OBJECTIVES: Since their regulatory approval, GLP-1 agonists have seen a surge in popularity, with the class expected to dethrone PD-1 inhibitors as the global best-selling drug class in 2024. This rapid growth has fuelled a robust pipeline of future weight loss drugs and is shaking up the industry. However, US market success may not equally translate to Europe where the payer/HTA hurdle can be significant. This research aims to evaluate the reimbursement outcomes of current EMA-approved weight loss drugs in EU4+UK.

METHODS: Publicly available information was screened to identify EMA-approved GLP-1 agonists and identify the corresponding reimbursement outcomes in EU4+UK between January 2015 and June 2024, with key information extracted.

RESULTS: A total of 3 drugs have received EMA approval for weight loss as of June 2024 (semaglutide, liraglutide, tirzepatide). 3/5 countries have granted reimbursement to semaglutide (France: SMR Substantial, ASMR V; Spain: reimbursed; UK: optimised to weight-related comorbidities with 2-year stopping rule), while liraglutide is only reimbursed in 1/5 countries (UK: optimised to BMI) as it has not been HTA-assessed in the remaining countries. Tirzepatide has yet to be reviewed by HTA agencies in EU4+UK. In Germany, all GLP-1s have been excluded from statutory health insurance coverage, with the G-BA citing a legal resolution from 2004 for its decision. Similarly, in Italy, all three GLP-1s are classified as Class-C and are not reimbursed.

CONCLUSIONS: The reception of GLP-1s by European payers has been lukewarm so far. Efficacy concerns in broader populations and legal frameworks pose significant barriers for positive reimbursement to EMA label so far in EU4+UK markets. This may shift, however, in the near future as the competitive landscape evolves with more GLP-1s entering the space.