Euripid guidance document on external reference pricing (ERP)

Background and Research Question: The comparison of the prices of pharmaceuticals is an important element of a popular policy tool in Europe, known as ‘External Reference Pricing’ (ERP). Albeit being a commonly used policy instrument, ERP is often challenged by stakeholders by claiming potential negative effects on patients’ access or that it is hampering uptake of products in a market. Between 2016 and 2018 the Euripid Collaboration developed recommendations which are meant to guide a coordinated approach of national competent authorities regarding the use of ERP to mitigate potential negative impact for patient access. *** Methods: Electronic databases were searched for publications published during the period of 2002-2016. Grey literature, government or European Commission publications on Pharmaceutical pricing published during the same period were also searched via the Internet. In addition primary data were collected through a survey with national and EU authorities, stakeholder in the field of medicines and members of the EURIPID collaboration. The final document was prepared following a two-stage (written comments and face-to-face workshops) review process Euripid members, further national competent authorities on pricing and reimbursement of medicines, the WHO-PPRI network, European Commission policy officers and stakeholders in the field, i.e. economic operators, professional associations, patient and consumer organisations and third party payers’ associations. *** Results: Based on evidence and experience, twelve principles were developed to provide guidance when applying ERP. The principles follow the structure: Framing the issue - Things to consider - Recommendations. They cover important areas as the use of ERP for decision making, the scope/selection of reference countries, the scope/selection of medicines, the comparability of pharmaceuticals and formula used during ERP procedures. (...