OBJECTIVES: A bio-hybrid medicinal product is a follow-on product to a biological reference product, but in contrast to a biosimilar product it may differ in strength, pharmaceutical form or route of administration. The revision of the EU pharmaceutical legislation aims to facilitate marketing authorization for bio-hybrids, as they have the potential to widen access to medicines. However, bio-hybrids could also be considered a form of product differentiation which enables suppliers to charge price premiums. The study aims to analyze whether routine data collected in the EURIPID database can be used to assess the impact of bio-hybrids on access to medicines.

METHODS: The EURIPID database is a comprehensive, continuously maintained, easy-to-use online database of prices of reimbursed pharmaceuticals in 28 countries (of which 25 are EU member states). Currently, members of the EURIPID Collaboration aim to develop new functionalities within the database and monitoring the impact of bio-hybrids is a promising area.

RESULTS: The expected results of the undertaking are: Since bio-hybrids mostly address the administration of biological medicines in ambulatory settings, their price information will be routinely collected within the EURIPID database. While this will enable the construction of indicators on availability (e.g. coverage status, proxy time to reimbursement), indicators on accessibility (e.g. proxy time to first sale) will be subject to structural issues of EURIPID. Measuring affordability poses a particularly difficult challenge: since bio-hybrids often come with a shift in the point of administration, list spending for bio-hybrids – as readily available in EURIPID - may be higher than list spending for reference biological products, but health expenditures could decrease.

CONCLUSIONS: Routine data collection within the EURIPID databases can capture impacts related to list prices of pharmaceutical. However, access to medicines has several dimensions and here routine data collection in EURIPID has headroom for improvement, e.g. information on conditions or restrictions of reimbursement.