• Rickard E Malmström, Brian B Godman, Eduard Diogene, Christoph Baumgärtel, Marion Bennie, Iain Bishop, Anna Brzezinska, Anna Bucsics, Stephen Campbell, Alessandra Ferrario, Alexander E Finlayson, Jurij Fürst, Kristina Garuoliene, Miguel Gomes, Iñaki Gutiérrez-Ibarluzea, Alan Haycox, Krystyna Hviding, Harald Herholz, Mikael Hoffmann, Saira Jan, Jan Jones, Roberta Joppi, Marija Kalaba, Christina Kvalheim, Ott Laius, Irene Langner, Julie Lonsdale, Sven-Äke Lööv, Kamila Malinowska, Laura McCullagh, Ken Paterson, Vanda Markovic-Pekovic, Andrew Martin, Jutta Piessnegger, Gisbert Selke, Catherine Sermet, Steven Simoens, Cankat Tulunay, Dominik Tomek, Luka Vončina, Vera Vlahovic-Palcevski, Janet Wale, Michael Wilcock, Magdalena Wladysiuk, Menno van Woerkom, Corrine Zara, and Lars L Gustafsson.
• Clinical Pharmacology Unit, Department of Medicine, Karolinska Institutet, Karolinska University Hospital Solna Stockholm, Sweden.
• Front Pharmacol. 2013 Jan 1;4:39.

BackgroundThere 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.ObjectiveTo (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.MethodologyDescriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process.ResultsThere 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.ConclusionModels 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.

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