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2023, Number 40

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INFODIR 2023; 19 (40)

Efficiency and budget impact of nimotuzumab in head and neck cancer

Pérez RL, Collazo HMM, Iznaga ENE

Language: Spanish
References: 37
Page: 1-38
PDF size: 777.83 Kb.


ABSTRACT

Introduction: From a health economics perspective, there is no evidence of the efficiency of nimotuzumab in the treatment of patients diagnosed with advanced stages of head and neck squamous cell cancer.
Objectives: To evaluate the efficiency of incorporating nimotuzumab into the Cuban health system as a treatment for head and neck cancer.
Methods: Two economic cost-effectiveness evaluations were carried out, based on phase III and IV clinical trials, and a budget impact analysis. The universe consisted of all patients included in both studies. Mean cost-effectiveness, incremental cost-effectiveness ratio and budget impact were calculated. Information was obtained from the data collection booklets of the trials and the established methodology for conducting economic evaluations was followed.
Results: The first evaluation showed that the nimotuzumab-radiotherapy combination was an efficient option. In the second evaluation, the sequential radiotherapy/chemotherapy plus nimotuzumab alternative was not cost-effective, although as the drug is included in the Ministry of Public Health's therapeutic scheme, a threshold for cancer treatment of $33,000/life-years gained is considered. The budget impact analysis showed that applying shorter nimotuzumab administration schedules would achieve an avoided cost of between 8-50 million Cuban pesos.
Conclusions: The incorporation of nimotuzumab means an additional cost to the health system, but its effectiveness and safety merit its use and the development of new treatment guidelines based on evidence of its efficacy.


REFERENCES

  1. Ministerio de Salud Pública. Anuario Estadístico de Cuba 2021. La Habana: MINSAP:Dirección Nacional de Registros Médicos y Estadísticas de Salud; 2022 [acceso 17/05/2022]. Disponible en: https://instituciones. sld. cu/fatesa/files/2022/11/Anuario-Estad%C3%ADstico-de-Salud-2021. -Ed-2022. pdf

  2. Pfister DG, Spencer S, Adelstein D, Adkins D, Anzai Y, Brizel DM, et al. NCCN ClinicalPractice Guidelines in Oncology. Head and Neck Cancers, Version 2. 2020. J Natl Compr Canc Netw. 2020 [acceso 30/05/2021];18(7):873-98. Disponible en: https://jnccn. org/view/journals/jnccn/18/7/article-p873. xml

  3. Oliveira M, Lopes AF, Gonçalves AP, Silvério S, Wilson A, Henrique C, et al. Aprospective study on oral adverse effects in head and neck cancer patients submitted to a preventive oral care protocol. Support Care Cancer. 2020 [acceso 30/05/2021]; 28:4263-4273. DOI: https://doi. org/10. 1007/s00520-019-05283-1

  4. Ferreiro J, García JL, Barceló R, Rubio I. Quimioterapia: efectos secundarios. GacMed Bilbao. 2003 [acceso 17/05/2023];100:69-74. Disponible: https://www. elsevier. es/es-revista-gaceta-medica-bilbao-316-pdf-S0304485803744321

  5. Centro Estatal para el Control de Medicamentos (CECMED). Nimotuzumab. Resumen de las características del producto. La Habana: CECMED; 2020 [acceso 30/05/2021]. Disponible en: https://www. cecmed. cu/registro/rcp/cimaherr-nimotuzumab

  6. ACTION Study Group, Jan S, Kimman M, Peters SA, Woodward M. Financialcatastrophe, treatment discontinuation and death associated with surgically operable cancer in South-East Asia: Results from the ACTION Study. Surgery. 2015;157(6):971-82. DOI: http://dx. doi. org/10. 1016/j. surg. 2015. 02. 012

  7. Patterson RH, Fischman VG, Wasserman I, Siu J, Shrime MG, Fagan JJ, et al. Globalburden of head and neck cancer: economic consequences, health, and the role of surgery. Otolaryngol Head Neck Surg. 2020;162(3):296-303. DOI: https://doi. org/10. 1177/0194599819897265 8. Prasad V, Wang RB, Afifi SH, Mailankody S. The rising price of cancer drugs-a newold problem? JAMA Oncol. 2017;3(2):277-8. DOI: 10. 1001/jamaoncol. 2016. 4275 9. Pérez L, Collazo MM, Iznaga N, Viada CE. Evaluación económica del tratamiento connimotuzumab para el cáncer de cabeza y cuello en Cuba. PharmacoEcon Span Res Artic. 2016;13:133–40. DOI: https://doi. org/10. 1007/s40277-016-0063-9

  8. Mauskopf J, Earnshaw SR, Brogan A, Wolowacz S, Brodtkorb TH. Budget-ImpactAnalysis of Health Care Interventions. A practical guide. Switzerland: Springer International Publishing AG; 2017.

  9. Soto J. Evaluación económica de medicamentos y tecnologías sanitarias. Cap. 1,Fundamento e introducción a la evaluación económica de medicamentos y tecnologías sanitarias. Madrid: Springer SBM Spain, S. A. U; 2012. p. 9-20.

  10. ICH Expert Working Group. ICH Harmonised Tripartite Guideline. Statisticalprinciples for clinical trials E9 version 4. London: ICH Expert Working Group; 1998 [acceso 21/07/2019]. Disponible en: http://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline. pdf

  11. Marrero M, García A. Bases conceptuales y metodológicas para estimar el costode las enfermedades neumocócicas en niños en el primer nivel de atención de salud. Rev. Cubana de Salud Pública. 2017 [acceso 21/07/2019];43(3):610-20. Disponible en: https://revsaludpublica. sld. cu/index. php/spu/article/view/919/943

  12. Marseille E, Larson B, Kazi D, Kahn JG, Rosen S. Thresholds for the cost-effectiveness of interventions: alternative approaches. Bull World Health Organ. 2015;93(2):118-24. DOI: 10. 2471/BLT. 14. 138206

  13. Oficina Nacional de Estadística e Información (ONEI). Anuario Estadístico Cuba2020. Cap. 5. Cuentas nacionales. La Habana: ONEI; 2021 [acceso 07/09/2021]. Disponible en: http://www. onei. gob. cu/node/16275

  14. Briggs A, Claxton K, Sculpher M. Decision Modelling for Health EconomicEvaluation. New York: Oxford University Press Inc; 2011.

  15. Consejo de Salubridad General. Guía para la Conducción de Estudios de EvaluaciónEconómica para la Actualización del Cuadro Básico y Catálogo de Insumos del Sector Salud en México. México DF: Dirección General Adjunta de Priorización; 2017 [acceso 23/07/2019]. Disponible en: http://www. csg. gob. mx/descargas/pdf/priorizacion/cuadro-basico/guias/conduccion_estudios/GCEEE_2017_Diciembre_x1x. pdf 18. Sullivan SD, Mauskopf JA, Augustovski F, Caro J, Lee KM, Minchin M, et al. BudgetImpact Analysis-Principles of Good Practice: Report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. Value in health; 2014;17:5-14. DOI: 10. 1016/j. jval. 2013. 08. 2291

  16. Alfonso I, Alonso L, Alonso P, Broche L, Calvo DM, Cruz MA, et al. FormularioNacional de Medicamentos. 4th ed. La Habana: ECIMED; 2014.

  17. Patil VM, Noronha V, Joshi A, Agarwal J, Ghosh-Laskar S, Budrukkar A, et al. Arandomized phase 3 trial comparing nimotuzumab plus cisplatin chemoradiotherapy versus cisplatin chemoradiotherapy alone in locally advanced head and neck cancer. Cancer. 2019;125(18):3184-97. DOI: http://dx. doi. org/10. 1002/cncr. 32179 21. Maasland DH, van den Brandt PA, Kremer B, Goldbohm RA, Schouten LJ. Alcoholconsumption, cigarette smoking and the risk of subtypes of head-neck cancer: results from the Netherlands Cohort Study. BMC Cancer. 2014;14:187. DOI: 10. 1186/1471-2407-14-187

  18. Cardemil F. Epidemiología del carcinoma escamoso de cabeza y cuello. Rev ChilCir. Dic. 2014;6(66):614-20. DOI: http://dx. doi. org/10. 4067/S0718-40262014000600017

  19. Crombet T, Mestre B, Mazorra Z, Iznaga NE. Nimotuzumab for patients withinoperable cancer of head and neck. Front. Oncol. 2020;10(817). DOI: 10. 3389/fonc. 2020. 00817

  20. Viada CE, Vega AM, Robaina M, Frías A, Álvarez M, Santiesteban Y, et al. Evaluaciónde Nimotuzumab para el tratamiento de cáncer de cabeza y cuello: Meta-análisis de ensayos controlados. BioNatura. 2020 [acceso 17/05/2023];5(1):1056-62. Disponible en: https://revistabionatura. com/files/2020_r6c7khv5. 05. 01. 8. pdf

  21. Vega A, Vila L, Venereo P, Valls A, De Armas E, Romero M, et al. Safety andeffectiveness of nimotuzumab in the treatment of advanced head and neck cancer patients. Phase IV clinical trial: final results. JJ Cancer Sci Res. 2019;4:057.

  22. Ang KK, Zhang Q, Rosenthal DI, Nguyen-Tan PF, Sherman EJ, Weber RS, et al. Randomized phase III trial of concurrent accelerated radiation plus cisplatin with or without cetuximab for stage III to IV head and neck carcinoma: RTOG 0522. J Clin Oncol. 2014;32:2940-50. DOI: http://dx. doi. org/10. 1200/JCO. 2013. 53. 5633

  23. Mesía R, Henke M, Fortin A, Minn H, Yunes Ancona AC, Cmelak A, et al. Chemoradiotherapy with or without panitumumab in patients with unresected, locally advanced squamous-cell carcinoma of the head and neck (CONCERT-1): a randomised, controlled, open-label phase 2 trial. Lancet Oncol. 2015;16:208-20. DOI: http://dx. doi. org/10. 1016/S1470-2045(14)71198-2

  24. León X, Hitt R, Constenla M, Rocca A, Stupp R, Kovács AF, et al. A retrospectiveanalysis of the outcome of patients with recurrent or metastatic squamous cell carcinoma of the head and neck who are progressing while on a platinum-based palliative chemotherapy. Proc Am Soc Clin Oncol. 2003;22:502. DOI: 10. 1016/j. clon. 2005. 02. 014

  25. Herbst RS, Arquette M, Shin DM, Dicke K, Vokes EE, Azarnia N, et al. Phase IImulticenter study of the epidermal growth factor receptor antibody cetuximab and cisplatin for recurrent and refractory squamous cell carcinoma of the head and neck. J Clin Oncol. 2005;23:5578-87. DOI: 10. 1200/JCO. 2005. 07. 120

  26. Baselga J, Trigo JM, Bourhis J, Tortochaux J, Cortes-Funes H, Hitt R, et al. A phaseII multicenter study of the anti-epidermal growth factor receptor monoclonal antibody cetuximab in combination with platinum-based chemotherapy in patients with refractory metastatic and/or recurrent squamous cell carcinoma of the head and neck. J Clin Oncol. 2005;23:5568-77. DOI: 10. 1200/JCO. 2005. 07. 119

  27. Trigo R, Hitt R, Koralewski P, Diaz-Rubio E, Rolland F, Knecht R, et al. Cetuximabmonotherapy is active in patients (pts) with platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN): results of a phase II study. Proc Am Soc Clin Oncol. 2004;23:487. DOI: 10. 1200/jco. 2004. 22. 90140. 5502

  28. Vermorken JB, Mesia R, Rivera F. Platinum-based chemotherapy plus cetuximab inhead and neck cancer. N Engl J Med. 2008;359(11):1116-27. DOI: 10. 1056/NEJMoa0802656

  29. Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA. Eastern CooperativeOncology Group. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: An Eastern Cooperative Oncology Group study. J Clin Oncol. 2005;23(24):8646-54. DOI: 10. 1200/JCO. 2005. 02. 4646

  30. Cressman S, Browman GP, Hoch JS, Kovacic L, Peacock SJ. A time-trend economicanalysis of cancer drug trials. The Oncologist. 2015;20:1-8. DOI: 10. 1634/theoncologist. 2014-0437

  31. Bagust A, Greenhalgh J, Boland A, Fleeman N, McLeod C, Dickson R, et al. Cetuximab for Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck A NICE Single Technology Appraisal. Pharmacoeconomics. 2010;28(6):439-48.

  32. Longson C. Update report on the application of the “end-of-life” supplementaryadvice in health technology appraisals. London: Centre for Health Technology Evaluation Peter Littlejohns; 2009 [acceso 20/01/2017]. Disponible en: http://www. nice. org. uk/media/835/8E/ITEM7EndOfLifeTreatments. pdf

  33. Walton MJ, O’Connor J, Carroll C, Claxton L, Hodgson R. A Review of IssuesAffecting the Efficiency of Decision Making in the NICE Single Technology Appraisal Process. Pharmacoecon Open. 2019;3(3):403-10. DOI: https://doi. org/10. 1007/s41669-018-0113-0

  34. Hannouf MB, Sehgal C, Cao JQ, Mocanu JD, Winquist E, Zari GS, et al. Cost-Effectiveness of Adding Cetuximab to Platinum-Based Chemotherapy for First Line Treatment of Recurrent or Metastatic Head and Neck Cancer. PLoS ONE. 2012;7(6): e38557. DOI: 10. 1371/journal. pone. 0038557

  35. Lang Y, Dong D. Cetuximab Plus Chemotherapy versus Chemotherapy Alone inRecurrent or Metastatic Head and Neck Squamous Cell Carcinoma: A Cost-Effectiveness Analysis. Cancer Management and Research. 2020; 12:11383-90. DOI: 10. 2147/CMAR. S272149

  36. González NE, Morales PP, Frómeta C, Ortiz R, Mestre JR, Pérez M, et al. Diagnósticoy Tratamiento del Cáncer de Cabeza y Cuello. La Habana: Editorial de Ciencias Médicas; 2019.

  37. Puig J, Oliva J, Trapero M, Abellán JM, Brosa M. Guía y recomendaciones para larealización y presentación de evaluaciones económicas y análisis de impacto presupuestario de medicamentos en el ámbito del CatSalut. Barcelona: Departament de Salut. Servei Català de la Salut; 2014 [acceso 10/10/2018]. Disponible en: https://n9. cl/hhzhy




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