OBJECTIVES

: The objective of this research is to present the development of the Managed Entry Agreements in Romania and the results after four years of implementation.

METHODS

: The authors performed a study literature comparing the international experience on Managed Entry Agreements with the local legislation. Looking on public data sources from 2015 to 2018, the authors performed an analysis of the existing Managed Entry Agreements in Romania, measuring the results of implementing them in terms of drugs reimbursed, eligible treated patients and the resources allocated.

RESULTS

: In Romania the Managed Entry Agreements are performed as Cost-Volume contracts (financial-based contracts with discounts based on market share) or Cost-Volume-Result contracts (outcome-based contracts with discounts based on market share).

There are 3 drugs with Cost-Volume-Result contracts, all for Hepatitis C treatment and 22 drugs with Cost-Volume contracts, most of them for Oncology drugs (18), but also for Rheumatology (2), Rare Disease (1) and Cardiovascular drugs (1). The actual methodology favors drugs with reduced length of treatment and does not allow several drugs to conclude contracts within one therapeutic area (4 drugs lost the “financial tender” and does not concluded contracts). The budget allocated to conclude these contracts was over 2 billion Euros in 4 years, but how much was used from this budget is not transparent.

CONCLUSIONS

: In Romania, the development of the Managed Entry Agreements is a process which evolves from one year to another. With the legislation revised in 2018, several pitfalls were removed (e.g. single winner for one therapeutic area and limited access for chronic diseases drugs), new concepts were introduced (e.g maximum price paid per cured patient), and the infrastructure allows now for multiple indication pricing. Meantime, in order to allow for other types of contracts, the health infrastructure has to be improved and the transparency/confidentiality aspects have to be better managed.