Dabigatran - a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs

Linköpings universitet, Avdelningen för läkemedelsforskning Linköpings universitet, Medicinska fakulteten Karolinska University Hospital Solna, Sweden Karolinska University Hospital Huddinge, Sweden; University of Liverpool, England; University of Strathclyde, Scotland Catalan Institute Heatlh, Spain Austrian Medical and Medical Dev Agency, Austria University of Strathclyde, Scotland; NHS National Serv Scotland, Scotland NHS National Serv Scotland, Scotland Agency Health Technology Assessment, Poland Hauptverband Osterreichischen Sozialversicherung, Austria University of Manchester, England LSEHealth, England Weston Educat Centre, England Health Insurance Institute, Slovenia National Health Insurance Fund, Lithuania Institute Nacl Farmacia and Med, Portugal Ministry Health Basque Country, Spain University of Liverpool, England Norwegian Medical Agency, Norway Kassenarztliche Vereinigung Hessen, Germany Horizon Blue Cross Blue Shield New Jersey, NJ USA NHS Tayside, Scotland Local Health Unit Verona, Italy Republ Institute Health Insurance, Serbia Norwegian Medical Agency, Norway State Agency Med, Estonia Wissenschaftliches Institute AOK, Germany Lancashire Commissioning Support Unit, England Stockholm County Council, Sweden HTA Consulting, Poland; Medical Centre Postgrad Educat, Poland St James Hospital, Ireland Scottish Medical Consortium, Scotland University of Banja Luka, Bosnia and Herceg; Ministry Health and Social Welfare, Bosnia and Herceg NHS Bury, England Hauptverband Osterreichischen Sozialversicherung, Austria State Agency Med, Estonia Institute Rech and Documentat Econ St, France Katholieke University of Leuven, Belgium President Turkish Rational Drug Use Platform, Turkey Comenius University, Slovakia; Slovak Medical University, Slovakia Minist Heatlh, Croatia University Hospital Rijeka, Croatia Independent Consumer Advocate, Australia Royal Cornwall Hospital NHS Trust, England HTA Consulting, Poland Dutch Institute Rational Use Med, Netherlands Catalan Health Serv, Spain Karolinska University Hospital Huddinge, Sweden FRONTIERS RESEARCH FOUNDATION 2013

Malmström, Rickard E.
Godman, Brian B.
Diogene, Eduard
Baumgartel, Christoph
Bennie, Marion
Bishop, Iain
Brzezinska, Anna
Bucsics, Anna
Campbell, Stephen
Ferrario, Alessandra
Finlayson, Alexander E.
Furst, Jurij
Garuoliene, Kristina
Gomes, Miguel
Gutierrez-Ibarluzea, Inaki
Haycox, Alan
Hviding, Krystyna
Herholz, Harald
Hoffmann, Mikael
Jan, Saira
Jones, Jan
Joppi, Roberta
Kalaba, Marija
Kvalheim, Christina
Laius, Ott
Langner, Irene
Lonsdale, Julie
Lööv, Sven-Åke
Malinowska, Kamila
McCullagh, Laura
Paterson, Ken
Markovic-Pekovic, Vanda
Martin, Andrew
Piessnegger, Jutta
Selke, Gisbert
Sermet, Catherine
Simoens, Steven
Tulunay, Cankat
Tomek, Dominik
Voncina, Luka
Vlahovic-Palcevski, Vera
Wale, Janet
Wilcock, Michael
Wladysiuk, Magdalena
van Woerkom, Menno
Zara, Corrine
Gustafsson, Lars L.

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.
Funding Agencies|Karolinska Institutet, Sweden

critical drug evaluation; dabigatran; demand-side measures; drug and therapeutics committees; managed introduction new medicines; pharmacovigilance; registries; risk sharing; Pharmacology and Toxicology; Farmakologi och toxikologi; Article in journal; info:eu-repo/semantics/article; text

10.3389.fphar.2013.00039

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UPE oai:DiVA.org:liu-141008
doi:10.3389/fphar.2013.00039
PMID 23717279
ISI:000347011700038
1234172199

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