Performance-based managed entry agreements for medicines: Much needed, but not feasible?

When payers see new and expensive therapies come to market with immature outcome data, they increasingly want to ‘pay for value’. That is, pricing and reimbursement (P&R) conditions should reward actual clinical performance and any potential cost savings achieved in real-world conditions. Despite increasingly frequent commentaries on the topic in the literature, progress towards value-based P&R has been slow across the major markets.

Managed entry agreements (MEAs) encompass a diverse range of contracts between drug manufacturers and payers, aimed at addressing payers’ concerns about clinical performance and/ or budgetary aspects. This article focuses on a subset of MEAs: performance-based MEAs. These can be viewed as tools that bridge the gap between the urgent need for value-based approaches and the reality of P&R systems that are slow to change. Such approaches are often described as valuable in both industry and payer circles.

After two decades of patchy experimentation in various countries, typically driven by a few companies and open-minded payers, what makes these types of agreements work well is still not well

This article analyses the drivers of, and barriers to, performancebased MEAs, and suggests ways to make them work.