Peter Rabbit is a Badger in Disguise: Deconstructing the Belief System of the Institute for Clinical and Economic Review in Health Technology Assessment

2022

F1000Res

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: Implications For Icer-modelled Claimsmentioning

confidence: 99%

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

2022

F1000Res

“…1 – 4 Central to these critiques has been the disregard by ISPOR/ICER of the standards of normal science where value claims must be credible, evaluable and replicable. 5 Add to this disregard of the standards of normal science is the mathematically impossible quality adjusted life year (QALY); ignoring the fact that the multiattribute preference scores are simply composite ordinal scores rather that the single attribute bounded ratio measure that you require to construct a QALY. 6 The preference scores in turn lack dimensional homogeneity and construct validity.…”

Section: Introductionmentioning

confidence: 99%

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

2022

F1000Res

One of the more unfortunate features of health technology assessment is the tenacity with which leaders in the field and organizations such as the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Institute for Clinical and Economic Review (ICER) cling to an evaluation framework that fails to meet the standards of normal science. Believers subscribe to a meme that is clearly non-science (metaphysics and pseudoscience) and one that should have been discarded over 30 years ago. Certainly, subscribing to an impossible belief is not unusual; indeed it may make the belief that much stronger. Yet the meme is non-sustainable; it is also pointless as the economic evaluation claims are non-evaluable. There is no acknowledgement of the standards of normal science or the limitations imposed by the axioms of fundamental measurement. The purpose of this commentary is to make the case that the recent release of the Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 22) checklist is misleading; CHEERS 22 fails to address the manifest deficiencies in the approach to economic evaluations endorsed by ISPOR and ICER. Instead, it continues to promote economic evaluations in healthcare that invent evidence and non-empirically evaluable value claims. Given the widespread publicity that has accompanied the release of CHEERS 22, the purpose of this commentary is to detail the deficiencies in CHEERS 22 and propose an alternative framework for economic evaluation in health care to meet the information needs of formulary committees. This means abandoning the standards for economic evaluations that have dominated health technology assessment for 30 years, notably the key role assigned to the mathematically impossible quality adjusted life year (QALY). The proposed new start recommends single attribute evaluable value claims that meet ratio or interval measurement standards and are supported by evaluation protocols.

“…The release on 4 November 2021 of the final evidence report by the Institute for Clinical and Economic Review (ICER) for tezepelumab (Tezspire; Amgen and Astra Zeneca) in severe asthma is critically examined in this commentary regarding the creation of imaginary evidence for cost-effectiveness and the consequent recommendations for a social Health Benefit Price Benchmark (HBPB) 1 . As detailed in previous commentaries and in submissions to ICER on previous evidence reports, the ICER reference case requirements for modelled comparative claims fail the standards for normal science 2 3 4 . Assumption driven simulation models produce just one of a potential multitude of tezepelumab models; none can claim superiority over the other in choice of assumption because claims from the past cannot support claims on an unknown future.…”

Section: Introductionmentioning

confidence: 95%

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.