- Which new drugs were sold in the United States only, in both the United States and other countries, and outside the United States only in 2018 through 2022?
- What were the differences between the United States' and other countries' new drug availability and the timing of new drug launches in these countries?
Prescription drug research and development is, particularly in its most expensive later stages, an increasingly global endeavor undertaken by large, multinational firms. However, the availability of the resulting new drugs in individual countries and the timing of their launch can vary because of regulatory differences, business decisions, and other factors. The now-enacted Inflation Reduction Act of 2022 and other policy proposals aim to lower U.S. prices for brand-name drugs that are between three and four times as expensive as in other higher-income countries. Some stakeholders assert that lower U.S. prices will prevent U.S. patients from accessing some drugs sold in other countries or delay the launch of new drugs in the United States. To address these concerns, the author uses 2018 to 2022 data to compare the availability and timing of entry of new prescription drugs between the United States and other high-income countries.
- The United States had more total new drugs sold by the end of 2022 (74 percent of all new drugs) compared with any other individual country in the study. Germany had the second-highest share (52 percent of new drugs).
- New drugs sold in both the United States and at least one other country by the end of 2022 accounted for 90 percent of 2022 spending on all new drugs in the United States.
- More than half of new drugs were launched first in the United States, and there was an average lag of about one year between launch in the United States and launch in other major markets (Australia, Canada, France, Germany, Italy, Japan, and the United Kingdom).
- Some new drugs launched in other countries before they were launched in the United States; however, the likelihood of launch of a new drug was considerably higher in the United States versus in other countries.
This research was sponsored by the U.S. Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation and conducted within the Payment, Cost, and Coverage Program within RAND Health Care.
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