A Managed Access Protocol for Liraglutide for Weight Management: A Retrospective, Observational Study in Ireland.

OBJECTIVES: Pivotal trial data highlight that liraglutide (Saxenda) is effective for weight management, versus placebo. However, cost-effectiveness in Ireland, is not proven. Here, we demonstrate how a Managed Access Protocol (MAP) in Ireland's healthcare service facilitates access to this high-budget-impact drug in a real-world subpopulation (of the fully licensed population), in whom the intervention is expected to be the most cost-effective, as determined by health technology assessment, while containing overall expenditure. METHODS: Two key data sources were analyzed; (1) national anonymized MAP database of liraglutide applications and (2) national reimbursed pharmacy claims database. Key characteristics of the applications approved for reimbursement under the MAP were compared with (1) those of an identified pivotal trial subgroup and (2) those not approved for reimbursement under the MAP. Utilization and expenditure were compared with those predicted in the absence of the MAP. RESULTS: Of the 7927 applications submitted in the first year of the MAP by physicians for individual patients, 52.2% were approved. Differences were noted in most of the key characteristics (including mean age, mean HbA1c, and mean body mass index) in the groups compared. Expenditure on liraglutide was approximately €3.1 million in 2023. Had all applications submitted under the MAP had been approved, expenditure of up to €5.5 million would have been expected. CONCLUSIONS: The MAP facilitates access for a subpopulation in whom liraglutide is effective and also expected to be most cost-effective, according to health technology assessment.