Langley Paul C
Adjunct Professor, College of Pharmacy, University of Minnesota.
Innov Pharm. 2020 Dec 10;11(4). doi: 10.24926/iip.v11i4.3585. eCollection 2020.
Understandably, after 30 years of ignoring the axioms of fundamental measurement, advocates of creating approximate information through the construction of lifetime cost-per-QALY worlds are somewhat unnerved by the realization that their methodology is incompatible with those axioms. This is made all the more unnerving when it is pointed out that this incompatibility was pointed out over 30 years ago, following the formalization of those axioms almost 80 years ago. Why this was overlooked is a mystery. The result was a commitment to the application of ordinal utility and other patient reported outcome measures to support claims for response to competing therapies; most egregiously, the advocacy of cost-per-QALY lifetime models and willingness to pay thresholds to support recommendations for pricing and access to pharmaceutical products and devices. Although this incompatibility has been pointed out in respect of simulation modeling, to groups such as the Institute for Clinical and Economic Review (ICER) they press on, producing evidence reports and recommendations for emerging products that fail the standards of normal science. While these are an analytical dead end, ICER has nowhere else to go. This is their business model; to admit otherwise would mean withdrawing their many evidence reports and admit they were wrong. ICER has rejected this; rather it has decided, together with its academic consultants, to challenge the axioms of fundamental measurement, to produce a parallel measurement universe that can sustain QALYs and the imaginary simulation lifetime models. The purpose here is to make clear that ICER is manifestly wrong and that there is no way it can maintain its credibility in pursuing this path. This is achieved by a deconstruction of the arguments put forward by ICER to defend its new vision of the axioms of fundamental measurement, a vision which provides a case study in the distinction between justified belief and opinion. Fortunately, we have the framework for a new paradigm in value assessment; a paradigm that recognizes the standards of normal science and rejects belief in an alternative reality consistent with fundamental measurement axioms.
可以理解的是,在忽视基本测量公理30年后,那些主张通过构建每质量调整生命年的终生成本世界来创建近似信息的人,在意识到他们的方法与这些公理不兼容时,多少有些不安。当有人指出这种不兼容性在大约80年前这些公理被形式化之后的30多年前就已被指出时,这就更加令人不安了。为何这一点被忽视是个谜。结果是致力于应用序数效用和其他患者报告的结局指标来支持关于对竞争性疗法反应的主张;最糟糕的是,倡导每质量调整生命年的终生模型以及支付意愿阈值,以支持对药品和器械定价及获取的建议。尽管在模拟建模方面已经指出了这种不兼容性,但对于临床和经济评论研究所(ICER)这样的团体来说,他们仍在继续推进,为不符合正常科学标准的新兴产品编写证据报告并提出建议。虽然这些是分析上的死胡同,但ICER别无他法。这就是他们的商业模式;否则就意味着撤回他们的许多证据报告并承认自己错了。ICER拒绝这样做;相反,它与学术顾问一起决定挑战基本测量的公理,构建一个能够维持质量调整生命年和虚构模拟终生模型的平行测量世界。这里的目的是明确指出ICER明显是错误的,并且它在这条道路上无法维持其可信度。这是通过解构ICER为捍卫其对基本测量公理的新观点而提出的论点来实现的,这种观点为合理信念与观点之间的区别提供了一个案例研究。幸运的是,我们有价值评估新范式的框架;这个范式承认正常科学的标准,并拒绝相信与基本测量公理一致的替代现实。