Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs

Brian Godman, Rickard E. Malmström, Eduardo Diogene, Sisira Jayathissa, Stuart McTaggart, Thomas Cars, Samantha Alvarez-Madrazo, Christoph Baumgärtel, Anna Brzezinska, Anna Bucsics, Stephen Campbell, Irene Eriksson, Alexander Finlayson, Jurij Fürst, Kristina Garuoliene, Iñaki Gutiérrez-Ibarluzea, Krystyna Hviding, Harald Herholz, Roberta Joppi, Marija KalabaOtt Laius, Kamila Malinowska, Hanne B. Pedersen, Vanda Markovic-Pekovic, Jutta Piessnegger, Gisbert Selke, Catherine Sermet, Susan Spillane, Dominik Tomek, Luka Vončina, Vera Vlahović-Palčevski, Janet Wale, Magdalena Wladysiuk, Menno van Woerkom, Corinne Zara, Lars L. Gustafsson

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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. © 2014 Godman, Malmström, Diogene, Jayathissa, McTaggart, Cars, Alvarez-Madrazo, Baumgärtel, Brzezinska, Bucsics, Campbell, Eriksson, Finlayson, Fürst, Garuoliene, Gutiérrez-Ibarluzea, Hviding, Herholz, Joppi, Kalaba, Laius, Malinowska, Pedersen, Markovic-Pekovic, Piessnegger, Selke, Sermet, Spillane, Tomek, Vončina, Vlahović-Palčevski, Wale, Wladysiuk, van Woerkom, Zara and Gustafsson.
Original languageEnglish
Article number109
JournalFrontiers in Pharmacology
Volume5
DOIs
Publication statusPublished - 10 Jun 2014

Keywords

  • Critical drug evaluation
  • Dabigatran
  • demand-side measures
  • managed introduction new medicines
  • registries
  • antithrombocytic agent
  • dabigatran
  • warfarin
  • aged
  • anticoagulant therapy
  • bleeding
  • cerebrovascular accident
  • clinical practice
  • controlled study
  • cost effectiveness analysis
  • descriptive research
  • drug cost
  • drug efficacy
  • drug safety
  • drug screening
  • drug utilization
  • education
  • Europe
  • female
  • health insurance
  • heart atrium fibrillation
  • human
  • Ireland
  • Italy
  • major clinical study
  • male
  • mortality
  • New Zealand
  • prescription
  • prevalence
  • process optimization
  • quality adjusted life year
  • review
  • risk factor
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom

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