Post-Menopausal Quality of Life Claims: Overlooking the Requirements of Normal Science and Fundamental Measurement in ICER'S Cost-Effectiveness Assessment of Fezolinetant for Moderate to Severe Vasomotor Symptoms.

One of the signal failures in health technology assessment is the absence of consideration given, not only to the standards of normal science, but to those of fundamental measurement. A recent evidence report by the Institute for Clinical and Economic Review (ICER) is emblematic of this failure. Based on a simple linear regression model that translates aggregate scores from the ordinal Menopause-specific Quality of Life Questionnaire (MENQOL) to the ordinal EuroQol EQ-5D-5L, ICER has applied these scores to an assumption driven model simulation to produce preferences, QALYs and incremental cost-per-QALY claims for fezolinetant for moderate to severe symptoms associated with menopause. Unfortunately, the attempt to crosswalk multidimensional or multiattribute ordinal scores is mathematically impossible. The 'created' EQ-5D-5L preferences are, as a result, of no interest. The overall result is that the ICER modelled claims for cost-effectiveness fail the required standards for normal science and fundamental measurement. fundamental are impossible. This is unfortunate, although it might be possible to assess certain domains of the MENQOL for their approximation to an interval score with the application of the Rasch Rating Scale Model, this will not support quality of life claims. A preferred approach would be to consider an alternative latent trait for quality of life in menopause, applying Rasch Measurement Theory (RMT), to develop a polytomous instrument that has the required measurement properties. The purpose of this commentary is to point out, as a number of previous commentaries have done, that this framework for creating assumption driven simulated modelled claims has no role in decisions for product assessment, access to formulary and pricing. This commentary expands upon these previous commentaries in placing RMT is the context of a needed paradigm shift to support the evolution of objective knowledge. This is critical if we are to understand, from the individual's perspective, not only an accurate assessment of the burden of menopause but to see this as part of an on-going research program that has to rely on fundamental measurement.

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. Rare disease, however stands apart: (i) the evidence base at product launch is limited; (ii) the therapy costs are often considered prohibitive; and (iii) the target patient population is small. At the same time, those seeking to implement an evidence-based engagement with health systems to support innovative rare disease interventions face a substantive technology assessment barrier. The focus in health technology assessment on assumption driven modeled cost-effectiveness simulations that support imaginary recommendations for cost-effective pricing and access is, however, an avoidable barrier. In the US, this barrier is the business model of the Institute for Clinical and Economic Review (ICER) and one endorsed by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Rare disease can be better served with other tools at our disposal with a proposed new start analytical framework in health technology assessment. The purpose of this brief note is to make the case that this proposed new start focused on single attribute value claims that meet the standards of normal science and fundamental evidence can not only dispense with the ICER imaginary modeling but, with a new start formulary submission package, integrate value claims with assessment protocols to set the stage for effective outcome-based contracting as the default standard for future payer negotiations.

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., it must support multiplication). Multiattribute utility scores (e.g. those generated by the EQ-5D-5L) fail to meet this standard. The multiattribute instruments produce ordinal scores that lack a true zero and they generate negative values. The manifest deficiencies of multiattribute utility instruments render them unfit, not only as a measure of therapy response but also in generating QALY claims. After 30 years of belief in their use, utilities and QALYs are clearly analytical dead ends. The purpose of this commentary is to demonstrate a coherent way forward in health technology assessment by focusing, not on clinical attributes as surrogates for quality of life, but on measures that are based on a conceptual model describing patient value in terms of need-fulfilment. Building on an extensive, yet often overlooked literature, need-based measures that fit Rasch Measurement Theory criteria are converted from ordinal scores to interval scores to evaluate response to therapy. These measures meet the requirements of single attribute fundamental measurement which is the standard in the physical sciences. It is proposed that a translation from a Rasch interval scale (defined by logits) can be transformed to a bounded ratio scale. Need based Quality of Life (N-QOL) scales bounded by 0 (where no needs are fulfilled) to 1 (where all needs are fulfilled) form such scales. The N-QOL supports the full range of arithmetic operations. Multiattribute utilities and mathematically invalid QALYs can be put to one side as unfortunate historical curiosities in favor of a disease or target population specific N-QOL scale. Such a scale has the required properties to evaluate disease specific response to therapy This can also support N-QOL adjusted life years with a need- fulfillment life year (NALY) metric with ratio properties.

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. It has been labeled pseudoscience. Yet ICER persists in its belief that all preference scales have ratio properties. ICER believes it can disregard these standards, notably in respect of the axioms of fundamental evidence, and continue its technology assessment activities. Challenging a belief system is not undertaken lightly, although in the case of ICER the belief system is built on such shaky foundations that the effort seems almost superfluous. This deeply held belief, shared apparently by the majority of health economists according to ICER, that all preference scores have ratio properties with a true zero, is easily overturned: if it has ratio properties how is it that preferences scores have been known for over 30 years to recognize health states worse than death? In other words, they can have negative preferences. Recognizing this manifest contradiction is important because it brings into relief the wider belief system of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) who share the same mythical certainties. A key issue is one of cultural relativity: can we accept with equanimity the parallel existence of two belief systems in health technology assessment when one is clearly nonsense? The answer proposed here is clearly no; although unfortunately the blowback by ICER and ISPOR will ensure the survival at least in the near term of their unfortunate meme.

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. 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.

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. Unfortunately, from the available evidence, it seems clear that many formulary assessment groups, last but not least those for whom the ICER modeling claims are targeted, have little if any appreciation of the limitations of ICER modeling. There are two substantive issues: (i) a failure to appreciate the limitations imposed by the standards of normal science for credible, empirically evaluable and replicable product claims and (ii) an understanding of limitations imposed by the axioms of fundamental measurement. In the latter case, a failure to recognize that the quality adjusted life year (QALY) is an impossible mathematical construct (hence the I-QALY). To these limitations should be added the potential for constructing competing imaginary claims. Surprisingly, ICER has provided the ideal opportunity to construct competing claims with the launch in late 2020 of the ICER Analytics cloud platform. Formulary committees and other health decision makers should be aware that claims based on the ICER Analytics platform together with competing lifetime modelled claims all fail the standards of normal science. Factoring these into formulary decisions is not only misguided but may have unintended consequences for pricing and access that may disadvantage significantly patients and caregivers. We have spent too much time debating the merits or otherwise of the I-QALY for targeted patient groups with the parties failing to recognize that the focus on simulated cost-per-I-QALY value assessments is a mathematical folly; I-QALY claims are a chimera. The I-QALY, at long last, should be abandoned together with modelled lifetime simulations. Medicaid formulary decision makes should rethink the required evidence base for formulary decisions and negotiations. Care should be taken to revisit previous negotiations where ICER recommendations have been utilized to support pricing and access.

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. The purpose of this commentary is provide a critical examination of this practice in recommendations for atopic dermatitis.

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.

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 Innovations in Pharmacy 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. ICER is fully aware of the fact that it fails these standards, yet perseveres. It justifies its cost-per-QALY framework by maintaining3, through unsubstantiated assertions, that it meets standards for scientific credibility; it denies the possibility of negative values and utilities which undercut completely the construction of QALYs. This is nonsense: not only does the ICER framework fail those standards, to include axioms of fundamental measurement, but also a simple rule of logic in basing its models on assumptions. ICER dogmatic adherence to simulation modeling is evidence in its latest report on multiple myeloma. The report is a charade; but unfortunately not one that is rejected by Bristol-Myer Squibb, GlaxoSmithKline, Sanofi and Amgen. Their responses to the draft evidence report points to their acceptance of imaginary simulation constructs to drive pricing decisions. Whether this reflects their unqualified acceptance of the imaginary simulation modelling to create evidence or a failure to appreciate the standards of normal science is unclear. Certainly, in this case they fail to recognize the devastating impact of believing in the use of the EQ-5D-5L preferences to create imaginary or I-QALYs. The question raised in this commentary is whether the willingness to accept the ICER analytical framework reflects a belief in the role of creating evidence, ICER style, or a willingness to accept ICER imaginary conclusions as the easy way out in negotiating prices with insurers and other payers. Accepting ICER imaginary constructs is an analytical dead end that will stifle the discovery of new facts. The question is: so what?

Measurement, modeling and QALYs.

Over the past 30 years, a mainstay of health technology assessment has been the creation of modeled incremental cost-per-quality adjusted life year (QALY) claims. These are intended to inform resource allocation decisions. Unfortunately, the reliance on the construction of QALYs from generic utility scales is misplaced. Those advocating QALY-based lifetime modeled claims fail to appreciate the limitations placed on these constructs by the axioms of fundamental measurement. Utility scales, such as those created by the EQ-5D-3L instrument, are nothing more than multidimensional, ordinal scales. Such scales cannot support basic arithmetic operations. Interval scales can support addition and subtraction; ratio scales the further operations of multiplication and division. Those who advocate the construction of QALYs fail to appreciate that such an operation is only possible if the utility scale is unidimensional and has ratio properties with a true zero. The utility measures available do not meet these requirements. As we cannot produce meaningful utility values, the QALY is an invalid construct. Consequently, cost-per-incremental QALY claims are impossible to sustain and the application of cost-per QALY thresholds meaningless. As utility is a latent, unidimensional variable, the best a measure of utility could achieve would be unidimensionality and interval scaling properties. Where such measures are available, they could support claims for response to therapy. Consequently, there would be no need to continue constructing imaginary lifetime value assessment frameworks. Admitting that the QALY is a fatally flawed construct means rejecting 30 years of cost-per-QALY models.

The National Pharmaceutical Council: Endorsing the Construction of Imaginary Worlds in Health Technology Assessment.

All too often, organizations embrace standards for health technology assessment that fail to meet those of normal science. A value assessment framework has been endorsed that is patently in the realm of pseudoscience. If a value assessment framework is to be accepted, then claims for the value of competing products must be credible, evaluable and replicable. If not, for example, when the assessment relies on the construction of an imaginary lifetime incremental cost-per-quality-adjusted-life-year (QALY) world, then that assessment should be rejected. Such an assessment would fail one of the central roles of normal science: the discovery of new facts through an ongoing process of conjecture and refutation where provisional claims can be continually challenged. It is no good defending an endorsement of a value framework that fails expected standards on the grounds that it has been endorsed by professional groups and reflects decades of development. This is intellectually lazy. If this is the case, then the scientific revolution of the 17th century need not have happened. The purpose of this commentary is to consider the recommended standards for health technology assessment of the National Pharmaceutical Council (NPC), with particular reference to proposed methodological standards in value assessment and the commitment to mathematically impossible QALYs.

Pharmacoeconomic Evaluations: Guidelines for Drug Purchasers.

OBJECTIVE: To propose a set of guidelines for use by health care organizations in the United States that seek useful, comparative clinical information and economic analysis on pharmaceutical products to make sound drug purchasing decisions. PRACTICE INNOVATION: Based on a therapy intervention approach, the guidelines provide a structured framework to help managed care purchasers become more consistent in how they evaluate drug products for inclusion in the formulary. The guidelines factor in the need to examine the impact of new drug products on overall costs within the entire health system. PRACTICE SETTING: Intended for use by managed care organizations in the U.S. that purchase prescription drugs. INTERVENTION: Not applicable. MAIN OUTCOME MEASURE: Not applicable. RESULTS: The guidelines provide MCOs with a new systematic approach for identifying the overall cost and clinical outcomes impact of drug therapies. The guidelines are designed to take into account the characteristics of the patient population being treated and the fact that patients generally are redistributed among different treatment categories once a new drug product is introduced, thus offering MCOs an analysis model that extends beyond the traditional partial cost-outcomes approach. Emphasis is placed on looking at the cost-outomes impact of a new drug or therapy within a systems or disease area framework in which the redistribution of patients between therapy options is explicitly modelled. The guidelines specify that the following information elements be used in pharmacoeonomic analysis: product description, place in therapy, comparator products, therapy intervention framework, supporting clinical data, supporting pharmacoeconomic data, system impact assessments-costs-outcomes, overall assessment, and bibliography and supporting materials.

Value Assessment in Cystic Fibrosis: ICER's Rejection of the Axioms of Fundamental Measurement.

One of the features of the ICER stakeholder involvement in the development of ICER evidence reports is the ability for public comment. Unfortunately, and this may just a miscommunication, the replies from ICER to public comments frequently miss the point or fail to provide backup for their claims. The purpose of this commentary is to review ICER's responses to public comments by the author on the just released final evidence report on cystic fibrosis. The message is quite simple: the ICER value assessment framework lacks credibility. It fails to meet the standards of normal science. This is seen in ICERs apparent ignorance or rejection of the axioms of fundamental measurement which point quite clearly to the mathematical impossibility of creating QALYs from generic multiattribute utility scores. The ICER report also fails standards by creating a model from prior assumptions; there is no logical basis for constructing a value assessment claim. Either ICER should withdraw its value claims or admit the dubious basis on which the model is built, as a duty to its readership.

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. This commitment to pseudoscientific claims, embracing intelligent design rather than natural selection, is endorsed by professional groups such as ISPOR as well as by self-appointed arbiters of value assessment such as ICER. Perhaps the answer is peer pressure rather than ignorance of the axioms of fundamental measurement. More to the point, if you have been an advocate of imaginary simulations a Damascene epiphany creates both psychological and professional challenges. After all, if cost-per-QALY constructs are rejected, then it is difficult to see what options there are for those attempting to model cost-effectiveness claims. If it is just ignorance of the axioms of fundamental measurement then a reasonable question is why these axioms, readily available on any number of internet sites, are ignored in health technology assessment programs. The purpose of this commentary is to review the ICER September 11th 2020 evidence report in ulcerative colitis, with particular reference to ICER's responses to questions raised in the public comment period on the measurement properties (or their absence) for utility scales; in this context the EQ-5D instruments. The critique pointed out that the utility scores had ordinal properties. ICER, without proof, disputed this statement asserting that health economists believed (or assumed) they were ratio scales. This is nonsensical. ICER has two options: first, to continue to believe that the EQ-5D instruments had ratio properties or second, to acknowledge that they indeed only had ordinal properties, rejecting their many modeled claims for pricing and access. Not surprisingly, the possibility of a Damascene epiphany was rejected. ICER maintained its assertion that health economists, presumably all of them, believe or possibly just assume for analytical convenience that the EQ-5D-3L and similar measures are in fact on a ratio scale. This introduces a new concept in fundamental measurement: a ratio scale without a true zero but with negative values. ICER is quite prepared to admit that negative I-QALYs are possible and their lifetime cost-per-incremental I-QALY modelling can yield negative I-QALYs.

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. As a result, current health technology assessment is dominated by value assessments that create claims that are neither credible, nor empirically evaluable or replicable. The fatal flaw is the failure to recognize that QALYS are an impossible mathematical construct (hence the term I-QALY). The proposed paradigm recognizes that if there are claims for product value then, regardless of whether the claim is for clinical impact, quality of life or resource utilization, all claims must be empirically evaluable. If not, then they should be rejected. The Minnesota guidelines propose a new evidence based approach to formulary assessment, together with ongoing disease area and therapeutic class reviews. The focus is on claims that are specific to target patient populations that are claims for specific attributes and are consistent with the axioms of fundamental measurement. Manufacturers are asked to support claims assessment through protocols detailing the evidence base for claims assessment, the timelines for those assessments and the process by which claims assessments are reported back to formulary committees. Value assessment leads naturally to value contracting, revisiting provisional prices as new information is discovered and delivered to the formulary committee.

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. 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.

Nonsense on Stilts - Part 1: The ICER 2020-2023 Value Assessment Framework for Constructing Imaginary Worlds.

Previous commentaries in the Formulary Evaluation section of INNOVATIONS in Pharmacy have pointed to the lack of credibility in modeled claims for cost-effectiveness and associated recommendations for pricing and access by the Institute for Clinical and Economic Review (ICER). The principal objection to ICER reports has been that their modeled claims fail the standards of normal science: they are best seen as pseudoscience. The purpose of this latest commentary is to provide a critique of the recently released ICER 2020 Value Assessment Framework (VAF). Although ICER has taken upon itself the pole position in health technology assessments and recommendations for product pricing in the US health care system, the incremental, lifetime cost-per-QALY modeling methodology should not be taken seriously. The creation of imaginary modeled worlds, built entirely from assumption, fails the demarcation test between science and pseudoscience. The ICER evidence reports are best seen as the health technology assessment equivalent of 'intelligent design' in counterpoint to 'natural selection'. It is surprising, therefore, that health care decision makers should take ICER's recommendations seriously as providing 'approximate information' for formulary decision making. What is not appreciated is that the claims made by ICER lack credibility, are impossible to evaluate and lack the ability to be replicated across treatment settings. Indeed, the models presented under the guise of a 'state of the art' value assessment were never intended to support evaluable claims. We have no idea and will never know if they are right or if they are wrong. ICER's position becomes even more untenable once the models presented are assessed in detail. Without in any way supporting the ICER methodology, it is worth noting that all too often ICER's claims for incremental QALYs in specific models are based upon what appears to be, from the limited evidence presented, a casual and ad hoc assemblage of utility scores from diverse constructs. This is a critical weakness given the role attributed by ICER to the modeled cost-per-QALY claims as central to ICERs imaginary value assessment. ICER also overlooks the fact that the utility scores it captures from the literature to populate its imaginary reference case world lack objectivity. They are ordinal rather than interval measures. To apply these manifest scores to time spent in a disease stage and then aggregate these over different disease stages is nonsensical. The critical issue is one of instrument development. The case made here is for the application of Rasch Measurement Theory (RMT) to construct a unidimensional instrument with interval properties, in this case from the needs fulfillment construct of quality of life (QoL). Unless an instrument meets RMT standards in its development, the logic of Rasch modeling to achieve fundamental measurement standards means that other scales are, by definition, ordinal. It is absurd to 'assume' they are interval. RMT is designed to create instruments to evaluate change and test hypotheses. In the absence of instruments that have RMT properties, the cost-per-QALY reference case modelling meme collapses. It is an analytical dead end. If we are to support a meaningful scientific program to discover new facts to support health care delivery and improve the lives of patients, caregivers and their families, then ICER should be put to one side.