OBJECTIVES: To assess the characteristics and trends in 30-day wholesale acquisition costs (WAC) at the market entry of antiepileptic drugs (AEDs) approved by the US Food and Drug Administration (FDA) in the period of 1984-2020.

METHODS: Regulatory information was derived from the FDA website. WACs at market entry were retrieved from the IBM Micromedex Red Book from the date of FDA approval FDA to December 31, 2020. The defined daily dose (DDD) for adult patients was obtained from the FDA approved labels. Consumer price index (CPI) and gross domestic product (GDP) data were collected from US government databases. The AWP/DDD per month of therapy was calculated for each formulation. Trends of median prices of 30-day WAC/DDD each year were plotted with the CPI and the GDP, and trends were analyzed.

RESULTS: The FDA approved 79 AEDs from 1984 to 2020, with 11 AEDs approved in the 1980s, 23 in the 1990s, 16 in the 2000s, 26 in the 2010s, and 3 in 2020. There were 33(41.8%) AEDs sponsored by US companies. The FDA used priority review to approve 19(24.1%) AEDs, and 16(20.3%) were designated as orphan drugs. The median market entry 30-day WAC/DDD was $22.50 in the 1980s (interquartile range [IQR]=$32.49), $92.66 (IQR=$90.33) in the 1990s, $174.69 (IQR=$224.47) in the 2000s, $1,097.85 (IQR=$2036.73) in the 2010s, and $8,217.00 (IQR=$8,604.75) for the 3 AEDs approved in 2020. WAC median prices determinately surpassed CPI in 1993 at $68.82 and GDP in 2000 at $130.74.

CONCLUSIONS: AEDs prices at market entry increased significantly during the period 1984-2020. The increase in AED prices exceeded the CPI and the GDP during the same period. Newer formulations of AEDs seem to offer novel and effective ways of treating seizures but at the cost of higher prices.