Langley Paul C
College of Pharmacy, University of Minnesota.
Innov Pharm. 2018 Apr 17;9(2):1-5. doi: 10.24926/iip.v9i2.1300. eCollection 2018.
The Institute for Clinical and Economic Review (ICER) announced at the end of March 2018 that it proposed to share executable draft economic models with relevant drug manufacturers during ICER evidence reviews. Taken at face value, ICER is offering manufacturers and other interested parties the possibility of a greater involvement in the assessment of modeled claims for product pricing. The purpose of this commentary is to point to the obvious limitations to this policy and to raise questions as to the extent to which ICER is willing to commit to transparency in the creation of modeled claims. While a commitment to greater transparency is to be welcomed, the fact remains that the ICER methodology does not meet the standards of normal science. ICER modeled claims not only lack credibility but are impossible to evaluate or replicate in treating environments. In proposing greater transparency ICER runs the risk of undermining its own credibility. If manufacturers have the opportunity to generate alternative models which create alternative claims, then ICER runs the risk of its pole position in health technology assessment being questioned. Rather than focused on non-evaluable lifetime modeled claims, there is the opportunity for ICER to reject its current business model, accepting instead a modelling paradigm that is consistent with the standards of normal science.
临床与经济评论研究所(ICER)于2018年3月底宣布,它提议在ICER证据审查期间与相关药品制造商分享可执行的经济模型草案。从表面上看,ICER为制造商和其他利益相关方提供了更多参与产品定价模型化主张评估的可能性。本评论的目的是指出该政策的明显局限性,并质疑ICER在创建模型化主张时愿意在多大程度上致力于透明度。虽然对更高透明度的承诺值得欢迎,但事实仍然是,ICER的方法不符合常规科学的标准。ICER的模型化主张不仅缺乏可信度,而且在治疗环境中无法评估或复制。在提议提高透明度的过程中,ICER冒着损害自身可信度的风险。如果制造商有机会生成产生替代主张的替代模型,那么ICER在卫生技术评估中的领先地位就有被质疑的风险。ICER有机会摒弃其当前的商业模式,转而接受一种符合常规科学标准的建模范式,而不是专注于不可评估的终身模型化主张。