OBJECTIVES: Health Technology Assessment (HTA) has been a practice in Portugal since 1991, with the first national guidelines published in 1998. In 2015, a major step forward was taken with the creation of the National Health Technology Assessment System (SiNATS). This new system aimed to improve health outcomes evaluation, ensure the sustainability of the National Health Service, and use public health resources efficiently. This analysis aims to give an overview of reimbursement decisions in Portugal from 2015 to 2023.

METHODS: We conducted a comprehensive analysis of all the reimbursement decisions published by INFARMED from 2015 to 2023. We looked at various factors such as therapeutic area, active substance, type of decision and year of decision.

RESULTS: We analysed a total of 494 official reimbursement decisions, with 89% approvals (439) and 11% refusals (55). The top-4 therapeutic areas in terms of reimbursement decisions were oncology (37.9%), central nervous system (CNS) (9.3%), cardiovascular (8.5%), and anti-infectious (7.1%), making up 63% of the decisions over this 9-year period. Considering all oncology requests the approval rate was 84.5%, while in anti-infectious was 100%. Among all the negative decisions, 53% (29 out of 55) were in oncology. Looking closely at oncology, the average number of reimbursement decisions increased by 35% after 2020. From 2015 to 2019, oncology accounted for around 31% of total reimbursement decisions (an average of 18 decisions per year), compared to 47% from 2020 to 2023 (an average of 24 decisions per year).

CONCLUSIONS: This analysis gives important insights into the reimbursement decisions by INFARMED in Portugal. The number of reimbursement decisions in oncology is increasing, reflecting global trends in the pharmaceutical industry pipelines. However, oncology is also one of the toughest areas to get a positive reimbursement decision.