OBJECTIVES:

Since a long time ago, Portugal has been concerned with the adoption of instruments that better enable to manage the total health expenditure on medicines. The Managed Entry Agreements (MEA) have proved to be a good mechanism for managing it as well as the uncertainty around the clinical evidence, eligible patient population, cost-effectiveness and budget cap.

Now, it is time to rethink on what has been done in this matter in recent years.

METHODS:

The study considered the MEAs approved between 2005 and 2016 in inpatient and outpatient settings by National Health Service (NHS) and monitored by INFARMED, I.P.

The analysis focused on the following:

- To classify the MEAs according to the European Taxonomy defined by Ferrario & Kanavos (2013);

- To characterize the MEAs (describing the main objectives, instruments, benefits, possible disadvantages, the criteria underlying its implementation);

- To build a SWOT analysis of what MEAs represents for portuguese NHS;

- To describe utilization variability among Therapeutic Areas.

RESULTS:

Portugal have focused mostly on financial schemes MEA and more recently implemented the performance-based MEA.

In the period 2005-2016, were celebrated more than 160 MEAs, of which approximately 62% and 38% occurred in the inpatient and outpatient setting, respectively. Around 50% of the MEAs were celebrated in three years (2014 – 2016).

The MEAs instrument most used is the price-volume agreement (PVA), followed up by outcome-guarantee and coverage with evidence development (CED) agreements.

CONCLUSIONS:

The variety of MEAs were increasingly used in Portugal to manage aspects of uncertainty associated with the introduction of medicines in the NHS. Therefore, MEAs represent a valuable strategic tool for overcoming these challenges and ensuring the sustainability of portuguese NHS.