Langley Paul C
College of Pharmacy, University of Minnesota.
Innov Pharm. 2021 Jan 20;12(1). doi: 10.24926/iip.v12i1.3606. eCollection 2021.
It has been noted on numerous occasions that modeled claims for cost-effectiveness, if driven by assumption for the lifetime of a hypothetical patient population, can be easily 'gamed' to create a required claim. These marketing exercises to support product entry are all too common in the literature. The institute for Clinical and Economic Review (ICER) in its launch of the ICER Analytics platform has provided a framework to support precisely these activities. Following the mainstream methodology in health technology assessment, the ICER Analytics platform facilitates the creation of approximate information to support formulary decisions. This is an odd development because it undercuts ICERs belief that it is the key arbiter in health technology assessment in the US, setting the stage for pricing and access recommendations. With the release of the ICER Analytics platform, others can now customize the 'backbone' ICER model in a disease area (i.e., change assumptions) to develop alternative and competing value assessments and 'fair' price claims. The problem is, of course, that without a reference point, there is no basis for comparing modeled claims other than through challenging assumptions. Indeed, ICER has made this easy by reducing barriers to lifetime model building so that manufacturers and others can create competing (and confusing) claims within, literally, a few minutes. ICER will then become one of a multitude of competing voices for the attention of formulary committees and other health decision makers; letting a thousand imaginary models bloom where no model can be judged on the basis of credible, empirically evaluable and replicable product claims.
多次有人指出,如果基于假设的虚拟患者群体的一生来模拟成本效益声明,那么这些声明很容易被“操纵”以得出所需的声明。在文献中,这些支持产品进入市场的营销手段屡见不鲜。临床与经济评论研究所(ICER)在推出ICER分析平台时,提供了一个框架来精准支持这些活动。遵循卫生技术评估的主流方法,ICER分析平台有助于创建近似信息以支持医保药品目录决策。这是一个奇怪的发展,因为它削弱了ICER认为自己是美国卫生技术评估关键仲裁者的信念,为定价和准入建议奠定了基础。随着ICER分析平台的发布,其他人现在可以在疾病领域定制ICER的“主干”模型(即改变假设),以开展替代性的、相互竞争的价值评估和“公平”价格声明。当然,问题在于,没有一个参考点,除了质疑假设之外,就没有比较模拟声明的依据。事实上,ICER通过降低构建终生模型的障碍,让制造商和其他人能够在几分钟内就创建出相互竞争(且令人困惑)的声明,从而使这变得轻而易举。ICER随后将成为众多争夺医保药品目录委员会和其他卫生决策者关注的声音之一;任由无数虚构模型竞相绽放,却没有一个模型能够基于可信的、可实证评估和可复制的产品声明来评判。