EUnetHTA Joint Action 2010–2012 | www.eunethta.eu
Collaboration in WP5 of
EUnetHTA. First experiences.
Wim Goettsch
HTA Workshop, Brussels, 2010
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–201222
The WP5 Partners
• 1 Lead 1 Co-lead
• 17 Associated Partners
• 12 Collaborative Partners
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Organisation of WP5• SG 1: Overview of the processes, the scope and the
scientific methods used for REA of pharmaceuticalsin European countries/US/Canada/Australia&NewZealand (concept available end 2010)
• SG2: Rapid Model for REA of Pharmaceuticals
• SG3: Full Model for REA of Pharmaceuticals
• SG4: Methodological issues for REA
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–20124
SG1 (CVZ)• Literature search on country overviews and
methodologies referred to by organisations– Responsibility delegated to 7 organisations (NICE,
AHTAPol, REGLOM, IRF, AETSA, ESKI, CVZ)
• Data abstraction per country based on standardiseddata abstraction form– Data abstraction is already performed by the 7 organisations
of SG1– Missing items will be discussed with the countries (targeted
queries/telecon)=joint operation between 7 organisationsand CVZ
– Validation of results during WP5 consultation of report (CVZ)
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
In process (28-09-2010)
Completed (28-09-2010)
Overview of countries included
30 European countries,Canada, US, Australia,New Zealand
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
Some interesting preliminary results
• Reimbursement assessment common foroutpatient pharmaceuticals (80% always,20% sometimes), only 50-60% for inpatientpharmaceuticals;
• Outpatient positive list >90% of countries,inpatient positive list 50%;
• Purpose of assessment is 100%reimbursement, 69% pricing and 23% clinicalguidance
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–20127
SG2&3 (CVZ)
• Rapid model is relevant for countries that assessdirectly after market authorisation– Will only use selected domains/topics from the core model
• Full model is relevant for countries that assessgroups of pharmaceuticals a longer period aftermarket authorisation (indication-based)– Will use most domains/topics from the core model
• Three phases during the construction of the Rapidand the Full REA model:– Phase 1: Develop 1st version of Rapid and Full model
– Phase 2: Pilot test
– Phase 3: Develop final version of Rapid and Full model
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–20128
SG2&3• Authors and reviewers were sought for the different
domains
• Difficulties to find authors and domain leads for somedomains
• Solutions:– Cooperation with WP4 on some domains in order to
decrease duplication;
– Responsibilities for author- and reviewership are sharedfor smaller parts of the domain.
• First results from the domain teams are coming innow at CVZ.
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–20129
• For each subject a guideline will be elaborated1. comparators & comparisons
• criteria for choice of the best comparator(s)/ methods of comparison/direct and indirect comparison
2. outcome• patient relevant outcomes/ clinical outcomes/ surrogate markers/ quality
of life outcomes/ safety/ composite endpoints
3. level of evidence• internal and external validity/ grading confidence in experts and
experience/ extrapolation from efficacy results to real life situation(effectiveness)
• For each subject one organisation is responsible
• For every topic at least one academic expert has anadvisory role.
SG4 (HAS)
16
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012
Example of first conceptguideline ‘Clinical outcomes’
• Prepared by HIQA (National Irish HTA agency)
• Expert involved is Prof A. de Boer (University ofUtrecht, The Netherlands)
• Search Strategy
• Analysis and synthesis
• Conclusion
• Final recommendations
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–201211
Lessons learned from collaborationpractical observations
• Willingness to participate in activities of the differentsubgroups is high;
• Delegation of activities, e.g. in SG1, seems a workableconcept;
• Timelines for completion of activities need to be strict;
• Necessary to redistribute some activities in smallerelements;
• Assistance from Lead and co-Lead partners is sometimesnecessary in order to complete activities.
EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–201212
Lessons learned from collaborationgeneral thoughts
• Active participation of organisations is essential in WP5:– To increase the support of the organisations for the final
products;
– To increase the knowledge input in the different subgroups;
– To increase the knowledge output from the WP to thedifferent involved organisations
– To increase the contact between the different organisations
– To decrease the workload for the Lead and co-Lead partner
• Cooperation between different workpackages isessential