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Economic Evaluation of Cinacalcet in the Treatment of Secondary Hyperparathyroidism in Italy


Background: Imbalanced levels of parathyroid hormone (PTH), serumcalcium (Ca) and phosphorous (P) are associated with an increased risk of cardiovascular (CV) death and fracture in dialysis patients with secondary hyperparathyroidism (SHPT). The calcimimetic agent cinacalcet can attenuate the mineral and hormonal imbalances characteristic of SHPT and may improve outcomes in such patients. Here we describe a cost-utility analysis of cinacalcet for SHPT in dialysis patients in Italy.

Methods: We developed a probabilistic Markov model to simulate the effect of cinacalcet on Ca, P and PTH levels in dialysis patients with SHPT, based on data from a European, multicentre, open-label study. The model then correlated these levels with mortality and morbidity (CV events, fractures and parathyroidectomies) using data from the literature, and incorporated Italian data for dialysis, drugs and management of events according to the national cost structure. The simulation horizon was patient lifetime; simulated treatment alternatives were standard treatment (mainly vitamin D sterols and phosphate binders) and cinacalcet + standard treatment.A 3.5% discount rate was applied to life expectancy (LE), quality-adjusted life-expectancy (QALE), costs and times below the upper ranges (time in range [TiR]) recommended by the National Kidney Foundation–Kidney Disease Outcomes Quality initiative for PTH, Ca, P and Ca × P. Utilities were derived from the published literature and took into account dialysis and the impairment of quality of life due to the occurrence of CV events and fractures. Costs were evaluated in year 2009 values from the perspective of the Italian National Healthcare System.

Results: Baseline results were calculated with 10 000 iterations. Compared with standard treatment alone, addition of cinacalcet was associated with a mean (SD) increase in TiR of 5.26 (6.59), 3.63 (6.87), 1.70 (6.66) and 2.68 (5.55) discounted patient-years for PTH, Ca and P, respectively, and combined PTH, Ca, P and Ca × P. Cinacalcet increased LE by 1.20 (3.75) life-years (LYs) and QALE by 0.89 (2.59) QALYs. When including the cost for dialysis, the incremental cost-effectiveness ratio (ICER) was €50 012 per LY and €67 361 per QALY, while, if dialysis costs were not included, the ICER was €23 473 per LY and €31 616 per QALY.

Conclusions: The results suggest that cinacalcet treatment could be considered cost effective for treatment of SHPT in the Italian healthcare setting, but further investigations are needed to confirm these findings.

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  1. 1.

    We checked for homogeneity in sex and age, as other data were not available. With respect to these two potential confounders the subgroups were almost homogeneous, although a formal test was not possible due to low numbers in each of the 16 subgroups.


  1. 1.

    Goodman WG, Goldin J, Kuizon BD, et al. Coronary-artery calcification in young adults with end-stage renal disease who are undergoing dialysis. N Engl J Med 2000; 342: 1478–83

    PubMed  Article  CAS  Google Scholar 

  2. 2.

    Ganesh SK, Stack AG, Levin NW, et al. Association of elevated serum PO(4), Ca x PO(4) product, and parathyroid hormone with cardiac mortality risk in chronic hemodialysis patients. J Am Soc Nephrol 2001; 12: 2131–8

    PubMed  CAS  Google Scholar 

  3. 3.

    London GM, Guérin AP, Verbeke FH, et al. Mineral metabolism and arterial functions in end-stage renal disease: potential role of 25-hydroxyvitamin D deficiency. J Am Soc Nephrol 2007; 18: 613–20

    PubMed  Article  CAS  Google Scholar 

  4. 4.

    Kraśniak A, Drozdz M, Pasowicz M, et al. Factors involved in vascular calcification and atherosclerosis in maintenance haemodialysis patients. Nephrol Dial Transplant 2007; 22: 515–21

    PubMed  Article  Google Scholar 

  5. 5.

    Jadoul M, Albert JM, Akiba T, et al. Incidence and risk factors for hip or other bone fractures among hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study. Kidney Int 2006; 70: 1358–66

    PubMed  Article  CAS  Google Scholar 

  6. 6.

    Block GA, Klassen PS, Lazarus JM, et al. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol 2004; 15: 2208–18

    PubMed  Article  CAS  Google Scholar 

  7. 7.

    Young EW, Albert JM, Satayathum S, et al. Predictors and consequences of altered mineral metabolism: the Dialysis Outcomes and Practice Patterns Study. Kidney Int 2005; 67: 1179–87

    PubMed  Article  CAS  Google Scholar 

  8. 8.

    Eknoyan G, Levin A, Levin N. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis 2003; 42 Suppl 3: S1–201

    Article  Google Scholar 

  9. 9.

    Young EW, Akiba T, Albert JM, et al. Magnitude and impact of abnormal mineral metabolism in hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis 2004; 44: 34–8

    PubMed  Article  Google Scholar 

  10. 10.

    Locatelli F. The need for better control of secondary hyperparathyroidism. Nephrol Dial Transplant 2004; 19 Suppl. 5: V15–9

    Article  Google Scholar 

  11. 11.

    Locatelli F, Limardo M, Pontoriero G. New approaches to treatment of secondary hyperparathyroidism. Curr Opin Investig Drugs 2008; 9: 363–70

    PubMed  CAS  Google Scholar 

  12. 12.

    Block GA, Martin KJ, de Francisco ALM, et al. Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. N Engl J Med 2004; 350: 1516–25

    PubMed  Article  CAS  Google Scholar 

  13. 13.

    Moe SM, Cunningham J, Bommer J, et al. Long-term treatment of secondary hyperparathyroidism with the calcimimetic cinacalcet HCl. Nephrol Dial Transplant 2005; 20: 2186–93

    PubMed  Article  CAS  Google Scholar 

  14. 14.

    Messa P, Macário F, Yaqoob M, et al. The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism. Clin J Am Soc Nephrol 2008; 3: 36–45

    PubMed  Article  CAS  Google Scholar 

  15. 15.

    Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work Group. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl 2009; (113): S1–130

    Google Scholar 

  16. 16.

    Chertow GM, Pupim LB, Block GA, et al. Evaluation of cinacalcet therapy to lower cardiovascular events (EVOLVE): rationale and design overview. Clin J Am Soc Nephrol 2007; 2: 898–905

    PubMed  Article  CAS  Google Scholar 

  17. 17.

    Cunningham J, Urena P, Reichel H, et al. Long-term (5-year) efficacy of cinacalcet in secondary hyperparathyroidism (HPT) of end stage renal disease (CKD STAGE 5) [abstract]. XLII ERA-EDTA Congress; 2005 Jun 4–7; Istanbul

    Google Scholar 

  18. 18.

    ISTAT: Italian National Institute of Statistics. Italian population life tables geographical area: Italia–males and females–year: 2005 [online]. Available from URL: [Accessed 2010 Jul 27]

    Google Scholar 

  19. 19.

    SIN-Italian Society for Nephrology. Registro Italiano di Dialisi e Trapianto. Report 2005 [online]. Available from URL: [Accessed 2008 Jun 26]

    Google Scholar 

  20. 20.

    Covic A, Kothawala P, Bernal M, et al. Systematic review of the evidence underlying the association between mineral metabolism disturbances and risk of all-cause mortality, cardiovascular mortality and cardiovascular events in chronic kidney disease. Nephrol Dial Transplant 2009; 24: 1506–23

    PubMed  Article  Google Scholar 

  21. 21.

    Kalantar-Zadeh K, Kuwae N, Regidor DL, et al. Survival predictability of time-varying indicators of bone disease in maintenance hemodialysis patients. Kidney Int 2006; 70: 771–80

    PubMed  Article  CAS  Google Scholar 

  22. 22.

    Slinin Y, Foley RN, Collins AJ. Calcium, phosphorus, parathyroid hormone, and cardiovascular disease in hemodialysis patients: the USRDS waves 1, 3, and 4 study. J Am Soc Nephrol 2005; 16: 1788–93

    PubMed  Article  CAS  Google Scholar 

  23. 23.

    Trespalacios FC, Taylor AJ, Agodoa LY, et al. Heart failure as a cause for hospitalization in chronic dialysis patients. Am J Kidney Dis 2003; 41: 1267–77

    PubMed  Article  Google Scholar 

  24. 24.

    Goldsmith D, Kothawala P, Chalian A, et al. Systematic review of the evidence underlying the association between mineral metabolism disturbances and risk of fracture and need for parathyroidectomy in CKD. Am J Kidney Dis 2009; 53: 1002–13

    PubMed  Article  CAS  Google Scholar 

  25. 25.

    Slinin Y, Foley RN, Collins AJ. Clinical epidemiology of parathyroidectomy in hemodialysis patients: the USRDS waves 1, 3, and 4 study. Hemodial Int 2007; 11: 62–71

    PubMed  Article  Google Scholar 

  26. 26.

    Kestenbaum B, Andress DL, Schwartz SM, et al. Survival following parathyroidectomy among United States dialysis patients. Kidney Int 2004; 66: 2010–6

    PubMed  Article  Google Scholar 

  27. 27.

    de Wit GA, Ramsteijn PG, de Charro FT. Economic evaluation of end stage renal disease treatment. Health Policy 1998; 44: 215–32

    PubMed  Article  Google Scholar 

  28. 28.

    Nichol G, Kaul P, Huszti E, et al. Cost-effectiveness of cardiac resynchronization therapy in patients with symptomatic heart failure. Ann Intern Med 2004; 141: 343–51

    PubMed  Google Scholar 

  29. 29.

    Martin AJ, Glasziou PP, Simes RJ. A cardiovascular extension of the Health Measurement Questionnaire. J Epidemiol Community Health 1999; 53: 548–57

    PubMed  Article  CAS  Google Scholar 

  30. 30.

    Nease RFJ, Kneeland T, O’Connor GT, et al. Variation in patient utilities for outcomes of the management of chronic stable angina. Implications for clinical practice guidelines. Ischemic Heart Disease Patient Outcomes Research Team. JAMA 1995; 273: 1185–90

    Google Scholar 

  31. 31.

    Brazier JE, Green C, Kanis JA. A systematic review of health state utility values for osteoporosis-related conditions. Osteoporos Int 2002; 13: 768–76

    PubMed  Article  CAS  Google Scholar 

  32. 32.

    Garside R, Pitt M, Anderson R, et al. The effectiveness and cost-effectiveness of cinacalcet for secondary hyperparathyroidism in end-stage renal disease patients on dialysis: a systematic review and economic evaluation.Health Technol Assess 2007; 11 (18): iii, xi-xiii, 1–167

    Google Scholar 

  33. 33.

    L’Informatore Farmaceutico. Italian directory of medicines and manufacturers. 69th Rev. Milan: Elsevier, 2009

    Google Scholar 

  34. 34.

    Nomenclatore Tariffario Nazionale: DRG tariffs. DMS 2006 Sep 12. Supplemento Ordinario alla Gazzetta Ufficiale 2006 Dec 13; 289

  35. 35.

    Cunningham J, Danese M, Olson K, et al. Effects of the calcimimetic cinacalcet HCl on cardiovascular disease, fracture, and health-related quality of life in secondary hyperparathyroidism. Kidney Int 2005; 68: 1793–800

    PubMed  Article  CAS  Google Scholar 

  36. 36.

    Eandi M, Giotta N, Santagostino Barbone G. Analisi costo/efficacia di sevelamer nel trattamento dell’iperfosforemia del paziente in dialisi. Farmeconomia e Percorsi Terapeutici 2004; 5: 201–18

    Google Scholar 

  37. 37.

    Briggs A. Handling uncertainty in economic evaluations and presenting the results. In: Drummond M, McGuire A, editors. Economic evaluation in health care. Oxford: Oxford University Press; 2001: 172–214

    Google Scholar 

  38. 38.

    Lindberg JS, Moe SM, Goodman WG, et al. The calcimimeticAMG073 reduces parathyroid hormone and calcium phosphorus in secondary hyperparathyroidism.Kidney Int 2003; 63: 248–54

    PubMed  Article  CAS  Google Scholar 

  39. 39.

    Quarles LD, Sherrard DJ, Adler S, et al. The calcimimetic AMG 073 as a potential treatment for secondary hyper-parathyroidism of end-stage renal disease. J Am Soc Nephrol 2003; 14: 575–83

    PubMed  Article  CAS  Google Scholar 

  40. 40.

    Lindberg JS, Culleton B, Wong G, et al. Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study. J Am Soc Nephrol 2005; 16: 800–7

    PubMed  Article  CAS  Google Scholar 

  41. 41.

    Block GA, Zaun D, Smits G, et al. Cinacalcet hydrochloride treatment significantly improves all-cause and cardiovascular survival in a large cohort of hemodialysis patients. Kidney Int. Epub 2010 Jun 16

    Google Scholar 

  42. 42.

    Fondazione Censis: I trattamenti sostitutivi della funzione renale in Italia: aspetti clinici, economici e sociali: Sintesi dei risultati. Rome, March 2009 [online]. Available from URL: [Accessed 2009 Sep 3]

  43. 43.

    Gincherman Y, Moloney K, McKee C, et al. Assessment of adherence to cinacalcet by prescription refill rates in hemodialysis patients. Hemodial Int 2010 Jan; 14 (1): 68–72

    PubMed  Article  Google Scholar 

  44. 44.

    Sabaté E. editor. Adherence to long term therapies: evidence for action. Geneva: WHO, 2003: 212

    Google Scholar 

  45. 45.

    Hughes D, Cowell W, Koncz T, et al. Methods for integrating medication compliance and persistence in Pharmacoeconomic Evaluations. Value Health 2007; 10: 498–509

    PubMed  Article  Google Scholar 

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L. Pradelli and S. Iannazzo are employees and owners of AdRes Srl, Turin, Italy, an independent health economics consulting and research company. Amgen (Europe) GmbH, Zug, Switzerland, supported the development of the model through a service contract with AdRes.

M. Eandi and G. Pontoriero cooperated with AdRes in the development of the model through a consulting agreement. S. Chiroli is employed by Amgen (Europe) GmbH.

All authors contributed to the paper and approved it. The authors thank Caterina Hatzifoti of Amgen (Europe) GmbH for editorial support. Editorial support was also provided by Julia Balfour, Medical Writer, Kilconquhar, Scotland, with financial support from Amgen.

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Correspondence to Sergio Iannazzo.

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Eandi, M., Pradelli, L., Iannazzo, S. et al. Economic Evaluation of Cinacalcet in the Treatment of Secondary Hyperparathyroidism in Italy. Pharmacoeconomics 28, 1041–1054 (2010).

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  • Chronic Kidney Disease
  • Chronic Kidney Disease Stage
  • Cinacalcet
  • Kidney Disease Outcome Quality Initiative
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