Faculty of Law, University of Zurich, Zurich, Switzerland.
Department of Health Sciences and Technology, ETH Zurich, Zurich, Switzerland.
JAMA Health Forum. 2024 Nov 1;5(11):e244461. doi: 10.1001/jamahealthforum.2024.4461.
High prices of new drugs are concerning. What remains to be understood are price developments after entering the market because not only initial prices, but also postlaunch prices, contribute to drug spending.
To analyze launch and postlaunch price developments of new drugs in the US, Germany, and Switzerland.
DESIGN, SETTING, AND PARTICIPANTS: This cohort study used the public databases of the US Food and Drug Administration, European Medicines Agency, and Swissmedic to identify all new drugs approved between January 2011 and December 2022. Data were collected and analyzed between January 2024 and September 2024. During the revision process in October 2024, SSR data were also analyzed. Drugs for which price data were available were included in the study cohort. Launch prices and postlaunch price developments in the US, Germany, and Switzerland were calculated from 2011 until 2023.
Standard statistics (mean, median, and IQR) were applied to analyze launch drug prices and postlaunch drug price developments over time in the US, Germany, and Switzerland.
The cohort study included 254 drugs in the US, 298 in Germany, and 235 in Switzerland. In the US, mean (SD) launch prices increased from $31 699 ($36 439) in 2011 to $228 658 ($571 252) in 2022, with an average increase of 19.7% per year. In Germany, mean (SD) launch prices increased from $77 237 ($228 672) to $146 072 ($306 091), with an average increase of 6.0% per year. In Switzerland, mean launch prices increased from $29 211 ($41 919) to $41 399 ($39 697), with an average increase of 3.2% per year. Post launch, trimmed mean prices of included drugs in the study cohort increased -0.6% at 3 years, 2.4% at 5 years, and 4.1% at 10 years post launch in the US. A larger increase of postlaunch prices was observed for cancer drugs compared with noncancer drugs. In Germany, trimmed mean drug prices decreased -30.9% at 3 years, -33.4% at 5 years, and -45.2% at 10 years post launch. In Switzerland, trimmed mean drug prices decreased -9.3% at 3 years, -13.5% at 5 years, and -29.5% at 10 years post launch. In Switzerland and Germany, postlaunch price developments were similar for cancer and noncancer drugs, but treatment costs of cancer drugs remained substantially higher compared with noncancer drugs.
The results of this cohort study suggest that, in contrast to Germany and Switzerland, prices of cancer drugs increased substantially post launch in the US. When developing solutions how drug prices can be decreased, launch as well as postlaunch prices require attention from policymakers.
重要性：新药的高价令人担忧。仍需要了解的是进入市场后的价格发展情况，因为不仅初始价格，而且后续价格都对药物支出有影响。
目的：分析美国、德国和瑞士新药的上市和上市后价格发展情况。
设计、设置和参与者：本队列研究使用美国食品和药物管理局、欧洲药品管理局和瑞士药品监管局的公共数据库，确定了 2011 年 1 月至 2022 年 12 月期间批准的所有新药。数据收集和分析于 2024 年 1 月至 2024 年 9 月进行。在 2024 年 10 月的修订过程中，还分析了 SSR 数据。研究队列纳入了有价格数据的药物。从 2011 年到 2023 年，计算了美国、德国和瑞士的上市价格和上市后价格发展情况。
主要结果和措施：应用标准统计（均值、中位数和 IQR）分析了美国、德国和瑞士的上市药物价格和上市后药物价格随时间的变化情况。
结果：该队列研究纳入了美国的 254 种药物、德国的 298 种药物和瑞士的 235 种药物。在美国，上市价格从 2011 年的 31699 美元（36439 美元）增加到 2022 年的 228658 美元（571252 美元），平均每年增长 19.7%。在德国，上市价格从 77237 美元（228672 美元）增加到 146072 美元（306091 美元），平均每年增长 6.0%。在瑞士，上市价格从 29211 美元（41919 美元）增加到 41399 美元（39697 美元），平均每年增长 3.2%。上市后，研究队列中包含药物的经修剪的平均价格在上市后 3 年时下降了 0.6%，5 年时上升了 2.4%，10 年时上升了 4.1%。与非癌症药物相比，癌症药物的上市后价格涨幅更大。在德国，上市后 3 年时，经修剪的平均药物价格下降了 30.9%，5 年时下降了 33.4%，10 年时下降了 45.2%。在瑞士，上市后 3 年时，经修剪的平均药物价格下降了 9.3%，5 年时下降了 13.5%，10 年时下降了 29.5%。在瑞士和德国，癌症药物和非癌症药物的上市后价格发展情况相似，但癌症药物的治疗费用仍明显高于非癌症药物。
结论和相关性：该队列研究的结果表明，与德国和瑞士不同，美国癌症药物的上市后价格大幅上涨。在制定降低药物价格的解决方案时，政策制定者需要关注上市价格和上市后价格。
