OBJECTIVES: Liraglutide (Saxenda®) for weight management is reimbursed in Ireland subject to a Managed Access Protocol (MAP). Reimbursement support (i.e. drug provision with co-payment from the patient under state-funded schemes) is granted on an individual patient basis for adults, prescribed the drug by a registered physician, and who have a body mass index (BMI) ≥35 kg/m² with prediabetes and high-risk for cardiovascular disease. The MAP objective is to provide certainty for Ireland’s payer, the Health Service Executive (HSE), and includes a responder assessment protocol by evaluating eligibility for ongoing reimbursement beyond six months. This study evaluates the success of the MAP as a cost containment measure during its first year of implementation.

METHODS: All Phase I reimbursement requests for liraglutide submitted through the HSE-Primary Care Reimbursement Services (PCRS) online application system during the first year of the MAP, 1 January 2023 to 31 December 2023, were reviewed. Data relevant to the study period were also extracted from the HSE-PCRS national pharmacy claims database. Analysis was performed using R-Studio.

RESULTS: A total of 7,927 Phase I individual reimbursement applications for liraglutide were submitted during the study period, over half of which were approved (52.12%, n=4,139). By December 2023, 1,697 individual patients were accessing liraglutide through the HSE funded Community Drugs Schemes. Expenditure in 2023 was just over €3 million. If all applications submitted had instead been approved, expenditure could have been approximately €13.5 million.

CONCLUSIONS: To date, implementation of the MAP has proven to be a cost containment measure as demonstrated by the overall approval rate observed in this study. The robustness of this MAP is improved by the two-phase approval approach. Future studies will assess persistence with liraglutide beyond the initial six-month approval, by assessing the number of applications submitted and approved for continued reimbursement.