Reglamento de ETS de la Unión

Europea y su recorrido

Dr. Iñaki Gutiérrez-Ibarluzea

Osteba, Servicio de Evaluación de Tecnologías Sanitarias de Euskadi

Departamento de Salud. Gobierno Vasco

16:00-17:00h: Taller 2: “Agencias de ETS, hacia recomendaciones vinculantes”

Los sistemas sanitarios…

» “You have to start with the truth. The truth is the only way that we can get anywhere. Because any decision-making that is based upon lies or ignorance can't lead to a good conclusion.”

― Julian Assange

» “The idea of technology is very simple, it’s the idea of knowledge applied to a purpose. But in health care we draw on a lot of knowledge and we have many, many different purposes. And the question for us always in health care is, ‘are we using that knowledge in a way that truly advances health?”

― Harvey V Fineberg. IOM 2012

Guión

• La tecnología y la ETS

• Historia de la ETS en Europa

– Eur-ASSESS

– HTA in Europe

– ECHTA-ECAHI

• La irrupción de EUnetHTA

• La nueva directiva y sus implicaciones

– Directiva dispositivos médicos

15/11/2018

El tema

12+1 Reunión Científica

ASOCIACIÓN ESPAÑOLA DE EVALUACIÓN DE TECNOLOGÍAS SANITARIAS

Valoración del evaluador vs

Evaluación del regulador

¿Qué es tecnología?

«la aplicación sistemática

del conocimiento

científico y de otro tipo a

la resolución de

problemas prácticos»

Galbraith, J. K. (1967).

The new industrial state.

Boston, MA: Houghton Mifflin.

5

¿Qué es ETS?

• The systematic evaluation of the properties and effects of a health technology, addressing the direct and intended effects of this technology, as well as its indirect and unintended consequences, and aimed mainly at informing decision making regarding health technologies.

HTA glossary

• Technology assessment is a form of policy research that examines short- and long-term social consequences (for example, societal, economic, ethical, legal) of the application of technology. The goal of technology assessment is to provide policy-makers with information on policy alternatives

(Banta 1993).

¿Pero qué es ETS?

• Technology Assessment is a concept, which embraces different forms of policy analysis on the relation between science and technology on the one hand, and policy, society and the individual on the other hand. Technology Assessment typically includes policy analysis approaches such as foresight; economic analysis; systems analysis; strategic analysis etc. …

– (European Parliamentary Technology Assessment 2013).

La ETS y sus dimensiones

Dimensión cognitiva

Dimensión normativa

Dimensión pragmática

1. Recuperar conocimiento

relevante para la toma de

decisiones

2. Establecer dialogo

que soporte la toma de

decisiones

3. Establecer un

procreso que facilite o

sustente las decisiones

European Parliamentary Technology Assessment 2013

Interacciones que se requieren

Tecnología

Sociedad

Políticas

Clinicalresearch

Health ServicesRelated

Assessment

Appropriate use

Innovation

PreclinicalResearch

RD+i

RegulationMarket authorisation

InvestmentHealth provision

DisinvestmentExclusion from provision

Research & developmentEarly dialogue

HTA reports

Including ELSOI

and economic

analysis

Clinical Practice Guidelines and

Post-introduction HTA reassessments

Clinical trials and other epidemiological designs

Proofs of conceptTechnology

feasibility reports

Evidence based life

cycle information

Health Impact

Assessment

Health Technology Assessment

Health Technology

Management

Health Needs

Assessment

Una relación entre preguntas y respuestas

Necesidades en salud y bienestar Tecnologías dirigidas a la salud y el bienestar

Demanda Oferta

La necesidad de una ETS para Europa

Therapeutic relevance Economic considerations

France Safety, effectiveness, severity of disease,

curative nature of product, interest in

terms of public health

Budget impact. New products with added therapeutic

value will be subject to economic evaluation from Oct

2013

Germany Yes, but the drug must not belong to

one of the categories excluded from

reimbursement by Federal Law

Efficiency frontier method (Caro 2010)

Italy Clinical effectiveness, disease relevance No

Belgium Efficacy, disease relevance Cost-effectiveness for innovative products, budget

impact

Denmark Yes Reasonable price in relation to therapeutic value

Netherlands Added therapeutic value Cost-effectiveness, budget impact

Spain Therapeutic value Reasonable price in relation to therapeutic value,

cost-effectiveness, budget impact

Sweden Yes Cost-effectiveness, need and solidarity, human

values principles

UK NICE does not grade products according

to therapeutic value

Cost-effectiveness

15/11/2018

Table 1.The goal and scope of HTA in European countries (Adapted from Paris and Belloni 2013)

¿Cómo decidimos?

Que no ¿Cómo evaluamos?

Europa paradigmática en la ETS

• Suecia (1987)

• España (1989)

– AQUAS (1989-1995)

– Osteba (1992)…

• NICE (1999)

• IQWIG (2004)

Los primeros intentos

• INAHTA (1993)

• EuroScan (1998)

• EUR-ASSESS (1994-1997)

• HTA in Europe (1997-1998)

• ECHTA-ECAHI (2000)

• EUnetHTA project (2006-2008)

• EUnetHTA collaboration(2009)

• EUnetHTA network– JA1 (210-2012)

– JA2 (2012-2015)

– JA3 (2016-2020

EUR-ASSESS (1994-1997)

• During 1994 to 1997, the Commission funded a collaborative project called the EUR-ASSESS project, which aimed at:

1. Harmonising the methodology for assessments,

2. Exploring mechanisms for efficient dissemination of results,

3. Investigating the possibilities of linking the results of assessments to financing and reimbursement and

4. Developing a process for setting priorities in health technology assessment.

HTA in Europe (1997-98)

• Aims:

1. Contribute to the effectiveness and cost-effectiveness of health care in Europe through improved HTA,

2. Contribute to the development of institutions for health care technology assessment in Europe,

3. Strengthen co-ordination of health care technology assessment in Europe,

4. Contribute to the development of methods of information transfer among European countries and

5. Furnish guidance to the European Commission concerning how to strengthen and aid co-ordination of HTA activities in Europe.

ECHTA-ECAHI (2000)

• Aims.

1. To assess health promotion and disease prevention activities in terms of benefits, risks, and economic, social, and ethical implications as a complement to community health indicators;

2. To develop systems for routine exchange of information between programs on: Emerging technology issues; Priorities for future evaluation; Conduct and timing of ongoing evaluations, including findings from evaluations;

3. To identify possible joint assessments and to coordinate findings and existing resources within the community to support joint assessments;

4. To develop and disseminate best practice in undertaking and reporting assessments, and to identify needs for methodologic development;

5. To develop and coordinate education and support networks for individuals and organizations undertaking or using assessment of health interventions, and to identify needs in the field and assist in the establishment of new provisions; and

6. To identify and share successful approaches to link findings of assessments, their contribution to health indicators, and healthcare decision making.

ECHTA-ECAHI (2000)

• “Nearly all of the European Union governments have established agencies for health technology assessment. Their purpose is to provide policy makers, the medical profession and the general public with syntheses of findings from research on the relative effectiveness and cost-effectiveness of different medical technologies.

• Most of the agencies have no regulatory function, but are advisory bodies.

• Different models are used at the operational level, especially in the methodology of synthesising evidence and in the dissemination of findings.

• Obviously, scientific evidence needs to be interpreted in the light of each country’s system for health care, its culture, demography, disease panorama, health care organisations, resources and wealth.”

EUnetHTA (2006-2020)

• Proyecto

• Colaboración

• Red

– Acciones conjuntas

1. Harmonización y

metodología

2. Utilización práctica de

los métodos

desarrollados

3. Producción conjunta e

impacto en los sistemas

Y después de EUnetHTA ¿Qué…?

La nueva directiva UE en ETS

– Unidades de ETS• Capacidad

• Compartir información y metodologías

• Realizar evaluaciones conjuntas

– Tomadores de decisiones • Información, transparencia y

rendición de cuentas

– Industria• Risk aversion, reglas del juego

– Pacientes• Acceso a tecnología en base a

valor que incluya sus resultados de interés

– Profesionales• Acceso a tecnología sobre bases

e incentivos claros y establecidos

¿Cómo empezó todo?

• En 2016, la UE comienza un informe para establecer una cooperación estable en ETS ebrespuesta a los estados miembros, el parlamentoeuropeo y las partes interesadas para asegurar suestabilidad más allá del 2020.

• Objetivos:1. Mejorar la disponibilidad de tecnología innovadora

para los pacientes de la UE

2. Asegurar la eficiencia de los recursos y reforzar la calidad de la ETS en la UE

3. Mejorar la previsibilidad de negocio.

La evolución…2018

1 octubre aprobado ENVI en

el parlamento europeo

12-13 septiembre. 62 enmiendas

aceptadas.

9 julio, convocados 300

stakeholders

1 julio la presidencia

Austriaca intenta conseguir acuerdo en los 8 primeros

artículos

31 enero propuesta enviada

parlamento

La decisión que desbloquea

Futuros desarrollos y retos

• ¿Una agencia única para los dominios de efectividad relativa?

• Una extensión del mandato de EMA … y en otras tecnologías?

• Directriz sobre dispositivos médicos

• Financiación

• Coordinación y localización

Más…

Dr. Iñaki Gutiérrez-Ibarluzea

Osteba,

Gobierno Vasco

Donostia-San Sebastian, 1

01010 – Vitoria-Gasteiz

osteba7-san@euskadi.eushttp://www.osakidetza.euskadi.eus/osteba

https://www.facebook.com/pages/Osteba/365563420144977