The Health Technology Assessment System in Portugal: A Study on Medicines Reimbursement Recommendations

OBJECTIVES: Health technology assessment (HTA) supports decision-making on the reimbursement of medicines within the National Health Service (NHS). This study aims to characterize HTA processes and their outcomes in Portugal.

METHODS: Reimbursement appraisal reports (2018-2022) were retrieved from INFARMED webpage, and analyzed to identify populations, interventions, comparators and outcomes (PICO), sources of evidence, and conclusions on therapeutic value and cost-effectiveness of medicines under evaluation. Medicines were classified according to Anatomical Therapeutic Chemical (ATC) codes, and legal status of supply to patients (i.e., non-restricted or restricted medical prescription), while comparators as active or best supportive care (BSC). Unfavorable and favorable reimbursement decisions were characterized. Descriptive statistics were used for data analyses with Microsoft Excel®.

RESULTS: Of 289 HTA processes, 249 (86%) had favorable reimbursement recommendations (199 [80%] involving medicines restricted to hospital use/follow-up; 89 [36%] antineoplastic agents), which supported by added therapeutic value (ATV) (n=171; 69%) and therapeutic equivalence (TE) (n=78; 31%) versus comparators (active, n=203; 82%; BSC, n=46; 18%). Therapeutic value (ATV or TE) was supported by evidence from Randomized Controlled Trials (RCTs) (n=134; 54%), Meta-Analyses (n=78; 31%), and RCTs and Meta-Analyses together (n=37; 15%). In subsequent economic analyses, 139 (56%) showed acceptable Incremental Cost-Effectiveness Ratios (ICERs), 107 (43%) economic advantage (i.e., cost-savings), and 3 (1%) medicines were not cost-effective versus comparators, but price reductions were further agreed. The remaining 40 (14%) HTA processes had unfavorable reimbursement recommendations due to absence of therapeutic value (n=36; 90%) or cost-effectiveness versus comparators (n=4; 10%).

CONCLUSIONS: The majority of HTA processes analyzed in Portugal over a 5-year period received a positive recommendation for reimbursement of the medicines in question, mainly based on ATV and acceptable ICERs versus comparators. Comparison studies should be carried out with results obtained in other countries.