Managed Entry Agreements in UK, Italy And Spain.

Stretched health care budgets and the increasing availability of high-cost medicines, together with increasing patient expectations, means that manufacturers seeking reimbursement for their products need to demonstrate more than ever that their drugs can provide value-for-money. Due to this complex environment, formal agreements between payers and manufacturers have been developed with the aim of sharing the financial risk surrounding the introduction of high cost products, in order to enable patient access to new medicines. These agreements, collectively known as ‘Managed Entry Agreements (MEAs)1 vary considerably in their terms and conditions from country to country and drug to drug. Also, within Europe there are varying degrees of acceptance of MEAs, where some countries like the UK have fully adopted MEAs as a mechanism for managing drug budgets, and other countries where there is no mechanism for negotiating MEAs, for example in Finland4. Where MEAs do exist, they are negotiated at varying levels e.g. with national, subnational and local agreements.