Dabigatran

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

Brian Godman, Rickard Malmström, Eduard Diogène, Sisira Jayathissa, Stuart McTaggart, Thomas Cars, Samantha Alvarez-Madrazo, Christoph Baumgärtel, Anna Brzezinska, Anna Bucsics, Stephen Campbell, Irene Eriksson, Alexander Finlayson, Jurij Furst, Kristina Garuoliene, Inaki Gutierrez-Ibarluzea, Krystyna Hviding, Herald 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 Voncina, Vera Vlahovic-Palcevski, Janet Wale, Magdalena Wladysiuk, Menno Van Woerkom, Corinne Zara, Lars Gustafsson

Research output: Contribution to journalArticle

20 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-, pen-, 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.
Original languageEnglish
Article number109
Pages (from-to)1-11
Number of pages11
JournalFrontiers in Pharmacology
Volume5
DOIs
Publication statusPublished - 2014
Externally publishedYes

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

Cite this

Godman, Brian ; Malmström, Rickard ; Diogène, Eduard ; Jayathissa, Sisira ; McTaggart, Stuart ; Cars, Thomas ; Alvarez-Madrazo, Samantha ; Baumgärtel, Christoph ; Brzezinska, Anna ; Bucsics, Anna ; Campbell, Stephen ; Eriksson, Irene ; Finlayson, Alexander ; Furst, Jurij ; Garuoliene, Kristina ; Gutierrez-Ibarluzea, Inaki ; Hviding, Krystyna ; Herholz, Herald ; Joppi, Roberta ; Kalaba, Marija ; Laius, Ott ; Malinowska, Kamila ; Pedersen, Hanne B ; Markovic-Pekovic, Vanda ; Piessnegger, Jutta ; Selke, Gisbert ; Sermet, Catherine ; Spillane, Susan ; Tomek, Dominik ; Voncina, Luka ; Vlahovic-Palcevski, Vera ; Wale, Janet ; Wladysiuk, Magdalena ; Van Woerkom, Menno ; Zara, Corinne ; Gustafsson, Lars. / 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. pp. 1-11.
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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-, pen-, 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.",
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Godman, B, Malmström, R, Diogène, E, Jayathissa, S, McTaggart, S, Cars, T, Alvarez-Madrazo, S, Baumgärtel, C, Brzezinska, A, Bucsics, A, Campbell, S, Eriksson, I, Finlayson, A, Furst, J, Garuoliene, K, Gutierrez-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, Voncina, L, Vlahovic-Palcevski, V, Wale, J, Wladysiuk, M, Van Woerkom, M, Zara, C & Gustafsson, L 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, pp. 1-11. 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; Diogène, Eduard; Jayathissa, Sisira; McTaggart, Stuart; Cars, Thomas; Alvarez-Madrazo, Samantha; Baumgärtel, Christoph; Brzezinska, Anna; Bucsics, Anna; Campbell, Stephen; Eriksson, Irene; Finlayson, Alexander; Furst, Jurij; Garuoliene, Kristina; Gutierrez-Ibarluzea, Inaki; Hviding, Krystyna; Herholz, Herald; Joppi, Roberta; Kalaba, Marija; Laius, Ott; Malinowska, Kamila; Pedersen, Hanne B; Markovic-Pekovic, Vanda; Piessnegger, Jutta; Selke, Gisbert; Sermet, Catherine; Spillane, Susan; Tomek, Dominik; Voncina, Luka; Vlahovic-Palcevski, Vera; Wale, Janet; Wladysiuk, Magdalena; Van Woerkom, Menno; Zara, Corinne; Gustafsson, Lars.

In: Frontiers in Pharmacology, Vol. 5, 109, 2014, p. 1-11.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Dabigatran

T2 - A continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs

AU - Godman, Brian

AU - Malmström, Rickard

AU - Diogène, Eduard

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 - Furst, Jurij

AU - Garuoliene, Kristina

AU - Gutierrez-Ibarluzea, Inaki

AU - Hviding, Krystyna

AU - Herholz, Herald

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 - Voncina, Luka

AU - Vlahovic-Palcevski, Vera

AU - Wale, Janet

AU - Wladysiuk, Magdalena

AU - Van Woerkom, Menno

AU - Zara, Corinne

AU - Gustafsson, Lars

PY - 2014

Y1 - 2014

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-, pen-, 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.

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-, pen-, 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.

KW - Critical drug evaluation

KW - Dabigatran

KW - Demand-side measures

KW - Managed introduction new medicines

KW - Registries

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