A nationwide register study on medicines exiting the reimbursement system in 2010-2022.

backgroundNational medicines reimbursement systems play a key role in supporting access to medicines. Although inclusion in these systems is important for patients to obtain necessary treatments at affordable costs, medicines exit reimbursement each year. However, research on the later stages of the medicine lifecycle, including reimbursement discontinuation, remains limited. Therefore, we evaluated medicines exiting the national reimbursement system in Finland.

methodsData on all market-authorized medicinal products that exited the reimbursement system for at least one full calendar year between 2010 and 2022 were retrieved from a nationwide database maintained by the Social Insurance Institution of Finland (SII). Reimbursement discontinuation was validated using data from the Pharmaceuticals Pricing Board and the SII's Pharmaceutical Price Register. The study was conducted at the level of active pharmaceutical ingredients (APIs), focusing on whether the entire API exited the reimbursement system. Therapeutic categories, age, price levels, criticality, and market availability after reimbursement discontinuation were examined. Prices per treatment day were calculated using Defined Daily Doses where available. APIs were categorized into short- and long-term use based on expert assessment supported by literature. Descriptive analyses were conducted.

resultsA total of 150 APIs exited the reimbursement system. The most common therapeutic categories were alimentary tract and metabolism (15%), cardiovascular system (15%), and nervous system (11%). Of all identified APIs, 49% were intended for short-term use 51% for long-term use. Overall, 6% of the APIs, including phenoxymethylpenicillin, were listed as critical medicines by the EU. After reimbursement discontinuation, 62% of the APIs remained on the market without reimbursement, whereas 38% were immediately withdrawn. APIs remaining on the market were older than those withdrawn (median age 31 vs. 28 years) and had a lower median price per treatment day (€0.90 vs. €1.50).

conclusionsAPIs, even some classified as critical in the EU, exit the national reimbursement system each year. APIs that remain on the market tend to be older and less expensive than those leaving the market. These findings highlight the importance of monitoring changes in the range of reimbursable medicines and their potential implications for availability and affordability.