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      ICER, ISPOR AND QALYs: Tales of Imaginary Worlds

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          Abstract

          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 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 twofold: first, to review the latest report by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) on standards and value claims for modeling imaginary cost-per-quality life year(QALY) worlds in health technology assessments and (ii) given ICER’s commitment to ISPOR standards, to consider thecredibility of ICER’s QALYs. The concern is that ICER gives the impression that there is a common and agreed utility metric to support QALY constructs and that there is an agreed standard for creating QALYs within the imaginary reference case meme. The purpose of this commentary is to emphasize that there is no ‘gold standard’ QALY, let alone a ‘gold standard’ utility metric. A QALY is what you assume the QALY should be; it is an artificial construct which allows any number of competing QALYs to be generated for the same target population under different imaginary constructs. Similar objections apply to the application of willingness-to-pay thresholds to support ICER’s business case as the sole arbiter, in pole position, of health technology assessments to support pricing recommendations. In the US. A threshold has to be defined for the QALYs and costs captured, by assumption, within the model. Even for the same target patient population a $50,000 cost per QALY threshold will yield different pricing recommendations depending upon the assumptions driving the QALY estimate, such as choice of utility metric, time spent by stage of disease, frequency and severity of adverse events and costs. While this is an obvious point, it appears not to occur to those who, with a limited technical understanding of how the ICER model is constructed (and ICER is not given to extended technical explanations) take at face value the ICER imaginary construct and the QALY value judgements. Of course, it is also beside the point that the ICER reference case imaginary world was never intended to support empirical assessments of the claims made; we have no idea of whether it is right, if it is wrong and, over the lifetime perspective, we will never know and were never intended to know.

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          Most cited references38

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          Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine.

          Since publication of the report by the Panel on Cost-Effectiveness in Health and Medicine in 1996, researchers have advanced the methods of cost-effectiveness analysis, and policy makers have experimented with its application. The need to deliver health care efficiently and the importance of using analytic techniques to understand the clinical and economic consequences of strategies to improve health have increased in recent years.
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            The estimation of a preference-based measure of health from the SF-36.

            This paper reports on the findings of a study to derive a preference-based measure of health from the SF-36 for use in economic evaluation. The SF-36 was revised into a six-dimensional health state classification called the SF-6D. A sample of 249 states defined by the SF-6D have been valued by a representative sample of 611 members of the UK general population, using standard gamble. Models are estimated for predicting health state valuations for all 18,000 states defined by the SF-6D. The econometric modelling had to cope with the hierarchical nature of the data and its skewed distribution. The recommended models have produced significant coefficients for levels of the SF-6D, which are robust across model specification. However, there are concerns with some inconsistent estimates and over prediction of the value of the poorest health states. These problems must be weighed against the rich descriptive ability of the SF-6D, and the potential application of these models to existing and future SF-36 data set.
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              Recommendations of the Panel on Cost-effectiveness in Health and Medicine.

              To develop consensus-based recommendations for the conduct of cost-effectiveness analysis (CEA). This article, the second in a 3-part series, describes the basis for recommendations constituting the reference case analysis, the set of practices developed to guide CEAs that inform societal resource allocation decisions, and the content of these recommendations. The Panel on Cost-Effectiveness in Health and Medicine, a nonfederal panel with expertise in CEA, clinical medicine, ethics, and health outcomes measurement, was convened by the US Public Health Service (PHS). The panel reviewed the theoretical foundations of CEA, current practices, and alternative methods used in analyses. Recommendations were developed on the basis of theory where possible, but tempered by ethical and pragmatic considerations, as well as the needs of users. The panel developed recommendations through 2 1/2 years of discussions. Comments on preliminary drafts prepared by panel working groups were solicited from federal government methodologists, health agency officials, and academic methodologists. The panel's methodological recommendations address (1) components belonging in the numerator and denominator of a cost-effectiveness (C/E) ratio; (2) measuring resource use in the numerator of a C/E ratio; (3) valuing health consequences in the denominator of a C/E ratio; (4) estimating effectiveness of interventions; (5) incorporating time preference and discounting; and (6) handling uncertainty. Recommendations are subject to the ¿rule of reason,¿ balancing the burden engendered by a practice with its importance to a study. If researchers follow a standard set of methods in CEA, the quality and comparability of studies, and their ultimate utility, can be much improved.
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                Author and article information

                Journal
                Innov Pharm
                Innov Pharm
                UMLP
                Innovations in Pharmacy
                University of Minnesota Libraries Publishing
                2155-0417
                31 October 2019
                2019
                : 10
                : 4
                : 10.24926/iip.v10i4.2266
                Affiliations
                Adjunct Professor, College of Pharmacy, University of Minnesota
                Author notes
                Corresponding author: Paul C Langley, PhD, Adjunct ProfessorCollege of Pharmacy, University of Minnesota, Minneapolis MN, Director, Maimon Research LLC; Tucson, AZ, Email: langley@ 123456maimonresearch.com
                Article
                jUMLP.v10.i4.pg10
                10.24926/iip.v10i4.2266
                8051886
                97f49e73-dddc-4612-9aad-f6a0458432cd
                © Individual authors

                This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial License, which permits noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Categories
                Commentary
                Formulary Evaluations

                icer,ispor,utility metric options,qaly options,imaginary worlds,pseudoscience,imaginary assumptions

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