AUTHOR=Malmstrom Rickard , Godman Brian , Diogene Eduardo , Baumgaertel Christoph , Bennie Marion , Bishop Iain , Brzezinska Anna , Bucsics Anna , Campbell Stephen , Ferrario Alessandra , Finlayson Alexander , Furst Jurij , Garuoliene Kristina , Gomes Miguel , Gutiérrez-Ibarluzea Iñaki , Haycox Alan , Hviding Krystyna , Herholz Harald , Hoffmann Mikael , Jan Saira , Jones Jan , Joppi Roberta , Kalaba Marija , Kvalheim Christina , Laius Ott , Langner Irene , Lonsdale Julie , Loov Sven-Ake , Malinowska Kamila , McCullagh Laura , Paterson Ken , Markovic-Pekovic Vanda , Martin Andrew , Piessnegger Jutta , Selke Gisbert , Sermet Catherine , Simoens Steven , Tulunay Faik C., Tomek Dominik , Voncina Luka , Vlahovic-Palcevski Vera , Wale Janet , Wilcock Michael , Wladysiuk Magda , Woerkom Menno v., Zara Corrine , Gustafsson Lars L.

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

JOURNAL=Frontiers in Pharmacology

VOLUME=4

YEAR=2013

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2013.00039

DOI=10.3389/fphar.2013.00039

ISSN=1663-9812

ABSTRACT=<p><bold>Background:</bold> 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.</p><p><bold>Objective:</bold> 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.</p><p><bold>Methodology:</bold> Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process.</p><p><bold>Results:</bold> 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-, peri-, and post-launch activities.</p><p><bold>Conclusion:</bold> 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.</p>