Münnch T
DIERKS + BOHLE Rechtsanwälte Partnerschaft mbB, Berlin, Germany.
Z Gastroenterol. 2016 Nov;54(11):1230-1232. doi: 10.1055/s-0042-117115. Epub 2016 Oct 10.
Biosimilars are subject to the efficiency evaluation according to section 106 Social Code Book Five (SGB V). The specific evaluation method influences the physician's prescription behaviour. In the case of an individual prescription limit evaluation (Richtgrößenprüfung), the prescription of biosimilars would usually not result in recourse but, as a start, in the initiation of the evaluation proceedings. Starting from 2017, the individual prescription limit evaluation will be cancelled. The active ingredient evaluation (Wirkstoffprüfung) expected instead at a regional level may provide for biosimilar to original drug ratios and result in recourses if these ratios are missed. First agreements on specific evaluation proceedings at a regional level are expected for this year.
生物类似药需根据《社会法典》第五卷第106条进行疗效评估。具体的评估方法会影响医生的处方行为。在进行个体处方限量评估时,生物类似药的处方通常不会导致追索,但一开始会启动评估程序。从2017年起,个体处方限量评估将被取消。取而代之的是预计在地区层面进行的活性成分评估,这可能会规定生物类似药与原研药的比例,若未达到这些比例则会导致追索。预计今年会就地区层面的具体评估程序达成首批协议。