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Paul C Langley - One of the best experts on this subject based on the ideXlab platform.
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more unnecessary Imaginary Worlds part 2 the icer evidence report on modeling oral semaglutide for type 2 diabetes
Innovations in pharmacy, 2020Co-Authors: Paul C LangleyAbstract:On 9 December2019, the Institute for Clinical and Economic Review (ICER) released its final evidence report to establish the value of oral semaglutide (Novo Nordisk) for Type 2 diabetes (T2DM). A key element in this report was the development of a lifetime cost effectiveness microsimulation model based on a small sample of NHANES diabetes respondents. The model contrasted oral semaglutide added to current antihyperglycemic treatment for T2DM. The purpose of the model was to estimate outcomes that included life years (LYs) gained, an estimate of equal value life years gained (evLYGs), QALYs gained, clinical events, cost per major adverse cardiovascular events (MACE) avoided and total costs for each intervention over a lifetime time horizon. Previous commentaries in INNOVATTIONS in Pharmacy have provided detailed critiques of the ICER modeling framework. While this model differs from previous ICER models, the result is still a framework that constructs a so-called evidence base that fails the demarcation test. It is best described as pseudoscience. The model creates, by assumption, an Imaginary World. The claims made for oral semaglutide by ICER should not be taken seriously by health care decision makers. The purpose of this commentary is to point to the limitations of the model with particular reference to the utility metrics employed, the resulting claims for quality adjusted life years (QALYs) and consequent recommendations for price discounting and affordability.
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more unnecessary Imaginary Worlds part 1 the institute for clinical and economic review s evidence report on janus kinase jak inhibitors in rheumatoid arthritis
Innovations in pharmacy, 2020Co-Authors: Paul C LangleyAbstract: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 to consider the recently released ICER evidence report for Janus Kinase (JAK) Inhibitors. As ICER continues, in the case of JAK Inhibitors, to apply its modeled cost utility framework with consequent recommendations for pricing adjustments, these recommendations also lack credibility. In contrast with previous ICER evidence reports, the present report adopts only a 12-month timeframe, one due, in large part, to ICER being unable to justify assumptions to drive its construction of Imaginary Worlds beyond 12 months. This commentary emphasizesagain, why the ICER methodology fails to meet the standards of normal science. Claims made by ICER for the competing JAK Inhibitor therapies lack credibility, are impossible to evaluate, let alone replicate across treatment settings. Even so, it is important to examine a number of key elements in the ICER invention of the 12-month JAK Inhibitor Imaginary World. While this does not imply any degree of acceptance of the ICER methodology, one element that merits particular attention is thefailure of the ICER modeling to meet logically defensible measurement standards in its application of generic health related quality of life (HRQoL) ordinal metrics to create its QALY claims. The failure to meet the required standards of fundamental measurement means that the cost-per-QALY claims are invalid. This raises the issue of the application of Rasch Measurement Theory (RMT) in instrument development and the potential role of patient centric outcome (PCO) instruments that represent the patient voice in value claims. The case made here is that the ICER approach should be abandoned as an unnecessary distraction. If we are to meet standards for the discovery of new facts in therapy response then our focus must be on proposing credible, evaluable and replicable claims within disease states. Instruments, such as the Rheumatoid Arthritis Quality of Life (RAQoL)questionnaire that build on the common construct that QoL is the extent to which human needs are fulfilled should be the basis for value claims. HRQoL Instruments that are clinically focused and reflect the value calculus of providers and not patients in measuring response by symptoms and activity limitations are irrelevant. This puts to one side the belief that incremental cost-per-QALY models, the construction of Imaginary Worlds are, in any sense, a 'gold standard'; a meme embraced by the health technology assessment profession. Claims for incremental cost per QALY outcomes and recommendations for pricing and access driven by willingness to pay thresholds are irrelevant to formulary decisions.
Langley Paul - One of the best experts on this subject based on the ideXlab platform.
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More Unnecessary Imaginary Worlds - Part 1: The Institute for Clinical and Economic Review’s Evidence Report on Janus Kinase (JAK) Inhibitors in Rheumatoid Arthritis
'University of Minnesota', 2020Co-Authors: Langley PaulAbstract: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 to consider the recently released ICER evidence report for Janus Kinase (JAK) Inhibitors. As ICER continues, in the case of JAK Inhibitors, to apply its modeled cost utility framework with consequent recommendations for pricing adjustments, these recommendations also lack credibility. In contrast with previous ICER evidence reports, the present report adopts only a 12-month timeframe, one due, in large part, to ICER being unable to justify assumptions to drive its construction of Imaginary Worlds beyond 12 months. This commentary emphasizes again, why the ICER methodology fails to meet the standards of normal science. Claims made by ICER for the competing JAK Inhibitor therapies lack credibility, are impossible to evaluate, let alone replicate across treatment settings. Even so, it is important to examine a number of key elements in the ICER invention of the 12-month JAK Inhibitor Imaginary World. While this does not imply any degree of acceptance of the ICER methodology, one element that merits particular attention is the failure of the ICER modeling to meet logically defensible measurement standards in its application of generic health related quality of life (HRQoL) ordinal metrics to create its QALY claims. The failure to meet the required standards of fundamental measurement means that the cost-per-QALY claims are invalid. This raises the issue of the application of Rasch Measurement Theory (RMT) in instrument development and the potential role of patient centric outcome (PCO) instruments that represent the patient voice in value claims. The case made here is that the ICER approach should be abandoned as an unnecessary distraction. If we are to meet standards for the discovery of new facts in therapy response then our focus must be on proposing credible, evaluable and replicable claims within disease states. Instruments, such as the Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire that build on the common construct that QoL is the extent to which human needs are fulfilled should be the basis for value claims. HRQoL Instruments that are clinically focused and reflect the value calculus of providers and not patients in measuring response by symptoms and activity limitations are irrelevant. This puts to one side the belief that incremental cost-per-QALY models, the construction of Imaginary Worlds are, in any sense, a ‘gold standard’; a meme embraced by the health technology assessment profession. Claims for incremental cost per QALY outcomes and recommendations for pricing and access driven by willingness to pay thresholds are irrelevant to formulary decisions. Article Type: Commentar
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More Unnecessary Imaginary Worlds – Part 2: The ICER Evidence Report on Modeling Oral Semaglutide for Type 2 Diabetes
'University of Minnesota', 2020Co-Authors: Langley PaulAbstract:On 9 December 2019, the Institute for Clinical and Economic Review (ICER) released its final evidence report to establish the value of oral semaglutide (Novo Nordisk) for Type 2 diabetes (T2DM). A key element in this report was the development of a lifetime cost effectiveness microsimulation model based on a small sample of NHANES diabetes respondents. The model contrasted oral semaglutide added to current antihyperglycemic treatment for T2DM. The purpose of the model was to estimate outcomes that included life years (LYs) gained, an estimate of equal value life years gained (evLYGs), QALYs gained, clinical events, cost per major adverse cardiovascular events (MACE) avoided and total costs for each intervention over a lifetime time horizon. Previous commentaries in INNOVATTIONS in Pharmacy have provided detailed critiques of the ICER modeling framework. While this model differs from previous ICER models, the result is still a framework that constructs a so-called evidence base that fails the demarcation test. It is best described as pseudoscience. The model creates, by assumption, an Imaginary World. The claims made for oral semaglutide by ICER should not be taken seriously by health care decision makers. The purpose of this commentary is to point to the limitations of the model with particular reference to the utility metrics employed, the resulting claims for quality adjusted life years (QALYs) and consequent recommendations for price discounting and affordability. Article Type: Commentar
Sebastian Lundmark - One of the best experts on this subject based on the ideXlab platform.
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gaming together when an Imaginary World affects generalized trust
Journal of Information Technology & Politics, 2015Co-Authors: Sebastian LundmarkAbstract:ABSTRACTTo disentangle the causal relationship between generalized trust and social experiences in a digitalized World, this article employs a three-wave, self-selected panel study following 533 players from the Massively Multiplayer Online Role-Playing Game (MMORPG), World of Warcraft (WoW), over 10 months. Focusing on whether generalized trust can be shaped by the social experiences one makes throughout a lifetime, this study finds a strong relationship between joining or exiting a voluntary association-like environment within the game and changes in generalized trust. Starting to play together in voluntary association-like environments is positively related to increases in generalized trust, while exiting is associated with a decrease in generalized trust. Hence, contrary to other recent studies on associations’ ability to affect generalized trust, this study demonstrates effects on generalized trust when studying social encounters within an MMORPG. In other words, a social experience such as gaming to...
Jonnabhotla Naga Lalith Shashank - One of the best experts on this subject based on the ideXlab platform.
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pw 2802 an Imaginary World for safety
Injury Prevention, 2018Co-Authors: Jonnabhotla Usha Rani, Jonnabhotla Nageswara Sarma, Gundavajhala Sunanda, Jonnabhotla Naga Ananda Vamsee, Jonnabhotla Naga Lalith ShashankAbstract:We aimed at prevention of injury under the sub-theme 2, Unintentional Injury caused due to road traffic. This model prevents heavy traffic and our studies can be extended to avoid Worldwide traffic congestion. Though we cannot find the substitute for wheel we can run the vehicles in airways through ropeways. People who travel through ropeways will have a feeling of swing that helps for all age groups to increase their potential energy. These ropeways are to be fixed at least 15 to 20 feet height from the ground. And these ropeways run by solar power. This is one of the safest methods that promote safety and avoid injuries for people moving on roads and air. By fixing net under every ropeway we can avoid unintentional injury. Yes, we agree that it’s an expensive proposition but large car manufacturers can divert their investments for the construction of ropeways instead of manufacturing cars. We designed a specific model for road safety through roadways, ropeways for people using own vehicles, pedestrians, children and old age people including emergency services. It’s a research project that we planned with an idea to prevent injury. In our analysis and findings, we specified the details of implementation of this project with all financial and technicalities. Before concluding, we included an outline of this model that justifies the legal and social security limitations and constraints. This model benefits us in avoiding pollution and accidents. This paper also highlights the strategies/policies within the framework of corporate governance and corporate social responsibilities.
Jonnabhotla Usha Rani - One of the best experts on this subject based on the ideXlab platform.
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pw 2802 an Imaginary World for safety
Injury Prevention, 2018Co-Authors: Jonnabhotla Usha Rani, Jonnabhotla Nageswara Sarma, Gundavajhala Sunanda, Jonnabhotla Naga Ananda Vamsee, Jonnabhotla Naga Lalith ShashankAbstract:We aimed at prevention of injury under the sub-theme 2, Unintentional Injury caused due to road traffic. This model prevents heavy traffic and our studies can be extended to avoid Worldwide traffic congestion. Though we cannot find the substitute for wheel we can run the vehicles in airways through ropeways. People who travel through ropeways will have a feeling of swing that helps for all age groups to increase their potential energy. These ropeways are to be fixed at least 15 to 20 feet height from the ground. And these ropeways run by solar power. This is one of the safest methods that promote safety and avoid injuries for people moving on roads and air. By fixing net under every ropeway we can avoid unintentional injury. Yes, we agree that it’s an expensive proposition but large car manufacturers can divert their investments for the construction of ropeways instead of manufacturing cars. We designed a specific model for road safety through roadways, ropeways for people using own vehicles, pedestrians, children and old age people including emergency services. It’s a research project that we planned with an idea to prevent injury. In our analysis and findings, we specified the details of implementation of this project with all financial and technicalities. Before concluding, we included an outline of this model that justifies the legal and social security limitations and constraints. This model benefits us in avoiding pollution and accidents. This paper also highlights the strategies/policies within the framework of corporate governance and corporate social responsibilities.
