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

Area of Science:

• Health Economics
• Pharmacoeconomics
• Clinical Practice

Background:

• Liraglutide (Saxenda) shows efficacy for weight management but its cost-effectiveness in Ireland was unproven.
• High-budget medications require careful management to ensure value within healthcare systems.

Purpose of the Study:

• To assess the role of a Managed Access Protocol (MAP) in facilitating real-world access to liraglutide.
• To evaluate the cost-effectiveness and expenditure control of liraglutide within a specific patient subpopulation in Ireland.

Main Methods:

• Analysis of national MAP database and pharmacy claims for liraglutide applications.
• Comparison of approved MAP applications with pivotal trial data and non-approved applications.
• Evaluation of utilization and expenditure against predicted scenarios without the MAP.

Main Results:

• In the first year, 52.2% of 7927 liraglutide applications under the MAP were approved.
• Approved patients differed in key characteristics (age, HbA1c, BMI) from pivotal trial subgroups and non-approved cases.
• Expenditure was €3.1 million, with a potential saving of up to €2.4 million had all applications been approved.

Conclusions:

• The MAP successfully facilitates access to liraglutide for a subpopulation.
• This approach ensures access for patients where liraglutide is effective and cost-effective, as per health technology assessment.
• The MAP effectively contains overall expenditure for this high-budget drug.