Background

Managed Entry Agreements (MEAs) have been used in Europe by manufacturers and industry to facilitate market access. They have become increasingly popular as the healthcare industry continues to face challenges in providing optimal care to patients due to several factors, such as budget constraints and the arrival of expensive, innovative therapies. There are many MEAs that have been put into practice in the EU, while Japan has not fully adopted MEAs as an approach.

Discussion

The taxonomy of MEAs continues to evolve and change. Several types of MEAs exist today with various names, each dedicated to fulfilling a particular purpose for specific products. The main types of MEAs are known as finance-based agreements, outcomes-based agreements, and service-based agreements. In Europe, there have been many MEAs implemented, however, not all have been entirely successful. Lessons may be learned as to how MEAs may be applied to mitigate constraints on healthcare spending to allow for market access for innovative therapies with high prices and limited evidence. MEAs may or not be a tool for Japan to apply for the facilitation of market access for innovative therapies.

Conclusion

MEAs, mainly FBAs, will continue to enjoy an expanding life in the EU as long as the Parliament and the Commission do not consider equitable access to innovative pharmaceutical a clear objective in Europe. The introduction of a differential pricing system with a compensation process may be the only way to address inequity in patient access to innovative drugs across EMS and to control parallel trade. The EU Parliament and Commission does not seem to be paying any interest nor attention to this critical equity matter. In the meanwhile, SBAs will continue to expand addressing stakeholders’ needs. MEAs currently do not appear to be suitable for application in Japan, unless certain obstacles are overcome.