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Dequen P.,University of Leicester | Sutton A.J.,University of Leicester | Scott D.A.,Oxford Outcomes Ltd. | Abrams K.R.,University of Leicester
Value in Health | Year: 2014

Objective To evaluate the effect of study identification methods and network size on the relative effectiveness and cost-effectiveness of recommended pharmacological venous thromboembolic events (VTEs) prophylaxis for adult patients undergoing elective total knee replacement surgery in the United Kingdom. Methods A stepwise literature search specifically designed to identify indirect evidence was conducted to extend the original clinical review from the latest National Institute for Health and Care Excellence (NICE) VTE technology appraisal. Different network sizes or network orders, based on the successive searches, informed three network meta-analyses (NMAs), which were compared with a replicated base case. The resulting comparative estimates were inputted in an economic model to investigate the effect of network size on cost-effectiveness probabilities. Results Searches increased the number of indirect comparisons between VTE interventions, progressively widening the relevant network of studies for NMA. Precision around mean relative treatment effects was increased as the network was extended from the base case to first-order NMA, but further extensions had limited effect. Cost-effectiveness analysis results were largely insensitive to variation in clinical inputs from the different NMA orders. Conclusions No standard methodology is currently recommended by NICE to identify the most relevant network of studies for NMA. Our study showed that optimizing the identification of studies for NMA can extend the evidence base for analysis and reduce the uncertainty in relative effectiveness estimates. Although in our example network extensions did not affect the acceptability of available treatments in VTE prevention based on cost-effectiveness results, it may in other applications. © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

Wyrwich K.W.,United Biosource Corporation | Norquist J.M.,Merck And Co. | Lenderking W.R.,United Biosource Corporation | Acaster S.,Oxford Outcomes Ltd.
Quality of Life Research | Year: 2013

Purpose: Interpretation guidelines are needed for patient-reported outcome (PRO) measures' change scores to evaluate efficacy of an intervention and to communicate PRO results to regulators, patients, physicians, and providers. The 2009 Food and Drug Administration (FDA) Guidance for Industry Patient-Reported Outcomes (PRO) Measures: Use in Medical Product Development to Support Labeling Claims (hereafter referred to as the final FDA PRO Guidance) provides some recommendations for the interpretation of change in PRO scores as evidence of treatment efficacy. Methods: This article reviews the evolution of the methods and the terminology used to describe and aid in the communication of meaningful PRO change score thresholds. Results: Anchor- and distribution-based methods have played important roles, and the FDA has recently stressed the importance of cross-sectional patient global assessments of concept as anchor-based methods for estimation of the responder definition, which describes an individual-level treatment benefit. The final FDA PRO Guidance proposes the cumulative distribution function (CDF) of responses as a useful method to depict the effect of treatments across the study population. Conclusions: While CDFs serve an important role, they should not be a replacement for the careful investigation of a PRO's relevant responder definition using anchor-based methods and providing stakeholders with a relevant threshold for the interpretation of change over time. © 2012 Springer Science+Business Media B.V.

Diepgen T.L.,University of Heidelberg | Scheidt R.,University of Heidelberg | Weisshaar E.,University of Heidelberg | John S.M.,University of Osnabruck | Hieke K.,Oxford Outcomes Ltd.
Contact Dermatitis | Year: 2013

Summary Background There is little knowledge about the costs of occupational hand eczema. Objectives To estimate the societal costs of patients with occupational hand eczema in Germany. Methods Resource use during the past year, disease severity and quality of life [Dermatology Life Quality Index (DLQI)] were gathered for patients with occupational hand eczema before they entered a special rehabilitation programme. Costs were calculated from the societal perspective. The analysis focused on all patients and the severity groups no signs/mild (group A) and moderate to severe (group B). Results One hundred and fifty-one patients were analysed, with a mean age of 44.9~years and a mean DLQI score of 10.9; 64.9% were male. Sickness absence was recorded for 62.9% of all patients (76.4~days on average in the last 12~months). Annual societal costs were €8799 per patient. Indirect costs represented 70% of total costs. Quality of life (DLQI) was statistically different across both severity groups (group A, 7.9; group B, 12.9), but direct treatment costs were not (€2705 versus €2610, respectively). There was a trend towards higher indirect costs in patients in severity group B (group A, €5120; group B, €6796). Conclusion The annual societal costs of patients with occupational hand eczema in this study are high, and similar to those for severe psoriasis and atopic dermatitis. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Hawkins N.,Oxford Outcomes Ltd.
Medical decision making : an international journal of the Society for Medical Decision Making | Year: 2010

The authors consider alternative mechanisms that might explain placebo responses and their implications for cost-effectiveness modeling. Three alternative placebo mechanisms are examined: a ''regression to the mean'' effect arising from natural variation and the preferential selection of patients with acutely severe disease into clinical trials, a patient expectancy effect specific to the clinical trial setting (Hawthorne effect), and a patient expectancy effect generalizable to routine clinical practice (true placebo effect). To estimate cost-effectiveness, the authors needed to generalize from trial data to estimate responses to treatment that they would see in routine clinical practice. They use an example analysis of the cost-effectiveness of adjunct epilepsy treatments to illustrate the potential effects of these different placebo mechanisms on this generalization and subsequent cost-effectiveness estimates and adoption decisions. If an acceptable willingness-to-pay threshold of 30,000 per quality-adjusted life year (QALY) is assumed, then each of the placebo effect scenarios identifies a different treatment alternative as being optimum. Estimated cost-effectiveness ratios and associated policy decisions may be sensitive to assumptions regarding the mechanism underlying placebo responses. These assumptions should, if possible, be investigated through analysis of trial or observational data and, in the absence of other evidence, sensitivity analysis.

Linde C.,University of Stockholm | Mealing S.,Oxford Outcomes Ltd. | Hawkins N.,Oxford Outcomes Ltd. | Eaton J.,Oxford Outcomes Ltd. | And 2 more authors.
European Heart Journal | Year: 2011

AimsTo assess the cost-effectiveness of cardiac resynchronization therapy (CRT) compared with optimal medical therapy in patients with New York Heart Association (NYHA) II heart failure (HF) or NYHA I with previous HF symptoms.Methods and resultsA proportion in state model with Monte Carlo simulation was developed to assess the costs, life years and quality-adjusted life year (QALYs) associated with CRT-ON and-OFF over a 10 year time period. Data from 262 patients in the European cohort of the REVERSE clinical trial (QRS ≥ 120 ms, left ventricular ejection fraction ≤ 40, CRT-ON, n=180, CRT-OFF, n=82) were used to model all-cause mortality, change in NYHA class and resource use. EQ-5D preference weights were taken from a previous cost-effectiveness model of CRT and unit costs from national UK databases. Costs and benefits were discounted at 3.5 p.a. Extensive deterministic and probabilistic sensitivity analyses were performed. Compared with CRT-OFF, 0.94 life years or 0.80 QALYs were gained in the CRT ON group at an additional cost of €11 455, yielding an incremental cost-effectiveness ratio of €14.278 per quality-adjusted life year (QALY) gained. At a threshold of €33 000 (£30 000) per QALY gained, the probability that CRT is cost-effective is 79.6. Cardiac resynchronization therapy becomes cost effective after ∼4.5 years. Cardiac resynchronization therapy needs only to demonstrate a modest impact on all cause mortality (hazard ratio=0.82) in order to demonstrate cost-effectiveness. The results are robust to changes in all other parameters.ConclusionCardiac resynchronization therapy is a cost-effective intervention for patients with mildly symptomatic HF and for asymptomatic patients with left ventricular dysfunction and previous HF symptoms. © 2011 The Author.

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