OBJECTIVES: To assess the authorization status of reimbursement applications rejected by the Swedish Dental and Pharmaceutical Benefits Agency (TLV) and to look for trends among these rejections in terms of authorization status. To examine, if the rejected medical products are nevertheless used by Swedish patients.

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 authorization status have been collected using European Medicines Agency (EMA) and Swedish Medical Products Agency (Läkemedelsverket) webpages. Dispensation data have been collected using

National Board of Health and Welfare (Socialstyrelsen) webpage.

RESULTS: A total of 54 TLV rejections concerning 40 medical products between January 2019 and December 2023 were identified, out of which 30 underwent centralized authorization procedure. Out of those, 18 had been granted orphan designation status. In addition to orphan designation, one was authorized under exceptional circumstances, four underwent accelerated assessment and two were granted a conditional marketing authorization.

Out of the total number of 40 analyzed medical products, 20 were present on the Swedish market in June 2024 despite not being reimbursed in any indication. Out of those, 16 had a product specific ATC-code, which allowed the analysis of dispensation data using the National Board of Health and Welfare (Socialstyrelsen) registry. 12 of those 16 were prescribed and dispensed in Sweden, most of them scarcely but three of them to several thousand patients.

CONCLUSIONS: A reimbursement rejection in Sweden most often leads to a very low number of prescriptions. However, if the purchasing price is low, the numbers can be significant, probably due to out-of-the pocket purchase.