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Objectives: This study aimed to assess whether recently proposed alternatives to the quality-adjusted life-year (QALY), intended to address concerns about discrimination, are suitable for informing resource allocation decisions., Methods: We consider 2 alternatives to the QALY: the health years in total (HYT), recently proposed by Basu et al, and the equal value of life-years gained (evLYG), currently used by the Institute for Clinical and Economic Review. For completeness we also consider unweighted life-years (LYs). Using a hypothetical example comparing 3 mutually exclusive treatment options, we consider how calculations are performed under each approach and whether the resulting rankings are logically consistent. We also explore some further challenges that arise from the unique properties of the HYT approach., Results: The HYT and evLYG approaches can result in logical inconsistencies that do not arise under the QALY or LY approaches. HYT can violate the independence of irrelevant alternatives axiom, whereas the evLYG can produce an unstable ranking of treatment options. HYT have additional issues, including an implausible assumption that the utilities associated with health-related quality of life and LYs are "separable," and a consideration of "counterfactual" health-related quality of life for patients who are dead., Conclusions: The HYT and evLYG approaches can result in logically inconsistent decisions. We recommend that decision makers avoid these approaches and that the logical consistency of any approaches proposed in future be thoroughly explored before considering their use in practice., Competing Interests: Author Disclosures Dr Sampson is a member of the EuroQol Group, and has historically received research funds from commercial organizations whose business might be affected by the contents of this paper. No other disclosures were reported., (Copyright © 2024. Published by Elsevier Inc.)

Objectives: This study aims to determine how population-based health-utility score (HUS) differences reflect individuals' health preferences using responses from the Canadian EQ-5D-5L Valuation Study, including time trade-off (TTO) and discrete-choice experiment (DCE) tasks (n = 1073)., Study Design and Setting: Cardinal TTO responses were transformed into pairwise comparisons to yield ordinal TTO responses. We investigated how EQ-5D-5L HUS differences differ from participants' stated cardinal preferences, and determined the smallest HUS difference that may be expected to represent participants' ordinal preferences., Results: HUS differences near zero have 30.6% (95% confidence interval: 29.1-31.9%) probability of representing a tie in individuals' TTO values. Differences in EQ-5D-5L HUS of -0.054 (-0.071 to -0.029) and 0.047 (0.026-0.076) maximized the sensitivity and specificity of discriminating transitions to worse/better health states. For small HUS differences of ±0.03 to ±0.07, the magnitude of respondents' average TTO difference on the cardinal scale was 0.17 and 0.35 whether ties were included or excluded, respectively. Absolute HUS differences between 0.042 and 0.062 had a 50% probability of representing respondents' ordinal preferences., Conclusion: A HUS needs to be large enough to reflect individuals' stated health preferences, which may lend support to the application of a minimally important difference for decision-making., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: This paper introduces a framework with which to conceptualize the decision-making process in health technology assessment for new interventions with high budgetary impacts. In such circumstances, the use of a single threshold based on the marginal productivity of the healthcare system is inappropriate. The implications of this for potential partial implementation, horizontal equity, and pharmaceutical pricing are illustrated using this framework., Results: Under the condition of perfect divisibility and given an objective of maximizing health, a large budgetary impact of a new treatment may imply that optimal implementation is partial rather than full, even at a given incremental cost-effectiveness ratio that would nevertheless mean the decision to accept the treatment in full would not lead to a net reduction in health. In a one-shot price-setting game, this seems to give rise to potential horizontal equity concerns. When the assumption of fixity of the incremental cost-effectiveness ratio (arising from the assumed exogeneity of the manufacturer's price) is relaxed, it can be shown that the threat of partial implementation may be sufficient to give rise to an incremental cost-effectiveness ratio at which cost the entire potential population is treated, maximizing health at an increased level, and with no contravention of the horizontal equity principle., (Copyright © 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Non-invasive prenatal testing (NIPT) is an exciting technology with the potential to provide a variety of clinical benefits, including a reduction in miscarriages, via a decline in invasive testing. However, there is also concern that the economic and near-future clinical benefits of NIPT have been overstated and the potential limitations and harms underplayed. NIPT, therefore, presents an opportunity to explore the ways in which a range of social pressures and policies can influence the translation, implementation, and use of a health care innovation. NIPT is often framed as a potential first tier screen that should be offered to all pregnant women, despite concerns over cost-effectiveness. Multiple forces have contributed to a problematic translational environment in Canada, creating pressure towards first tier implementation. Governments have contributed to commercialization pressure by framing the publicly funded research sector as a potential engine of economic growth. Members of industry have an incentive to frame clinical value as beneficial to the broadest possible cohort in order to maximize market size. Many studies of NIPT were directly funded and performed by private industry in laboratories lacking strong independent oversight. Physicians' fear of potential liability for failing to recommend NIPT may further drive widespread uptake. Broad social endorsement, when combined with these translation pressures, could result in the "routinization" of NIPT, thereby adversely affecting women's reproductive autonomy. Policymakers should demand robust independent evidence of clinical and public health utility relevant to their respective jurisdictions before making decisions regarding public funding for NIPT., (Copyright © 2017 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.)

The National Institute for Health and Clinical Excellence (NICE) recently recommended differential discounting of costs and health effects in the economic appraisal of health care interventions in certain circumstances. The recommendation was published in an amendment to NICE's Guide to the Methods of Technology Appraisal. The amendment states that differential discounting should be applied where "treatment effects are both substantial in restoring health and sustained over a very long period (normally at least 30 years)." Renewed interest in differential discounting from NICE is welcome; however, the recommendation's selective application of differential discounting raises a number of concerns. The stated criteria for applying differential discounting are ambiguous. The rationale for the selective application of differential discounting has not been articulated by NICE and is questionable. The selective application of differential discounting leads to several inconsistencies, the most concerning of which is the lower valuation of health gains for those with less than 30 years remaining life expectancy, which can be interpreted as age discrimination. Furthermore, the discount rates chosen by NICE do not appear to be informed by recent advances in the theoretical understanding of differential discounting. NICE's apparent motivation for recommending differential discounting was to ensure a favorable cost-effectiveness ratio for a pediatric oncology drug. While flexibility may be appropriate to allow some interventions that exceed conventional cost-effectiveness thresholds to be adopted, the selective adjustment of appraisal methods is problematic and without justification., (Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Objectives: Adjuvant chemotherapy decisions in early breast cancer are complex. The 21-gene assay can potentially aid such decisions, but costs US $4175 per patient. Adjuvant! Online is a freely available decision aid. We evaluate the cost-effectiveness of using the 21-gene assay in conjunction with Adjuvant! Online, and of providing adjuvant chemotherapy conditional upon risk classification., Methods: A probabilistic Markov decision model simulated risk classification, treatment, and the natural history of breast cancer in a hypothetical cohort of 50-year-old women with lymph node-negative, estrogen receptor- and/or progesterone receptor-positive, human epidermal growth factor receptor 2/neu-negative early breast cancer. Cost-effectiveness was considered from an Ontario public-payer perspective by deriving the lifetime incremental cost (2012 Canadian dollars) per quality-adjusted life-year (QALY) for each strategy, and the probability each strategy is cost-effective, assuming a willingness-to-pay of $50,000 per QALY., Results: The 21-gene assay has an incremental cost per QALY in patients at low, intermediate, or high Adjuvant Online! risk of $22,440 (probability cost-effective 78.46%), $2,526 (99.40%), or $1,111 (99.82%), respectively. In patients at low (high) 21-gene assay risk, adjuvant chemotherapy increases (reduces) costs and worsens (improves) health outcomes. For patients at intermediate 21-gene assay risk and low, intermediate, or high Adjuvant! Online risk, chemotherapy has an incremental cost per QALY of $44,088 (50.59%), $1,776 (77.65%), or $1,778 (82.31%), respectively., Conclusions: The 21-gene assay appears cost-effective, regardless of Adjuvant! Online risk. Adjuvant chemotherapy appears cost-effective for patients at intermediate or high 21-gene assay risk, although this finding is uncertain in patients at intermediate 21-gene assay and low Adjuvant! Online risk., (Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Background: Quality indicators in coronary heart disease (CHD) measure the practice gap between optimal care and current clinical practice. However, the potential impact of achieving quality indicator benchmarks remains unknown., Methods: Using a validated, epidemiologic model of CHD in Ontario, Canada, we estimated the potential impact on mortality of improved utilization on CHD quality indicators from 2005 levels to recommend benchmark utilization of 90%. Eight CHD disease subgroups were evaluated, including inpatients with acute myocardial infarction (AMI), acute coronary syndromes, and heart failure, in addition to ambulatory patients who were post-acute myocardial infarction survivors, or had heart failure, chronic stable angina, hypertension, or hyperlipidemia. The primary outcome was the predicted mortality reduction associated with meeting quality indicator targets for each CHD subgroup-treatment combination., Results: In 2005, there were 10,060 CHD deaths in Ontario, representing an age-adjusted CHD mortality of 191 per 100,000 people. By meeting quality indicator utilization benchmarks, mortality could be potentially reduced by approximately 20% (95% confidence interval 17.8-21.1), representing approximately 1960 avoidable deaths. The bulk of this potential benefit was in ambulatory patients with chronic stable angina (36% of reduction) and heart failure (31% of reduction). The biggest drivers were optimizing angiotensin-converting enzyme inhibitor use in chronic stable angina patients (approximately 440 avoidable deaths) and β-blocker use in heart failure (approximately 400 avoidable deaths)., Conclusions: These findings reinforce the importance of quality indicators and could aid policy makers in prioritizing strategies to meet the goals outlined in the Canadian Heart Health Strategy and Action Plan for reducing cardiovascular mortality., (Copyright © 2011 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Objectives: To compare the use of pair-wise meta-analysis methods to multiple treatment comparison (MTC) methods for evidence-based health-care evaluation to estimate the effectiveness and cost-effectiveness of alternative health-care interventions based on the available evidence., Methods: Pair-wise meta-analysis and more complex evidence syntheses, incorporating an MTC component, are applied to three examples: 1) clinical effectiveness of interventions for preventing strokes in people with atrial fibrillation; 2) clinical and cost-effectiveness of using drug-eluting stents in percutaneous coronary intervention in patients with coronary artery disease; and 3) clinical and cost-effectiveness of using neuraminidase inhibitors in the treatment of influenza. We compare the two synthesis approaches with respect to the assumptions made, empirical estimates produced, and conclusions drawn., Results: The difference between point estimates of effectiveness produced by the pair-wise and MTC approaches was generally unpredictable-sometimes agreeing closely whereas in other instances differing considerably. In all three examples, the MTC approach allowed the inclusion of randomized controlled trial evidence ignored in the pair-wise meta-analysis approach. This generally increased the precision of the effectiveness estimates from the MTC model., Conclusions: The MTC approach to synthesis allows the evidence base on clinical effectiveness to be treated as a coherent whole, include more data, and sometimes relax the assumptions made in the pair-wise approaches. However, MTC models are necessarily more complex than those developed for pair-wise meta-analysis and thus could be seen as less transparent. Therefore, it is important that model details and the assumptions made are carefully reported alongside the results., (Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)