TY - JOUR
T1 - Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs
AU - Godman, Brian
AU - Malmström, Rickard E.
AU - Diogene, Eduardo
AU - Jayathissa, Sisira
AU - McTaggart, Stuart
AU - Cars, Thomas
AU - Alvarez-Madrazo, Samantha
AU - Baumgärtel, Christoph
AU - Brzezinska, Anna
AU - Bucsics, Anna
AU - Campbell, Stephen
AU - Eriksson, Irene
AU - Finlayson, Alexander
AU - Fürst, Jurij
AU - Garuoliene, Kristina
AU - Gutiérrez-Ibarluzea, Iñaki
AU - Hviding, Krystyna
AU - Herholz, Harald
AU - Joppi, Roberta
AU - Kalaba, Marija
AU - Laius, Ott
AU - Malinowska, Kamila
AU - Pedersen, Hanne B.
AU - Markovic-Pekovic, Vanda
AU - Piessnegger, Jutta
AU - Selke, Gisbert
AU - Sermet, Catherine
AU - Spillane, Susan
AU - Tomek, Dominik
AU - Vončina, Luka
AU - Vlahović-Palčevski, Vera
AU - Wale, Janet
AU - Wladysiuk, Magdalena
AU - van Woerkom, Menno
AU - Zara, Corinne
AU - Gustafsson, Lars L.
PY - 2014/6/10
Y1 - 2014/6/10
N2 - 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.
AB - 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.
KW - Critical drug evaluation
KW - Dabigatran
KW - demand-side measures
KW - managed introduction new medicines
KW - registries
KW - antithrombocytic agent
KW - dabigatran
KW - warfarin
KW - aged
KW - anticoagulant therapy
KW - bleeding
KW - cerebrovascular accident
KW - clinical practice
KW - controlled study
KW - cost effectiveness analysis
KW - descriptive research
KW - drug cost
KW - drug efficacy
KW - drug safety
KW - drug screening
KW - drug utilization
KW - education
KW - Europe
KW - female
KW - health insurance
KW - heart atrium fibrillation
KW - human
KW - Ireland
KW - Italy
KW - major clinical study
KW - male
KW - mortality
KW - New Zealand
KW - prescription
KW - prevalence
KW - process optimization
KW - quality adjusted life year
KW - review
KW - risk factor
KW - Slovenia
KW - Spain
KW - Sweden
KW - United Kingdom
UR - http://www.scopus.com/inward/record.url?eid=2-s2.0-84904859153&partnerID=40&md5=dbeae091f2f41f089d8d2fd653ad7814
U2 - 10.3389/fphar.2014.00109
DO - 10.3389/fphar.2014.00109
M3 - Article
SN - 1663-9812
VL - 5
JO - Frontiers in Pharmacology
JF - Frontiers in Pharmacology
M1 - 109
ER -