PNS4 CAN Entry-Agreements be Managed?

Abstract

Managed-entry agreements (MEAs) have become mainstay in a number of mature markets to reduce uncertainty around reimbursement decisions of costly pharmaceuticals. In Japan however, they do not exist. This research aims to explore if some of the agreements that are in place in the major markets could be applied to the Japanese healthcare system Thorough secondary research with supplementary primary research was conducted with reimbursement agencies and payers in key markets to understand the agreements that are currently in place, any challenges experienced since their introduction, and what lessons could be applied to the Japanese market. Structured qualitative research with key industry members, payer and payer-advisors within Japan was also conducted, in order to understand the challenges industry have faced thus far within Japan, how payers within the MHLW have responded to any proposed MEAs, and the feasibility of implementing specific agreements based on successes in other markets. While MEAs were in place in all the markets researched, the majority of these were financial-based agreements, most often consisting of straight discounts. Administrative burden was noted as one of the most common barriers for not introducing more performance-based agreements, although there was an acknowledgement that, moving forward, these are likely to be more common. Within Japan, industry members noted that, to date, discussions around MEAs have been limited, but are keen to create more dialogue around this moving forward. Payers displayed openness to consider MEAs, although showed concerns around the additional admin that these may entail if introduced. The research suggests that MEAs could be considered by the MHLW moving forward. As in other markets, however, performance-based agreements appear to be less welcome, suggesting that, at least initially, financial-based agreements may be more welcome. For performance-based agreements to be considered, supporting the infrastructure to manage may have to be considered.