Pricing and reimbursement of medicinal products is a challenge to be faced by all the different national authorities to achieve the sustainability of healthcare systems while providing appropriate access to cures for patients. A better coordination in this field at the European level is pursued by the European Integrated Price Information Database Collaboration (EURIPID), a voluntary non-profit initiative grouping many authorities in charge of pricing and reimbursement in different member States. Its main objective is the control of pricing, in order to make medicines affordable and accessible. In Norway, for example, the local competent authority utilises EURIPID data to re-evaluate the prices of about 70% of products on the market on an annual basis to keep it updated again the fluctuations of the local currency against the Euro, explains the expert of the Norwegian Medicines Agency, Helga Festøy, from the blog of the European Commission.
Data sharing to access the database
The Collaboration was launched in 2010 and currently sees the participation of 24 European countries plus the European Commission (resulting from an initial invitation sent to 31 countries of the EU and EEA/EFTA and to 19 stakeholders. Croatia leaved the Collaboration in 2018). National competent authorities for pricing and reimbursement can access the EURIPID database that contains standardised data on official prices (and other information) of publicly reimbursed – mainly out-patient medicinal products – as published according to the Directive 89\105\EC. Access to the database is provided only to those countries available to share their data with the other participants, and this is subject to opposing voices that claim more transparency among the stakeholders (see for example here). Access is also provided on an ad hoc basis to researchers.
The next step in the development of the project (to be run under the health programme) should see the inclusion in the database of information on the sales volumes of pharmaceuticals, wrote Festøy. The improvement of transparency shall be pursued also by the distribution among stakeholders of a Guidance Document on external price referencing (EPR), and the creation of a new dialogue platform.
A European project improve policies on pricing and reimbursement
The amelioration and implementation of the EURIPID database was the focus of a European project run in years 2015-2018 and aimed to achieve a better control on public budgets for medicinal products at the level of external reference pricing (ERP). The adhesion to the project (and to the EURIPID Collaboration) is voluntary, since the definition of the prices for medicinal products falls under the competence of the single nations.
The optimisation of the dataset and layout of the existing EURIPID database and website, the ability to provide the necessary information in a standardised web-based format and the development of the operational policy paper on a coordinated approach of national competent authorities regarding the use of ERP were the three key actions of the project. The project focused on the reviewing of the currently available datasets and on how to ameliorate and standardise them in order to provide a more uniform source of information to run the external reference pricing (ERP) procedures.
In the first phase of the project a User’s Requirement Specification document was drafted and shared with the participants, after formal approval by the Board of Participants of the Collaboration. This has been followed by the development of the EURIPID website and the update of the country “fact sheet” providing country-specific background information important for the right interpretation of the prices, which has been integrated into the website.
Data are provided by national competent authorities in a standardised format and are upload to the system using and improved procedure as for quality assurance measures and encryption of data. EURIPID provides also information on sales volumes and on the existence of managed entry agreements (just for 5 countries).
The technical Guidance document
The “Technical Guidance Document on External Reference Pricing” consists of an overview of the 12 principles governing the initiative and a detailed technical background report explaining how the principles were developed. The project also allowed to renew many functionalities of the database, both in the field of the general improvement of the informatics interface and the subsequent inclusion of new pieces of information.
The drafting of the Document was based on the reviewing of the literature and best practices on ERP in Europe. The document analyses how to mitigate the possible negative effects of ERP on patients’ access to medicines, while it does not discuss the appropriateness of ERP or the suitability of alternative policy options or approaches. The final technical document is mainly targeted to experts of the national competent authorities dealing with pricing and reimbursing of medicinal products, and it may prove useful also for other stakeholders involved in the process.