AMDEA, como miembro de la Coordinadora Nacional de Asociaciones de Espondilitis, ha participado en la presentación del manifiesto respecto a la sustitución de medicamentos biológicos originales por biosimilares. El encuentro tuvo lugar en la sede central en Madrid de la Sociedad Española de Reumatología, el pasado miércoles día 13 de febrero con la presencia del Dr. Gratacós Mamitjá, primer galardonado en el Premio Iberoamericano «José Román» de Investigación en Espondiloartritis 2015.
A continuación puedes leeer el manifiesto, o descargártelo haciendo clic aquí.
ACERCA DE CEADE
Desde la Coordinadora Española de Asociaciones de Espondiloartritis, CEADE, representamos a las personas afectadas por cualquiera de las patologías englobadas bajo esta denominación, defendiendo sus derechos, en aras de conseguir su plena integración en la sociedad. En España, hay aproximadamente 500.000 personas diagnosticadas con estas enfermedades, que en muchos casos generan un alto impacto en la calidad de vida de los pacientes. Desde CEADE velamos por garantizar y mejorar el conocimiento, la asistencia y el manejo de estas patologías.
Como parte del cometido de CEADE, en representación de los intereses y derechos de los pacientes con espondiloartritis, en el presente documento expresamos nuestra posición sobre la introducción de biosimilares en el ámbito sanitario y especialmente en el campo de las enfermedades reumáticas.
ANTECENTES
CEADE ha recogido informaciones de que en algunas comunidades autónomas se están realizando cambios de tratamiento a los pacientes sin que previamente hayan sido informados por su especialista. Según nos relatan y verifican los pacientes ni siquiera el especialista tenía información de dicho cambio, siendo la farmacia hospitalaria quien directamente había realizado una sustitución automática del tratamiento al paciente, sin que éste hubiera sido informado.
Asimismo, en varios hospitales se ha informado al paciente de que no existe posibilidad de seguir con el tratamiento original, ni siquiera en caso de fallo del nuevo fármaco.
Ante este hecho, desde CEADE, queremos poner de manifiesto nuestra total oposición a los cambios de medicamentos biológicos originales a biosimilares que se están llevando a cabo por motivos económicos en algunas comunidades autónomas y hospitales, sin el consenso del reumatólogo y el paciente. Creemos que este hecho vulnera los derechos mínimos de cada paciente, dejando a un lado lo que debería ser prioritario para el sistema de salud: las necesidades específicas de cada enfermo y su contexto vital.
POSICIONAMIENTO DE CEADE SOBRE LOS MEDICAMENTOS BIOSIMILARES
1. Uso de los biosimilares
CEADE está de acuerdo con la implantación de los biosimilares en el sistema de salud, ya que son una opción terapéutica más y han sido aprobados por la EMA y la AEMPS por demostrar biosimilitud en eficacia y seguridad. También entendemos que ayudan a la racionalización del gasto, al mantenimiento del sistema y a una mayor facilidad de acceso a este tipo de tratamientos para los afectados que los precisen debido a la bajada de precios que supone la competencia entre las empresas.
2. Cambio de medicamento biológico original a biosimilar.
Las decisiones sobre un cambio de tratamiento de biológico original a biosimilar, se deben realizar con el consenso entre médico y paciente. El paciente tiene derecho a ser informado sobre las opciones clínicas disponibles y el derecho a decidir libremente.
El consentimiento informado del paciente es indispensable y debe recoger las firmas del paciente y del médico prescriptor.
3. Supuestos en los que el médico considere que es posible realizar un cambio de medicamento biológico original a biosimilar.
El especialista debe ser quien informe al paciente para que éste pueda dar su consentimiento a dicho cambio, tras evaluar los riesgos que pueda tener en su salud. Que sea otro profesional, como por ejemplo el responsable de farmacia hospitalaria, es, como mínimo, de dudosa legalidad, debilita la posición del paciente y su relación con el especialista, generando desconfianza con el sistema.
4. Seguridad clínica y beneficios del paciente.
Estos criterios han de primar en el entorno hospitalario por encima de consideraciones gerenciales y/o económicas. Se trata de uno de los principios fundamentales de la atención sanitaria que reclama la Organización Mundial de la Salud.
5. Regreso al tratamiento original
Esta posibilidad ha de estar siempre contemplada en los casos en que el cambio no tenga éxito, ya sea por pérdida de eficacia del tratamiento, por efectos adversos o por cualquier otra circunstancia.
6. Equidad
El paciente debe poder acceder al tratamiento más adecuado disponible, con independencia de la comunidad autónoma, localidad de residencia y área sanitaria. Por ello, las Autoridades Sanitarias deben aplicar medidas de control para evitar cualquier desigualdad en el acceso a un tratamiento adecuado a cada patología, independientemente del lugar de residencia o del centro de referencia.
MARCO LEGAL
La realización del cambio de medicamento biológico original a biosimilar, en aquellos casos en que no se ha recabado el consentimiento informado del paciente, se realiza en contra de los principios básicos enunciados en el artículo 2 de la Ley 41/2002, de 14 de noviembre, básica reguladora de la autonomía del paciente y de derechos y obligaciones en materia de información y documentación clínica.
- Toda actuación en el ámbito de la sanidad requiere, con carácter general, el previo consentimiento de los pacientes o usuarios. El consentimiento, que debe obtenerse después de que el paciente reciba una información adecuada, se hará por escrito en los supuestos previstos en la
- El paciente o usuario tiene derecho a decidir libremente, después de recibir la información adecuada, entre las opciones clínicas disponibles.
ADHESIÓN AL DOCUMENTO DE POSICIONAMIENTO SOBRE BIOSIMILARES
En febrero de 2018, CEADE, junto a Acción Psoriasis, Asociación Española de Síndrome de Sjögren, Asociación Española de Enfermedad de Behçet, Coordinadora Nacional de Artritis (ConArtritis), Federación Española de Lupus (Felupus), Foro Español de Pacientes y Liga Reumatológica Española (LIRE), se adhirió al documento de posicionamiento sobre fármacos biosimilares junto con la SER i (Sociedad Española de Reumatología), donde dice textualmente:
- Punto 4
El intercambio de un medicamento biológico original por su biosimilar debe ser realizado exclusivamente por el médico prescriptor, con el consentimiento del paciente. En el caso de pacientes con enfermedad estable puede ser aceptable un intercambio entre el fármaco medicamento biológico original de referencia y su biosimilar, aunque debe ser una decisión individualizada y con el consentimiento del paciente.
- Punto 5
Actualmente no hay evidencias científicas sobre la eficacia y la seguridad del intercambio entre distintos biosimilares de un mismo fármaco de referencia. Esto debería de ser tenido en cuenta e informar sobre este punto al paciente en el caso de que el médico prescriptor aconseje un intercambio entre BS.
- Punto 10
El uso óptimo de los biosimilares requiere diálogo e interacción continuos entre médicos, farmacia hospitalaria, asociaciones de pacientes y entidades reguladoras, con la intención de preservar el derecho a la salud de los pacientes y el objetivo de ofertarles productos de calidad, eficaces y seguros.
La directora de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), María Jesús Lamas ha mostrado su acuerdo con la SER en este tema, declarando que «en ningún caso se está sustituyendo la función prescriptora del médico por la de una Comisión, ya que no se ha realizado ninguna modificación en las reglas de sustitución de medicamentos establecidas en la ley. Desde la agencia se considera irregular el cambio de tratamientos ya instaurados sin intervención expresa del médico prescriptor»
En definitiva, creemos en la necesidad de que todos los agentes implicados en el manejo de estas enfermedades pongamos freno a la inequidad y vulnerabilidad de los derechos de los pacientes. Es prioritario y urgente actuar en esta materia, y así lo declaramos en el presente manifiesto.
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