OBJECTIVES: To assess trends in the price at the market entry of new nervous system drugs (NSD) approved by the FDA in the period 1980-2021.

METHODS: Regulatory information for new molecular entities (NME) was collected from the FDA website and the whole acquisition cost (WAC) from IBM Micromedex Red Book. We classified the drugs using the WHO Anatomical Therapeutic Chemical (ATC) Classification System. We estimated the cost per year or treatment duration as defined on the drug label. The WAC was adjusted to 2021 dollars using the consumer price index. Descriptive statistics and multiple linear regression were performed.

RESULTS: The FDA approved 153 NSD (11.7% of all new drugs), including 148 NME and 5 BLA. The FDA approved 21 drugs in the 1980s, 39 in the 1990s, 43 in the 2000s, 34 in the 2010s, and 16 in 2020-2021. The subtherapeutic classes with the largest number of approvals were psycholeptics (36, 23.5%), psychoanaleptics (32, 20.9%), and analgesics (22, 14.4%). The median market entry was $ 810 (IQR= $ 475.53) for chronic use of NS approved in the 1980s, $ 1,788.28 in the 1990s (IQR= $3,179.88), $3,323.66 in 2000s (IQR=$5,925.49), $10,490.15 in 2010s (IQR= $ 21,467.39) and $11,910.35 in 2020-2021 (IQR=$ 12,032.30). The regression model explained 33.4% of the variance in prices. FDA priority review (p= 0.02), chronic use (p=0.007), and approval date (p=0.05) were positively associated, and the therapeutic subgroups analgesics(p= 0.004), antiepileptics (p=0.002), psychoanaleptics (p<0.001), and psycholeptics (p= 0.001) were negatively associate with market entry prices.

CONCLUSIONS: The inflation-adjusted WAC at market entry of nervous system drugs significantly increased during the study period. Factors positively associated with market entry prices were FDA priority review, chronic use, and approval date. Subtherapeutic class was associated with market entry prices, with certain classes being associated with higher prices than others.