Hörbrand Franziska, Schuch Florian, Bleß Hans-Holger, Messinger David, Bretthauer Bork, Killian Peter
Kassenärztliche Vereinigung Bayerns (KVB), München, Deutschland.
Rheumatologische Schwerpunktpraxis Erlangen, Erlangen, Deutschland.
Z Rheumatol. 2023 Nov;82(9):787-797. doi: 10.1007/s00393-022-01259-5. Epub 2022 Aug 25.
With the introduction of tumor necrosis factor (TNF) alpha inhibitors, the treatment of inflammatory rheumatic diseases (IRD) has undergone a fundamental change. Several of the originally high-priced biologics are now accessible as lower cost biosimilars, removing a significant impediment to prescription.
The present study investigated whether the availability of biosimilars is associated with an improvement in the care of IRD. Moreover, the subjective acceptance of biosimilars by physicians and patients was investigated and compared with objectifiable parameters.
Pseudonymized claims data of the Bavarian Association of Statutory Health Insurance Physicians from 2014 to 2019 as well as a paper and pencil survey of patients and rheumatologists formed the data basis of the study.
During the observation period, the proportion of diagnosed patients receiving drug therapy increased from 38.5% to 43.2%. Also, the care changed in terms of the prescribed agents. Conventional drug therapy declined overall and, in particular, glucocorticoid prescriptions decreased from 39.3% in 2014 to 34.3% in 2019. At the same time, the proportion of targeted treatments increased from 12.3% to 20.4%. The median duration of basic treatment before first-time bDMARD use dropped from 3.15 years in 2014 to 2.17 years in 2019.
Over the observation period, in which three biosimilars entered the market, the care of patients with IRD improved both quantitatively and qualitatively. The market share of biosimilars increased in parallel with this development. With an overall high acceptance of biosimilars, the assessment of the disease course by physicians and patients indicates a slight subjectively perceived advantage of therapy with originals compared to biosimilars, which, however, is not confirmed when standardized scores are applied. A possible explanation for this might be a nocebo effect, which could be minimized by suitable communication strategies.
随着肿瘤坏死因子（TNF）α抑制剂的引入，炎症性风湿性疾病（IRD）的治疗发生了根本性变化。几种原本价格高昂的生物制剂现在可以以成本更低的生物类似药形式获得，消除了处方方面的重大障碍。
本研究调查生物类似药的可及性是否与IRD护理的改善相关。此外，还调查了医生和患者对生物类似药的主观接受度，并与可客观化的参数进行比较。
2014年至2019年巴伐利亚法定医疗保险医生协会的匿名理赔数据以及对患者和风湿病学家的纸笔调查构成了本研究的数据基础。
在观察期内，接受药物治疗的确诊患者比例从38.5%增至43.2%。此外，所开药物方面的护理也发生了变化。传统药物治疗总体下降，尤其是糖皮质激素处方从2014年的39.3%降至2019年的34.3%。同时，靶向治疗的比例从12.3%增至20.4%。首次使用生物改善病情抗风湿药物（bDMARD）之前的基础治疗中位持续时间从2014年的3.15年降至2019年的2.17年。
在三种生物类似药进入市场的观察期内，IRD患者的护理在数量和质量上均有所改善。生物类似药的市场份额也随之增加。尽管生物类似药总体接受度较高，但医生和患者对疾病进程的评估表明，与生物类似药相比，使用原研药治疗在主观感受上略有优势，然而，应用标准化评分时并未得到证实。对此的一种可能解释可能是反安慰剂效应，可通过适当的沟通策略将其降至最低。
