OBJECTIVES To compare Managed Entry Agreements (MEAs) in the UK, Italy, and Spain, and analyse the type of MEAs, number of agreements, and therapy areas in which they exist. Finally, to determine MEA impact on market access delay in these countries. METHODS HTA databases were searched for types and quantities of MEAs (publicly available). The data were analysed by indication, and country specific knowledge applied, to quantify the average delay to market access. RESULTS All types of MEA have been granted previously in the UK, the majority were non-outcomes based (76%). In Italy, and Spain, all MEA’s were outcomes based, with Italy focused purely on risk-sharing agreements. UK has 42 MEA’s since 2000, Italy has 44 MEAs since 2006 and Spain has 9 MEAs since 2010. Of 95 MEAs, 56% were for oncology drugs, 12% musculoskeletal, 10% ophthalmology, 7% CNS, 5% respiratory and 10% other therapy areas. NICE average time to HTA decision is 21 months, and is delayed up to 10 months depending on the type of MEA. AIFA average time to HTA decision is 8 months; however MEAs are part of the pricing negotiation, so it may be a way to gain market access faster. In Spain, the average time to HTA decision is 8 months with decisions for drugs with double pricing arrangements taking on average 14 months. For high cost hospital and orphan drugs, the delay can be up to a year. CONCLUSIONS Negative reimbursement decisions can have a significant impact on achieving market access, and revenue generation. MEAs represent an avenue for overcoming these negative decisions and market access for high cost medicines. Companies aiming for MEAs in UK, Italy, and Spain, should be aware of the potential market access delay and the precedence of MEAs that the payers in these countries are amenable to