INNOVATIONS In Pharmacy Research Articles

Sentiment analysis in medication adherence: using ruled-based and artificial intelligence-driven algorithms to understand patient medication experiences.

Studies are exploring ways to improve medication adherence, with sentiment analysis (SA) being an underutilized innovation in pharmacy. This technique uses artificial intelligence (AI) and natural language processing to assess text for underlying feelings and emotions. This study aimed to evaluate the use of two SA models, Valence Aware Dictionary for Sentiment Reasoning (VADER) and Emotion English DistilRoBERTa-base (DistilRoBERTa), for the identification of patients' sentiments and emotions towards their pharmacotherapy. A dataset containing 320,095 anonymized patients' reports of experiences with their medication was used. VADER assessed sentiment polarity on a scale from - 1 (negative) to + 1 (positive). DistilRoBERTa classified emotions into seven categories: anger, disgust, fear, joy, neutral, sadness, and surprise. Performance metrics for the models were obtained using the sklearn.metrics module of scikit-learn in Python. VADER demonstrated an overall accuracy of 0.70. For negative sentiments, it achieved a precision of 0.68, recall of 0.80, and an F1-score of 0.73, while for positive sentiments, it had a precision of 0.73, recall of 0.59, and an F1-score of 0.65. The AUC for the ROC curve was 0.90. DistilRoBERTa analysis showed that higher ratings for medication effectiveness, ease of use, and satisfaction corresponded with more positive emotional responses. These results were consistent with VADER's sentiment analysis, confirming the reliability of both models. VADER and DistilRoBERTa effectively analyzed patients' sentiments towards pharmacotherapy, providing valuable information. These findings encourage studies of SA in clinical pharmacy practice, paving the way for more personalized and effective patient care strategies.

Public perspectives on digital innovations in pharmacy: A survey on health informatics and medication management

Public perspectives on digital innovations in pharmacy: A survey on health informatics and medication management

Artificial Intelligence: A Way to Promote Innovation

The theme of artificial intelligence is how to use it to make computers useful in solving problems concerning health. We interpret the data obtained by diagnosing various diseases, such as various types of cancer, diabetes, etc. The largest scientific goal of information construction—the theory of processing intelligence. It is the science and engineering of manufacturing. Intelligent machines, especially an intelligent computer. This work presents artificial intelligence (A.I.). Study how to make computers that have some characteristics of the human mind. A.I. systems are now routinely used in the economy, Medicine, and the military. They also have broad data that can potentially solve many problems in clinical trials. This article provides an overview of A.I. and its innovations. It is one of the cutting-edge technologies shaping the future of pharmacy. Various advanced systems, such as mathematics, machining performance, cloud computing, and algorithm design, have accelerated the development of methods that can be used to analyze, interpret, and make predictions using these data sources. We can learn how to get machines to solve problems by observing others.There has been sporadic research growth in two main areas: genomics and digital Medicine. This article examines the introduction, definition, history, applications, and innovation in pharmacy.

A survey of South Carolina pharmacists' readiness to prescribe human immunodeficiency virus pre-exposure prophylaxis.

HIV pre-exposure prophylaxis (PrEP) is largely underutilized in the Southern United States. Given their community presence, pharmacists are well positioned to provide PrEP within rural, Southern regions. However, pharmacists' readiness to prescribe PrEP in these communities remains unknown. To determine the perceived feasibility and acceptability of prescribing PrEP by pharmacists in South Carolina (SC). We distributed a 43-question online descriptive survey through the University of SC Kennedy Pharmacy Innovation Center's listerv of licensed SC pharmacists. We assessed pharmacists' comfort, knowledge, and readiness to provide PrEP. A total of 150 pharmacists responded to the survey. The majority were White (73%, n=110), female (62%, n=93), and non-Hispanic (83%, n=125). Pharmacists practiced in retail (25%, n=37), hospital (22%, n=33), independent (17%, n=25), community (13%, n=19), specialty (6%, n=9), and academic settings (3%, n=4); 11% (n=17) practiced in rural locales. Pharmacists viewed PrEP as both effective (97%, n=122/125) and beneficial (74% n=97/131) for their clients. Many pharmacists reported being ready (60% n=79/130) and willing (86% n=111/129) to prescribe PrEP, although over half (62% n=73/118) cited lack of PrEP knowledge as a barrier. Pharmacists described pharmacies as an appropriate location to prescribe PrEP (72% n=97/134). Most SC pharmacists surveyed considered PrEP to be effective and beneficial for individuals who frequent their pharmacy and are willing to prescribe this therapy if statewide statutes allow. Many felt that pharmacies are an appropriate location to prescribe PrEP but lack a complete understanding of required protocols to manage these patients. Further investigation into facilitators and barriers of pharmacy-driven PrEP are needed to enhance utilization within communities.

INNOVATIONS IN PHARMACY

Pharmaceutical innovation requires novelty of effectiveness. The main factor of innovations in pharmacy should have safety measures .Pharmaceutical innovations create value to society by making it possible to generate improvements in patient health (net of treatment risks) that were previously unattainable. Some of the innovations such as countdown medicine timer, pill intake tracker, glucose maintaining device, migraine preventing headbands, smart asthmatic gadgets, mobile mini kits .in these serious of innovations will bring to the recent trends of pharmaceutical industry.

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?

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.

"Pharmacy to Dose": An Approach to Enhancing Team-Based Care.

Inspiring Inquiry and Improvement in Pharmacy Practice, Education, and Policy. A quarterly publication featuring case studies, clinical experiences, commentaries, idea papers, original research, review articles, and student projects that focus on leading edge, novel ideas for improving, modernizing, and advancing pharmacy practice, education, and policy. INNOVATIONS in pharmacy.

Using network analysis to explore factors moderating the implementation of a medication review service in community pharmacy.

Implementation factors are hypothesised to moderate the implementation of innovations. Although individual barriers and facilitators have been identified for the implementation of different evidence-based services in pharmacy, relationships between implementation factors are usually not considered. To examine how a network of implementation factors and the position of each factor within this network structure influences the implementation of a medication review service in community pharmacy. A mixed methods approach was used. Medication review with follow-up service was the innovation to be implemented over 12 months in community pharmacies. A network analysis to model relationships between implementation factors was undertaken. Two networks were created. Implementation factors hindering the service implementation with the highest centrality measures were time, motivation, recruitment, individual identification with the organization and personal characteristics of the pharmacists. Three hundred and sixty-nine different interrelationships between implementation factors were identified. Important causal relationships between implementation factors included: workflow-time; characteristics of the pharmacy-time; personal characteristics of the pharmacists-motivation. Implementation factors facilitating the implementation of the service with highest centrality scores were motivation, individual identification with the organization, beliefs, adaptability, recruitment, external support and leadership. Four hundred and fifty-six different interrelationships were identified. The important causal relationships included: motivation-external support; structure-characteristics of the pharmacy; demographics-location of the pharmacy. Network analysis has proven to be a useful technique to explore networks of factors moderating the implementation of a pharmacy service. Relationships were complex with most implementation factors being interrelated. Motivation and individual identification with the organisation seemed critical factors in both hindering and facilitating the service implementation. The results can inform the design of implementation programs and tailored strategies to promote faster implementation of innovations in pharmacy.

Relevance of implementing a logistic approach to innovation management in the development and registration of medicines for the treatment of coronavirus disease (COVID-19)

Aim. To analyze and summarize the existing scientific approaches and mechanisms for innovation management when developing and registering medicines for the treatment of coronavirus disease (COVID-19) based on the implementation of a logistic approach and the creation of the integrated logistics innovation and information system.Materials and methods. Databases of the Internet, such as PubMed, the Food and Drug Administration, the European Medicines Agency were used. The retrospective, logical, and graphical methods of research, as well as the content analysis were applied. Results. In order to overcome the current therapeutic crisis in the world, 2 strategies are used: repurposing of the existing drugs (favipiravir, tocilizumab, etc.) and development of candidates for drugs with a direct targeted mechanism of action against COVID-19 (remdesivir, vaccines, etc.). Traditional approaches to the innovative process of activity as a closed one, oriented to the internal environment of the innovation system become ineffective. For this purpose, it is promising to apply a logistic approach to innovation management in the development and registration of medicines for the treatment of coronavirus disease (COVID-19). In the conditions of open innovation processes, those organizations and countries that can quickly implement an innovative idea gain a competitive advantage. It is necessary to manage innovation processes so that when an innovative idea enters the first stage, the idea is transformed into the final product with the shortest possible time. Logistization of innovation activities involves continuous improvement and optimization of the existing processes, allows you to organize innovation processes as a through integrated flow, reduce the time and costs for the implementation of innovative projects, gain benefits by optimizing innovative information, material and other flows.Conclusions. The result of the logistics of innovation in pharmacy will be: the creation of a complete cycle – from scientific research in scientific institutions, universities, pharmaceutical companies to the development of the production of innovative drugs; optimizing the use of resources associated with the implementation of innovative projects, as well as reducing the duration of the implementation of these projects; creation of a modern innovative infrastructure in the industry; wider attraction of investments in R&D from extra-budgetary sources; use of R&D results in training specialists.

Post QALY: Scientific Approaches to Real World Formulary Decision Making

The purpose of this anniversary supplement for Innovations in Pharmacy is to consider and / or propose modern, scientific methods for determining the evidence base for the fair pricing and accessibility of pharmaceutical products and medical devices. At present, such decisions are based on the construction of imaginary value assessment models that fail to meet the standards of normal science. Such a business model has been adopted by the Institute for Clinical and Economic Review (ICER) in the US, NICE in the UK and in a number of other countries.
 
 Article Type: Call for Papers

Balancing the solemn with the uplifting

On April 1, our colleagues in Spain observed a minute of silence in tribute to five pharmacists who died while caring for their patients in the thick of the COVID-19 pandemic. The International Pharmaceutical Federation (FIP) encouraged others across the globe to participate in solidarity with the brave pharmacists and pharmacy team members we lost in Spain, as well as in Italy and China. We are not alone in the world. Pharmacists and pharmacy personnel have stepped up. We will look back on and build our future upon their stories of heroic service. APhA, our fellow pharmacy associations, and the community itself have called out for the protection, appreciation, and recognition that pharmacy staff have duly earned. As I write this, things are changing: We called on CDC to protect frontline pharmacists and issue pharmacy-specific guidance. CDC’s guidance recommended the use of masks and other protective measures, and advised under what circumstances pharmacists should continue providing immunizations. We asked for greater latitude for pharmacists with COVID-19 testing. The U.S. Department of Health and Human Services issued guidance to authorize licensed pharmacists to order and administer FDA-approved COVID-19 tests, including serology tests. This is progress! Information and noise fill social media. APhA staff quickly shifted toward providing trustworthy and practical information to support your needs as frontline providers. Our COVID-19 educational programming and website at pharmacist.com/coronavirus is regularly updated with new guidance and content. We pivoted from live to virtual with the launch of APhA2020V, which took more than 2,000 staff hours to produce and has launched at pharmacist.com/apha2020update. As we navigate new frontiers, there exists a need for guidance and regulations to overcome barriers. We’re leading a pharmacy coalition to advocate on behalf of the profession and to gain clarity from FDA and CMS on pharmacist testing. I encourage you to turn to APhA for resources that will help you keep up with the best and late-breaking developments on testing, COVID-19 treatment, protecting your staff, changes in state scopes of practice, fraudulent products, pharmacy innovation, and managing suspected cases of the virus—it’s all on pharmacist.com/coronavirus. APhA couldn’t be more proud and impressed by what all of you have done in the face of fear and danger. We hope our work to keep you informed and connected meets your needs! Please take care of yourselves, stay safe, and THANK YOU FOR ALL YOU DO EVERY DAY!

More Unnecessary Imaginary Worlds - Part 3: Cystic Fibrosis and the Institute for Clinical and Economic Review's Draft Evidence Report.

On 20 February 2020, the Institute for Clinical and Economic Review (ICER) released its draft evidence report to establish the value of innovative therapies in the treatment of cystic fibrosis. Following its usual practice, ICER contracted with an outside group to construct a value assessment framework, in this case a microsimulation model, to generate value claims. The primary outcomes for value claims were incremental cost-per-QALY simulations for four target cystic fibrosis populations. The value assessment, in common with the same model applied earlier by ICER in cystic fibrosis, recommended substantial price discounts based on arbitrary threshold cost-per-QALY values. Unfortunately, the entire exercise, as detailed in previous commentaries in INNOVATIONS in Pharmacy is essentially a waste of time. Not only is the reference case model presented by ICER only one of a multiverse of other models, all driven by a selective application of model structure and assumptions, but the fact that the utilities that are applied to hypothetical time spent in different disease stages to modeled QALYs and lifetime cost-per-QALY claims fail to meet fundamental measurement axioms: they are ordinal manifest scores. Applied to target cystic fibrosis target patient groups, the modeled claims are meaningless. From the manufacturer's perspective, in this case Vertex Pharmaceuticals who have developed all the cystic fibrosis therapies 'modeled' by the ICER contractor, their response to ICER claims should be to reject them out of hand; the constructs are imaginary and the outcome claims nonsense.

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.

Disruptive Innovation in Pharmacy: Lessons from the Amazon Frontier.

Disruptive Innovation in Pharmacy: Lessons from the Amazon Frontier.

More Unnecessary Imaginary Worlds - Part 1: The Institute for Clinical and Economic Review's Evidence Report on Janus Kinase (JAK) Inhibitors in Rheumatoid Arthritis.

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.

Yet another Ersatz World: The ICER Final Evidence Report for Additive Cardiovascular Therapies.

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 report for Additive Cardiovascular Disease therapies. This report should not be taken seriously in its claims for cost-effectiveness and pricing in cardiovascular disease (CVD). The analytical framework applied by ICER fails to meet the standards of normal science in demarcating science from pseudoscience. Irrespective of the value judgements and recommendations of an ICER report, these lack credibility. They were never intended to be evaluable and replicable across treatment settings. The claims made are constructed, driven by assumption, and should be put to one side by health system decision makers. In this review the focus is on to the ICER modeled estimates of utility scores in CVD, the insistence on utilizing a generic utility algorithm (the EQ-5D-3L) and the consequent quality adjusted life year (QALY) estimates. Two issues are raised that will be the subject of future commentaries: the lack of appreciation of fundamental measurement and (ii) the importance of the patient voice in benefit claims. Given the importance in the ICER methodology of QALYS, the ad hoc nature of the ordinal utilities introduced to the cardiovascular model must raise concerns over the role the ICER evidence report may play in health care decision-making. These concerns extend to the claim by ICER that, on ICER's own affordability threshold for individual new molecular entities, the anticipated uptake of these therapies may raise questions of overall affordability. Again, we are dealing with an arbitraryconstruct that may adversely impact patient access.

Enhancing financial performance by pharmacy innovation

AbstractAntecedents and consequences of customer orientation have been the subject of significant empirical investigation. Although several studies have explored employee variables as antecedents to customer orientation, work ethic has received little research attention. Additionally, there have been incongruent findings related to the effect of customer orientation on performance, as some have found it to be direct or indirect via innovation. This study explores overall work ethic as an antecedent to customer orientation and innovativeness as the missing link between customer orientation and performance among Canadian retail pharmacies. The results show support for the influence of work ethic on customer orientation, and the role of innovation as a mediating variable. This study advances the understanding of work ethic, customer orientation, innovation, and performance in Canadian retail pharmacy.

The Need for Disruptive Innovation in Pharmacy

Disruptive innovation became a buzz phrase in the mid-1990s in the business world. In this commentary, the application of this term to pharmacy within the context of the current status of pharmacy education and practice, highlighting barriers, discussing requirements, and identifying implications for future innovative opportunities in pharmacy is discussed.

ICER, ISPOR AND QALYs: Tales of 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 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.