Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry. Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures. Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab. Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80-90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 - €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures. Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries.

5 A Trapeznikov Institute of Control Sciences of Russian Academy of Sciences Moscow Russia

Amgros Copenhagen Denmark

AOK Research Institute Berlin Germany

Austrian Social Insurance Vienna Austria

Clinical Research and Drug Evaluation Unit Local Health Authority of Verona Verona Italy

Department of Medicines and Medical Devices The National Health Service Riga Latvia

Department of Pharmaceutical and Pharmacological Sciences KU Leuven Leuven Belgium

Department of Pharmacy University of Medicine Tirana Tirana Albania

Department of Social Pharmacy and Pharmacy Practice Faculty of Medicine University of Banja Luka Banja Luka Bosnia and Herzegovina

Division of Clinical Pharmacology Department of Laboratory Medicine Karolinska Institutet Karolinska University Hospital Huddinge Stockholm Sweden

Division of Public Health Pharmacy and Management School of Pharmacy Faculty of Health Sciences Sefako Makgatho Health Sciences University Pretoria South Africa

Drug Area Catalan Health Service Barcelona Spain

Erasmus University Medical Center Rotterdam Netherlands

Faculty of Health Studies University of Rijeka Rijeka Croatia

Faculty of Pharmacy Medical University of Sofia Sofia Bulgaria

Health Insurance Fund Banja Luka Bosnia and Herzegovina

Health Insurance Institute Ljubljana Slovenia

Health Insurance Organization Nicosia Cyprus

HTA Consulting Cracow Poland

Mario Negri Institute for Pharmacological Research Milan Italy

Ministry of Health of the Republic of Lithuania Vilnius Lithuania

Ministry of Welfare Reykjavik Iceland

National Organization for the Provision of Healthcare Services Athens Greece

NHS Greater Glasgow and Clyde Queen Elizabeth University Hospital Glasgow United Kingdom

Pharmaceuticals Pricing Board Ministry of Social Affairs and Health Helsinki Finland

Public Health and Management Department Faculty of Medicine Carol Davila University of Medicine and Pharmacy Bucharest Bucharest Romania

Reviews and Health Technology Assessments Norwegian Institute of Public Health Oslo Norway

St James's Hospital Dublin Ireland

State Agency of Medicines Tartu Estonia

State Institute for Drug Control Prague Czechia

Stockholm County Council Stockholm Sweden

Strathclyde Institute of Pharmacy and Biomedical Sciences University of Strathclyde Glasgow United Kingdom

The National University Hospital of Iceland Reykjavik Iceland

UBT Higher Education Institute Prishtina Kosovo

ZEM Solutions Belgrade Serbia

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