未经证实:乳腺癌是影响欧洲女性的最常见癌症类型。晚期乳腺癌(ABC)提出了重大的治疗挑战,因此,及时获得治疗至关重要。本研究的目的是评估保加利亚ABC的治疗模式和患者获得新疗法的机会。
UNASSIGNED:我们在2008-2021年期间进行了一项回顾性研究。根据欧洲药品管理局(EMA)的数据库,在过去的13年中,我们分析了许多获得ABC上市许可的药品.进入市场的时间被评估为可用性的程度,这是通过患者可用的药物数量来衡量的(可用性指数,AI),以及获得上市许可与列入阳性药物清单之间的平均时间。通过MicrosoftExcel版本10通过描述性统计分析数据。
UNASSIGNED:靶向治疗的平均时间为564天。晚期乳腺癌化疗和激素治疗的可用性和依从性指数为1,而靶向治疗的平均AI为0.67。患者获得ABC的靶向肿瘤治疗高于欧洲的平均水平,需要1-2年。
UNASSIGNED:对于生物仿制药来说,更快的获取更为明显。国家对定价和报销的监管要求对市场准入有重大影响。
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 via 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.