Pharmaceutical policy analysis – A European perspective on pricing and reimbursement in challenging times

The pharmaceutical policy environment is dynamic as new medicines are being developed and different medical needs arise, while diverse interests by stakeholders influence policy making. 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. As public health care budgets – including pharmaceutical expenditure – are limited policy makers have to constantly adjust and implement pharmaceutical policies to cope with the changing pharmaceutical environment. This financial pressure even increased during the last years of the economic recession. The goal of this thesis is to understand pharmaceutical pricing and reimbursement policies and their impact on medicines prices and consumption in Europe. The underlying basis for this thesis is pricing and reimbursement policy data in European countries, which are analyzed in descriptive as well as through statistical methods by evaluating the impact of these policies on medicine prices and consumption, especially during the economic recession. Chapter 2 addresses the question as to how national pharmaceutical policies aim at controlling public pharmaceutical spending by regulating medicine prices. In particular, chapter 2.1 gives a descriptive overview of one of the most commonly used pricing policies in Europe: external price referencing. Chapter 2.2 explores how national medicine prices may be affected by policies such as external price referencing. The aspect of how national policies affect the overall medicine price level in European countries and whether these policies lead to price convergence across Europe is addressed in chapter 2.3. Chapter 3 focuses on how countries re-evaluate and adjust national policies in times of economic recession. Chapter 3.1 analyses which pharmaceutical pricing and reimbursement policies were implemented by countries during the time of the economic recession and evaluates the correlation with medicines sales in eight European countries. Chapter 3.2 presents a detailed evaluation of the impact of different policy measures on the consumption of antipsychotic medicines in Portugal and Finland during the time of the economic recession. In Europe, there is an increasing use of personalized medicines which require prior genetic testing which entail new challenges to policy makers with respect to pricing and reimbursement. In specific, chapter 4.1 looks into how European pricing and reimbursement authorities deal with the increasing challenge of how to evaluate and assess these ‘treatment packages’ which included both new and often expensive medicines as well as medical devices such as diagnostics. The concluding chapter (chapter 5) of this thesis contains a general discussion of the benefits and limitations of research on pharmaceutical pricing and reimbursement policy interventions. In specific, methodological challenges of comparing medicines prices are described and the policy implications of all study findings are presented. Finally, areas for future research are identified which could improve access and affordability of medicines