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

Malmström, Rickard E and Godman, Brian B. and Diogene, Eduard and Baumgärtel, Christoph and Bennie, Marion and Bishop, Iain and Brzezinska, Anna and Bucsics, Anna and Campbell, Stephen and Ferrario, Alessandra and Finlayson, Alexander E. and Fürst, Jurij and Garuoliene, Kristina and Gomes, Miguel and Gutiérrez-Ibarluzea, Iñaki and Haycox, Alan and Hviding, Krystyna and Herholz, Harald and Hoffmann, Mikael and Jan, Saira and Jones, Jan and Joppi, Roberta and Kalaba, Marija and Kvalheim, Christina and Laius, Ott and Langner, Irene and Lonsdale, Julie and Lööv, Sven-Äke and Malinowska, Kamila and McCullagh, Laura and Paterson, Ken and Markovic-Pekovic, Vanda and Martin, Andrew and Piessnegger, Jutta and Selke, Gisbert and Sermet, Catherine and Simoens, Steven and Tulunay, Cankat and Tomek, Dominik and Vončina, Luka and Vlahovic-Palcevski, Vera and Wale, Janet and Wilcock, Michael and Wladysiuk, Magdalena and van Woerkom, Menno and Zara, Corrine and Gustafsson, Lars L (2013) Dabigatran - a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs. Frontiers in Pharmacology, 4. 39. (https://doi.org/10.3389/fphar.2013.00039)

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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. 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. Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process. 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. 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.