title: How Can Pricing and Reimbursement Policies Improve Affordable Access to Medicines? Lessons Learned from European Countries.
abstract: This article discusses pharmaceutical pricing and reimbursement policies in European countries with regard to their ability to ensure affordable access to medicines. A frequently applied pricing policy is external price referencing. While it provides some benchmark for policy-makers and has been shown to be able to generate savings, it may also contribute to delay in product launch in countries where medicine prices are low. Value-based pricing has been proposed as a policy that promotes access while rewarding useful innovation; however, implementing it has proven quite challenging. For high-priced medicines, managed-entry agreements are increasingly used. These agreements allow policy-makers to manage uncertainty and obtain lower prices. They can also facilitate earlier market access in case of limited evidence about added therapeutic value of the medicine. However, these agreements raise transparency concerns due to the confidentiality clause. Tendering as used in the hospital and offpatent outpatient sectors has been proven to reduce medicine prices but it requires a robust framework and appropriate design with clear strategic goals in order to prevent shortages. These pricing and reimbursement policies are supplemented by the widespread use of Health Technology Assessment to inform decision-making, and by strategies to improve the uptake of generics, and also biosimilars. While European countries have been implementing a set of policy options, there is a lack of thorough impact assessments of several pricing and reimbursement policies on affordable access. Increased cooperation between authorities, experience sharing and improving transparency on price information, including the disclosure of confidential discounts, are opportunities to address current challenges.
authors.affiliation: WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Pharmacoeconomics Department, Gesundheit Österreich GmbH (Austrian Public Health Institute), 1010, Vienna, Austria. sabine.vogler@goeg.at.
authors.forename: Sabine
authors.initials: S
authors.lastname: Vogler
authors.affiliation: Health Division, Organisation for Economic Co-operation and Development (OECD), 75116, Paris, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Paris
authors.affiliation: LSE Health and Department of Social Policy, London School of Economics and Political Science, London, WC2A 2AE, UK.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Ferrario
authors.affiliation: Department of Global Health, Boston University School of Public Health, Boston, MA, 02118, USA.
authors.forename: Veronika J
authors.initials: VJ
authors.lastname: Wirtz
authors.affiliation: Essential Medicines and Health Products Department (EMP), World Health Organization (WHO), 1211, Geneva 27, Switzerland.
authors.forename: Kees
authors.initials: K
authors.lastname: de Joncheere
authors.affiliation: WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Pharmacoeconomics Department, Gesundheit Österreich GmbH (Austrian Public Health Institute), 1010, Vienna, Austria.
authors.forename: Peter
authors.initials: P
authors.lastname: Schneider
authors.affiliation: World Health Organization (WHO) Regional Office for Europe, Copenhagen, 2100, Denmark.
authors.forename: Hanne Bak
authors.initials: HB
authors.lastname: Pedersen
authors.affiliation: World Health Organization (WHO) Regional Office for Europe, Copenhagen, 2100, Denmark.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Dedet
authors.affiliation: School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Private Mail Bag, 92019, Auckland, New Zealand.
authors.forename: Zaheer-Ud-Din
authors.initials: ZU
authors.lastname: Babar
mesh_terms: D003365:Costs and Cost Analysis / Q000191:economics* / Q000706:statistics & numerical data*; D016527:Drug Costs / Q000706:statistics & numerical data*; D017850:Economics, Pharmaceutical / Q000706:statistics & numerical data*; D005060:Europe; D006291:Health Policy / Q000191:economics; D006297:Health Services Accessibility / Q000191:economics* / Q000706:statistics & numerical data; D006801:Humans; D007349:Insurance, Health, Reimbursement / Q000191:economics* / Q000706:statistics & numerical data*