the eunethta experience – lessons learned for a new eu hta ... · the eunethta experience –...
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Sonia García Pérez
Agencia Española de Medicamentos y Productos Sanitarios
The EUnetHTA Experience – Lessons Learned for a New EU HTA Cooperation
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EUnetHTA - AEMPSEuropean Network of Health Technology AssessmentObjective: to build a sustainable model for the scientific and technical cooperation on Health Technology Assessment (HTA) in Europe
• Joint Action 1 (2010-2012) • Joint Action 2 (2012-2015).
• Joint Action 3 (2016 – 2020) - 78 organisations from 29 countries
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EUnetHTA organisation
HTA Network meetingWim Goettsch
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WP4 – Joint ProductionProduction of joint assessments within the networkHorizon scanning, product selection and prioritisation
Types of Assessments:
Timeframe: • Parallel with the assessment by the CHMP
Activity: • 5/43 medical devices• 2/37 pharma
Joint AssessmentsCollaborative assessments
Rapid Relative Effectiveness Assessments (REA)Full Assessments
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WP5 – Evidence GenerationObjective: Provide support for evidence generation along the lifecycle of thetechnology.
Strand A: Early Dialogues: Advice in an early stage of clinical development
• Parallel Consultations EMA-EUnetHTA: Launched last June– Consolidated Parallel Consultations– Individual Parallel Consultations
• Multi-HTA: Only HTA participation
Activity: • 2 Multi-HTA ED • 11 Parallel Consultations EMA-EUnetHTA
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Parallel Scientific Advice
Parallel Consultations EMA-EUnetHTA
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WP5 – Evidence Generation
Strand B: Post-launch Evidence GenerationFirst pilot of a European registry in parallel with EMA
Informática médica y salud
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WP7 – National ImplementacionObjective: Provide support for the development of a sustainablemechanism of cooperation among HTAb.
Inform about about the stay of play, barriers for implementation, degree of uptake, mechanisms for adaptation and adoption, etc.
Activity: Case Reports
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Policy options for strengthened EU cooperation on HTA
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8th meeting of the HTA Network
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Is the cooperation possible?Same aim:Timely access of health technologies
to patients considering the limitedresources
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Similar methodologies: Same domains included in the asessment: Health problem
and current use of the technology, Description of technical characteristics of the technology, Clinicaleffectiveness/efficacy, Safety, Non-clinical domains
Same comparator: Comparator most likely to be replaced by the new technology
Surrogate and composite endpoints (outcomes) are accepted in the absence of final endpoints
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However… how? Including costs in de assessments? Country and Regional
Specific Budgets
Descentralised or Central coordination?By a existing Agency (EMA)/ New Agency/ Comisson
How it should be financed?? European funding /Member states/ Industry
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“Coming together is a beginning; keeping together is progress; working
together is success” Henry Ford
Thanks for your attention