A nationwide register study of new outpatient medicines: trends in initial costs and medicine selection in Finland, 2011–2021

Health care expenditures are increasing globally. New, more expensive medicines entering the market are seen as one of the main reasons for this. This study examines new outpatient medicines approved for reimbursement under the Finnish National Health Insurance following approval between 2011 and 2021. We describe trends in the characteristics of new medicines and their initial costs. We identified new reimbursable medicines and their six-month costs at the time of inclusion from the national register of reimbursed medicine purchases. Statistical averages and distributions were used to describe the medicines and their initial costs. A linear regression model was used to examine the associations between initial costs and characteristics of the medicines. Between 2011 and 2021, a total of 193 new medicines were included in the reimbursement system in Finland. Almost a third were cancer medicines, and 15% were first-of-kind medicines. In 2011, the median cost of a six-month treatment was €1,209, compared to €10,652 in 2021. The initial costs for medicines with orphan designation were 12.2 times higher ( P < 0.001) than for other medicines. The number of products entering the reimbursement system with limited evidence of benefits increased during the study period. The medicines included in the reimbursement system were increasingly intended for a small number of patients. High initial cost was associated with orphan medicine designation, oncological indication, and the biologic status of the medicine. Medicines with limited evidence of benefits have been increasingly included in the reimbursement system and initial costs have been rising, especially during the latter half of the study period.