Department of "Organization and Economics of Pharmacy", Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria.
Front Public Health. 2023 Mar 3;11:1073733. doi: 10.3389/fpubh.2023.1073733. eCollection 2023.
Breast cancer is the most common type of cancer affecting women in Europe. Advanced breast cancer (ABC) poses a significant therapeutic challenge, and therefore, timely access to treatment is crucial. The aim of the present study was to evaluate the treatment patterns and patients' access to new therapies for ABC in Bulgaria.
We conducted a retrospective study in the period 2008-2021. Based on the European Medicines Agency (EMA) database, we analyzed a number of medicinal products with marketing authorization for ABC in the last 13 years. Time to market access was evaluated as the degree of availability, which is measured by the number of medicines that are available to patients (availability index, AI), and the average time elapsed between obtaining a marketing authorization and time to inclusion in the Positive Drug List. Data were analyzed through descriptive statistics Microsoft Excel version 10.
The average time to access was 564 days for targeted therapy. The availability and compliance index for chemotherapy and hormonal therapy in advanced breast cancer was 1, while the average AI for targeted therapy was 0.67. Patient access to targeted oncology therapy of ABC is above average for Europe and takes 1-2 years.
Faster access is more evident for biosimilars. National regulatory requirements for pricing and reimbursement have a major impact on market access.
乳腺癌是欧洲女性最常见的癌症类型。晚期乳腺癌（ABC）是一个极具挑战性的治疗难题，因此及时获得治疗至关重要。本研究旨在评估保加利亚 ABC 的治疗模式和患者获得新疗法的情况。
我们进行了一项回顾性研究，时间范围为 2008 年至 2021 年。根据欧洲药品管理局（EMA）数据库，我们分析了过去 13 年来 ABC 获批的多种药物。市场准入时间通过可及性程度进行评估，通过患者可用药物的数量（可及性指数，AI）和获得营销授权与纳入积极药物清单之间的平均时间来衡量。数据通过 Microsoft Excel 版本 10 的描述性统计进行分析。
靶向治疗的平均准入时间为 564 天。化疗和激素治疗在晚期乳腺癌中的可及性和合规性指数为 1，而靶向治疗的平均 AI 为 0.67。ABC 靶向肿瘤疗法的患者准入情况高于欧洲平均水平，需要 1-2 年时间。
生物类似药的准入速度更快。国家定价和报销的监管要求对市场准入有重大影响。
