What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results from the second EBE biological medicines policy survey

摘要

Introduction/Study objective Biosimilar policies with a focus on uptake have received a lot of attention at national and regional level inthe last few years. It is now 10 years since the first biosimilar was approved in the European Union (EU), but do policies in the MemberStates take the diff erences between biological medicines and small-molecule generics into account? To map the policy landscape inEurope, European Biopharmaceutical Enterprises (EBE) has conducted a second round of its descriptive survey on pricing andreimbursement policies for off-patent biologicals.Methods: The EBE survey was conducted among national pharmaceutical trade associations in 32 countries, the 28 EU MemberStates plus Norway, Serbia, Switzerland and Turkey. The questionnaire was a revised version of the previous survey of 2014 and wasdeveloped by the EBE Biosimilars Working Group. It contained 44 questions about eight policy areas: Availability of biologicalmedicines, Tendering, Health Technology Assessment, International Nonproprietary Name prescribing, Internal Reference Pricing,Substitution, Interchangeability and Quotas.Results: Responses were received from all national trade associations contacted. According to the responses, the majority of the 32countries surveyed have specific policies for off-patent biologicals in place and therefore take account of the specificities of biologicals.Nevertheless, variations exist and reflect the responsibilities in healthcare policymaking in Europe. In the majority of countries,treatment decisions remain in the hands of physicians. Compared to the first EBE survey, shifts have been seen in the areas ofsubstitution and interchangeability.Conclusion: The second EBE survey on biological medicines policies indicates that nearly all jurisdictions have policies in place thatreflect the different nature of biological medicines. However, policies and their implementation vary among different jurisdictions.