Beinlich Peggy, Müller-Berghaus J, Sudhop T, Vieths S, Broich K
Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Deutschland,
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2015 Mar;58(3):227-31. doi: 10.1007/s00103-014-2108-z.
The early benefit assessment of newly approved drugs with new active substances or new applications that came into force on 1 January 2011 still presents a challenge to the parties involved. This article highlights the interplay between drug marketing approval and early benefit assessment. The constellation of a European, and even an international, largely harmonized, drug authorization process, with a mostly nationally regulated drug reimbursement situation causes inevitably friction, which could be reduced through joint advice discussions during the planning phase for pivotal studies. In 2013, the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI) provided 439 scientific advice procedures, compared with 98 advice meetings held at the Federal Joint Committee (G-BA), for 12 of which the BfArM or PEI provided written advice. The numbers of advice meetings held at the G-BA are increasing; however, the national competent authorities are involved in only a fraction of these. From the perspective of the national competent authorities, prompt and consistent involvement in the advice procedures regarding early benefit assessment would be useful and desirable.
对于2011年1月1日生效的具有新活性物质或新适应症的新批准药物进行早期效益评估，对相关各方而言仍是一项挑战。本文着重介绍了药品上市许可与早期效益评估之间的相互作用。欧洲乃至国际层面在很大程度上协调统一的药品授权程序，与大多由各国自行监管的药品报销情况，必然会产生摩擦，而在关键研究的规划阶段通过联合咨询讨论可以减少这种摩擦。2013年，联邦药品和医疗器械研究所（BfArM）及保罗·埃利希研究所（PEI）提供了439次科学咨询程序，相比之下，联邦联合委员会（G-BA）召开了98次咨询会议，其中12次会议BfArM或PEI提供了书面建议。G-BA召开的咨询会议数量在增加；然而，国家主管当局仅参与了其中的一小部分。从国家主管当局的角度来看，迅速且持续地参与早期效益评估的咨询程序将是有益且必要的。
