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Access to Cancer Medicines in Europe: an Analysis of Existing Challenges and Countries’ Responses

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Access to Cancer Medicines in Europe: an Analysis of Existing Challenges and Countries’ Responses London School of Economics and Political Science ! ! ! Access to cancer medicines in Europe: An analysis of existing challenges and countries’ responses ! ! Alessandra Ferrario A thesis submitted to the Department of Social Policy at the London School of Economics for the degree of Doctor of Philosophy, London, December, 2016 1 Declaration of authorship I certify that the thesis I have presented for examination for the MPhil/PhD degree of the London School of Economics and Political Science is solely my own work other than where I have clearly indicated that it is the work of others (in which case the extent of any work carried out jointly by me and any other person is clearly identified in it). The copyright of this thesis rests with the author. Quotation from it is permitted, provided that full acknowledgement is made. This thesis may not be reproduced without my prior written consent. I warrant that this authorisation does not, to the best of my belief, infringe the rights of any third party. I declare that my thesis consists of 63 373 words including footnotes, excluding references and appendices. 2 Statement of conjoint work Chapter 7: Alessandra Ferrario, Panos Kanavos, Dealing with uncertainty and high prices of new medicines: A comparative analysis of the use of managed entry agreements in Belgium, England, the Netherlands, and Sweden, Social Science and Medicine, 124: 39-7, 2015 I designed the study, collected the data, performed the analysis, wrote the first draft of the paper and finalised it. Panos Kanavos provided feedback on drafts of the paper. Chapter 8: Submitted as a technical report for the WHO consultation on fair pricing: Alessandra Ferrario, Guillaume Dedet, Tifenn Humbert, The role of strategic procurement in increasing access to cancer medicine I conducted the literature review with the support of Mackenzie Mills who run the search and conducted the title screening. I devised the search strategy, reviewed all the abstracts of the papers selected based on their titles, collected primary data from competent authorities on their experience with different procurement methods, I wrote the first draft of the chapter and finalised it. Guillaume Dedet and Tifenn Humbert provided feedback on the first draft of the paper. Chapter 9: Conclusions Parts of the subchapter on ‘Policy implications’ (more specifically point 4) ‘Prices represent a barrier to access and efforts to address their impact are needed at national and international levels’) are part of a perspective paper currently under-review by the WHO Bulletin: Alessandra Ferrario, Tifenn Humbert, Panos Kanavos, Hanne Bak-Petersen, Improving access to medicines through strategic procurement: The role of inter-country collaboration I conceptualized the paper, wrote the first draft and finalized it. Tifenn Humbert, Panos Kanavos, Hanne Bak-Petersen provided feedback on the first draft of the paper. 3 Abstract Access to new cancer medicines, particularly their coverage and affordability, is a matter of great concern to payers, patients and the pharmaceutical industry. Yet, little comparative evidence on actual use and its determinants is available. This thesis aimed to analyse the extent to which access to cancer medicines varies across a sample of European countries, what determines these differences, whether they matter, and what are countries doing to improve access. These objectives were achieved through the use of quantitative and qualitative methods including multilevel mixed effects models, survival analysis and the complementary log-log transformation of the Cox proportional hazard model, literature reviews and interviews to inform the development of conceptual frameworks, and a comparative longitudinal analysis of the implementation of MEAs. Results show that there are wide cross-country differences in access to cancer medicines in Belgium, Estonia, Scotland, and Sweden. These differences were determined by time to entry of new medicines, medical need (i.e. incidence of the disease) and factors affecting treatment decisions (e.g. coverage, prices, and financing mechanisms). The added clinical value of medicines explained the shorter time to launch in Estonia and higher consumption in Scotland but not in the other countries. This emphasises the importance of health technology assessment processes in identifying and making cost-effective medicines available and limiting the utilisation of non-cost-effective ones. The latter is particularly important given the opportunity cost of funding new cancer medicines. Managed entry agreements have increasingly been implemented to address issues of uncertainty and high prices when making coverage decisions. Through their action on price, effectiveness and use, they are able to influence cost-effectiveness and budget impact, two key variables guiding reimbursement decisions. Some of the most important contributions from this thesis include: (1) the development of a blueprint to analyse access to cancer medicines in Europe quantitatively and qualitatively; (2) the identification of likely determinants of differences in access to cancer medicines which can guide policy-makers efforts in managing access to new therapies; and (3) the development of a conceptual framework for managed entry agreements which can support their design and evaluation. 4 Acknowledgements I would like to thank my supervisors Dr Panos Kanavos and Prof. Alistair McGuire for their guidance and support. A number of people helped me gaining access to data, replied to my many questions and facilitated the arrangement of interviews. In Belgium: Ellen Vanhaeren and Hans Van Der Meersch (former INAMI-RIZIV), Catherine Adriaens, Marc de Falleur, and Francis Arickx from the National Institute for Health and Disability Insurance (INAMI-RIZIV). In Estonia: Erki Laidmäe and Keili Kolves from the Estonian Health Insurance Fund, Ott Laius from the Estonian Medicines Agency, Marge Reinap from WHO, and Riina Sikkut. In Scotland: staff at the Scottish Medicines Consortium and NHS Scotland, in particular Lindsay McClure. In Sweden: Karl Arnberg from TLV, Mikael Hoffman from Nepi, and Ingrid Kössler. I am very grateful to the oncologists who agreed to speak with me and the many people I spoke to and who inspired me in my research and writing process. I would like to thank my dear friends and colleagues Elena Nicod (a very special thank you), Wei Yang, Hala Hourani, and Anna Sagan for their support and encouragement throughout the PhD journey. Finally, I would like to thank Sam, for reminding me that everything has a beginning and an end, and that the darkest hour of the night is before dawn. It always seems impossible until it's done. Nelson Mandela This thesis is dedicated to my loving parents who always believe in me. Statement on editorial help I gratefully acknowledge my friends Janice Lam, Lilian Li and Oliver Wouters for proofreading various chapters of this thesis. 5 Table of Contents DECLARATION+OF+AUTHORSHIP+.....................................................................................................................+2! STATEMENT+OF+CONJOINT+WORK+..................................................................................................................+3! ABSTRACT+.....................................................................................................................................................+4! ACKNOWLEDGEMENTS+..................................................................................................................................+5! TABLE+OF+CONTENTS+.....................................................................................................................................+6! LIST+OF+FIGURES+............................................................................................................................................+9! LIST+OF+TABLES+............................................................................................................................................+10! LIST+OF+APPENDICES+....................................................................................................................................+11! ABBREVIATIONS+..........................................................................................................................................+12! NOTES+ON+THE+STRUCTURE+OF+THIS+THESIS+.................................................................................................+14! 1! INTRODUCTION+..................................................................................................................................+16! 1.1! MEDICINES!LIFE-CYCLE!AND!DETERMINANTS!OF!ACCESS!..................................................................................!17! 1.2! ACCESS!TO!CANCER!MEDICINES!.................................................................................................................!35! 1.3! VALUE!FRAMEWORKS!..............................................................................................................................!47! 2! GAPS+IN+THE+LITERATURE+AND+HYPOTHESES,+RESEARCH+QUESTION,+STRUCTURE+OF+THE+THESIS+.......+53! 2.1! GAPS!IN!THE!LITERATURE!AND!HYPOTHESES!.................................................................................................!53! 2.2! AIM!AND!RESEARCH!QUESTIONS!................................................................................................................!55! 2.3! STRUCTURE!OF!THE!THESIS!.......................................................................................................................!56!
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