NICE continues to muddy the waters of osteoporosis

Abstract

The storm generated by the National Institute for Health and Clinical Excellence (NICE) over the appraisal of osteoporosis treatments in the UK continues unabated. An editorial in Bone earlier this year outlined the history of the prolonged appraisal process, begun in 2002, that continues to evaluate the cost-effectiveness of interventions for the primary and secondary prevention of osteoporotic fractures [1]. At that time NICE had issued its Final Appraisal Determinations (FADs) for primary and secondary prevention that restricted the use of interventions to generic alendronate [2, 3]. The appraisal was successfully appealed for this and other reasons. As a result, further consultation documents have been issued [4, 5]. The new documents now include appraisals for other treatments, including risedronate, raloxifene, strontium ranelate and (for secondary prevention only) teriparatide. Other changes have been microscopic despite public and private concern. What are these concerns, and why should they trouble the international readership of Osteoporosis International? NICE is one of the premier agencies that assess health technology in the UK. Estimates of cost-effectiveness by an Appraisal Committee are generally followed by Clinical Guidelines issued by a Guideline Development Group (GDG). The guidance that is issued by the Appraisal Committee is mandatory in England and Wales. Despite some criticism [6], NICE has a good track record with a prodigious output of excellent appraisals supported by clinical guidelines. Indeed, the reputation of NICE is such that the many countries that have less capacity for health technology appraisals look to NICE for their own guidance. This is beneficial to the international community where the guidance is fair, but disastrous in other circumstances— which brings us back to osteoporosis. A major concern has been that, despite a six-fold reduction in the price of alendronate, the estimates of cost-effectiveness have barely changed. This has been achieved by alteration of some of the model assumptions, in the absence of new evidence, so that the costeffectiveness of alendronate has remained unchanged despite its fall in price. Furthermore, these changes to the model have had a negative impact on the cost-effectiveness of the other treatments under consideration. The manner in which this has been achieved has been explored in an independent analysis commissioned by the National Osteoporosis Society [7]. Contrary to the findings of NICE, this analysis showed cost-effectiveness of generic alendronate in treating all women with osteoporosis and established osteoporosis, and cost-effective scenarios were found for other treatments in a sensitivity analysis. A second concern relates to the model construct that is based on a 10-year time horizon, rather than considering the lifetime of the patient as is the norm for chronic diseases. As noted previously, “an individual who dies after 9 years is dead for life, and not for 1 year, as would be assumed with a 10-year horizon” [1]. Whereas deaths after 10 years were ‘bolted’ onto the NICE model, none of the other consequences of fracture were included. Sensitivity analyses in the independent report [7] and, ironically, previous Osteoporos Int (2008) 19:1105–1107 DOI 10.1007/s00198-008-0649-4