Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs
Godman, Brian (University of Strathclyde)
Malmström, Rickard E. (Karolinska University Hospital and Karolinska Institutet (Suècia))
Diogène Fadini, Eduard (Hospital Universitari Vall d'Hebron)
Jayathissa, Sisira (Hutt Valley DHB. Department of Medicine)
McTaggart, Stuart (NHS National Services Scotland)
Cars, Thomas (Uppsala University. Department of Medical Sciences)
Alvarez-Madrazo, Samantha (University of Strathclyde)
Baumgärtel, Christoph (Austrian Medicines and Medical Devices Agency)
Brzezinska, Anna (Agency for Health Technology Assessment)
Bucsics, Anna (Hauptverband der Österreichischen Sozialversicherungsträger)
Campbell, Stephen (University of Manchester. Centre for Primary Care)
Eriksson, Irene (Stockholm County Council. Department of Healthcare Development)
Finlayson, Alexander (University of Oxford. Green Templeton College)
Fürst, Jurij (Health Insurance Institute)
Garuoliene, Kristina (National Health Insurance Fund)
Gutiérrez-Ibarluzea, Iñaki (Osasun Saila. Ezagutu Osteba arloa)
Hviding, Krystyna (Norwegian Medicines Agency)
Herholz, Harald (Kassenärztliche Vereinigung Hessen)
Joppi, Roberta (Azienda Sanitaria Locale of Verona. Pharmaceutical Drug Department)
Kalaba, Marija (Republic Institute for Health. Department of Medicines and Pharmacoeconomics)
Laius, Ott (State Agency of Medicines)
Malinowska, Kamila (National Health Fund. Drug Management Department)
Pedersen, Hanne B. (Division of Health Systems and Public Health, Health Technologies and Pharmaceuticals, WHO Regional Office for Europe)
Markovic-Pekovic, Vanda (Ministry of Health and Social Welfare)
Piessnegger, Jutta (Hauptverband der Österreichischen Sozialversicherungsträger)
Selke, Gisbert (Wissenschaftliches Institut der AOK (WidO))
Sermet, Catherine (IRDES)
Spillane, Susan (Trinity College. Department of Pharmacology and Therapeutics)
Tomek, Dominik (Slovak Medical University. Faculty of Pharmacy)
Vončina, Luka (Ministry of Health)
Vlahović-Palčevski, Vera (University Hospital Rijeka. Unit for Clinical Pharmacology)
Wale, Janet (Independent Consumer Advocate, VIC)
Wladysiuk, Magdalena (HTA Consulting)
van Woerkom, Menno (Dutch Institute for Rational Use of Medicine)
Zara, Corinne (Institut Català de la Salut)
Gustafsson, Lars L. (Karolinska University Hospital and Karolinska Institutet (Suècia))
Universitat Autònoma de Barcelona

Date:	2014
Abstract:	Background : There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are effectiveness, 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 showed dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. These concerns resulted in extensive activities pre- to post-launch to manage its introduction. Objective : To (i) review authority activities across countries, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications based on post-launch activities. Methodology : (i) Descriptive review and appraisal of activities regarding dabigatran, (ii) development of guidance for key stakeholder groups through an iterative process, (iii) refining guidance following post launch studies. Results : Plethora of activities to manage 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. Post-launch activities include increasing use of patient registries to monitor the safety and effectiveness of new drugs in clinical practice. Conclusion : Models for introducing new drugs are essential to optimize their prescribing especially where concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Critical drug evaluation ; Cabigatran ; Dmand-side measures ; Managed introduction new medicines ; Registries
Published in:	Frontiers in Pharmacology, Vol. 5 (june 2014) , ISSN 1663-9812

DOI: 10.3389/fphar.2014.00109
PMID: 24959145

11 p, 1.1 MB

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