Managed Entry Agreements (MEA)

A Managed Entry Agreement (MEA) is a confidential arrangement between a manufacturer and payer/provider that enables access to (coverage/reimbursement of) a health technology subject to specified conditions.

These arrangements can be applicable often with very expensive innovative pharmaceuticals and limited public resources. Available evidence on relative effectiveness and cost-effectiveness of innovative treatments is often insufficient at the time of licensing. Public health authorities and pharmaceutical companies have therefore looked for alternative funding mechanisms, i.e. managed entry agreements (MEA), to share the risks and uncertainties arising from public coverage of pharmaceuticals, whose (cost-)effectiveness is still unknown or for which the budget impact is expected to be very high, but for which early access for the patient is wanted. Rather than to wait for more solid evidence before making a definite reimbursement decisions, MEA should allow to grant early access to pharmaceutical products, while at the same time collecting the relevant data to assess (cost-) effectiveness, controlling the budget impact, monitoring the (rational) use in clinical practice, or generating real life data on effectiveness and use. MEA’s do not result in permanent reimbursement, but in temporary reimbursement.

As this is a complicated subject, it is advised to be informed and consulted by a local specialist. Innosens has a broad experience in managed entry agreements and is able to give reliable advice on this subject. Innosens provides its clients with all the necessary support in the process of finding a suitable payer/provider and consults the client in what it takes to form a managed entry agreement.