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 Kalaba & 16 others Ott 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

Research output: Contribution to journalArticle

19 Citations (Scopus)

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.
LanguageEnglish
Article number109
JournalFrontiers in Pharmacology
Volume5
DOIs
Publication statusPublished - 10 Jun 2014

Fingerprint

Drug Utilization
Budgets
Pharmaceutical Preparations
Atrial Fibrillation
Essential Drugs
Safety
Antidotes
Wales
Financial Management
Anticoagulants
Registries
Dabigatran
Stroke
Hemorrhage
Costs and Cost Analysis

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

Cite this

Godman, Brian ; Malmström, Rickard E. ; Diogene, Eduardo ; Jayathissa, Sisira ; McTaggart, Stuart ; Cars, Thomas ; Alvarez-Madrazo, Samantha ; Baumgärtel, Christoph ; Brzezinska, Anna ; Bucsics, Anna ; Campbell, Stephen ; Eriksson, Irene ; Finlayson, Alexander ; Fürst, Jurij ; Garuoliene, Kristina ; Gutiérrez-Ibarluzea, Iñaki ; Hviding, Krystyna ; Herholz, Harald ; Joppi, Roberta ; Kalaba, Marija ; Laius, Ott ; Malinowska, Kamila ; Pedersen, Hanne B. ; Markovic-Pekovic, Vanda ; Piessnegger, Jutta ; Selke, Gisbert ; Sermet, Catherine ; Spillane, Susan ; Tomek, Dominik ; Vončina, Luka ; Vlahović-Palčevski, Vera ; Wale, Janet ; Wladysiuk, Magdalena ; van Woerkom, Menno ; Zara, Corinne ; Gustafsson, Lars L. / Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs. In: Frontiers in Pharmacology . 2014 ; Vol. 5.
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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. {\circledC} 2014 Godman, Malmstr{\"o}m, Diogene, Jayathissa, McTaggart, Cars, Alvarez-Madrazo, Baumg{\"a}rtel, Brzezinska, Bucsics, Campbell, Eriksson, Finlayson, F{\"u}rst, Garuoliene, Guti{\'e}rrez-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.",
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author = "Brian Godman and Malmstr{\"o}m, {Rickard E.} and Eduardo Diogene and Sisira Jayathissa and Stuart McTaggart and Thomas Cars and Samantha Alvarez-Madrazo and Christoph Baumg{\"a}rtel and Anna Brzezinska and Anna Bucsics and Stephen Campbell and Irene Eriksson and Alexander Finlayson and Jurij F{\"u}rst and Kristina Garuoliene and I{\~n}aki Guti{\'e}rrez-Ibarluzea and Krystyna Hviding and Harald Herholz and Roberta Joppi and Marija Kalaba and Ott Laius and Kamila Malinowska and Pedersen, {Hanne B.} and Vanda Markovic-Pekovic and Jutta Piessnegger and Gisbert Selke and Catherine Sermet and Susan Spillane and Dominik Tomek and Luka Vončina and Vera Vlahović-Palčevski and Janet Wale and Magdalena Wladysiuk and {van Woerkom}, Menno and Corinne Zara and Gustafsson, {Lars L.}",
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Godman, B, Malmström, RE, Diogene, E, Jayathissa, S, McTaggart, S, Cars, T, Alvarez-Madrazo, S, Baumgärtel, C, Brzezinska, A, Bucsics, A, Campbell, S, Eriksson, I, Finlayson, A, Fürst, J, Garuoliene, K, Gutiérrez-Ibarluzea, I, Hviding, K, Herholz, H, Joppi, R, Kalaba, M, Laius, O, Malinowska, K, Pedersen, HB, Markovic-Pekovic, V, Piessnegger, J, Selke, G, Sermet, C, Spillane, S, Tomek, D, Vončina, L, Vlahović-Palčevski, V, Wale, J, Wladysiuk, M, van Woerkom, M, Zara, C & Gustafsson, LL 2014, 'Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs' Frontiers in Pharmacology , vol. 5, 109. https://doi.org/10.3389/fphar.2014.00109

Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs. / Godman, Brian; Malmström, Rickard E.; Diogene, Eduardo; Jayathissa, Sisira; McTaggart, Stuart; Cars, Thomas; Alvarez-Madrazo, Samantha; Baumgärtel, Christoph; Brzezinska, Anna; Bucsics, Anna; Campbell, Stephen; Eriksson, Irene; Finlayson, Alexander; Fürst, Jurij; Garuoliene, Kristina; Gutiérrez-Ibarluzea, Iñaki; Hviding, Krystyna; Herholz, Harald; Joppi, Roberta; Kalaba, Marija; Laius, Ott; Malinowska, Kamila; Pedersen, Hanne B.; Markovic-Pekovic, Vanda; Piessnegger, Jutta; Selke, Gisbert; Sermet, Catherine; Spillane, Susan; Tomek, Dominik; Vončina, Luka; Vlahović-Palčevski, Vera; Wale, Janet; Wladysiuk, Magdalena; van Woerkom, Menno; Zara, Corinne; Gustafsson, Lars L.

In: Frontiers in Pharmacology , Vol. 5, 109, 10.06.2014.

Research output: Contribution to journalArticle

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

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