Presentation (CTI)

OBJECTIVES: To assess the number of MDD treatments that have been approved and reimbursed globally over the past 20 years comparing their rates of positive reimbursement decisions with other diseases.
METHODS: Assessments of MDD treatments conducted by regulatory bodies of HC, EMA, and TGA and HTA agencies of PBAC, CADTH, INESSS, TC, G-BA, TLV, NICE, and SMC between 2001 and 2021 were reviewed to determine outcomes across Australia, Canada, France, Germany, Sweden, and the UK. Decision was set as a categorical variable with three values: not reimbursed; reimbursed with restrictions; fully reimbursed. Rates from these categories for MDD were then compared against five physical conditions (hepatitis C, melanoma, AMD, psoriasis, and COPD) and two severe mental disorders (schizophrenia and bipolar disorder) within the same scope countries and period. Countries were stratified based on the HTA value frameworks between cost-effectiveness and clinical effectiveness.
RESULTS: In the analyzed countries, HTAs for MDD (n=35) were considerably lower than the average number of assessments for the physical conditions (n=328 total, average of 65.6 per disease). Among the conditions studied, the rate of negative HTA outcomes (43%) is the highest in MDD compared to the other conditions (15%). Positive HTA outcomes were consistently lower for MDD compared to the seven other conditions, and it was more pronounced in cost-effectiveness HTA countries, where the rate of negative HTA outcomes in MDD is more than four times higher than the basket of conditions (48% vs. 10%).
CONCLUSIONS: Despite the high burden of disease, the rate of positive reimbursement decision in MDD is low, limiting patient access to innovative therapies. Further research is needed to fully understand key barriers to approval and access of innovative MDD treatments on a global scale.