Advertisement

PharmacoEconomics Spanish Research Articles

, Volume 8, Issue 3, pp 99–110 | Cite as

Análisis de coste-utilidad de cinacalcet en el hiperparatiroidismo secundario en España

  • Sergio Iannazzo
  • Michela Carsi
  • Francesc Sorio
  • Silvia Chiroli
Artículo de Investigación Original

Resumen

Antecedentes y objetivo: El calcimimético cinacalcet (Mimpara®) es eficaz para controlar los parámetros del metabolismo mineral en pacientes con hiperparatiroidismo secundario (HPTS). La alta secreción de hormona paratiroidea (PTH) y el metabolismo alterado del calcio (Ca) y el fósforo (P) son característicos del HPTS y se asocian a la mortalidad, a la morbilidad cardiovascular (CV) y a un mayor riesgo de fracturas incidentes y paratiroidectomía. El mayor coste del tratamiento con cinacalcet respecto al tratamiento estándar justifica la realización de una evaluación farmacoeconómica completa. Utilizando un modelo de Markov de simulación a nivel de paciente, realizamos una evaluación amplia de coste-utilidad del tratamiento de por vida con cinacalcet añadido al tratamiento estándar (TE) para el HPTS, en el contexto del sistema sanitario español.

Métodos: El modelo estimó la evolución de PTH, Ca y P para pacientes individuales simulados, durante el curso de la vida, siguiendo dos opciones terapéuticas: TE solo y TE más cinacalcet, basándose en datos de un estudio clínico. A continuación, el modelo correlacionó los niveles de Ca, P y PTH con la mortalidad y la morbilidad, basándose en datos publicados españoles e internacionales. Se evaluaron los costes según los precios y tarifas españolas actuales, incluidos los costes de cinacalcet y TE (análogos de la vitamina D y quelantes del fósforo), diálisis, tratamiento de acontecimientos CV, y fracturas y operaciones de paratiroidectomía. Se aplicó una tasa de descuento del 3,5% a costes y resultados.

Resultados: En comparación con los que recibían TE solo, los pacientes tratados con cinacalcet alcanzaron un aumento medio (DE) de 1,20 (3,74) años de vida (AV) y 0,90 (2,62) años de vida ajustados por calidad (AVAC), a un coste adicional de 25.933 € (48.534), sin considerar los costes de diálisis. El riesgo relativo de paratiroidectomía, fractura y hospitalización por CV en los pacientes tratados con cinacalcet fue de 0,41, 0,79 y 0,95, respectivamente, en comparación con el TE solo. La relación de coste-efectividad incremental para cinacalcet fue de 21.695 €/AV y 28.988 €/AVAC, sin incluir los costes de diálisis. Los resultados fueron consistentes en las 10.000 iteraciones realizadas. Un escenario alternativo construido a partir de datos basales tomados de un estudio español multicéntrico, retrospectivo y observacional (REHISET) mostró resultados similares.

Conclusión: Los resultados del modelo mostraron que cinacalcet puede considerarse un tratamiento coste-efectivo para el HPTS en el contexto del sistema sanitario español. Esta conclusión parece estar en consonancia con los hallazgos de dos análisis de coste-consecuencia previos españoles.

Palabras clave

cinacalcet hiperparatiroidismo secundario coste-utilidad España diálisis 

Abstract

Background and objectives: Cinacalcet (Mimpara®), a calcium-mimetic drug, has proved effective to control mineral metabolism parameters in patients with secondary hyperparathyroidism (SHPT). High parathyroid hormone (PTH) release and altered calcium (Ca) and phosphorus (P) metabolism are typical features in SHPT, and such findings are associated to mortality, cardiovascular (CV) morbidity, and a higher risk for incident fractures and parathyroidectomy. Since cost of cinacalcet therapy is higher than costs of standard treatment, a complete pharmacoeconomical evaluation is warranted. Using a Markov model simulation at patient level, a large cost-utility evaluation was carried out for lifelong treatment with cinacalcet added to standard treatment (ST) for SHPT, in Spanish health system context.

Methods: PTH, Ca, and P course was estimated in the model, for simulated individual patients, using two life-long therapeutic options: ST alone and ST plus cinacalcet, based on data from a clinical study. Ca, P, and PTH levels were then correlated with mortality and morbidity, based on published Spanish and international data. Costs were assessed according to current Spanish prices and costs, including costs for cinacalcet and for ST (vitamin D analogues and phosphate quelating agents), dialysis, CV events therapy, and fractures and parathyroidectomy procedures. A 3.5% discount rate was used for both costs and results.

Results: Compared with those receiving ST alone, cinacalcet-treated patients achieved a mean (SD) increase of 1.20 (3.74) life-years (LY) and 0.90 (2.62) quality-adjusted life-years (QALY), with an additional cost of 25,933 € (48,534) (dialysis costs not included). Relative risks for parathyroidectomy, fracture, or CV admission in cinacalcet-treated patients were 0.41, 0.79, and 0.95, respectively, when compared with ST alone. Incremental cost-effectiveness ratio for cinacalcet was 21,695 €/LY and 28,988 €/QALY (dialysis costs not included). Results were consistent for 10,000 iterations. Similar findings were obtained for an alternative scenario bases on baseline data from a Spanish multicentre retrospective observational study (REHISET).

Conclusion: Results from our model demonstrated that cinacalcet can be considered a cost-effective treatment for SHPT in Spanish health system context. Such a conclusion appears to be consistent with findings from two other previous Spanish cost-consequence analyses.

Key words

cinacalcet secondary hyperparathyroidism cost-utility Spain dialysis 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

Bibliografía

  1. 1.
    Wei M, Taskapan H, Esbaei K, y cols. K/DOQI guideline requirements for calcium, phosphate, calcium phosphate product, and parathyroid hormone control in dialysis patients: can we achieve them?. Int Urol Nephrol 2006;38:739–743.PubMedCrossRefGoogle Scholar
  2. 2.
    Arenas MD, Alvarez-Ude F, Gil MT, y cols. Application of NKF-K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease: changes of clinical practices and their effects on outcomes and quality standards in three haemodialysis units. Nephrol Dial Transplant 2006; 21:1663–1668.PubMedCrossRefGoogle Scholar
  3. 3.
    Lindberg JS, Moe SM, Goodman WG y cols. The calcimimetic AMG 073 reduces parathyroid hormone and calcium phosphorus in secondary hyperparathyroidism. Kidney Int 2003; 63:248–254PubMedCrossRefGoogle Scholar
  4. 4.
    Quarles LD, Sherrard DJ, Adler S y cols. The calcimimetic AMG 073 as a potential treatment for secondary hyperparathyroidism of end-stage renal disease. J Am Soc Nephrol 2003; 14: 575–583PubMedCrossRefGoogle Scholar
  5. 5.
    Block GA, Martin KJ, de Francisco ALM, y cols. Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. N Engl J Med 2004;350:1516–1525.PubMedCrossRefGoogle Scholar
  6. 6.
    Moe SM, Cunningham J, Bommer J, y cols. Long-term treatment of secondary hyperparathyroidism with the calcimimetic cinacalcet HCl. Nephrol Dial Transplant 2005;20:2186–2193.PubMedCrossRefGoogle Scholar
  7. 7.
    Cunningham J, Urena P, Reichel H, y cols. Long-Term (5-year) Efficacy of Cinacalcet in Secondary Hyperparathyroidism (HPT) of End Stage Renal Disease (ESRD). XLII ERA-EDTA Congress, June 2005. Poster code SP-210.Google Scholar
  8. 8.
    Arenas MD, Alvarez-Ude F, Gil MT, y cols. Implementation of ‘K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease’ after the introduction of cinacalcet in a population of patients on chronic haemodialysis. Nephrol Dial Transplant 2007;22:1639–1644.PubMedCrossRefGoogle Scholar
  9. 9.
    Messa P, Macário F, Yaqoob M, y cols. The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism. Clin J Am Soc Nephrol 2008;3:36–45.PubMedCrossRefGoogle Scholar
  10. 10.
    Covic A, Kothawala P, Bernal M, y cols. 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;24:1506–1523.PubMedCrossRefGoogle Scholar
  11. 11.
    Goldsmith D, Kothawala P, Chalian A, y cols. 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;53:1002–1013.PubMedCrossRefGoogle Scholar
  12. 12.
    Chertow GM, Pupim LB, Block GA, y cols. Evaluation of Cinacalcet Therapy to Lower Cardiovascular Events (EVOLVE): rationale and design overview. Clin J Am Soc Nephrol 2007;2:898–905.PubMedCrossRefGoogle Scholar
  13. 13.
    Bover J, Torregrosa JV, Lozano J, y cols. Análisis farmacoeconómico de cinacalcet (Mimpara) vs terapia tradicional en el control del metabolismo mineral en pacientes en diálisis con hiperparatiroidismo secundario (HPTS). Nefrología 2007; 27 (Suppl 4):38. Abstract 142Google Scholar
  14. 14.
    Arenas MD, Rebollo P, Álvarez-Ude F, y cols. Is cinacalcet a cost-effective treatment in severe secondary hyperparathy roidism in patients on hemodialysis? Nefrología 2008;28:511–516PubMedGoogle Scholar
  15. 15.
    Garside R, Pitt M, Anderson R, y cols. 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:iii, xi–xiii, 1–167.Google Scholar
  16. 16.
    Eandi M, Pradelli L, Iannazzo S, y cols. Economic evaluation of cinacalcet in the treatment of secondary hyperparathyroidism in Italy. Pharmacoeconomics. 2010;28:1041–54.PubMedCrossRefGoogle Scholar
  17. 17.
    Eandi M, Pradelli L, Iannazzo S, y cols. A Patient-Level Simulation Model for Economic Evaluation of Cinacalcet in the Treatment of Secondary Hyperparathyroidism (SHPT) in Italy. ISPOR 12th Annual European Congress, 25–27 October 2009, Paris, France.Google Scholar
  18. 18.
    INE- Instituto Nacional de Estadística: Mortality tables by age and sex for the population of Spain 2009. http://www.ine.es/jaxi/tabla.do?path=/t20/p319a/serie/l0/&file=01001.px&type=pcaxis&L=0 Last accessed March 28st 2011.Google Scholar
  19. 19.
    S.E.N. - Sociedad Española de Nefrología. Registro Español de Enfermos Renale. Report 2007Google Scholar
  20. 20.
    Block GA, Klassen PS, Lazarus JM, y cols. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol 2004;15:2208–2218.PubMedCrossRefGoogle Scholar
  21. 21.
    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;16:1788–1793.PubMedCrossRefGoogle Scholar
  22. 22.
    Trespalacios FC, Taylor AJ, Agodoa LY, y cols. Heart failure as a cause for hospitalization in chronic dialysis patients. Am J Kidney Dis 2003;41:1267–1277.PubMedCrossRefGoogle Scholar
  23. 23.
    Jadoul M, Albert JM, Akiba T, y cols. Incidence and risk factors for hip or other bone fractures among hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study. Kidney Int 2006;70:1358–1366.PubMedCrossRefGoogle Scholar
  24. 24.
    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.PubMedCrossRefGoogle Scholar
  25. 25.
    Kestenbaum B, Andress DL, Schwartz SM, y cols. Survival following parathyroidectomy among United States dialysis patients. Kidney Int 2004;66:2010–2016.PubMedCrossRefGoogle Scholar
  26. 26.
    de Wit GA, Ramsteijn PG, de Charro FT. Economic evaluation of end stage renal disease treatment. Health Policy 1998;44:215–232.PubMedCrossRefGoogle Scholar
  27. 27.
    Nichol G, Kaul P, Huszti E, y cols. Cost-effectiveness of cardiac resynchronization therapy in patients with symptomatic heart failure. Ann Intern Med 2004;141:343–351.PubMedGoogle Scholar
  28. 28.
    Martin AJ, Glasziou PP, Simes RJ. A cardiovascular extension of the Health Measurement Questionnaire. J Epidemiol Community Health 1999;53:548–557.PubMedCrossRefGoogle Scholar
  29. 29.
    Nease RFJ, Kneeland T, O’Connor GT, y cols. 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;273:1185–1190.PubMedCrossRefGoogle Scholar
  30. 30.
    Brazier JE, Green C, Kanis JA. A systematic review of health state utility values for osteoporosis-related conditions. Osteoporos Int 2002;13:768–776.PubMedCrossRefGoogle Scholar
  31. 31.
    Spanish Official Drug List. Catálogo de Especialidades Farmacéuticas. Consejo General de Colegios, Oficiales de Farmacéuticos. http://www.portalfarma.com. Last accessed March 30th 2011.
  32. 32.
    DRG 2008: Weight of DRG in the National Health System, All Patient version 25.http://www.msc.es/estadEstudios/estadisticas/inforRecopilaciones/anaDesarrolloGDR.htm Last accessed March 28st 2011.
  33. 33.
    Statistics on hospital admittance episodes classified by the DRG. http://www.msc.es/en/estadEstudios/estadisticas/cmbd.htm Last accessed March 28st 2011.
  34. 34.
    Cunningham J, Danese M, Olson K, y cols. Effects of the calcimimetic cinacalcet HCl on cardiovascular disease, fracture, and health-related quality of life in secondary hyperparathyroidism. Kidney Int 2005;68:1793–1800.PubMedCrossRefGoogle Scholar
  35. 35.
    BOE — Boletín Oficial del Estado. Ministerio de Sanidad y Consumo.: Resolution of March 1st, 2006, revising economic conditions applicable in 2006 to the healthcare services. http://www.boe.es/aeboe/consultas/bases_datos/doc.php?coleccion=iberlex&id=2006/04590 Last accessed May 3rd 2010.Google Scholar
  36. 36.
    Bover J, Pérez R, Molina M, y cols. Cinacalcet treatment for secondary hyperparathyroidism in dialysis patients: an observational study in routine clinical practice. Nephron Clin Pract 2011;118:c109–c121PubMedCrossRefGoogle Scholar
  37. 37.
    Briggs A. Handling uncertainty in economic evaluations and presenting the results. In: Economic Evaluation in Health Care. Edited by Drummond M, McGuire A. Oxford University Press; 2001:172–214.Google Scholar
  38. 38.
    World Health Organization. WHO/CHOosing Interventions that are cost/effective (WHO-CHOICE), 2000. Available online at http://www.who.int/choice. Last accessed May 3rd 2010.Google Scholar
  39. 39.
    Raftery J. NICE: faster access to modern treatments? Analysis of guidance on health technologies. Br Med J 2001;323:1300–1303.CrossRefGoogle Scholar
  40. 40.
    Eurostat. Gross domestic product at market prices. Year 2009. http://epp.eurostat.ec.europa.eu/portal/page/portal/national_accounts/data/main_tables. Last accessed March 28 2011Google Scholar

Copyright information

© Adis Data Information BV 2011

Authors and Affiliations

  • Sergio Iannazzo
    • 1
  • Michela Carsi
    • 1
  • Francesc Sorio
    • 2
  • Silvia Chiroli
    • 3
  1. 1.AdRes Health Economics & Outcomes ResearchTurínItalia
  2. 2.Amgen SABarcelonaEspaña
  3. 3.Amgen (Europe) GmbHZugSuiza

Personalised recommendations