Nothing to Cheer About: Endorsing Imaginary Economic Evaluations and Value Claims with CHEERS 22

2022

F1000Res

Self Cite

The current standards for health technology cost-effectiveness assessment rest on the creation of lifetime assumption-driven modeled simulations for imaginary pricing and consequent patient access recommendations. A recent BMJ paper reports a detailed assessment of 8,192 cost-effectiveness analyses, concluding that industry-sponsored modeled claims were more likely to publish incremental cost-effectiveness ratios (ICERs) below a USD 50,000 threshold than non-industry sponsored studies, supporting the claim that the product was cost-effective. This is unsurprising; indeed, the opposite can occur with a modeled claim deliberately resulting in ICER is excess of USD 50,000. This methodology is well entrenched with the recently published Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 guidance for creating imaginary cost-effectiveness modeled claims ensuring the opportunity for deliberately manipulated cost-effectiveness claims. This overlooks limitations imposed by fundamental measurement, rendering assumption-driven simulations redundant analytical exercises. Manipulation of ICERs and claims for cost-effectiveness are mathematically impossible; including cost-utility thresholds, because the preference or utilities supporting creation of quality-of-life years (QALYs) are ordinal scores. Nevertheless, with the promotion of CHEERS 2022, the belief in imaginary modeled value claims is both facilitated and reinforced. With CHEERS 2022, there is a concerted effort, largely in self-interest, to perpetuate the current belief system. This is a self-defeating strategy. Rather than admitting to the deficiencies of assumption-driven simulated imaginary claims, leaders are maintaining that health system decision makers can ignore standards of normal science and fundamental measurement in value claims for pharmaceutical products. This disregard of standards that are commonplace in the sciences and mainstream social sciences perpetuates the opportunity for self-serving modeled claims; where models are a marketing vehicle leading to sponsored systematic bias in formulary submissions. This supports the need for a NEW START paradigm for health technology assessment, focusing on evaluable single-attribute value claims, meeting the required standards for normal science and fundamental measurement.

Section: The Price Of Failurementioning

confidence: 99%

Section: New Start Paradigmmentioning

confidence: 99%

Section: New Start Paradigmmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Facilitating bias in cost-effectiveness analysis: CHEERS 2022 and the creation of assumption-driven imaginary value claims in health technology assessment

2022

F1000Res

Self Cite

“…Value claims for pharmaceutical products and devices can only be understood if we are clear about the standards that must be applied in the development, application and evaluation of instruments to capture response to therapy within disease and therapy areas 1 . Certainly, within this potential profile of value claims, patient-centric value claims can play a key role in informing decision makers; but these must not be seen in isolation from the purely clinical claims for a product or device and impact claims in terms of drug utilization and other elements of resource utilization.…”

Section: Introductionmentioning

confidence: 99%

Evidentiary Standards for Patient-Centered Core Impact (PC-CIS) Value Claims

2022

Innov Pharm

Proposals for a patient centered core impact set (PC-CIS) are of little relevance to formulary and health system decisions, let alone patients and providers, unless the elements included in the data set meet the standards of normal science and fundamental measurement. Adhering to these standards will have the effect of focusing on the adequacy of proposed core impact measures, with a filter in place to accept only those that meet the standards not only of the physical sciences but also mainstream economics. and health economics. Fortunately, we are well aware of what the criteria for acceptance and rejection of the core impacts within disease states should be in terms of their required attributes and their relevance for supporting evaluable value claims, notably for patient reported outcomes, Rasch or modern measurement theory. Care must be taken to delineate the core impact elements: separately identifying those that are purely clinical from core patient centric impacts, which is turn should be separated from impacts defined in terms of drug utilization and resource utilization. The purpose of this brief commentary is to set out the required standards for core impact patient-centric value claims and the framework for evaluating those claims. The critical issue for patient-centered core impacts is to recognize the constraints imposed by the standards of fundamental measurement for target patient populations within disease areas; unless these constraints are recognized we will fail. The leads to the role of Rasch or modern measurement theory calibration as the framework for patient centric measures of latent traits or attributes. From these perspectives PC-CIS is premature; until we have agreed standards for measurement for the impact or outcomes for clinical, patient-centric and resource utilization as a core set of disease specific instruments, it seems pointless to push forward to a wider scope when the present evidentiary foundation is so weak.

Mapping Impossible Utilities: The ICER Report on Tezepelumab for Severe Asthma

2022

Innov Pharm

The focus of this commentary is on the attempt to create EQ-5D-3L ordinal preferences from a disease specific asthma questionnaire, the Asthma Quality of Life Questionnaire (AQLQ). The question is whether it is possible from the perspective of fundamental measurement to create a simple linear algorithm to map AQLQ scores to EQ-5D-3L preferences. It is proposed that this is mathematically impossible as the aggregate AQLQ score is ordinal, apart from the fact that the AQLQ is a multiattribute score that lacks construct validity and any pretense to having interval properties. Disallowing the mapped utilities means that the modelling cannot be sustained. It is proposed that the focus should be on single attribute measures of the latent construct “need fulfillment quality of life”. These measures would meet the required standards of Rasch Measurement Theory (RMT) applying simultaneous conjoint standards of measurement theory, as well as capturing the patient voice.