Cost-effectiveness analysis of Mucosal Leishmaniasis diagnosis with PCR-based vs parasitological tests in Colombia


Autoři: Liliana Castillo-Rodríguez aff001;  Clemencia Ovalle-Bracho aff002;  Diana Díaz-Jiménez aff001;  Guillermo Sánchez-Vanegas aff002;  Sandra Muvdi-Arenas aff002;  Carlos Castañeda-Orjuela aff001
Působiště autorů: Observatorio Nacional de Salud, Instituto Nacional de Salud, Bogotá, D.C., Colombia aff001;  Hospital Universitario Dermatológico Federico Lleras Acosta, Bogotá, D.C., Colombia aff002
Vyšlo v časopise: PLoS ONE 14(11)
Kategorie: Research Article
doi: 10.1371/journal.pone.0224351

Souhrn

To estimate the cost-effectiveness of available diagnosis alternatives for Mucosal Leishmaniasis (ML) in Colombian suspected patients. A simulation model of the disease’s natural history was built with a decision tree and Markov models. The model´s parameters were identified by systematic review and validated by expert consensus. A bottom-up cost analysis to estimate the costs of diagnostic strategies and treatment per case was performed by reviewing 48 clinical records of patients diagnosed with ML. The diagnostic strategies compared were as follows: 1) no diagnosis; 2) parasite culture, biopsy, indirect immunofluorescence assay (IFA), and Montenegro skin test (MST) combined ; 3) parasite culture, biopsy, and IFA combined; 4) PCR-miniexon; and 5) PCR-kDNA. Three scenarios were modeled in patients with ML clinical suspicion, according to ML prevalence scenarios: high, medium and low. Adjusted sensitivity and specificity parameters of a combination of diagnostic tests were estimated with a discrete event simulation (DES) model. For each alternative, the costs and health outcomes were estimated. The time horizon was life expectancy, considering the average age at diagnosis of 31 years. Incremental cost-effectiveness ratios (ICERs) were calculated per Disability Life Year (DALY) avoided, and deterministic and probabilistic sensitivity analyses were performed. A threshold of willingness to pay (WTP) of three-time gross domestic product per capita (GDPpc) (US$ 15,795) and a discount rate of 3% was considered. The analysis perspective was the third payer (Health System). All costs were reported in American dollars as of 2015. PCR- kDNA was the cost-effective alternative in clinical suspicion levels: low, medium and high with ICERs of US$ 7,909.39, US$ 5,559.33 and US$ 4,458.92 per DALY avoided, respectively. ML diagnostic tests based on PCR are cost-effective strategies, regardless of the level of clinical suspicion. PCR-kDNA was the most cost-effective strategy in the competitive scenario with the parameters included in the present model.

Klíčová slova:

Biopsy – Colombia – Cost-effectiveness analysis – Diagnostic medicine – Health economics – Leishmaniasis – Lesions – Parasitology


Zdroje

1. Lessa MM, Lessa HA, Castro TW, Oliveira A, Scherifer A, Machado P, et al. Mucosal leishmaniasis: epidemiological and clinical aspects. Rev Bras Otorrinolaringol. 2007;73(6):843–7.

2. World Health Organization. Control of the Leishmaniases. Report of a meeting of the WHO Expert Committee on the Control of Leishmaniases. Geneva. 2010.

3. Marsden PD. Mucosal leishmaniasis (“espundia” Escomel, 1911). Trans R Soc Trop Med Hyg. 1986;80(6):859–76. doi: 10.1016/0035-9203(86)90243-9 3037735

4. Ovalle CE, Porras L, Rey M, Ríos M, Camargo YC. Geographic distribution of Leishmania species isolated from patients at the National Institute of Dermatology Federico Lleras Acosta E.S.E., 1995–2005. Biomédica. 2006;26:145–51.

5. Marsden PD. Clinical presentations of Leishmania braziliensis braziliensis. Parasitol Today. 1985;1(5):129–33. doi: 10.1016/0169-4758(85)90057-2 15275583

6. Cuba CC, Marsden PD, Barreto AC, Rocha R, Sampaio RR, & Patzlaff L. Parasitologic and immunologic diagnosis of American (mucocutaneous) leishmaniasis. Bull Pan Am Health Organ. 1981;15(3):249–59. 7030439

7. Weigle KA, de Davalos M, Heredia P, Molineros R, Saravia NG, & D’alessandro A. Diagnosis of cutaneous and mucocutaneous leishmaniasis in Colombia: a comparison of seven methods. Am J Trop Med Hyg. 1987;36(3):489–96. doi: 10.4269/ajtmh.1987.36.489 2437815

8. Zajtchuk JT, Casler JD, Netto EM, Marsden PD, Grogl M, Neafie RC, et al. Mucosal leishmaniasis in Brazil. Laryngoscope. 1989;99(9):925–39. doi: 10.1288/00005537-198909000-00006 2671555

9. Boggild AK, Valencia BM, Veland N, Ramos AP, Calderon F, Arevalo J, et al. Non-invasive cytology brush PCR diagnostic testing in mucosal leishmaniasis: superior performance to conventional biopsy with histopathology. PLoS One. 2011;6(10):e26395. doi: 10.1371/journal.pone.0026395 22046280

10. Gomes CM, de Paula NA, Cesetti MV, Roselino AM, & Sampaio RN. Mucocutaneous leishmaniasis: accuracy and molecular validation of noninvasive procedures in a L.(V.) braziliensis–endemic area. Diagn Microbiol Infect Dis. 2014;79(4):413–8. doi: 10.1016/j.diagmicrobio.2014.05.002 24923211

11. Saenz RE, de Rodriguez CG, Johnson CM, Berman JD. Efficacy and toxicity of pentostam against Panamanian mucosal leishmaniasis. Am J Trop Med Hyg. 1991;44:394–398. doi: 10.4269/ajtmh.1991.44.394 1645930

12. Sampaio RNR, Sampaio JHD, &, Marsden PD. Pentavalent antimony treatment in mucosal leishmaniasis. Lancet. 1980;(i):1097.

13. Meheus F, Balasegaram M, Olliaro P, Sundar S, Rijal S, Faiz MA, et al. Cost-effectiveness analysis of combination therapies for visceral leishmaniasis in the Indian subcontinent. PLoS Negl Trop Dis. 2010;4(9):e818. doi: 10.1371/journal.pntd.0000818 20838649

14. Vanlerberghe V, Diap G, Guerin P, Meheus F, Gerstl S, Stuyft P. Drug policy for visceral leishmaniasis: a cost‐effectiveness analysis. Trop Med Int Heal. 2007;12(2):274–83.

15. Orellano PW, Vazquez N, & Salomon OD. Cost-effectiveness of prevention strategies for American tegumentary leishmaniasis in Argentina. Cad Saude Publica. 2013;29(12):2459–72. doi: 10.1590/0102-311x00172512 24356692

16. Ministerio de la Protección Social—Instituto Nacional de Salud—Organización Panamericana de la Salud. Guía para la atención clinica integral del paciente con Leishmaniasis. Bogotá.; 2010. p. 1–58.

17. Instituto Nacional de Salud Vigilancia y análisis del riesgo en salud pública TG. Informe de evento leishmaniasis, Colombia. 2016. p. 5.

18. Llanos-Cuentas A, Echevarria J, Seas C, Chang E, Cruz M, Alvarez E, et al. Parenteral aminosidine is not effective for Peruvian mucocutaneous leishmaniasis. Am J Trop Med Hyg. 2007;76(6):1128–31. 17556623

19. Instituto Nacional de Salud. Informe final Leishmaniasis, Colombia 2014. 2015. p. 1–27.

20. Departamento Administrativo Nacional de Estadística(DANE). Información Estadística Colombia Indicadores de mortalidad 1985–2015.

21. Instituto Nacional de Salud. Informe del evento Leishmaniasis, hasta el periodo epidemiológico IX, Colombia, 2015. 2015. p. 1–22.

22. SISPRO. Ministerio de Salud. Sistema de Vigilancia en Salud Pública (Sivigila). Información notificada 2007–2013.

23. Salomon JA, Vos T, Hogan DR, Gagnon M, Naghavi M, Mokdad A, et al. Common values in assessing health outcomes from disease and injury: disability weights measurement study for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2129–43. doi: 10.1016/S0140-6736(12)61680-8 23245605

24. Soto J, Toledo J, Valda L, Balderrama M, Rea I, Parra R, et al. Treatment of Bolivian mucosal leishmaniasis with miltefosine. Clin Infect Dis. 2007;44(3):350–6. doi: 10.1086/510588 17205440

25. Ovalle‐Bracho C, Díaz‐Toro YR, & Muvdi‐Arenas S. Polymerase chain reaction–miniexon: a promising diagnostic method for mucocutaneous leishmaniasis. Int J Dermatology. 2015;1–9.

26. Disch J, Pedras MJ, Orsini M, Pirmez C, de Oliveira MC, Castro M et al. Leishmania (Viannia) subgenus kDNA amplification for the diagnosis of mucosal leishmaniasis. Diagnostic Microbiol Infect Dis. 2005;51(3):185–90.

27. Fagundes A, Schubach A, De Paula CC, Bogio A, Antonio L de F, Schiavoni PB et al. Evaluation of polymerase chain reaction in the routine diagnosis for tegumentary leishmaniasis in a referral centre. Mem Inst Oswaldo Cruz. 2010;105(1):109–12. doi: 10.1590/s0074-02762010000100018 20209340

28. Marco JD, Barroso PA, Mimori T, Locatelli FM, Tomatani A, Mora MC et al. Polymorphism-specific PCR enhances the diagnostic performance of American tegumentary leishmaniasis and allows the rapid identification of Leishmania species from Argentina. BMC Infect Dis. 2012;12:191. doi: 10.1186/1471-2334-12-191 22894734

29. Ovalle Bracho C, Porras de Quintana L, Muvdi Arenas S, & Rios Parra M. Polymerase chain reaction with two molecular targets in mucosal leishmaniasis’ diagnosis: a validation study. Mem Inst Oswaldo Cruz. 2007;102(5):549–54. doi: 10.1590/s0074-02762007005000061 17710297

30. Thomaz-Soccol A, Mocellin M, Mulinari F, de Castro EA, de Queiroz-Telles F, de Alcântara FS, et al. Clinical aspects and relevance of molecular diagnosis in late mucocutaneous leishmaniasis patients in Paraná, Brazil. Brazilian Arch Biol Technol. 2011;54(3):487–94.

31. Atehortúa S, Ceballos M, Gaviria CF, & Mejía A. Evaluación de la calidad metodológica de la literatura en evaluación económica en salud en Colombia: una revisión sistemática. Biomédica. 2013;33(4):615–30.

32. Smith D, &, Gravelle H. The practice of discounting in economic evaluations of healthcare interventions. Int J Technol Assess Heal Care. 2001;17((02)):236–43.

33. Banco de la República. PIB total por habitante a pesos constantes de 2005 (preliminar). 2014.

34. Gobierno Nacional. Decreto 2423 de 2006, actualizado 2016. Manual tarifario SOAT. 2016;1–112.

35. Ministerio de Salud y Protección Social. Subdirección Enfermedades Transmisibles. 2012.

36. Observatorio de precios de medicamentos y Dispositivos Médicos. Consulta Pública de Precios de Medicamentos en la Cadena de Comercialización—Circular 2 de 2012. 2015.

37. Organización Panamericana de la Salud. Manual de procedimientos para vigilancia y control de las leishmaniasis en las Américas. OPS, editor. Washington, D.C; 2019.

38. Bertram MY, Lauer JA, De Joncheere K, Edejer T, Hutubessy R, Kieny M-P, et al. Use and misuse of thresholds Cost–effectiveness thresholds: pros and cons. Vol. 94, WHO Bulletin. 2016. p. 925–30.

39. Mitropoulos P, Konidas P, Durkin-Konidas M. New World cutaneous leishmaniasis: updated review of current and future diagnosis and treatment. J Am Acad Dermatol. 2010;63(2):309–22. doi: 10.1016/j.jaad.2009.06.088 20303613

40. Lawn SD, Armstrong M, Chilton D, Whitty CJ. Electrocardiographic and biochemical adverse effects of sodium stibogluconate during treatment of cutaneous and mucosal leishmaniasis among returned travellers. Trans R Soc Trop Med Hyg. 2006;100(3.):264–9. doi: 10.1016/j.trstmh.2005.03.012 16289167

41. Rojas R, Valderrama L., Valderrama M, Varona MX, Ouellette M, &, Saravia NG. Resistance to antimony and treatment failure in human Leishmania (Viannia) infection. J Infect Dis. 2006;193(10):1375–83. doi: 10.1086/503371 16619185

42. Vélez Bernal F, Vélez Trujillo JA, Vélez Bernal ID. Reconstrucción quirúrgica tras destrucción nasal por Leishmania Panamensis. Cirugía Plástica Ibero-Latinoamericana. 2013;39(1):73–80.

43. Altman DG, Bland JM. Statistics Notes: Diagnostic tests 2: predictive values. Br Med J. 1994;102.

44. Satow MM, Yamashiro-Kanashiro EH, Rocha MC, Oyafuso LK, Soler RC, Cotrim PC, et al. Appicability of kDNA-PCR for routine diagnosis of American Tegumentary Leishmaniasis in a tertiary reference hospital. Rev Inst Med Trop Sao Paulo. 2013;55(6):393–9. doi: 10.1590/S0036-46652013000600004 24213191

45. Barrio A, Mora MC, Ramos F, Moreno S, Samson R, Basombrío MA. Short report: Use of kDNA-based polymerase chain reaction as a sensitive and differentially diagnostic method of American Tegumentary Leishmaniasis in disease-endemic areas of northern Argentina. Am J Trop Med Hyg. 2007;77(4):636–9. 17978063

46. Galluzzi L, Ceccarelli M, Diotallevi A, Menotta M, Magnani M. Real-time PCR applications for diagnosis of leishmaniasis. Parasites and Vectors. 2018;11(1):1–13. doi: 10.1186/s13071-017-2573-y

47. Saldarriaga OA, Castellanos-Gonzalez A, Porrozzi R, Baldeviano GC, Lescano AG, de Los Santos MB, et al. An Innovative Field-Applicable Molecular Test to Diagnose Cutaneous Leishmania Viannia spp. Infections. PLoS Negl Trop Dis. 2016;10(4):1–12.

48. Mimori T, Sasaki J ichiro, Nakata M, Gomez EA, Uezato H, Nonaka S, et al. Rapid identification of Leishmania species from formalin-fixed biopsy samples by polymorphism-specific polymerase chain reaction. Gene. 1998;210(2):179–86. doi: 10.1016/s0378-1119(97)00663-x 9573358

49. De Fátima Arruda Pereira E, Thomaz-Soccol V, Lima HC, Thomaz-Soccol A, De Castro EA, Mulinari-Brenner F, et al. Molecular diagnosis of leishmaniosis in the Paranástate of southern Brazil. Exp Dermatol. 2008;17(12):1024–30. doi: 10.1111/j.1600-0625.2008.00744.x 18637136

50. Gomes AHS, Armelin IM, Menon SZ, Pereira-Chioccola VL. Leishmania (V.) braziliensis: Detection by PCR in biopsies from patients with cutaneous leishmaniasis. Exp Parasitol. 2008;119(3):319–24. doi: 10.1016/j.exppara.2008.02.014 18442815

51. Niño Cuervo CP. Análisis de Costo-Efectividad de los tratamientos incluidos en la Guía de Atención Integral del Ministerio de Protección Social de 2010 en pacientes adultos con Leishmaniasis Cutánea y Mucocutánea en Colombia: Universidad Nacional de Colombia.

52. Machado de Assis TS, Azeredo-da-Silva ALF, Werneck GL, Rabello A. Cost-effectiveness analysis of diagnostic tests for human visceral leishmaniasis in Brazil. Trans R Soc Trop Med Hyg. 2016;110(8):464–71. doi: 10.1093/trstmh/trw050 27618920

53. Mohammadi M, Bamorovat M, Fasihi Harandi M, Karimi T, Sharifi I, Aflatoonian M. Comparison of three PCR-based methods for simplicity and cost effectiveness identification of cutaneous leishmaniasis due to Leishmania tropica. 2017;12(2):215–23.

54. Peñaloza RE, Salamanca N, Rodríguez JM, Rodríguez J, Beltrán AR. Estimación de la carga de enfermedad para Colombia, 2010. Bogotá, D.C.,: Pontificia Universidad Javeriana; 2010.

55. Strazzulla A, Cocuzza S, Pinzone MR, Postorino MC, Cosentino S, Serra A, et al. Mucosal leishmaniasis: an underestimated presentation of a neglected disease. Biomed Res Int. 2013;1–7.

56. Mcgwire BS, Satoskar AR. Leishmaniasis: Clinical syndromes and treatment. QJM An Int J Med. 107(1):7–14.


Článek vyšel v časopise

PLOS One


2019 Číslo 11