Resumen
Introducción
El objetivo fue estimar los ahorros potenciales derivados de la introducción progresiva del fentanilo intranasal en pectina (PecFent®) en el tratamiento de pacientes mayores de edad con dolor irruptivo oncológico, desde la perspectiva del Sistema Sanitario Español.
Métodos
Se desarrolló un análisis de impacto presupuestario a un año para estimar el coste total por año, por paciente y por episodio, de la administración de los diferentes fentanilos comercializados hasta el momento del análisis. Los datos se obtuvieron de distintas fuentes de literatura y de un panel de 10 expertos. Se consideraron los costes médicos directos de la medicación y los ajustes de dosis, la medicación de rescate y las visitas médicas necesarias. Los costes se expresaron en euros del año 2011. Se realizaron múltiples análisis de sensibilidad univariados.
Resultados
La introducción progresiva de fentanilo intranasal en pectina en el arsenal terapéutico disponible para el tratamiento de los episodios de dolor irruptivo oncológico permite ahorros anuales de 681.020 € en España, considerando únicamente la sustitución por fentanilo intranasal en pectina de un 2,5 % de las actuales formulaciones de otros fentanilos. Los ahorros anuales por episodio y por paciente serían, respectivamente, de 25,42 € y 9,36 €. Los análisis de sensibilidad demostraron que los resultados fueron robustos, y hubo mayores ahorros en aquellos escenarios en los que hay un mayor número de episodios tratados con fentanilo intranasal en pectina (los ahorros anuales oscilarían entre 184.934 € y 15.723.443 €).
Conclusión
Debido al perfil farmacocinético y a la posología de fentanilo intranasal en pectina, los pacientes con este tratamiento supondrán una menor carga económica para el Sistema Sanitario Español, principalmente por el menor consumo de recursos sanitarios que precisarán.
Abstract
Introduction
The objective was to estimate the potential savings related to the progressive introduction of fentanyl pectin nasal spray (PecFent®) for the treatment of adult population with breakthrough cancer pain for the Spanish health care system.
Methods
A one year budget impact model analysis was developed to estimate the total cost per year, per patient and per episode, for the different fentanyl formulations available. Data source was a literature review and a panel of 10 experts. Direct medical costs were considered in the analysis (medication, dose adjustment, rescue medication and medical visits costs). Costs were expressed in 2011 euros. Several univariate sensitivity analyses were performed.
Results
The progressive introduction of fentanyl pectin nasal spray as a therapeutic option for the treatment of breakthrough cancer pain episodes showed savings to the Spanish healthcare system amounting to € 681,020, when considering a substitution of just a 2.5 % of the current fentanyl prescriptions. Yearly savings per episode and per patient were € 25.42 and € 9.36, respectively. The sensitivity analyses demonstrated the robustness of the results, with higher savings in scenarios with a higher number of episodes treated with fentanyl pectin nasal spray (yearly savings would range from € 184,934 to € 15,723,443).
Conclusions
Due to the pharmacokinetics and to the dosage, the treatment with fentanyl pectin nasal spray would result in a lower economic burden for the Spanish health system, mainly because of the lower health resource utilization for these patients.
Bibliografía
Portenoy RK, Bruns D, Shoemaker B, et al. Breakthrough pain in community-dwelling patients with cancer pain and noncancer pain, part 2: impact on function, mood, and quality of life. J Opioid Manag. 2010;6(2):109–16.
Zeppetella G. Impact and management of breakthrough pain in cancer. Curr Opin Support Palliat Care. 2009;3:1–6.
Davies AN, Dickman A, Reid C, Stevens AM, Zeppetella G, Science Committee of the Association for Palliative Medicine of Great Britain and Ireland. The management of cancer-related breakthrough pain: recommendations of a task group of the Science Committee of the Association for Palliative Medicine of Great Britain and Ireland. Eur J Pain. 2009;13(4):331–8.
Porta-Sales J, et al. Dolor irruptivo en cáncer. Med Clin (Barc). 2010;135(6):280–5.
Hwang SS, Chang VT, Kasimis B. Cancer breakthrough pain characteristics and responses to treatment at a VA medical center. Pain. 2003;101:55–64.
Portenoy RK, Payne D, Jacobsen P. Breakthrough pain: characteristics and impact in patients with cancer pain. Pain. 1999;81:129–34.
Zeppetella G. Opioids for cancer breakthrough pain: a pilot study reporting patient assessment of time to meaningful pain relief. J Pain Symptom Manag. 2008;35(5):563–7.
Zeppetella G, O’Doherty DA, Collins S, et al. Prevalence and characteristics of breakthrough pain in cancer patients admitted to a hospice. J Pain Symptom Manag. 2000;20(2):87–92.
Portenoy RP, Burton AW, Gabrail N, et al, On behalf of the Fentanyl Pectin Nasal Spray 043 Study Group. A multicenter placebo-controlled, double-blind, multiple-crossover study of Fentanyl Pectin Nasal Spray (FPNS) in the treatment of breakthrough cancer pain. Pain. 2010. doi:10.1016/j.pain.2010.07.028.
Fortner BV, Okon TA, Portenoy RK. A survey of pain-related hospitalizations, emergency department visits, and physician office visits reported by cancer patients with and without history of breakthrough pain. J Pain. 2002;3:38–44.
European Public Assessment Report—Human Medicinal Products. PecFent®. Disponible en: www.emea.europa.eu.
Collado F. Qué se puede hacer con el dolor intercurrente? Rev Soc Esp Dolor. 2004;11(4):181–3.
Dickman A. Integrated strategies for the successful management of breakthrough cancer pain. Curr Opin Support Palliat Care. 2011;5(1):8–14.
Documento de Consenso sobre el diagnóstico y tratamiento del dolor irruptivo oncológico. Que en 2002 firman la Sociedad Española de Oncología Médica (SEOM), la Sociedad Española de Cuidados Paliativos (SECPAL) y la Sociedad Española del Dolor (SED).
Ficha Técnica PecFent®. Agencia Española del Medicamento y Productos Sanitarios. http://www.aemps.gob.es/cima/fichasTecnicas.do?metodo=detalleForm.
Farrar JT, Cleary J, Rauck R, Busch M, Nordbrock E. Oral transmucosal fentanyl citrate: randomized, double-blinded, placebo-controlled trial for treatment of breakthrough pain in cancer patients. J Natl Cancer Inst. 1998;90(8):611–6.
Rauck RL, Tark M, Reyes E, et al. Efficacy and long-term tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain. Curr Med Res Opin. 2009;25(12):2877–85.
Portenoy RK, Taylor D, Messina J, Tremmel L. A randomized, placebo-controlled study of fentanyl buccal tablet for breakthrough pain in opioid-treated patients with cancer. Clin J Pain. 2006;22(9):805–11.
Brosa M, Gisbert R, Rodríguez JM, Soto J. Principios, métodos y aplicaciones del análisis del impacto presupuestario en el sector sanitario. Pharmacoecon Span Res Artic. 2005;2:64–78.
Mauskopf JA, Sullivan SD, Annemans L, et al. Principles of good practice for budget impact analysis: report of the ISPOR task force on good research practices-budget impact analysis. Value Health. 2007;10:336–47.
López-Abente G, Pollán M, Aragonés N, et al. La situación del cáncer en España. Ministerio de Sanidad y Consumo, Madrid, 2005.
INE. Cifras oficiales de población resultantes de la revisión del Padrón municipal a 1 de enero de 2011. Real Decreto 1782/2011, de 16 de diciembre, por el que se declaran oficiales las cifras de población resultantes de la revisión del padrón municipal referidas al 1 de enero de 2011.
World Health Organization. Cancer pain relief and palliative care. Geneva: World Health Organization; 1996.
Breivik H, Cherny N, Collett B, et al. Cancer-related pain: a pan-European survey of prevalence, treatment, and patient attitudes. Ann Oncol. 2009;20(8):1420–33. doi:10.1093/annonc/mdp001.
Svendsen KB, Andersen S, Arnason S. Breakthrough pain in malignant and non malignant diseases: a review of prevalence, characteristics and mechanisms. Eur J Pain. 2005;9:195–206.
Portenoy RK, Burton AW, Gabrail N, Taylor D, Fentanyl Pectin Nasal Spray 043 Study Group. A multicenter, placebo-controlled, double-blind, multiple-crossover study of Fentanyl Pectin Nasal Spray (FPNS) in the treatment of breakthrough cancer pain. Pain. 2010;151(3):617–24.
Datos IMS, unidades y valores en euros prescritas entre Marzo 2011–Febrero 2012 para el tratamiento del DIO.
Portenoy RK, Payne D, Jacobsen P. Breakthrough pain: characteristics and impact in patients with cancer pain. Pain. 1999;81(1–2):129–34.
Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain. 1990;41(3):273–81.
Zeppetella G, O’Doherty CA, Collins S. Prevalence and characteristics of breakthrough pain in cancer patients admitted to a hospice. J Pain Symptom Manag. 2000;20:87–92.
Petzke F, Radbruch L, Zech D, et al. Temporal presentation of chronic cancer pain: transitory pains on admission to a multidisciplinary pain clinic. J Pain Symptom Manag. 1999;17:391–401.
Fine PG, Busch MA. Characterization of breakthrough pain by hospice patients and their caregivers. J Pain Symptom Manag. 1998;16(3):179–83.
Breivik H, et al. Cancer-related pain: a pan-European survey of prevalence, treatment and patient attitudes. Ann Oncol. 2009;20:1420–33.
Caraceni A, Portenoy RK. An international survey of cancer pain characteristics and syndromes. IASP task force on cancer pain international association for the study of pain. Pain. 1999;82:263–74.
Swanwick M, Haworth M, Lennard R. The prevalence of episodic pain in cancer: a survey of hospice patients on admission. Palliat Med. 2001;15(1):9–18.
Mercadante S. Pharmacotherapy for breakthrough cancer pain. Drugs. 2012. doi:10.2165/11597260-000000000-000000012-6667/12/0000-0000/$55.55/0.
Gomez-Batiste X, Madrid F, Moreno F, et al. Breakthrough cancer pain: prevalence and characteristics in patients in Catalonia, Spain. J Pain Symptom Manag. 2002;24:45–52.
Carulla J, Lynd F, Sanz X, et al. Prevalencia del uso de opioides potentes en Cataluña en pacientes con enfermedad neoplásica avanzada. Med Paliat. 1999;6(2):67–74.
Rodríguez M, Cassinello J, Mañas A, et al. A cross-sectional study to assess the prevalence and impact of breakthrough pain in cancer patients with chronic background pain. Eur J Pain. 2011;5(Suppl):75.
Mauskopf JA, Sullivan SD, Annemans L, et al. Principles of good practice for budget impact analysis: report of the ISPOR task force on good research practices-budget impact analysis. Value Health. 2007;10:336–47.
Scottish Medicines Consortium Advise. Disponible en: http://www.scottishmedicines.org.uk/files/advice/fentanyl_pectin_nasal_spray_PecFent_FINAL_DECEMBER_2010.doc_for_website.pdf.
Consejo General de Colegios de Farmacéuticos. Catálogo de Especialidades Farmacéuticas. Consejo Plus 2012. Madrid: Consejo General de Colegios de Farmacéuticos; 2012.
Oblikue Consulting. Base de datos sanitarios e-salud [consultada 25/01/2011]. Disponible en: http://www.oblikue.com/bddcostes/.
McCarberg BH. The treatment of breakthrough pain. Pain Med. 2007;8(Suppl 1):S8–S13.
Agradecimientos
Financiación y conflicto de intereses
El presente trabajo ha sido financiado por Archimedes Pharma.
Los autores declaran no tener ningún ningún conflicto de intereses pertinente al contexto de este estudio.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
López, R., Cruz, J.J., Gálvez, R. et al. Análisis de impacto presupuestario del uso de fentanilo intranasal en pectina para el tratamiento del dolor irruptivo oncológico. PharmacoEcon Span Res Artic 11, 51–60 (2014). https://doi.org/10.1007/s40277-013-0018-3
Published:
Issue Date:
DOI: https://doi.org/10.1007/s40277-013-0018-3