Dabigatran - A case history demonstrating the need for comprehensive approaches to optimize the use of new drugs

Rickard Malmström, Brian Godman, Eduard Diogène, Christoph Baumgärtel, Marion Bennie, Iain Bishop, Anna Brzezinska, Anna Bucsics, Stephen Campbell, Alessandra Ferrairo, Alexander E. Finlayson, Krystyna Hviding, Herald Herholz, Mikael Hoffmann, Saira Jan, Jan Jones, Roberta Joppi, Marija Kalaba, Christina Kvalheim, Ott Laius & 22 others Irene Langner, Julie Lonsdale, Sven-Åke Lööv, Kamila Malinowska, Laura McCullagh, Ken Paterson, Vanda Markovic-Pekovic, Andrew Martin, Jutta Piessnegger, Gisbert Selke, Catherine Sermet, Steven Simoens, Cankat Tulunay, Dominik Tomek, Luka Voncina, Vera Vlahovic-Palcevski, Janet Wale, Michael Wilcock, Magdalena Wladysiuk, Menno Van Woerkom, Corrine Zara, Lars Gustafsson

Research output: Contribution to journalArticle

45 Citations (Scopus)

Abstract

Background: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are 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 have shown dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. There are also issues with potentially re-designing anticoagulant services. This has resulted in activities across countries to better manage its use.

Objective: To (i) review authority activities in over 30 countries and regions, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications for all major stakeholder groups.

Methodology: Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process.

Results: There has been a plethora of activities among authorities to manage the prescribing of 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.

Conclusion: Models for introducing new drugs are essential to optimize their prescribing especially where there are concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding
Original languageEnglish
Pages (from-to)1-31
Number of pages31
JournalFrontiers in Pharmacology
Volume4
DOIs
Publication statusPublished - 2013
Externally publishedYes

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

Cite this

Malmström, R., Godman, B., Diogène, E., Baumgärtel, C., Bennie, M., Bishop, I., ... Gustafsson, L. (2013). Dabigatran - A case history demonstrating the need for comprehensive approaches to optimize the use of new drugs. Frontiers in Pharmacology, 4, 1-31. https://doi.org/10.3389/fphar.2013.00039
Malmström, Rickard ; Godman, Brian ; Diogène, Eduard ; Baumgärtel, Christoph ; Bennie, Marion ; Bishop, Iain ; Brzezinska, Anna ; Bucsics, Anna ; Campbell, Stephen ; Ferrairo, Alessandra ; Finlayson, Alexander E. ; Hviding, Krystyna ; Herholz, Herald ; Hoffmann, Mikael ; Jan, Saira ; Jones, Jan ; Joppi, Roberta ; Kalaba, Marija ; Kvalheim, Christina ; Laius, Ott ; Langner, Irene ; Lonsdale, Julie ; Lööv, Sven-Åke ; Malinowska, Kamila ; McCullagh, Laura ; Paterson, Ken ; Markovic-Pekovic, Vanda ; Martin, Andrew ; Piessnegger, Jutta ; Selke, Gisbert ; Sermet, Catherine ; Simoens, Steven ; Tulunay, Cankat ; Tomek, Dominik ; Voncina, Luka ; Vlahovic-Palcevski, Vera ; Wale, Janet ; Wilcock, Michael ; Wladysiuk, Magdalena ; Van Woerkom, Menno ; Zara, Corrine ; Gustafsson, Lars. / Dabigatran - A case history demonstrating the need for comprehensive approaches to optimize the use of new drugs. In: Frontiers in Pharmacology. 2013 ; Vol. 4. pp. 1-31.
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abstract = "Background: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are 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 have shown dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. There are also issues with potentially re-designing anticoagulant services. This has resulted in activities across countries to better manage its use.Objective: To (i) review authority activities in over 30 countries and regions, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications for all major stakeholder groups.Methodology: Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process.Results: There has been a plethora of activities among authorities to manage the prescribing of 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.Conclusion: Models for introducing new drugs are essential to optimize their prescribing especially where there are concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding",
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Malmström, R, Godman, B, Diogène, E, Baumgärtel, C, Bennie, M, Bishop, I, Brzezinska, A, Bucsics, A, Campbell, S, Ferrairo, A, Finlayson, AE, Hviding, K, Herholz, H, Hoffmann, M, Jan, S, Jones, J, Joppi, R, Kalaba, M, Kvalheim, C, Laius, O, Langner, I, Lonsdale, J, Lööv, S-Å, Malinowska, K, McCullagh, L, Paterson, K, Markovic-Pekovic, V, Martin, A, Piessnegger, J, Selke, G, Sermet, C, Simoens, S, Tulunay, C, Tomek, D, Voncina, L, Vlahovic-Palcevski, V, Wale, J, Wilcock, M, Wladysiuk, M, Van Woerkom, M, Zara, C & Gustafsson, L 2013, 'Dabigatran - A case history demonstrating the need for comprehensive approaches to optimize the use of new drugs', Frontiers in Pharmacology, vol. 4, pp. 1-31. https://doi.org/10.3389/fphar.2013.00039

Dabigatran - A case history demonstrating the need for comprehensive approaches to optimize the use of new drugs. / Malmström, Rickard; Godman, Brian; Diogène, Eduard; Baumgärtel, Christoph; Bennie, Marion; Bishop, Iain; Brzezinska, Anna; Bucsics, Anna; Campbell, Stephen; Ferrairo, Alessandra; Finlayson, Alexander E.; Hviding, Krystyna; Herholz, Herald; Hoffmann, Mikael; Jan, Saira; Jones, Jan; Joppi, Roberta; Kalaba, Marija; Kvalheim, Christina; Laius, Ott; Langner, Irene; Lonsdale, Julie; Lööv, Sven-Åke; Malinowska, Kamila; McCullagh, Laura; Paterson, Ken; Markovic-Pekovic, Vanda; Martin, Andrew; Piessnegger, Jutta; Selke, Gisbert; Sermet, Catherine; Simoens, Steven; Tulunay, Cankat; Tomek, Dominik; Voncina, Luka; Vlahovic-Palcevski, Vera; Wale, Janet; Wilcock, Michael ; Wladysiuk, Magdalena; Van Woerkom, Menno; Zara, Corrine; Gustafsson, Lars.

In: Frontiers in Pharmacology, Vol. 4, 2013, p. 1-31.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Dabigatran - A case history demonstrating the need for comprehensive approaches to optimize the use of new drugs

AU - Malmström, Rickard

AU - Godman, Brian

AU - Diogène, Eduard

AU - Baumgärtel, Christoph

AU - Bennie, Marion

AU - Bishop, Iain

AU - Brzezinska, Anna

AU - Bucsics, Anna

AU - Campbell, Stephen

AU - Ferrairo, Alessandra

AU - Finlayson, Alexander E.

AU - Hviding, Krystyna

AU - Herholz, Herald

AU - Hoffmann, Mikael

AU - Jan, Saira

AU - Jones, Jan

AU - Joppi, Roberta

AU - Kalaba, Marija

AU - Kvalheim, Christina

AU - Laius, Ott

AU - Langner, Irene

AU - Lonsdale, Julie

AU - Lööv, Sven-Åke

AU - Malinowska, Kamila

AU - McCullagh, Laura

AU - Paterson, Ken

AU - Markovic-Pekovic, Vanda

AU - Martin, Andrew

AU - Piessnegger, Jutta

AU - Selke, Gisbert

AU - Sermet, Catherine

AU - Simoens, Steven

AU - Tulunay, Cankat

AU - Tomek, Dominik

AU - Voncina, Luka

AU - Vlahovic-Palcevski, Vera

AU - Wale, Janet

AU - Wilcock, Michael

AU - Wladysiuk, Magdalena

AU - Van Woerkom, Menno

AU - Zara, Corrine

AU - Gustafsson, Lars

PY - 2013

Y1 - 2013

N2 - Background: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are 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 have shown dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. There are also issues with potentially re-designing anticoagulant services. This has resulted in activities across countries to better manage its use.Objective: To (i) review authority activities in over 30 countries and regions, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications for all major stakeholder groups.Methodology: Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process.Results: There has been a plethora of activities among authorities to manage the prescribing of 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.Conclusion: Models for introducing new drugs are essential to optimize their prescribing especially where there are 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 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 have shown dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. There are also issues with potentially re-designing anticoagulant services. This has resulted in activities across countries to better manage its use.Objective: To (i) review authority activities in over 30 countries and regions, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications for all major stakeholder groups.Methodology: Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process.Results: There has been a plethora of activities among authorities to manage the prescribing of 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.Conclusion: Models for introducing new drugs are essential to optimize their prescribing especially where there are concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding

U2 - 10.3389/fphar.2013.00039

DO - 10.3389/fphar.2013.00039

M3 - Article

VL - 4

SP - 1

EP - 31

JO - Frontiers in Pharmacology

JF - Frontiers in Pharmacology

SN - 1663-9812

ER -