Recommendations for the Health Economics Analysis to be Performed with a Drug to be Registered in Prevention or Treatment of Osteoporosis

Recommendations for the conduct of economic evaluations in osteoporosis: outcomes of an experts’ consensus meeting organized by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the US branch of the International Osteoporosis Foundation

“…Especially, it is important that the model replicates all population estimates for each individual parameter [19]. Validation process should be described and reported (e.g., by estimating the number of fractures produced by the model, lifetime risk of fracture, or life expectancy and comparing them to (epidemiological) data).…”

“…The model needs to be validated in line with the ISPOR/SMDM guidelines for model transparency and validation including face validity, internal validity, cross validity external validity, and predictive validity [ 61 ]. Especially, it is important that the model replicates all population estimates for each individual parameter [ 19 ]. Validation process should be described and reported (e.g., by estimating the number of fractures produced by the model, lifetime risk of fracture, or life expectancy and comparing them to (epidemiological) data).…”

“…Finally, evaluating the effect of implementation of these recommendations on the quality of future economic evaluations in osteoporosis should be considered. Although some disease-specific recommendations for economic evaluations have been developed [16–19], this study is one of the first that provides a list of recommendations and minimum requirements for the design, conduct, and reporting of an osteoporosis-specific economic evaluation.…”

“…The literature search was conducted in January 2018 using the key terms “economic evaluation or cost-effectiveness” and “osteoporosis” in PubMed. The list of relevant articles ( n  = 17) included a background study on health technology assessment and economic evaluation [1]; reviews of economic evaluation in osteoporosis [3, 28]; some examples of published economic evaluations in osteoporosis [5, 8, 29–31]; the technical appendix of a publication [32]; a report of the Institute for Clinical and Economic Review in the USA [33]; a report of the National Institute for Clinical Excellence and Health in the UK [34]; the CHEERS checklist for good reporting of economic evaluation [14]; the recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses from the Second Panel on Cost-Effectiveness in Health and Medicine [15]; and some disease-specific guidelines for economic evaluations [16–19]. A preliminary list of areas where recommendations would be needed was developed by MH and reviewed/completed by SS and JYR.…”

“…An important limitation of such methodological standards is that they are, of necessity, fairly general and tend to neglect the unique circumstances that surround particular clinical context [16]. A few disease-specific guidelines have thus been developed to provide additional disease-specific recommendations for economic evaluations [16–20], including one that is outdated in the field of osteoporosis [19]. To supplement the generally accepted methodologic standards, disease-specific recommendations for the conduct and reporting of economic evaluations can be very useful for improving the quality and use of economic evaluations.…”