Beyond Just Talking Strategy: Using Gaming Simulations to Catalyze Airline Managers' Buy-in to Novel Strategies that Can Shape or Adapt to Profit Cyclicality.

This empirical qualitative study explores the role of gaming simulations in catalyzing changes to organization-wide management's perspectives on a novel strategy for aircraft orders and retirements. A large US airline developed the new strategy to tackle the pervasive problem of profit cyclicality, driving poor average profit performance across the cycle. Based on the dynamic model used to develop the strategy with senior management, a gaming simulation workshop was designed and delivered in groups of 20 to over 200 organization-wide managers.

Rasch Measurement and Patient Reported Value Claims: A Primer for Hemophilia.

This commentary proposes that Rasch Measurement Theory (RMT) is an innovative method for assessments of patient-centric therapy response in hemophilia A and B, as they are in other disease states or target patient populations. RMT is a necessary and sufficient approach to moving from ordinal observations to interval measurement, which has arithmetic properties. This applies across the board in hemophilia and other disease states for clinical value claims, patient centric or subjective value claims as well as those for anticipated drug utilization and other medical care resources.

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

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.

Concerns with Patient Reported Outcome Measurement and Value Claims for Therapy Response: The Case of Mavacamten and Symptomatic Hypertrophic Cardiomyopathy (SHCM).

Fundamental measurement is the basis for a rational assessment of patient reported outcome (PRO) value claims; both as response to therapy and the submission of credible and evaluable value claims to formulary committees and other health system decision makers. It is important to emphasize the importance of creating interval and ratio scales as opposed to nominal and ordinal scales to support value claims; a recognition that follows from acceptance of conjoint simultaneous measurement and the contribution of Rasch or modern measurement theory (RMT). Failure to appreciate the role of RMT has led thousands of researchers simply to apply numerals to events, inappropriately applying the techniques of classical statistical analysis, with the result that all that is produced are ordinal PRO scores.

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

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.

Formulary Submissions: Value Claims, Protocols and Outcomes Based Contracting in Rare Disease.

Outcomes based payments contracting is in its infancy. The increased attention being given to rare disease place a premium on the ability to engage with payers to ensure that there is an analytical framework relevant to value claims contracting. Rare disease is not, of course, alone; many other chronic disease states may be suitable candidates and have been over the past 10 years or more.

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

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 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.

A Critical Examination for the Pricing of Eculizumab and Efgartigimod in Myasthenia Gravis.

The purpose of this commentary is to focus on the downside of assumption-driven simulation modeling, the potential creation of a multitude of competing models, the mathematically impossible quality adjusted life year (QALY) and the failure to observe the axioms of fundamental measurement in mapping ordinal EQ-5D-5L preferences from the ordinal Quantitative Myasthenia Gravis (QMG) score. A second aspect of this commentary is to propose standards that should be set for the creation and evaluation of value claims in health technology assessment, in particular need fulfillment quality of life (QoL), that meet the demarcation test to distinguish science from non-science. The result is that the present ICER pricing claims for eculizumab and efgartigimod in myasthenia gravis should not be applied without consideration of more relevant evidence.

A Critical Examination of Simulation Pricing and Access Recommendations for Atopic Dermatitis.

It has been demonstrated conclusively that value and utility preference scores have only ordinal properties. This means, as has been pointed out on numerous occasions, that the quality adjusted life year (QALY) is a mathematically impossible construct. The implications are profound: Some 30 years of health technology assessment is called into question due to a failure to recognize the well-documented limitations imposed by the axioms of fundamental measurement.

Supping with the Devil: Belief and the Imaginary World of Multiple Myeloma Therapies Invented by the Institute for Clinical and Economic Review.

Previous commentaries in and other peer reviewed journals have made the case that the analytical framework, if that is not too strong a term, to support pricing and access recommendations endorsed by the Institute for Clinical and Economic Review (ICER) fails to meet the standards of normal science. By any criteria the ICER analysis is best described as pseudoscience; it fails the demarcation test between biological evolution and intelligent design. Like intelligent design it has its believers; a meme for all seasons.

Abandoning Eugenics and the QALY.

Should decision making in health care, notably in respect of the allocation of resources between individuals and disease states, rest on notions of the burden of disease and denial of care as assessed by societal evaluations or on the extent to which the need of patients and caregivers is fulfilled. The prospect of the denial of health care, for those deemed 'unworthy' has a long history in the eugenics movement. Many have assumed that this 'utilitarian aberration' has long been discredited.

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

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.

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

The Institute for Clinical and Economic Review (ICER), a Boston-based consulting group, has seen itself as the lead organization in the US for evaluating pharmaceuticals and, at product launch, making recommendations for pricing and access. Previous commentaries in Innovations in Pharmacy have made the case that the ICER analytical framework is nonsensical. It abandons the standards of normal science in favor of inventing evidence through unsupported assertions regarding measurement properties and lifetime assumption driven simulations.

Fundamental Outcome Measurement: Selecting Patient Reported Outcome Instruments and Interpreting the Data they Produce.

Over the past 40 years literally thousands of generic and disease specific patient reported outcome (PRO) instruments have been developed. While most were developed for a specific study and were never used again, there is still the question of how manufacturers and others should select a PRO instrument for a study. These studies may be clinical pivotal trials or observational tracking studies to support therapy response.

Fundamental Measurement: The Need Fulfilment Quality of Life (N-QOL) Measure.

The quality adjusted life year (QALY) has serious problems related to its failure to adhere to measurement theory. If a QALY is to be meaningful, the utility score that translates time spent to an equivalent time spent in so-called perfect health must have ratio properties (i.e.

Medicaid Formulary Decisions and the Institute for Clinical and Economic Review: Abandoning Pseudoscience in Imaginary Pharmaceutical Pricing Claims.

Medicaid formulary committees and other gatekeepers face a difficult task. On the one hand they can utilize technical expertise in evaluating the real world evidence for clinical, quality of life and resource utilization claims for competing products while on the other hand they may be asked to assess claims built by simulation models for pricing and product access. A common option has been to take modeled claims from third parties such as the Institute for Clinical and Economic Review (ICER) at face value without challenging the model structure, its assumptions and its incremental cost-per-QALY claims set against competing products or the existing standard of care.

Let a Thousand Models Bloom: ICER Analytics Opens the Floodgates to Cloud Pseudoscience.

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.

To Dream the Impossible Dream: The Commitment by the Institute for Clinical and Economic Review to Rewrite the Axioms of Fundamental Measurement for Hemophilia A and Bladder Cancer Value Claims.

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.

Value Assessment, Real World Evidence and Fundamental Measurement: Version 3.0 of the Minnesota Formulary Submission Guidelines.

This latest version of the Minnesota guidelines is intended to reassert the application of the standards of normal science in formulary submissions for new and existing pharmaceutical products and devices. This represents a paradigm shift from the existing value assessment standards which are focused on imaginary or I-QALY modeling of lifetime claims. The proposed new paradigm rejects this as pseudoscience; a failure to recognize the standards of normal science, in particular a failure to recognize the constraints of fundamental measurement.

The Great I-QALY Disaster.

The QALY is an impossible construct; it defies common sense. It fails completely once we consider the axioms of fundamental measurement. Utilities as ordinal scales cannot be used to create QALYS.

The Impossible QALY and the Denial of Fundamental Measurement: Rejecting the University of Washington Value Assessment of Targeted Immune Modulators (TIMS) in Ulcerative Colitis for the Institute for Clinical and Economic Review (ICER).

All too often organizations embrace standards for health technology assessment that fail to meet the standards of normal science. A continuing puzzle is why the axioms of fundamental measurement are ignored by researchers such as the University of Washington Model Group in constructing lifetime cost-per-QALY claims. The University of Washington Model Group is not alone; it is an accepted article of faith that multiattribute utility scales can be manipulated as if they had ratio scale properties, which they do not.

More Unnecessary Imaginary Worlds - Part 4: The ICER Evidence Report for Crizanlizumab, Voxelotor and L-Glutamine for Sickle Cell Disease.

A number of commentaries have been published over the past 4 years by the present author on the manifest flaws in the reference case value assessment framework of the Institute for Economic and Clinical Review. The recent release of the evidence report on sickle cell disease continues ICER's commitment to what has been described as the creation of imaginary worlds to support value assessment. The purpose of the present commentary is to continue the critiques that have been presented for earlier evidence reports.