- Design (study protocol, methods);
- Data collect (algorithms);
- Statistical analysis and data visualization (softwares: R, Python),
- Writing of the study report,
- Publication of the study (international).
Definition : The comparative effectiveness research of an innovative treatment is defined as the estimation of its incremental clinical value, in comparison to the best of comparators (reference strategy) or to all existing treatments (#bayesian multi-treatment meta-analysis #mixed treatment comparison MTC #network meta-analysis NMA #R software # Winbugs).
Mixed Treatment Comparison (MTC)Comparative Effectiveness Research: Direct, Indirect and Mixed Treatment Comparisons (MTC): Positioning your innovative technology in the studied therapeutic area [For Transparency Commission and medico-economic modeling (CEESP)] |
- Static methods: Decision Trees (RStudio, Excel®);
- Dynamic methods: Markovian modeling (homogeneous, non-homogeneous), Semi-Markovian modeling, Markov microsimulation model, MCMC, bayesian modeling (RStudio, R, Winbugs, OpenBugs, Python, Excel®), DICE modeling;
- Interactive Modeling : Cost-Effectiveness Model (CEM), Cost-Utility Model (CUM), Budget Impact Model (BIM);
- Quantifying uncertainty of results: deterministic sensitivity analysis (DSA) and probabilistic (PSA) - Simulation of second-order Monte Carlo and Bootstrap techniques.
- Early meeting with HAS / DEAI
- Adapted or de novo medico-economic models for French settings
- Writing of the technical report (cost-effectiveness or cost-utility analysis, budget impact analysis)
- Writing of the CEESP file
- CEESP auditions
- Franck MAUNOURY, PhD, HDR, can help you validate your medico-economic models (Verification of calculation formulas and functional testing by a statistician health economist not involved in your model development): Usually required by HAS (cf. HAS-CEESP opinions)
Cost-effectiveness ModelingTo estimate an uncertain ex-ante cost-effectiveness of your health technology or innovative treatment (prospective assessment, CEA): Performing the cost-effectiveness acceptability curve (CEAC), the efficiency frontier and positioning the compared strategies with respect to this border. |
Interactive Budget Impact Analysis (IBIA)Assessing the affordability of your innovative product, from the Health insurance perspective. |
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- Correlation analysis and explanatory and predictive models: Linear Regression Analysis, logistic regression, polytomous ordered regression, semi-Markovian modelling (care pathway, time spent in a health state at a given time);
- Use of databases of health system (SNDS): Cost Studies, Cost of illness and care pathway, medical consumption, segmentation of patients and caregivers;
- Comparability of patient groups included in the study: the high dimentional propensity score (hdPS) method(*) (conditional probability for an individual to belong to the treated group, knowing covariates of individuals in the control group);
- Quantifying the uncertainty of results: Parametric simulation of health state pathway with Monte Carlo method (calculation of confidence intervals at 95%).
Cost-effectiveness Studies in Real Life (source : SNDS)
To estimate the ex-post cost-effectiveness of your health strategy, from the Health care system or Health insurance perspective: Statistical analysis and modelling of real life data (cost of illness studies, healthcare pathway analysis, prescription treatment use in real life).
(*)Schneeweiss S, Rassen JA, Glynn RJ, Avorn J, Mogun H, Brookhart MA. High-dimensional propensity score adjustment in studies of treatment effects using health care claims data [published correction appears in Epidemiology. 2018 Nov;29(6):e63-e64]. Epidemiology. 2009;20(4):512‐522. doi:10.1097/EDE.0b013e3181a663cc