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OBJECTIVE: The aim of this study was to determine the budget impact of everolimus (in combination with letrozole/anastrozole) as a second-line treatment for ER+ HER2- negative advanced and metastatic breast cancer in post-menopausal women.
RESEARCH DESIGN & METHODS: A cumulative cohort model was developed to estimate the 5-year costs associated with introducing everolimus to the Kazakh healthcare system. Two alternative market share scenarios were compared: with everolimus and without everolimus. PFS and OS data were taken from the trial and extrapolated. The background costs of the pre-progressed and post-progressed health states, drug costs and costs associated with adverse events were included in the model.
RESULTS: The 5-year results from the budget impact analysis demonstrate that the introduction of everolimus leads to a 12% increase in drug costs, a 2% reduction in pre-progression health state costs, a 1% increase in post-progression health state costs, and a 2% reduction in adverse event costs. The net result is only a modest increase in total costs; a 2.69% increase of T201 million, from T7.5 billion to T7.7 billion over a period of 5 years.
CONCLUSIONS: The analysis estimated that, if everolimus were to be introduced to the Kazakh healthcare market for the treatment of ER+ HER2- advanced breast cancer, there would be minimal impact upon overall healthcare expenditure. An increase in drug acquisitions costs was almost exactly offset by a reduction in other healthcare costs, due to improved management of the disease.
OBJECTIVES: This study evaluated the cost-effectiveness of everolimus plus exemestane (EVE+EXE) versus exemestane (EXE) and fulvestrant (FUL) in the treatment of postmenopausal women with ER+ HER2- metastatic breast cancer in the United Kingdom (UK) from a societal perspective.
METHODS: A partitioned survival model was developed to compare treatment with EVE+EXE versus EXE and FUL over a 10-year time horizon. Progression-free survival and overall survival for EVE+EXE and EXE were estimated from the BOLERO-2 trial. Log-logistics functions were used to extrapolate trial data beyond the follow-up period. In the absence of head-to-head evidence vs. FUL an indirect treatment comparison was conducted using a Bayesian fixed effect model. Background health state and terminal care resource use were derived from NICE Clinical Guideline 81. Drug costs were taken from the British National Formulary. Productivity loss, defined as working days lost due to disease, was included in the analysis. Utilities from published sources were combined with trial data to calculate quality-adjusted life years (QALYs) for the model health state.
RESULTS: EVE+EXE led to an incremental gain in life years of 0.20 vs. EXE and 0.19 vs. FUL. The incremental QALY gain was 0.31 vs. EXE and 0.27 vs. FUL. The cost of lost productivity was £66,163 in the EVE+EXE compared to £75,067 in the EXE arm and £73,434 in the FUL arm. The incremental cost per QALY was £27,644 vs. EXE and £14,030 vs. FUL. Probabilistic sensitivity analysis demonstrated that, at a threshold of £30,000 per QALY gained, EVE+EXE had a 51.6% likelihood of being cost-effective vs. EXE and 59.0% vs. FUL.
CONCLUSIONS: Patients receiving EVE+EXE experienced an improvement in survival which translated into health gains in terms of both LYs and QALYs. EVE+EXE was associated with savings in productivity costs compared to both EXE and FUL.
BACKGROUND: Several authors have developed and applied methods to routine data sets to identify the nature and rate of complications following interventional procedures. But, to date, there has been no systematic search for such methods. The objective of this article was to find, classify and appraise published methods, based on analysis of clinical codes, which used routine healthcare databases in a United Kingdom setting to identify complications resulting from interventional procedures.
METHODS: A literature search strategy was developed to identify published studies that referred, in the title or abstract, to the name or acronym of a known routine healthcare database and to complications from procedures or devices. The following data sources were searched in February and March 2013: Cochrane Methods Register, Conference Proceedings Citation Index – Science, Econlit, EMBASE, Health Management Information Consortium, Health Technology Assessment database, MathSciNet, MEDLINE, MEDLINE in-process, OAIster, OpenGrey, Science Citation Index Expanded and ScienceDirect. Of the eligible papers, those which reported methods using clinical coding were classified and summarised in tabular form using the following headings: routine healthcare database; medical speciality; method for identifying complications; length of follow-up; method of recording comorbidity. The benefits and limitations of each approach were assessed.
RESULTS: From 3688 papers identified from the literature search, 44 reported the use of clinical codes to identify complications, from which four distinct methods were identified: 1) searching the index admission for specified clinical codes, 2) searching a sequence of admissions for specified clinical codes, 3) searching for specified clinical codes for complications from procedures and devices within the International Classification of Diseases 10th revision (ICD-10) coding scheme which is the methodology recommended by NHS Classification Service, and 4) conducting manual clinical review of diagnostic and procedure codes.
CONCLUSIONS: The four distinct methods identifying complication from codified data offer great potential in generating new evidence on the quality and safety of new procedures using routine data. However the most robust method, using the methodology recommended by the NHS Classification Service, was the least frequently used, highlighting that much valuable observational data is being ignored.
PURPOSE: The aim of this study was to evaluate the cost effectiveness of ranibizumab compared with verteporfin photodynamic therapy (vPDT) or no treatment (observation) in patients with visual impairment due to myopic choroidal neovascularization (CNV).
METHODS: A Markov model with health states defined by best-corrected visual acuity and a 3-month cycle length was developed. It had a healthcare provider (UK National Health Service and personal social services) perspective, a lifetime time horizon, and was based on 2011 prices; future costs and health outcomes were discounted at 3.5 % per annum. Baseline characteristics were based on the phase III RADIANCE (Ranibizumab and vPDT Evaluation in Myopic CNV) study, and year 1 health-state transitions were based on this and the VIP (Verteporfin in Photodynamic Therapy) study. Extensive sensitivity analyses tested the robustness of the model.
RESULTS: The lifetime cost of treating myopic CNV with ranibizumab was £12,866, whereas vPDT and observation were associated with total costs of £14,421 and £8,163, respectively. Ranibizumab treatment produced higher cumulative quality-adjusted life-years (QALYs; 12.99) than vPDT (12.60) or observation (12.45). Ranibizumab treatment was therefore dominant, with greater health gains and lower overall costs than vPDT. Ranibizumab was cost effective compared with observation, with an incremental cost-effectiveness ratio of £8,778/QALY. In the probabilistic sensitivity analysis, ranibizumab had a 100 % and 88 % probability of being cost effective compared with vPDT and observation, respectively, at a willingness-to-pay threshold of £20,000/QALY.
CONCLUSION: This study indicates that ranibizumab therapy is dominant over vPDT for the treatment of visual impairment due to CNV secondary to pathologic myopia in the UK healthcare setting and cost effective compared with observation.
OBJECTIVE: The aim of this paper is to provide new insights into the psychometrics of the Quality of Life in Adult Cancer Survivors (QLACS) questionnaire, originally developed for longer-term survivors 5 + years post-diagnosis. Specifically, to examine the classic psychometric properties of QLACS in a sample of shorter-term survivors, and to undertake Rasch analysis to explore the extent to which the Generic and Cancer-Specific summary scales (and separately-analysed Benefits of cancer domain) are unidimensional, with linear measurement properties and no differential item functioning (DIF).
METHODS: Patients with potentially curable breast, colorectal or prostate cancer completed QLACS 15 months post-diagnosis (N = 407). Score distributions, floor and ceiling effects, internal reliability, and feasibility (completion time and missing data) were examined. Rasch analysis included examination of item fit, DIF and unidimensionality.
RESULTS: The QLACS domains and summary scales had very similar score distributions and classic psychometric properties (no ceiling effects, majority no floor effects, acceptable reliability) to those found in development work with longer-term survivors. Median completion time was 10 min and total missing data 2.3%. The Generic summary scale contained several misfitting items and exhibited multidimensionality. The Cancer-Specific summary scale and Benefits domain showed fit to the Rasch model and demonstrated unidimensionality and no DIF, with just one or no item modifications respectively.
CONCLUSION: QLACS demonstrates similarly good classic psychometric properties among shorter-term as among longer-term survivors, and has good feasibility. The Cancer-Specific summary scale and Benefits domain showed an impressive degree of fit to the Rasch model, although the validity of computing the Generic summary score was not supported.
BACKGROUND: There is evidence to suggest that component randomized controlled trials (RCTs) within systematic reviews may be biased. It is important that these reviews are identified to prevent erroneous conclusions influencing health care policies and decisions.
PURPOSE: To assess the likelihood of bias in trials in 12 meta-analyses.
DESIGN: A review of 12 systematic reviews.
DATA SOURCES: Twelve recently published systematic reviews with 503 component randomized trials, published in the British Medical Journal, The Lancet, Journal of the American Medical Association, and The Annals of Internal Medicine before May 2012.
STUDY SELECTION AND DATA EXTRACTION: Systematic reviews were eligible for inclusion if they included only RCTs. We obtained the full text for the component RCTs of the 12 systematic reviews (in English only). We extracted summary data on age, number of participants in each treatment group, and the method of allocation concealment for each RCT.
DATA SYNTHESIS: Five of the 12 meta-analyses exhibited heterogeneity in age differences (I2 > 0.30), when there should have been none. In two meta-analyses, the age of the intervention group was significantly greater than that of the control group. Inadequate allocation concealment was a statistically significant predictor of heterogeneity in one trial as observed by a metaregression.
CONCLUSIONS: Most of the sample of recent meta-analyses showed that there were signs of imbalance and/or heterogeneity in ages between treatment groups, when there should have been none. Systematic reviewers might consider using the techniques described here to assess the validity of their findings.
Food and feed safety risk assessment uses multi-parameter models to evaluate the likelihood of adverse events associated with exposure to hazards in human health, plant health, animal health, animal welfare, and the environment. Systematic review and meta-analysis are established methods for answering questions in health care, and can be implemented to minimize biases in food and feed safety risk assessment. However, no methodological frameworks exist for refining risk assessment multi-parameter models into questions suitable for systematic review, and use of meta-analysis to estimate all parameters required by a risk model may not be always feasible. This paper describes novel approaches for determining question suitability and for prioritizing questions for systematic review in this area. Risk assessment questions that aim to estimate a parameter are likely to be suitable for systematic review. Such questions can be structured by their "key elements" [e.g., for intervention questions, the population(s), intervention(s), comparator(s), and outcome(s)]. Prioritization of questions to be addressed by systematic review relies on the likely impact and related uncertainty of individual parameters in the risk model. This approach to planning and prioritizing systematic review seems to have useful implications for producing evidence-based food and feed safety risk assessment.
