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Pharmaceutical Policy Analysis – a European Perspective on Pricing and Reimbursement in Challenging Times

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Pharmaceutical Policy Analysis – a European Perspective on Pricing and Reimbursement in Challenging Times PHARMACEUTICAL POLICY ANALYSIS – A EUROPEAN PERSPECTIVE ON PRICING AND REIMBURSEMENT IN CHALLENGING TIMES Christine Leopold The research presented in this PhD thesis was conducted under the umbrella of the Utrecht World Health Organization (WHO) Collaborating Centre for Pharmaceutical Policy and Regulation, which is based at the Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the Netherlands. The Collaborating Centre aims to develop new methods for independent pharmaceutical policy research, evidence-based policy analysis and conceptual innovation in the area of policy making and evaluation in general. The research in this thesis was performed in collaboration with the Gesundheit Österreich GmbH / Austrian Health Institute / WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policy, Vienna, Austria. Leopold, C. Pharmaceutical Policy Analysis – A European perspective on pricing and reimbursement in challenging times Thesis Utrecht University – with ref. – with summary in Dutch and German ISBN: 978-94-6182-363-2 Printed by: Off Page, www.offpage.nl Copyright © 2014 by C. Leopold. All rights reserved. No part of this book may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, without prior permission of the author. PHARMACEUTICAL POLICY ANALYSIS – A EUROPEAN PERSPECTIVE ON PRICING AND REIMBURSEMENT IN CHALLENGING TIMES Prijzen en vergoeding van geneesmiddelen in een economische recessie - farmaceutisch beleid in perspectief (met een samenvatting in het Nederlands) Analyse arzneimittelpolitischer Maßnahmen – ein Blick auf Europa in wirtschaftlich schwierigen Zeiten (mit einer Zusammenfassung in deutscher Sprache) Proefschrift ter verkrijging van de graad van doctor aan de Universiteit Utrecht op gezag van de rector magnificus, prof.dr. G.J. van der Zwaan, ingevolge het besluit van het college voor promoties in het openbaar te verdedigen op woensdag 8 januari 2014 des ochtends te 10.30 uur door Christine Leopold geboren op 29 september 1979 te Wenen, Oostenrijk Promotores: Prof. dr. H.G.M. Leufkens Prof. dr. R.O. Laing Co-promotores: Dr. A.K. Mantel-Teeuwisse Dr. S. Vogler TABLE OF CONTENTS Chapter 1 General introduction 7 Chapter 2 External price referencing and its impact on medicine prices 21 2.1 Differences in external price referencing in Europe 23 - A descriptive overview 2.2 Impact of external price referencing on medicine prices 43 – a price comparison among 14 European countries 2.3 Is Europe still heading to a common price level for on-patent 59 medicines? An exploratory study among 15 Western European countries Chapter 3 Re-evaluation and adjustment of pharmaceutical policies 75 in times of economic recession 3.1 Impact of the recession on the pharmaceutical policy 77 environment and medicines sales in eight European countries 3.2 Impact of pharmaceutical policy interventions on utilization 99 of antipsychotic medicines in Finland and Portugal: interrupted time series analyses Chapter 4 Personalized medicine as a challenge for policy makers 115 4.1 Personalized medicine as a challenge for public pricing 117 and reimbursement authorities– a survey among 27 European countries (including Iceland and Norway) on the example of trastuzumab Chapter 5 General discussion 135 Chapter 6 Summary, Samenvatting, and Zusammenfassung 153 6.1 Summary 155 6.2 Samenvatting 163 6.3 Zusammenfassung 171 Chapter 7 Addendum 179 7.1 Acknowledgements 181 7.2 List of co-authors 185 7.3 List of publications 189 7.4 About the author 195 CHAPTER General introduction 1 BACKGROUND 1 National pharmaceutical policies are embedded in a framework with many different stakeholders, different levels of legal requirements and different national policy objectives such as ensuring General introduction public affordability of health care while rewarding innovation [1,2]. In European Union (EU) Member States, policy makers are taking their decisions within a framework of legal regulations at national and European level. They have to relate to the political and social context of their country, while at the same time consider European and international developments. Within a national pharmaceutical system policy makers have many different policy choices, for example policies targeting at regulating prices, reimbursement limits and rational use of medicines. However, policy making is also shaped by the diverse interests and power of other stakeholders in the system such as prescribers, regulators, pharmacists, payers, industry and patients [2]. The pharmaceutical policy environment is dynamic as new medicines are being developed and different medical needs arise. Tensions are especially noticeable with respect to pricing and reimbursement of medicines; what health care plans may view as necessary to maintain equitable access to medicines, industry may view as inimical to research and development (R&D) and innovation [3]. Therefore, the question for policy makers is, given that resources will always be too limited to address all problems at the same time, which aspects of a pharmaceutical policy should they prioritize to obtain the best public health for the lowest cost [4]. To ensure a sustainable environment governments are required to regularly monitor policies, implement new ones and readjust existing polices. For this reason pharmaceutical policy analysis aims at assessing the effects and the performance of these implemented policies and policy changes at different levels: at the starting point of research and innovation; at the regulatory and policy making level; at the level of outcomes or finally at the level of measuring the impact on public health, as illustrated in Figure 1. Policy analysis examines the intended and unintended impacts of policies or policy changes on various outcomes such as medicine prices, pharmaceutical expenditure, medicine utilization and eventually on overall public health such as mortality rates of a population. Although an increasing number of descriptions of national pharmaceutical systems were published in recent years to address the need for country specific information, analyses and evaluations of the impact of national pharmaceutical pricing and reimbursement policies are still rare [4-8]. Besides peer-reviewed articles, reports by international organizations such as the Organization for Economic Co-operation and Development (OECD) [9-16], the World Health Organization (WHO) [17], the European Commission [18-19] and networks of European of public authorities [20,21] became key references for research on pricing and reimbursement policies. However, as the pharmaceutical policy landscape is rapidly evolving, research and impact analyses are constantly needed. This thesis is a body of work belonging to a series of pharmaceutical policy analysis projects undertaken under the umbrella of the Utrecht WHO Collaborating Centre for Pharmaceutical Policy and Regulation, all focusing on different aspects of the policy cycle depicted in Figure 1 [22-25]. The focus of this thesis is to understand pharmaceutical policies through the lens of analyzing European pricing and reimbursement policies and their impacts. 9 1 Public health / General introduction therapeutic needs Research / innovation Usage / outcomes Regulation / policy making Source:Figure 1.WHO Pharmaceutical Collaborating Policy Centre Analysis. for Source:Pharmaceutic WHO Collaboratingal Policy and Centre Regulation, for Pharmaceutical Utrecht Institute Policy and for PharmaceuticalRegulation, Utrecht Sciences, Institute Utrecht for Pharmaceutical University Sciences, Utrecht University THE PHARMACEUTICAL POLICY LANDSCAPE GLOBALLY AND IN EUROPE In the last decades pharmaceutical expenditure accounted for a considerable proportion of total health care spending in Europe and worldwide. These percentages of total health care expenditure varied to a great extent among countries ranging from 6.8% in Norway to 28.5% in Greece and 33.4% in Hungary in 2011; examples from other high income countries outside of Europe showed ranges from 9.4% in New Zealand to 16.6% in Canada in 2011 [26]. These variations in pharmaceutical expenditure can be explained by decisions made by national policy makers. They are acting within a triangle of granting access to medicines within the limits of available public resources and ensuring sustainability in funding and at the same time rewarding innovation. Each of the three pillars within this triangle creates challenges for policy makers who need to take national situations such as wealth of a country, the political climate as well as cultural and historical developments into account: Access to medicines: Even though marketing authorization is harmonized in Europe through the implementation of the European Medicine Agency (EMA) and EU legislation on marketing authorization on the basis of a medicine’s quality, safety and efficacy [27], discrepancies in access to medicines still appear. Reasons include delays during the pricing and reimbursement process, which can be caused by authorities or by insufficient documentation of companies or strategic behavior of companies after the decision on pricing and reimbursement is taken, as prices in one country influence the prices in other countries due to policies such as external price referencing [28]. Cost-containment and ensuring of sustainable public funds: In Europe reimbursable medicines (which account for the majority of medicines on the market) are paid for – either
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