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Front Pharmacol. 2014 Jun 10;5:109. doi: 10.3389/fphar.2014.00109. eCollection 2014.

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

Author information

1
Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge Stockholm, Sweden ; Medicines Use and Health, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde Glasgow, UK.
2
Clinical Pharmacology Unit, Department of Medicine, Karolinska Institutet, Karolinska University Hospital Solna Stockholm, Sweden.
3
Clinical Pharmacology Service, Vall d'Hebron University Hospital, Fundació Institut Català de Farmacologia, Autonomous University of Barcelona Barcelona, Spain.
4
Department of Medicine, Hutt Valley DHB Lower Hutt, Wellington, New Zealand.
5
Public Health and Intelligence Business Unit, NHS National Services Scotland Edinburgh, UK.
6
Department of Healthcare Development, Public Healthcare Services Committee, Stockholm County Council Stockholm, Sweden ; Department of Medical Sciences, Uppsala University Uppsala, Sweden.
7
Medicines Use and Health, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde Glasgow, UK.
8
Austrian Medicines and Medical Devices Agency Wien, Austria.
9
Agency for Health Technology Assessment Warsaw, Poland.
10
Department of Finance, Faculty of Business, Economics and Statistics, University of Vienna Vienna, Austria ; Hauptverband der Österreichischen Sozialversicherungsträger Vienna, Austria.
11
Centre for Primary Care, Institute of Population Health, University of Manchester Manchester, UK.
12
Department of Healthcare Development, Public Healthcare Services Committee, Stockholm County Council Stockholm, Sweden.
13
Green Templeton College, University of Oxford Oxford, UK.
14
Health Insurance Institute Ljubljana, Slovenia.
15
Medicines Reimbursement Department, National Health Insurance Fund Vilnius, Lithuania.
16
Basque Office for HTA, Ministry of Health and Consumer Affairs, Basque Government Basque Country, Spain.
17
Norwegian Medicines Agency Oslo, Norway.
18
Kassenärztliche Vereinigung Hessen Frankfurt am Main, Germany.
19
Pharmaceutical Drug Department, Azienda Sanitaria Locale of Verona Verona, Italy.
20
Department of Medicines and Pharmacoeconomics, Republic Institute for Health Insurance Belgrade, Serbia.
21
State Agency of Medicines Tartu, Estonia.
22
Department of Epidemiology and Health Promotion, Public Health School Warsaw, Poland ; Drug Management Department, National Health Fund Warsaw, Poland.
23
Division of Health Systems and Public Health, Health Technologies and Pharmaceuticals, WHO Regional Office for Europe Copenhagen, Denmark.
24
Faculty of Medicine, University of Banja Luka Banja Luka, Bosnia and Herzegovina ; Ministry of Health and Social Welfare Banja Luka, Bosnia and Herzegovina.
25
Hauptverband der Österreichischen Sozialversicherungsträger Vienna, Austria.
26
Wissenschaftliches Institut der AOK (WidO) Berlin, Germany.
27
IRDES Paris, France.
28
Department of Pharmacology and Therapeutics, Trinity College Dublin Dublin, Ireland.
29
Faculty of Pharmacy, Comenius University and Faculty of Medicine, Slovak Medical University Bratislava, Slovakia.
30
Ministry of Health Zagreb, Croatia.
31
Unit for Clinical Pharmacology, University Hospital Rijeka Rijeka, Croatia.
32
Independent Consumer Advocate, VIC Melbourne, Australia.
33
HTA Consulting Cracow, Poland.
34
Dutch Institute for Rational Use of Medicine Utrecht, Netherlands.
35
Barcelona Health Region, Catalan Health Service Barcelona, Spain.
36
Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge Stockholm, Sweden.

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.

KEYWORDS:

critical drug evaluation; dabigatran; demand-side measures; managed introduction new medicines; registries

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