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Overview: This paper describes stakeholder involvement and formative qualitative research in the creation of health state descriptions (HSDs) or vignettes for low-risk thyroid cancer. The aim of this project was to engage stakeholders in the contribution of a novel set of HSDs, an important first step in the process of assessing value in thyroid cancer health states., Methods: We draw upon formative, descriptive qualitative methods, following a multi-stage framework of data collection. We conducted individual semi-structured interviews, cognitive interviews, and focus groups with thyroid cancer patients, community providers, academic subspecialists, and participants with no thyroid cancer diagnosis (N = 31). The HSDs went through several iterations over the course of a year, in collaboration with a highly engaged community advisory board, laying the groundwork for HSDs that are comprehensible, comparable, and appropriate for stated-preference research., Findings: Thyroid cancer survivors compared their experiences with those described in the HSDs. Feedback included concern for the emotional well-being of study participants who would be reading them. Providers were attuned to the need for clinical accuracy and made suggestions to reflect their clinical experience, including for patients with complications or disease progression. The pilot participants with no thyroid cancer were particularly valuable in promoting the need to simplify language and maximize readability., Discussion: Stakeholder engagement was critical to being responsive to feedback as the iterations were refined and presented. Continuous engagement and consultation with multiple sources strengthened the HSDs. A secondary outcome from this project is that stakeholders expressed interest in adapting the HSDs into decision aids for people newly diagnosed with low-risk thyroid cancer., (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, and the increased role of stakeholder involvement, including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as healthcare, public health, education, social care, etc.). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer-reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making., (© 2021. The Author(s).)

Background: Innovations in hepatitis C virus (HCV) therapy included in traditional comparative evaluations focus on sustained virologic response (SVR) without addressing challenges patients report beyond virologic cure. This study aims to evaluate the cost-effectiveness of HCV drug therapy with a patient-centered approach., Methods: An individual-based Markov model was constructed using guidance from a stakeholder advisory board (SAB), a patient Delphi panel, and published literature to evaluate direct-acting antivirals (DAAs) compared to no treatment. The United States (US) health sector and societal perspectives were considered for 10- and 20-year time horizons. Inputs for treatment costs and effectiveness reflect a generic regimen. Indirect costs used for the societal model included estimates from self-reported productivity in a matched-control sample. Beyond the traditional quality-adjusted life-year (QALY) health outcome, this study included two novel measures developed from the Delphi panel and SAB: infected life-years and workdays missed. All costs were measured in 2018 US dollars., Results: Health sector costs and QALYs were higher in the treatment group in both 10- and 20-year models. Total infected life-years and workdays missed were reduced in the treatment group for both models. When costs of absenteeism, presenteeism, and patient/caregiver time were included, the DAA intervention was cost-saving at both 10 and 20 years. Health sector results were sensitive to drug costs and utility estimates for post-SVR health states. Societal results were sensitive to presenteeism estimates and drug costs., Conclusion: Treatment was cost-effective from a health sector perspective and cost-saving when including non-health costs such as patient/caregiver time and productivity.

Objective: Comparative evaluations of innovations in hepatitis C virus (HCV) drug therapy typically focus on sustained virologic response (SVR) without addressing psychological and socioeconomic challenges that extend beyond virologic cure. This study aims to identify and prioritize variables important to patients when making the decision to start HCV treatment., Methods: A three-round Delphi process was conducted with the first round derived from a systematic literature review and advisory board input, including patients who have been affected by HCV, physicians, pharmacists, and a patient group representative. Delphi panelists were HCV patients who had received treatment or were considering treatment. Panelists were asked about factors influencing their HCV treatment decisions. Thematic analysis of open-ended responses based on grounded theory was used. Agreement with each category and rankings based on order of importance from the patient perspective was reported., Results: Treatment effectiveness (100% agreement), longer life (88%), fear of complications (84%), financial issues (80%), quality of life (100%), and impact on society (80%) were considered important factors to patients in decisions to seek treatment. A fear of harming others (87%) was considered more important than physical symptoms (83%) in terms of patient-reported problems caused by HCV. Medication costs (91%) were identified as the most important costs of having HCV, followed by doctor costs (77%)., Conclusions: In addition to treatment effectiveness, patient experiences with financial problems, quality of life, and altruistic desires impact HCV patients' decisions. The risk of infecting others may motivate patients to seek treatment as much as personally experienced physical symptoms.

Objective: The aim of this study was to assess the budget impact of introducing the proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) alirocumab and evolocumab to market for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular (CV) disease requiring additional lowering of low-density lipoprotein cholesterol (LDL-C)., Methods: A 3-year model estimated the costs of lipid-modifying therapy (LMT) and CV events to a hypothetical US health plan of 1 million members, comparing two scenarios-with and without the availability of PCSK9i as add-on therapy to statins. Proportions of patients with uncontrolled LDL-C despite receiving statins, and at risk of CV events, were estimated from real-world data. Total undiscounted annual LMT costs (2017 prices, including PCSK9i costs of $14,563.50), dispensing and healthcare costs, including the costs of CV events, were estimated for all prevalent patients in the target population, based on baseline risk factors. Maximum PCSK9i utilization of 1-5% over 3 years according to risk group (following the same pattern as current ezetimibe use), and 5-10% as a secondary scenario, were assumed., Results: Total healthcare budget impacts per target patient (and per member) per month for years 1, 2 and 3 were $3.62($0.10), $7.22($0.20) and $10.79($0.30), respectively, assuming 1-5% maximum PCSK9i utilization, and $15.81($0.44), $31.52($0.88) and $47.12($1.31), respectively, assuming 5-10% utilization. Results were sensitive to changes in model timeframe, years to maximum PCSK9i utilization and PCSK9i costs., Conclusions: The budget impact of PCSK9i as add-on therapy to statins for patients with hypercholesterolemia is relatively low compared with published estimates for other specialty biologics. Drug cost rebates and discounts are likely to further reduce budget impact.

Achieving comprehensive patient centricity in cost-effectiveness analyses (CEAs) requires a statistical approach that accounts for patients' preferences and clinical and demographic characteristics. Increased availability and accessibility of patient-level health-related utility data from clinical trials or observational database provide enhanced opportunities to conduct more patient-centered CEA. Regression-based approaches that incorporate patient-level data hold great promise for enhancing CEAs to be more patient centered; this paper provides guidance regarding two CEA approaches that apply regression-based approaches utilizing patient-level health-related utility and costs data. The first approach utilizes patient-reported preferences to determine patient-specific utility. This approach evaluates how individuals' unique clinical and demographic factors affect their utility and cost levels over the course of treatment. The underlying motivation of this approach is to produce CEA estimates that reflect patient-level utilities and costs while adjusting for socio-demographic and clinical factors to aid patient-centered coverage and treatment decision-making. In the second approach, patient utilities are estimated based on the clinically defined health states through which a patient may transition throughout the course of treatment. While this approach is grounded on the widely used Markov transition model, we refine the model to facilitate an enhancement in conducting regression-based analysis to achieve transparent understanding of differences in utilities and costs across diverse patient populations. We discuss the unique statistical challenges of each approach and describe how these analytical strategies are related to non-regression-based models in health services research.

Objective: To provide a framework for addressing payers' criteria during the development of pharmaceuticals., Methods: A conceptual framework was presented to an international health economic expert panel for discussion. A structured literature search (from 2010 to May 2015), using the following databases in Ovid: Medline(®) and Medline(®) In-Process (PubMed), Embase (Ovid), EconLit (EBSCOhost) and the National Health Service Economic Evaluation Database (NHS EED), and a 'grey literature' search, were conducted to identify existing criteria from the payer perspective. The criteria assessed by existing frameworks and guidelines were collated; the most commonly reported criteria were considered for inclusion in the framework. A mnemonic was conceived as a memory aide to summarise these criteria., Results: Overall, 41 publications were identified as potentially relevant to the objective. Following further screening, 26 were excluded upon full-text review on the basis of no framework presented (n = 13), redundancy (n = 11) or abstract only (n = 2). Frameworks that captured criteria developed for or utilised by the pharmaceutical industry (n = 5) and reimbursement guidance (n = 10) were reviewed. The most commonly identified criteria-unmet need/patient burden, safety, efficacy, quality-of-life outcomes, environment, evidence quality, budget impact and comparator-were incorporated into the summary framework. For ease of communication, the following mnemonic was developed: BEACON (Burden/target population, Environment, Affordability/value, Comparator, Outcomes, Number of studies/quality of evidence)., Conclusions: The BEACON framework aims to capture the 'essence' of payer requirements by addressing the most commonly described criteria requested by payers regarding the introduction of a new pharmaceutical., Competing Interests: Compliance with Ethical Standards WCND is an employee of Mundipharma International Limited. AE and LH are employees of Adelphi Values Limited (Adelphi Values Limited received budgetary compensation for involvement in the manuscript development). OP, CDM, RG and MJP participated in the advisory board meeting (in Vienna in December 2014); they subsequently voluntarily participated in the work on this manuscript, did not receive any honoraria for this manuscript and declare no conflicts of interest. OP, CDM, RG and MJP have all previously received honoraria/fees from Mundipharma International Limited for other advisory services. Author contributions WCND was involved in the conceptualisation of the pilot framework and the advisory board meeting. WCND, LH and AE were involved in the design of the search strategy, the conduct of the literature review and development of the manuscript and the BEACON framework. CDM, OP, RG and MJP were part of the advisory board, reviewed the pilot framework, contributed to the search strategy and research strategy, and reviewed and provided input on all drafts of the manuscript and the BEACON framework.

Introduction: Cost-of-illness (COI) studies provide policy-relevant information for cross-country, longitudinal, and other cost comparisons. Prior studies have called for standardization in COI methods. We investigated trends, identified factors associated with variation in COI estimation methods, and characterized reporting of heterogeneity in COI estimates., Methods: The review of COI studies was implemented following (i) a structured search of PubMed, SCOPUS and EMBASE; (ii) a review of abstracts; (iii) a full-text review; and (iv) classification of articles according to six COI estimation methods: Sum_All Medical, Sum_Diagnosis Specific, Matched, Regression, Other_Total and Other_Incremental. Descriptive and multivariable regression analyses were conducted., Results: Of the 993 studies included in the full-text review, 186 (18.7 %) were Sum_All Medical, 458 (46.1 %) were Sum_Diagnosis Specific, 96 (9.7 %) were Matched, 97 (9.8 %) were Regression, 70 (7.1 %) were Other_Incremental, and 68 (6.9 %) were Other_Total. Compared with the early period, publications in the middle and late period were associated with lower odds of using Sum_All Medical compared with Sum_Diagnosis Specific (adjusted odds ratio [AOR]middle 0.14; 95 % CI 0.07-0.28; AORlate 0.44; 95 % CI 0.29-0.67). Overall, 640 articles (64 %) reported COI estimates across patient groups defined by patient-level factors, while 247 articles (25 %) reported COI estimates across patient groups defined by non-patient-level factors., Conclusion: The disease-specific total costing method (Sum_Diagnosis Specific) was most commonly used and its use increased over the time period covered by this review. The investigation of subgroup heterogeneity in COI estimates represents an area for future research.

Background and Objective: Advanced prostate cancer patients with bone metastasis are predisposed to skeletal complications termed skeletal-related events (SREs). There is limited information available on Medicare costs associated with treating SREs. The objective of this study was to ascertain SRE-related costs among older men with metastatic prostate cancer in the US., Methods: We analysed patients aged 66 years or older who were diagnosed with incident stage IV (M1) prostate cancer between 2000 and 2007 from the linked Surveillance, Epidemiology and End Results (SEER)-Medicare dataset. A propensity score for the incidence of an SRE was estimated using a logistic regression model including demographic and clinical baseline variables. Patients with SREs (cases) were matched to patients without SREs (controls) based on the propensity score, length of follow-up (i.e. date of prostate cancer diagnosis to last date of observation) and death. Health resource utilization cost differences between cases and controls over time were compared using generalized linear models. Healthcare costs were examined by type of SRE (pathological fracture only, pathological fracture with concurrent surgery, spinal cord compression only, spinal cord compression with concurrent surgery, and bone surgery only) and by source of care (inpatient, physician/non-institutional provider, skilled nursing facility, outpatient and hospice). All costs were adjusted to 2009 US dollars, using the medical care component of the Consumer Price Index., Results: Application of the inclusion criteria resulted in 1,131 metastatic prostate cancer patients with SREs and 6,067 patients without SREs during follow-up. The average age of the sample was 79 years, and 14 % were African American. A total of 928 patients with SREs were matched to 928 patients without SREs. The average health care utilization cost of patients with SREs was US$29,696 (95 % confidence interval [CI] US$24,730-US$34,662) higher than that of the controls. The most expensive SRE group was spinal cord compression with concurrent surgery (US$82,868: 95 % CI US$67,472-US$98,264) followed by bone surgery only (US$37,496: 95 % CI US$29,684-US$45,308), pathological fracture with concurrent surgery (US$34,169: 95 % CI US$25,837-US$ 42,501), spinal cord compression only (US$25,793: 95 % CI US$20,933-US$30,653) and pathological fracture only (US$14,649: 95 % CI US$6,537-US$22,761). The largest cost difference by source of care was observed for hospitalizations (p < 0.01)., Conclusion: Metastatic prostate cancer patients with SREs incur higher costs compared to similar patients without SREs. SRE costs among older stage IV (M1) prostate cancer patients vary by SRE type, with spinal cord compression and concurrent surgery costing at least twice as much as other SREs.

Background: The incidence of hepatocellular carcinoma (HCC) is increasing in the USA and worldwide. Several treatments are available for patients diagnosed at any disease stage. It remains unclear how medical expenditures vary across patients who remain untreated or undergo different modes of therapy. We evaluate the comparative and cost effectiveness of treatment modalities for HCC from a Medicare perspective., Methods: The Surveillance, Epidemiology, and End Results (SEER) registries and linked Medicare database with claims from Parts A/B were used to identify Medicare enrollees with initial diagnosis of HCC between 2000 and 2007 and followed through 2009. Patients were assigned to treatment modalities based on HCC staging systems: transplant, resection, liver directed, radiation, chemotherapy or no treatment. Survival benefits and cumulative Medicare expenditures were estimated in multivariate models, stratified by initial disease stage, to control for confounding. Cost-effectiveness ratios compared costs and benefits of the modalities across initial stages., Results: Cancer stages I, II, III, IV and unstaged represented 24, 9, 14, 17 and 37 % of 11,047 patients, respectively. Fewer than 40 % received any treatment. Relative to no treatment, transplant was most effective in reducing mortality, followed by resection, liver directed, and radiation or chemotherapy. Resection tended to be most cost effective in early staged and unstaged patients; transplant was least cost effective. In stage IV patients, liver directed therapy was more cost effective than chemotherapy or radiation., Conclusions: Survival benefit was attributable to all treatment modalities. More effective treatments incurred greater Medicare expenditures, but resection patients incurred the least expenditures per year of life gained.

The application of cost-effectiveness analysis in healthcare has become commonplace in the US, but the validity of this approach is in jeopardy unless the proverbial $US50,000 per QALY benchmark for determining value for money is updated for the 21st century. While the initial aim of this article was to review the arguments for abandoning the $US50,000 threshold, it quickly turned to questioning whether we should maintain a fixed threshold at all. Our consideration of the relevance of thresholds was framed by two important historical considerations. First, cost-effectiveness analysis was developed for a resource allocation exercise where a threshold would be determined endogenously by maximizing a fixed budget across all possible interventions and not for piecemeal evaluation where a threshold needs to be set exogenously. Second, the foundations of the $US50,000 threshold are highly dubious, so it would be unacceptable merely to adjust for inflation or current clinical practice. Upon consideration of both sides of the argument, we conclude that the arguments for abandoning the concept for maintaining a fixed threshold outweigh those for keeping one. Furthermore, we document a variety of reasons why a threshold needs to vary in the US, including variations across payer, over time, in the true budget impact of interventions and in the measurement of the effectiveness of interventions. We conclude that while a threshold may be needed to interpret the results of a cost-effectiveness analysis, that threshold must vary across payers, populations and even procedures.

Comparative effectiveness research (CER), or research design to meet the needs of post-regulatory decision makers, has been brought into the spotlight with the introduction of the American Recovery and Reinvestment Act, which provided $US1.1 billion over 2 years to support CER. In the short run, the majority of this money will be invested in observational studies and building of infrastructure; however, in the long run, we will likely see an increase in the number of randomized controlled trials (RCTs), as this method is arguably the most unbiased approach for establishing causal effect between treatments and health outcomes. RCTs are an integral component of CER for generating credible evidence on the relative value of alternative interventions in order to meet the needs of post-regulatory decision makers (patients, physicians, payers and policy makers). Explanatory phase III RCTs are fit for purpose; researchers make use of guidance documents produced by the US FDA to inform the design of these clinical trials. Historically, without explicit FDA guidance, broad patient populations, including women and minorities, often were not considered in trial design. In addition, attempts to minimize cost and maximize efficiency have led to smaller sample sizes, as is clear from the increase in 'creeping phase II-ism'. To demonstrate effectiveness, RCTs must be reflective of how an intervention will be used in the healthcare market. The concept of pragmatic clinical trials has emerged to describe those trials that are designed explicitly with this need in mind. Use of pragmatic trials will be most impactful if post-regulatory decision makers are engaged in the development of recommendations for trial design features, such as indicating outcomes measures and articulating patient populations of interest, which clearly express their evidence needs.

The number of cost-of-illness (COI) studies has expanded considerably over time. One outcome of this growth is that the reported COI estimates are inconsistent across studies, thereby raising concerns over the validity of the estimates and methods. Several factors have been identified in the literature as reasons for the observed variation in COI estimates. To date, the variation in the methods used to calculate costs has not been examined in great detail even though the variations in methods are a major driver of variation in COI estimates. The objective of this review was to document the variation in the methodologies employed in COI studies and to highlight the benefits and limitations of these methods. The review of COI studies was implemented following a four-step procedure: (i) a structured literature search of MEDLINE, JSTOR and EconLit; (ii) a review of abstracts using pre-defined inclusion and exclusion criteria; (iii) a full-text review using pre-defined inclusion and exclusion criteria; and (iv) classification of articles according to the methods used to calculate costs. This review identified four COI estimation methods (Sum&#95;All Medical, Sum&#95;Diagnosis Specific, Matched Control and Regression) that were used in categorising articles. Also, six components of direct medical costs and five components of indirect/non-medical costs were identified and used in categorising articles.365 full-length articles were reflected in the current review following the structured literature search. The top five cost components were emergency room/inpatient hospital costs, outpatient physician costs, drug costs, productivity losses and laboratory costs. The dominant method, Sum&#95;Diagnosis Specific, was a total costing approach that restricted the summation of medical expenditures to those related to a diagnosis of the disease of interest. There was considerable variation in the methods used within disease subcategories. In several disease subcategories (e.g. asthma, dementia, diabetes mellitus), all four estimation methods were represented, and in other cases (e.g. HIV/AIDS, obesity, stroke, urinary incontinence, schizophrenia), three of the four estimation methods were represented. There was also evidence to suggest that the strengths and weaknesses of each method were considered when applying a method to a specific illness. Comparisons and assessments of COI estimates should consider the method used to estimate costs both as an important source of variation in the reported COI estimates and as a marker of the reliability of the COI estimate.

Background: This study identifies and compares the individual cost components of hospital and ambulatory services that manage the care of hypertensive patients in eight countries: the US, the UK, France, Spain, Germany, Italy, Canada and Australia., Methods: Hypertension-related costs are classified according to four major cardiovascular events: (i) acute myocardial infarction; (ii) congestive heart failure; (iii) stroke; and (iv) renal failure, which was subdivided into renal failure treated by dialysis and renal failure treated by kidney transplantation. To make cross-country costs comparisons, we used the DRG codes used in the US and DRG-like codes from each country. US cost information was obtained from hypertension data available from the literature and health economics researchers. For costs in other countries, we consulted with national health economics experts in each country, used analyses by the Research Triangle Institute, and performed Medline and international literature searches. When available, we obtained information from the countries' public and private nationally representative data sources. For cross-country currency adjustments, all currencies were converted using the Purchasing Power Parities from the Organisation for Economic Cooperation and Development, and then converted into inflation-adjusted year 2000 US dollars., Results: There exists considerable variation in hypertension-related costs from multinational clinical studies. This study documents that costs are generally higher in the US than in other countries; however, this is not always true. In particular, costs of treating heart failure in France and the costs of renal failure without transplantation in Germany and the UK are relatively high., Discussion: While analysing multinational hypertensive cost data, this study also addresses the impact of cross-country cost variations on cost analyses. During the last decade, drug-development researchers have drawn extensively upon multinational trials to resolve enrollment problems and drug-registration issues. At the same time, formulary decision-makers are increasingly demanding multinational cost-effectiveness analyses of the clinical differences found between drug-treatment regimens. Since these data are typically not captured by randomised clinical trials, standard cost estimates must be applied to the clinical trials' resource data, although such standardised calculations do not necessarily account for clinical and cost variations between countries., Conclusion: This paper serves as an instrument for identifying which national and event cost data are comparable for analysis as well as highlighting specific problem areas for cost data integration. Although the study focuses on hypertension-related costs, its results may provide insight for multinational cost comparisons of other diseases where similar hospitalisation costs may be analysed.

Background: Projecting future breast cancer treatment expenditure is critical for budgeting purposes, medical decision making and the allocation of resources in order to maximise the overall impact on health-related outcomes of care. Currently, both longitudinal and cross-sectional methodologies are used to project the economic burden of cancer. This pilot study examined the differences in estimates that were obtained using these two methods, focusing on Maryland, US Medicaid reimbursement data for chemotherapy and prescription drugs for the years 1999-2000., Methods: Two different methodologies for projecting life cycles of cancer expenditure were considered. The first examined expenditure according to chronological time (calendar quarter) for all cancer patients in the database in a given quarter. The second examined only the most recent quarter and constructed a hypothetical expenditure life cycle by taking into consideration the number of quarters since the respective patient had her first claim., Results: We found different average expenditures using the same data and over the same time period. The longitudinal measurement had less extreme peaks and troughs, and yielded average expenditure in the final period that was 60% higher than that produced using the cross-sectional analysis; however, the longitudinal analysis had intermediate periods with significantly lower estimated expenditure than the cross-sectional data., Conclusions: These disparate results signify that each of the methods has merit. The longitudinal method tracks changes over time while the cross-sectional approach reflects more recent data, e.g. current practice patterns. Thus, this study reiterates the importance of considering the methodology when projecting future cancer expenditure.

Previous research indicates that in order to make pharmacoeconomic information applicable and useful for pharmaceutical benefit management (PBM) companies, several aspects need to be considered and improved. These include: timely availability of information, head-to-head comparators, peer-reviewed publications, independent sponsorship of pharmacoeconomic studies, use of relevant populations in research and published pharmacoeconomic models, and pharmacoeconomics training for pharmaceutical companies' sales personnel. In addition to these measures, guidelines have been playing an important role in improving the applicability of pharmacoeconomic information. This paper examines the progress to date in enhancing the applicability of pharmacoeconomics for optimal PBM decision making. The greatest improvements have been made in enhancing the quality of pharmacoeconomic research and the quality of peer-reviewed publications. Direct comparator studies are starting to emerge, but in limited numbers. The need for additional training of pharmaceutical representatives and PBM staff members remains a critical issue.

Objective: To estimate the cost per ischaemic event (death, nonfatal myocardial infarction, subsequent revascularisation procedure) avoided at 6 months in high risk patients undergoing coronary revascularisation treated with abciximab during routine medical care., Design: Retrospective, matched cohort design., Setting: University teaching hospital., Patients: 62 abciximab-treated patients and 62 patients not treated with abciximab with high risk coronary lesions were matched according to gender, hyperlipidaemia, diabetes mellitus and stenting., Main Outcome Measures: Using a third-party payer's perspective, an incremental cost-effectiveness ratio (ICER) was computed as the cost per ischaemic event avoided over 6 months. Fieller's theorem was used to estimate confidence sets and confidence ellipses were generated to visually represent the variability in the data., Results: At 6 months, abciximab-treated patients experienced an approximately 40% lower rate of ischaemic events (16.1 vs 27.4%; p = 0.128). The point estimate of the ICER was $US21,789 per ischaemic event avoided. Fieller's theorem resulted in a 95% confidence set consisting of 2 half-lines (-infinity to -$US115,461) and ($US391 to +infinity), reflecting the finding that the ICER denominator was not significantly different from zero at the p = 0.05 level., Conclusions: In high risk patients treated during routine care, the effectiveness of abciximab was consistent with efficacy rates from clinical trials. However, abciximab-treated patients remained approximately $US2400 more costly at 6 months.