Staab Thomas R, Walter Miriam, Mariotti Nesurini Sonja, Dintsios Charalabos-Markos, Graf von der Schulenburg J-Matthias, Amelung Volker E, Ruof Jörg
Roche Pharma AG, Grenzach-Wyhlen, Germany.
Medical School of Hanover, Hanover, Germany.
Health Econ Rev. 2018 Sep 18;8(1):23. doi: 10.1186/s13561-018-0209-3.
According to the AMNOG act, the German Federal Joint Committee (G-BA) determines the additional benefit of new medicines as a basis for subsequent price negotiations. Pharmaceutical companies may withdraw their medications from the market at any time during the process. This analysis aims to compare recommendations in clinical guidelines and HTA appraisals of medicines that were withdrawn from the German market since the introduction of AMNOG in 2011.
Medications withdrawn from the German market between January 2011 and June 2016 following benefit assessment were categorized as opt-outs (max. 2 weeks after start of price negotiations) or supply terminations (during or after further price negotiations). Related guidelines were systematically analyzed. For all withdrawals, therapeutic area, additional benefit rating and recommendation status in relevant clinical guidelines were assessed.
Among 139 medications, 10 opt-outs and 12 supply terminations were identified. Twenty-one out of 22 withdrawn medicines (95%) received 'no additional benefit' appraisal by the G-BA (average 'no additional benefit' rating for all AMNOG products: 47%). Of the 22 medicines, 15 (68%) were recommended by at least one guideline at the time of benefit assessment and 18 (82%) on 1 June 2016. Heterogeneity among guidelines was high. Acceptance of clinical trial endpoints was different between G-BA appraisals and clinical guidelines.
Our analysis revealed considerable differences across clinical guidelines as well as between clinical guidelines and HTA appraisals of the medicines that were withdrawn from the German market. Better alignment of the clinical perspective and close collaboration between all involved parties is required to achieve and maintain optimization of patient care.
根据《德国药品市场改革法》（AMNOG），德国联邦联合委员会（G-BA）确定新药的额外效益，作为后续价格谈判的基础。在这一过程中，制药公司可随时将其药物撤出市场。本分析旨在比较自2011年引入AMNOG以来从德国市场撤出的药物在临床指南和卫生技术评估（HTA）中的建议。
将2011年1月至2016年6月期间在效益评估后从德国市场撤出的药物分为主动退出（价格谈判开始后最多2周）或供应终止（在进一步价格谈判期间或之后）。对相关指南进行系统分析。对于所有撤出的药物，评估其治疗领域、额外效益评级以及在相关临床指南中的推荐状态。
在139种药物中，确定了10种主动退出和12种供应终止的药物。22种撤出药物中有21种（95%）被G-BA评估为“无额外效益”（所有AMNOG产品的平均“无额外效益”评级：47%）。在这22种药物中，15种（68%）在效益评估时至少被一项指南推荐，18种（82%）在2016年6月1日被推荐。指南之间的异质性很高。G-BA评估与临床指南对临床试验终点的接受程度不同。
我们的分析显示临床指南之间以及临床指南与从德国市场撤出药物的HTA评估之间存在显著差异。需要更好地协调临床观点并让所有相关方密切合作，以实现并维持患者护理的优化。
