Problema de salud AUGE N° 45
Leucemia en personas de 15 años y más
Leucemia Aguda – Recomendación T2 – Juicio del Panel y Evidencia
T.2 En personas con leucemia linfoblástica aguda Philadelphia positivo Ph (+), el Ministerio de Salud SUGIERE utilizar inhibidores de tirosina quinasa más quimioterapia por sobre quimioterapia sola.
Comentarios del Panel de Expertos:
►El uso de inhibidores de tirosina quinasa aumenta la sobrevida global y sobrevida libre de enfermedad a largo plazo en personas con leucemia linfoblástica aguda Ph (+).
El Panel de Expertos analizó y debatió cada uno de las preguntas de la “Tabla de la evidencia a la decisión”, considerando tanto la evidencia de investigación, experiencia clínica, conocimiento de gestión o experiencia de los pacientes. Una vez consensuada la postura del panel respecto a las preguntas, emitieron un juicio seleccionando la opción de respuesta que mejor representaba la opinión del conjunto (destacada con color). Finalmente cuando el panel emitió su juicio sobre todas las preguntas, se emitió la recomendación.
A continuación se presenta la “Tabla de la evidencia a la decisión” con el resumen de los juicios, la evidencia de investigación evaluada, consideraciones adicionales y comentarios planteados por el panel.
1.- ¿El problema es una prioridad?
| No | Probablemente no | Probablemente sí | Sí | Varía | No lo sé |
|---|
El problemade salud ha sido definido como prioritario de abordar a través de una Guía de Práctica Clínica por la División de Prevención y Control de Enfermedades del Ministerio de Salud. La pregunta ha sido priorizada por el equipo de esta Guía, ya sea porque existía variabilidad o incertidumbre.
2.- ¿Qué tan significativos son los efectos deseables anticipados?
| Trivial | Pequeño | Moderado | Grande | Varía | No lo sé |
|---|
Grandes: El equipo elaborador de la Guía estimó que los efectos deseables de «utilizar inhibidores de tirosina quinasa más quimioterapia» en comparación a «solo quimioterapia» son grandes, considerando la evidencia, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud.
Consideraciones Adicionales
El panel señala que el uso de inhibidores de tirosina kinasa aumenta la sobrevida global y sobrevida libre de enfermedad a largo plazo en pacientes con leucemia linfoblástica aguda Ph(+).
Evidencia de investigación
Tabla de Resumen de Resultados (Summary of Findings)
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Inhibidores de tirosina kinasa para leucemia linfoblástica aguda Philadelphia positivo |
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Población |
Personas con leucemia linfoblástica aguda Philadelphia positivo Ph (+). |
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Intervención |
Inhibidores de tirosina kinasa más quimioterapia |
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Comparación |
Quimioterapia. |
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Desenlaces |
Efecto |
Certeza de la evidencia (GRADE) |
Mensajes clave en términos sencillos |
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Impacto clínico |
Se decidió no construir la tabla de resumen de resultados. Ver detalles en estimador del efecto. |
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— |
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GRADE: Grados de evidencia Grading of Recommendations Assessment, Development and Evaluation.
*Impacto clínico se refiere a cualquier desenlace que tenga impacto directo o indirecto en el manejo de los pacientes. Esto incluye a los desenlaces priorizados por el panel de expertos.
Fecha de elaboración de la tabla: Diciembre, 2018.
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Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de efectos deseables e indeseables
3.- ¿Qué tan significativos son los efectos indeseables anticipados?
| Grande | Moderado | Pequeño | Trivial | Varía | No lo sé |
|---|
Pequeños: El equipo elaborador de la Guía estimó que los efectos indeseables de «utilizar inhibidores de tirosina quinasa más quimioterapia» en comparación a «solo quimioterapia» son pequeños, considerando la evidencia, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud.
Consideraciones Adicionales
Los efectos adversos varían dependiendo de cada inhibidor de tirosina kinasa. Sin embargo, la mayoría de estos efectos son leves y tratables.
Evidencia de investigación
Tabla de Resumen de Resultados (Summary of Findings)
|
Inhibidores de tirosina kinasa para leucemia linfoblástica aguda Philadelphia positivo |
|
|||
|
Población |
Personas con leucemia linfoblástica aguda Philadelphia positivo Ph (+). |
|
||
|
Intervención |
Inhibidores de tirosina kinasa más quimioterapia |
|
||
|
Comparación |
Quimioterapia. |
|
||
|
Desenlaces |
Efecto |
Certeza de la evidencia (GRADE) |
Mensajes clave en términos sencillos |
|
|
Impacto clínico |
Se decidió no construir la tabla de resumen de resultados. Ver detalles en estimador del efecto. |
— |
— |
|
GRADE: Grados de evidencia Grading of Recommendations Assessment, Development and Evaluation.
*Impacto clínico se refiere a cualquier desenlace que tenga impacto directo o indirecto en el manejo de los pacientes. Esto incluye a los desenlaces priorizados por el panel de expertos.
Fecha de elaboración de la tabla: Diciembre, 2018.
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Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de efectos deseables e indeseables
4.- ¿Cuál es la certeza general de la evidencia sobre efectos?
| Muy baja | Baja | Moderada | Alta | Ningún estudio incluido |
|---|
Ningún estudio incluido: No se encontraron estudios que respondieran la preguntan de interés, por lo tanto existe considerable incertidumbre respecto del efecto de «utilizar inhibidores de tirosina quinasa más quimioterapia» en comparación a «solo quimioterapia».
5.- ¿Hay incertidumbre importante o variabilidad sobre qué tanto valora la gente los desenlaces principales?
| Incertidumbre o variabilidad importantes | Posiblemente hay incertidumbre o variabilidad importantes | Probablemente no hay incertidumbre ni variabilidad importantes | No hay variabilidad o incertidumbre importante |
|---|
No hay variabilidad o incertidumbre importante: En función de la evidencia de investigación, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud, el equipo elaborador de la Guía consideró que no existe incertidumbre o variabilidad importante respecto a lo que escogería una persona informada de los efectos deseables e indeseables de «utilizar inhibidores de tirosina quinasa más quimioterapia» y «solo quimioterapia». Todas o casi todas las personas escogerían utilizar inhibidores de tirosina quinasa más quimioterapia.
Evidencia de investigación
No se encontraron estudios que desarrollen los valores y preferencia de pacientes con Leucemia Aguda linfoblástica Ph (+) y los medicamentos indicados.
Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de valores y preferencias de los pacientes
6.- El balance entre efectos deseables e indeseables favorece la intervención o la comparación?
| Favorece la comparación | Probablemente favorece la comparación | No favorece la intervención ni la comparación | Probablemente favorece la intervención | Favorece la intervención | Varía | No lo sé |
|---|
Favorece la intervención: Considerando que la intervención es «utilizar inhibidores de tirosina quinasa más quimioterapia» y la comparación es «solo quimioterapia», el equipo elaborador de la Guía opinó que el balance entre efectos deseables e indeseables claramente favorece «utilizar inhibidores de tirosina quinasa más quimioterapia».
7.- ¿Qué tan grandes son los recursos necesarios (costos)?
| Costos extensos | Costos moderados | Costos y ahorros despreciables | Ahorros moderados | Ahorros extensos | Varía | No lo sé |
|---|
Costos extensos: El equipo elaborador de la Guía consideró que los costos de «utilizar inhibidores de tirosina quinasa más quimioterapia» son grandes si se compara con los costos de «solo quimioterapia», en función de los antecedentes, experiencia clínica, conocimiento de gestión o experiencia de los pacientes.
Consideraciones Adicionales
El panel destaca que hay que considerar que se estima 50 a 60 casos nuevos al año en personas mayores de 15 años.
Evidencia de investigación
Tabla. Precios referenciales *
|
|
Personas mayores de 15 años y menores de 60 años con leucemia linfoblástica aguda Philadelphia positivo Ph (+) |
||
|
Realizar quimioterapia más Inhibidores de la Tirosina Quinasa (TKI) de 1era y 2ª generación** |
Realizar quimioterapia sin TKI |
||
|
QMT: Protocolo Mayores de 15 y menores de 60 años LLA Ph +
|
QMT Con Imatinib (De marca)
|
QMT Con Imatinib (Genérico)
|
QMT Sin imatinib
|
|
Inducción Hyper-CVAD, CICLO A
|
$362.237
|
$90.559
|
$ 137.313
|
|
Hyper CVAD, Ciclo B (cálculo a 1 año)
|
$6.491.082 |
$ 1.622.771
|
$ 626.992
|
|
Mantención Hyper-CVAD |
$15.176.160 |
$ 3.794.040 |
$3.608.640 |
|
|
$ 22.029.479 |
$ 5.507.370 |
$ 4.372.945 |
|
Total |
$ 22.029.479 |
$ 5.507.370 |
$ 4.372.945 |
*El porcentaje de cobertura del seguro de salud sobre el precio de la(s) prestación(es) sanitaria(s), dependerá del tipo de seguro de cada paciente.
**Otro TKI: Dasatinib (70 mg) 70 mg c/12 hrs VO x día x30 días x 24 meses $ 69.003 por comprimido= $ 66.364.320
Referencias
1. Precios obtenidos de la base de datos del Estudio de Verificación de Costos 2015 MINSAL. El precio fue actualizado utilizando la UF al 1 de julio 2018.
2. Precio de Imatinib fue obtenido de Mercado Público, últimas adjudicaciones 2018.
2. Precio de Imatinib fue obtenido de Mercado Público, últimas adjudicaciones 2018.
Búsqueda y Síntesis de Evidencia
Búsqueda de costos
8.- ¿La costo-efectividad de la intervención beneficia la intervención o la comparación?
| Favorece la comparación | Probablemente favorece la comparación | No favorece la intervención ni la comparación | Probablemente favorece la intervención | Favorece la intervención | Varía | Ningún estudio incluido |
|---|
Probablemente favorece la intervención: Considerando que la intervención es «utilizar inhibidores de tirosina quinasa más quimioterapia» y la comparación es «solo quimioterapia», el equipo elaborador de la Guía opinó que probablemente la alternativa más costo-efectiva es «utilizar inhibidores de tirosina quinasa más quimioterapia».
Evidencia de investigación
No hay estudios costo-efectividad.
Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de costo-efectividad y de costos
9.- ¿Cuál sería el impacto en equidad en salud?
| Reducido | Probablemente reducido | Probablemente ningún impacto | Probablemente aumentado | Aumentado | Varía | No lo sé |
|---|
Reducida: El equipo elaborador de la Guía consideró que la equidad en salud se reduciría si se recomendase «utilizar inhibidores de tirosina quinasa más quimioterapia», dado que identificó grupos o contextos que actualmente tiene barreras de acceso importantes, ya sea en términos económicos, geográficos u otros.
10.- ¿La intervención es aceptable para las partes interesadas?
| No | Probablemente no | Probablemente sí | Sí | Varía | No lo sé |
|---|
Probablemente no: El equipo elaborador de la Guía consideró que «utilizar inhibidores de tirosina quinasa más quimioterapia» probablemente NO es aceptable para las partes interesadas (profesionales de la salud, gestores de centros de salud, directivos de centros de salud, pacientes, cuidadores, seguros de salud, otros).
11.- ¿Es factible implementar la intervención?
| No | Probablemente no | Probablemente sí | Sí | Varía | No lo sé |
|---|
Sí: El equipo elaborador de la Guía consideró que «utilizar inhibidores de tirosina quinasa más quimioterapia» SÍ es factible implementar, contemplando la capacidad de la red asistencial, los recursos humanos disponibles a nivel país, recursos financieros, etc.