, EduardCatalan Institute Heatlh, Spain
(author)
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Baumgartel, ChristophAustrian Medical and Medical Dev Agency, Austria
(author)
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Bennie, MarionUniversity of Strathclyde, Scotland; NHS National Serv Scotland, Scotland
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Bishop, IainNHS National Serv Scotland, Scotland
(author)
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Brzezinska, AnnaAgency Health Technology Assessment, Poland
(author)
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Bucsics, AnnaHauptverband Osterreichischen Sozialversicherung, Austria
(author)
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Campbell, StephenUniversity of Manchester, England
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Ferrario, AlessandraLSEHealth, England
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Finlayson, Alexander E.Weston Educat Centre, England
(author)
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Furst, JurijHealth Insurance Institute, Slovenia
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Garuoliene, KristinaNational Health Insurance Fund, Lithuania
(author)
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Gomes, MiguelInstitute Nacl Farmacia and Med, Portugal
(author)
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Gutierrez-Ibarluzea, InakiMinistry Health Basque Country, Spain
(author)
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Haycox, AlanUniversity of Liverpool, England
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Hviding, KrystynaNorwegian Medical Agency, Norway
(author)
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Herholz, HaraldKassenarztliche Vereinigung Hessen, Germany
(author)
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Hoffmann, MikaelLinköpings universitet,Avdelningen för läkemedelsforskning,Medicinska fakulteten(Swepub:liu)mikho37
(author)
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Jan, SairaHorizon Blue Cross Blue Shield New Jersey, NJ USA
(author)
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Jones, JanNHS Tayside, Scotland
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Joppi, RobertaLocal Health Unit Verona, Italy
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Kalaba, MarijaRepubl Institute Health Insurance, Serbia
(author)
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Kvalheim, ChristinaNorwegian Medical Agency, Norway
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Laius, OttState Agency Med, Estonia
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Langner, IreneWissenschaftliches Institute AOK, Germany
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Lonsdale, JulieLancashire Commissioning Support Unit, England
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Lööv, Sven-ÅkeStockholm County Council, Sweden
(author)
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Malinowska, KamilaHTA Consulting, Poland; Medical Centre Postgrad Educat, Poland
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McCullagh, LauraSt James Hospital, Ireland
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Paterson, KenScottish Medical Consortium, Scotland
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Markovic-Pekovic, VandaUniversity of Banja Luka, Bosnia and Herceg; Ministry Health and Social Welfare, Bosnia and Herceg
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Martin, AndrewNHS Bury, England
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Piessnegger, JuttaHauptverband Osterreichischen Sozialversicherung, Austria
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Selke, GisbertState Agency Med, Estonia
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Sermet, CatherineInstitute Rech and Documentat Econ St, France
(author)
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Simoens, StevenKatholieke University of Leuven, Belgium
(author)
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Tulunay, CankatPresident Turkish Rational Drug Use Platform, Turkey
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Tomek, DominikComenius University, Slovakia; Slovak Medical University, Slovakia
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Voncina, LukaMinist Heatlh, Croatia
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Vlahovic-Palcevski, VeraUniversity Hospital Rijeka, Croatia
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Wale, JanetIndependent Consumer Advocate, Australia
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Wilcock, MichaelRoyal Cornwall Hospital NHS Trust, England
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Wladysiuk, MagdalenaHTA Consulting, Poland
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van Woerkom, MennoDutch Institute Rational Use Med, Netherlands
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Zara, CorrineCatalan Health Serv, Spain
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Gustafsson, Lars L.Karolinska Institutet,Karolinska University Hospital Huddinge, Sweden
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Karolinska InstitutetKarolinska University Hospital Solna, Sweden
(creator_code:org_t)
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In:Frontiers in Pharmacology: FRONTIERS RESEARCH FOUNDATION41663-9812
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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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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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Linköping University
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Karolinska Institutet