Vogler S., Pertile P., Gamba S. (2019)

Conference 2019: Medicines access challenge – The value of pricing and reimbursement policies. Journal of Pharmaceutical Policy and Practice, 12(Suppl 3):34.


Background: Governments have increasingly implemented managed-entry agreements (MEAs) to ensure the market entry of new, high-priced medicines. However, information on their quantitative impact on prices is still extremely scarce. It has been suggested that manufacturers might raise (list) prices in expectation of a MEA to reduce the size of the losses that they could imply [1].

Objectives: The study aims to analyse the quantitative impact of the existence of a MEA, and its type (financial- or performance-based), on the list prices of medicines (i.e. before the deduction of any discount).

Methodology: A difference-in-difference identification strategy was adopted to estimate the impact of MEAs on ex-factory prices in six European countries (Belgium, England, Italy and the Netherlands = MEA-applying countries; Norway and Greece = no MEA) in December 2016. Publicly accessible information on MEA was retrieved from public authorities; list price data were obtained from the Pharma Price Information (PPI) service. 111 medicines (666 observations) subject to a MEA in at least one of the countries were included in the analysis, and for each medicine, a single pharmaceutical presentation (i.e. a specific pharmaceutical form, dosage and pack size) was selected based on clinical relevance and price data availability across countries.

Region covered: WHO European region

Time period: December 2016

Results: Preliminary results show that, on average, the implementation of a MEA increases the list price by 5.2% (significant at the 5% level). The increase is mainly driven by financial-based agreements which also account for the majority of MEAs in force in December 2016 in the countries of our sample. Controlling for possible heterogeneous effects of MEAs across countries, prices of medicines subject to a MEA in Belgium are 9.5% higher, whereas in Italy and England the effect of the presence of a MEA is statistically lower (Italy: 5.2%, p-value = 0.009; England: 6.1%, p-value = 0.000). The Netherlands is the sole studied country where the effect of a MEA is negative (-7.6%, p−value = 0.038).

Conclusions and lessons learned: Preliminary results tend to confirm the hypothesis that the implementation of a MEA increases list prices of medicines. Since we attribute a MEA to a product even when the agreement applies only to a limited number of indications, our estimate of the impact of MEA may be downward biased. The findings imply that payers may overestimate the financial benefits they can obtain from a MEA if they only consider the difference between the list price and the negotiated price net of any discounts.