caa a22 4500 445295260 CHVBK 20180317142539.0 cr unu---uuuuu 170323e20101201xx s 000 0 eng 10.1007/s11657-010-0045-5 doi (NATIONALLICENCE)springer-10.1007/s11657-010-0045-5 An evaluation of the NICE guidance for the prevention of osteoporotic fragility fractures in postmenopausal women [Elektronische Daten] [John Kanis, Eugene McCloskey, Bengt Jonsson, Alun Cooper, Oskar Ström, Fredrik Borgström] Summary: The National Institute for Health and Clinical Excellence (NICE) in the UK issued guidance based on a health economic assessment of interventions for the primary and secondary prevention of osteoporosis. The recommendations in the guidance are unworkable in clinical practice and the foundation on which they are based is insecure. Introduction: The NICE in the UK recently issued final appraisal documents on the health economic assessment of interventions for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. The majority of interventions were considered to be cost-ineffective except at very low T scores for bone mineral density (BMD). Concerns have been raised with respect to the construct and assumptions that populate the model used by NICE and the feasibility of implementing the subsequent guidance. Results: The application of the NICE guidance to primary care is problematic. Intervention thresholds are based on a complex array that includes the agent to be used, age, T scores and the presence of different categories of risk factors. Alendronate is the first-line treatment, but women who cannot take or tolerate alendronate may have to wait till their T score deteriorates before they qualify for treatment. The guidance takes no account of women with a T score > −2.5 SD, of glucocorticoid-induced disease or of men. Newer interventions, such as ibandronate and zoledronic acid, are not included. The development of guidelines by the National Osteoporosis Guideline Group (NOGG) avoids many of these problems and unlike the NICE guidance, can be used with FRAX®, the WHO-supported fracture risk assessment tool. NOGG provides intervention thresholds based on fracture probabilities computed from clinical risk factors for fracture with or without information on BMD that are readily accessed by primary care physicians for the assessment of all postmenopausal women and men over the age of 50years. The NICE guidance is based on a health economic assessment of several interventions. The model used to assess cost-effectiveness is based on Gaussian regression functions which were derived from an individual state transition model. Since the source individual state transition model is not available, the Gaussian functions cannot be evaluated. Moreover, neither the internal nor external validity of the model is established, and the model is not accessible for such an evaluation. Although the NICE model incorporates the clinical risk factors (CRFs) used in FRAX, it neglects the impact of CRFs on the death hazards giving estimates of fracture probability that differ from those using FRAX®. The estimates of cost-effectiveness differ from reference models for reasons that relate in part to the model construct and in particular to the assumptions used to populate the model. Conclusions: The guidance provided by NICE is cumbersome and cannot be readily used in the setting of primary care. The model on which the guidance is based is opaque. The authors do not support the view of NICE that there are no issues which cause it to doubt the validity of the model or that raise justifiable doubts about the appropriateness of the use of the model to inform its guidance. International Osteoporosis Foundation and National Osteoporosis Foundation, 2010 FRAX nationallicence Economic models nationallicence Fracture probability nationallicence Clinical risk factors nationallicence Intervention thresholds nationallicence BMI : Body mass index (computed as kg/m2) nationallicence BMD : Bone mineral density (in this report at the femoral neck measured by dual energy X-ray absorptiometry) nationallicence CRFs : Clinical risk factors nationallicence DSU : Decision support unit nationallicence FAD : Final appraisal document nationallicence FRAX® : Algorithms that assess the probability of fracture related to any combination of clinical risk factors with or without BMD nationallicence HTA : Health technology assessment nationallicence ICER : Incremental cost-effectiveness ratio nationallicence NICE : National Institute for Health and Clinical Excellence nationallicence NOGG : National Osteoporosis Guideline Group nationallicence QALY : Quality-adjusted life years nationallicence RCP : Royal College of Physicians, London nationallicence ScHARR : School of Health and Related Research, University of Sheffield, UK nationallicence T score : The deviation in SD units of measured BMD from the mean of the young adult female reference range nationallicence WHO : World Health Organization nationallicence WTP : Willingness to pay nationallicence Kanis John WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Beech Hill Road, S10 2RX, Sheffield, UK aut McCloskey Eugene Academic Unit of Bone Metabolism, Northern General Hospital, Sheffield, UK aut Jonsson Bengt Stockholm School of Economics, Stockholm, Sweden aut Cooper Alun Crawley Fracture Liaison Service, Crawley, UK aut Ström Oskar i3 Innovus, Stockholm, Sweden aut Borgström Fredrik i3 Innovus, Stockholm, Sweden aut Archives of Osteoporosis Springer-Verlag 5/1-2(2010-12-01), 19-48 1862-3522 5:1-2<19 2010 5 11657 https://doi.org/10.1007/s11657-010-0045-5 text/html Onlinezugriff via DOI 1 review-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s11657-010-0045-5 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Kanis John WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Beech Hill Road, S10 2RX, Sheffield, UK aut NATIONALLICENCE 700 1- McCloskey Eugene Academic Unit of Bone Metabolism, Northern General Hospital, Sheffield, UK aut NATIONALLICENCE 700 1- Jonsson Bengt Stockholm School of Economics, Stockholm, Sweden aut NATIONALLICENCE 700 1- Cooper Alun Crawley Fracture Liaison Service, Crawley, UK aut NATIONALLICENCE 700 1- Ström Oskar i3 Innovus, Stockholm, Sweden aut NATIONALLICENCE 700 1- Borgström Fredrik i3 Innovus, Stockholm, Sweden aut NATIONALLICENCE 773 0- Archives of Osteoporosis Springer-Verlag 5/1-2(2010-12-01), 19-48 1862-3522 5:1-2<19 2010 5 11657 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer