PHP151 Evidence on the Impact of Managed Entries on Payers, Patients, Manufacturers, and Health Care Workers

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Managed entries (MEs) are innovative pricing and reimbursement agreements aiming to share the risk related to the introduction of new, high-cost drugs between the payer and the manufacturer. This study aims to review evidence on the impact of MEs on payer, patients, manufacturer, and health care workers and to analyse emerging trends in managed entries at international level. A systematic literature review (grey and peer-reviewed) was performed complemented by search of health technology assessment agency's websites and selective interviews with decision makers in key European countries. Evidence exists of improved cost-effectiveness and lower drug price following the implementation of coverage with evidence development in Sweden. Data from France shows that price-volume agreements led to rebates totalling around 3% of the total drugs bill. Evidence from Italy shows that authorization with a risk-sharing agreement was associated with more rapid patient access in comparison to authorization without such an agreement. It is unclear whether managed entries constitute a reward for manufacturers, however, various benefits have been reported such as reimbursement for drugs which received an initial negative recommendation (e.g. bortezomib and trabectedin, UK) and competitive advantage in the form of better formulary position (sitagliptin & sitagliptin + metformin, USA); not to mention the possibility of granting discounts while leaving list prices untouched. Considerable administrative burden is placed on health care staff due to the diversity of existing schemes, the complexities linked with retrospective reimbursement, and lack of management capacity at current staffing levels. Although evidence on the impact of MEs is patchy, the systematic literature review showed that there are already lessons to be learnt. Preliminary findings seem to suggest that MEs have indeed the potential of meeting payer, patient, and manufacturer expectations, yet important threats such as implementation difficulties, administrative burden and lack of management capacity need to be addressed.