Cinacalcet: a pharmacoeconomic review of its use in secondary hyperparathyroidism in end-stage renal disease.

This article provides an overview of the clinical profile of the calcimimetic agent cinacalcet (Mimpara®, Sensipar®) in the treatment of patients with secondary hyperparathyroidism (SHPT) undergoing dialysis for end-stage renal disease (ESRD), followed by a comprehensive review of pharmacoeconomic analyses with cinacalcet in this patient population. Most patients with ESRD undergoing dialysis develop SHPT, which is associated with disturbances in bone mineral metabolism and the development of fractures, cardiovascular disease and other clinical events. Standard treatment of SHPT includes phosphate binders and active vitamin D derivatives. However, standard treatment alone seldom achieves recommended target plasma or serum levels of parathyroid hormone (PTH), calcium and phosphorous. The addition of cinacalcet to standard therapy in patients with SHPT undergoing dialysis for ESRD improves the likelihood of achieving target biochemical levels compared with standard therapy alone. On the basis of association studies, improvements in these intermediate endpoints are likely to reduce the risk of clinical events, such as fractures and cardiovascular disease. Therefore, part of the acquisition cost of cinacalcet is likely to be offset by reductions in other healthcare resource use, such as reductions in costs associated with a lower likelihood of clinical events, as well as potential reductions in dosages of standard treatment. A number of pharmacoeconomic analyses across various country settings indicate that cinacalcet plus standard therapy is cost effective relative to standard therapy alone if dialysis costs are excluded, or that early initiation of cinacalcet is cost effective compared with delaying cinacalcet treatment until PTH levels become very uncontrolled. However, across analyses with cinacalcet, results were variable and not always favourable. This wide range of results stems from differences in selection of data sources used to populate the models, regional differences in healthcare resource use and costs, as well as other factors. Future cost-effectiveness analyses with cinacalcet should incorporate data on hard clinical outcomes from the EVOLVE study once this information becomes available.