PHARAO-Studie: Arzneimittelversorgung entzündlich rheumatischer Erkrankungen: Leitliniengerechte Versorgung mit Biologika folgt Verfügbarkeit von Biosimilars

BACKGROUND: 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. OBJECTIVE: 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. MATERIAL AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.