An overview of policies on biosimilars used in European countries was obtained via a questionnaire, administered to different country experts, and supplemented with relevant articles. Topics for the questionnaire were derived from previous work on generic medicines [16 (link)] and The Belgian Health Care Knowledge Centre (KCE) report 199 on biosimilars [17 ]. Topics were organized in five themes: the availability of biosimilars, pricing policies, reimbursement policies, demand-side policies (broken down by the 4Es–Education, Engineering, Economics and Enforcement [18 (link)]), and recommendations to enhance uptake of biosimilars. Open as well as closed questions were included. The questionnaire was written in English. The questionnaire as updated in August 2016 can be consulted as supporting information (S1 Questionnaire ). All molecules for which a biosimilar was marketed in Europe at that time (filgrastim, somatropin, erythropoietin alfa, insulin glargine, follitropin, infliximab and etanercept) were included. This article presents several highlights from this extensive questionnaire. Results were rearranged in three themes: i) availability of biosimilars, ii) national policies, and iii) recommendations from the country experts.
A pilot survey was carried out in two countries (Slovenia, Lithuania) to validate the questions in terms of clarity, after which the refined questionnaire was sent out to experts of different European countries with knowledge of the biosimilar market. These experts were initially contacts within the Piperska Group [19 ], which is a network of professionals doing research on the rational use of medicines. These contacts were then further supplemented with other contacts in the network of the KU Leuven / Erasmus MC team. Country experts represented regulatory authorities in different European countries, pricing and reimbursement authorities, health insurance companies, health technology assessment (HTA) bodies, procurement agencies, and academia, and were contacted via e-mail or telephone to participate in this study. Initially, one expert per country was contacted. This expert acted as the national contact, responsible for collecting data for the survey, and contacting additional national stakeholders. When responses were not clear, clarification was requested via e-mail or phone calls. This approach was used before when assessing different policies and their impact, as well as debating key issues such as managed entry agreements, personalized medicine and new models to enhance the managed entry of new medicines [20 (link)–26 (link)]. The data obtained via the questionnaire were supplemented with relevant articles, and, if possible, responses were validated by contacting other experts in the individual countries. Descriptive statistics were used to analyze the data, with frequencies being reported where appropriate, and open questions being examined via qualitative analysis. During critical review of the manuscript, the experts were asked to include data collected until the end of April 2017. Data was collected between November 2015 and May 2017.
A pilot survey was carried out in two countries (Slovenia, Lithuania) to validate the questions in terms of clarity, after which the refined questionnaire was sent out to experts of different European countries with knowledge of the biosimilar market. These experts were initially contacts within the Piperska Group [19 ], which is a network of professionals doing research on the rational use of medicines. These contacts were then further supplemented with other contacts in the network of the KU Leuven / Erasmus MC team. Country experts represented regulatory authorities in different European countries, pricing and reimbursement authorities, health insurance companies, health technology assessment (HTA) bodies, procurement agencies, and academia, and were contacted via e-mail or telephone to participate in this study. Initially, one expert per country was contacted. This expert acted as the national contact, responsible for collecting data for the survey, and contacting additional national stakeholders. When responses were not clear, clarification was requested via e-mail or phone calls. This approach was used before when assessing different policies and their impact, as well as debating key issues such as managed entry agreements, personalized medicine and new models to enhance the managed entry of new medicines [20 (link)–26 (link)]. The data obtained via the questionnaire were supplemented with relevant articles, and, if possible, responses were validated by contacting other experts in the individual countries. Descriptive statistics were used to analyze the data, with frequencies being reported where appropriate, and open questions being examined via qualitative analysis. During critical review of the manuscript, the experts were asked to include data collected until the end of April 2017. Data was collected between November 2015 and May 2017.
Free full text: Click here
