OBJECTIVES: To assess the most common reasons for rejection of reimbursement by the Swedish Dental and Pharmaceutical Benefits Agency (TLV) and to look for trends among these rejections in terms of disease area and age of the indicated population (children/adults).

METHODS: All TLV reimbursement rejections published during the years 2019 to 2023 were identified by the Nordic Market Access proprietary database NMAi, using built-in filters. Information on disease area, population, comparator and outcomes were then collected as well as primary and, if applicable, secondary reason for rejection.

RESULTS: A total of 54 TLV rejections between January 2019 and December 2023 were identified and reviewed. The most common reason for rejection was the cost being too high in relation to the benefit, in other words the ICER being too high, followed by insufficient clinical evidence to support crucial assumptions. The third most common reason was a reluctancy from the company to provide a comparison that TLV had requested, and the fourth that the study population did not correspond to the Swedish population intended for treatment. No trends in terms of disease areas were observed, but in intended population: only one of the rejected drugs was intended for only children. A limitation of our study is that companies may withdraw their application, in which case it is not visible in the database.

CONCLUSIONS: The fact that the Swedish HTA system is based on cost-effectiveness is well mirrored in that the main reason for rejection is the ICER being too high. A continuation of this study could be to compare reasons for rejection in the other Nordic countries.