School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, China.
School of Health Policy and Management, Nanjing Medical University, Nanjing, China.
Int J Equity Health. 2024 Jun 5;23(1):116. doi: 10.1186/s12939-024-02208-1.
PCSK9 inhibitors are a novel class of lipid-lowering drugs that have demonstrated favorable efficacy and safety. Evolocumab and alirocumab have been added to China's National Reimbursement Drug List through the National Drug Price Negotiation (NDPN) policy. This study aims to evaluate the impact of the NDPN policy on the utilization and accessibility of these two PCSK9 inhibitors.
The procurement data of evolocumab and alirocumab were collected from 1,519 hospitals between January 2021 and December 2022. We determined the monthly availability, utilization, cost per daily defined dose (DDDc), and affordability of the two medicines. Single-group interrupted time series (ITS) analysis was performed to assess the impact of the NDPN policy on each drug, and multiple-group ITS analysis was performed to compare the differences between them.
The NDPN policy led to a significant and sudden increase in the availability and utilization of PCSK9 inhibitors, along with a decrease in their DDDc. In the year following the policy implementation, there was an increase in the availability, utilization, and spending, and the DDDc remained stable. The affordability of PCSK9 inhibitors in China have been significantly improved, with a 92.97% reduction in out-of-pocket costs. The availability of both PCSK9 inhibitors was similar, and the DDDc of alirocumab was only $0.23 higher after the intervention. The market share of evolocumab consistently exceeded that of alirocumab. Regional disparities in utilization were observed, with higher utilization in the eastern region and a correlation with per capita disposable income.
The NDPN policy has successfully improved the accessibility and utilization of PCSK9 inhibitors in China. However, regional disparities in utilization indicate the need for further interventions to ensure equitable medicine access.
PCSK9 抑制剂是一类新型降脂药物，已证明具有良好的疗效和安全性。依洛尤单抗和阿利西尤单抗已通过国家药品价格谈判（NDPN）政策纳入中国国家医保药品目录。本研究旨在评估 NDPN 政策对这两种 PCSK9 抑制剂的可及性和使用情况的影响。
我们收集了 2021 年 1 月至 2022 年 12 月期间 1519 家医院的依洛尤单抗和阿利西尤单抗的采购数据。我们确定了这两种药物的每月可及性、使用率、每日常用剂量成本（DDDc）和可负担性。采用单组中断时间序列（ITS）分析评估 NDPN 政策对每种药物的影响，并进行多组 ITS 分析比较它们之间的差异。
NDPN 政策导致 PCSK9 抑制剂的可及性和使用率显著且突然增加，同时 DDDc 降低。在政策实施后的一年中，可及性、使用率和支出增加，而 DDDc 保持稳定。中国 PCSK9 抑制剂的可负担性显著提高，自付费用降低了 92.97%。两种 PCSK9 抑制剂的可及性相似，干预后阿利西尤单抗的 DDDc 仅高出 0.23 美元。依洛尤单抗的市场份额始终高于阿利西尤单抗。利用方面存在地区差异，东部地区利用率较高，与人均可支配收入呈正相关。
NDPN 政策成功提高了中国 PCSK9 抑制剂的可及性和使用率。然而，利用方面的地区差异表明需要进一步干预，以确保公平获得药物。
