Collaboration in WP5 of EUnetHTA. First experiences. · Collaboration in WP5 of EUnetHTA. First...

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


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


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)


In process (28-09-2010)

Completed (28-09-2010)

Overview of countries included

30 European countries,Canada, US, Australia,New Zealand


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


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


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.


• 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


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


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.


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

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