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EU HTA Solutions - IQVIA
Explore IQVIA by region
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Europe
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Regional Thought Leadership
Explore IQVIA by region
As a global community, IQVIA continuously invests and commits to advancing human health.
Americas
Europe
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Regional Thought Leadership
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VIEW ROLESIQVIA EU HTA SOLUTIONS
JCA success with one partner. EU‑wide.
Let’s build your custom solution, for EU HTA success at global, regional and national level.
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Content Ticker
JCA success with one partner. EU-wide.
The implementation of the EU HTA Regulation represents a turning point for health technology assessments (HTA), impacting market access strategies and launch preparations at global, regional and national level.
Tap into IQVIA’s unparalleled combination of expertise and skills, to maximise the benefits of the new Joint Clinical Assessments (JCA) process for your assets. With IQVIA EU HTA Solutions you have one partner by your side to support you on your JCA journey – end-to-end, and EU-wide.
IQVIA EU HTA Solutions
Our experience
480+
European HTA dossiers developed since 2020
Our experience
25+
PICO simulations conducted
Our experience
5+
JCA dossiers underway
Our team
290+
Local on-the-ground market access experts across 17 European countries
OUR TEAM
60+
HTA epidemiologists, statisticians, ITC and health economics specialists
Our publications
25+
Thought Leadership publications on EU HTA since 2024
EU HTA Newsletter
Stay up-to-date on the latest policy news and methodological guidance published, EU Member State preparations for EU HTA, key conferences and more with our quarterly EU HTA Newsletter. Click on the button if you are interested in this offering.
Case studies
Getting ready for EU HTA at global, regional and local level - with IQVIA EU HTA Solutions
JCA readiness at global, regional, and local level
Client need: Guidance to optimize teams, resources, and internal processes ahead of their first Joint Clinical Assessment (JCA) submission in 2025
Solution: Conducted EU HTA readiness assessment and peer benchmarking to identify existing gaps, and co-created comprehensive guidance for the operationalization of JCA together with cross-functional client teams
Results: Established new ways of working at global, regional, and local level, to meet JCA requirements and successfully execute their first Joint Clinical Assessment (JCA) submission
Early scientific advice strategy and execution
Client need: (i) Tool to define optimal approach for early HTA scientific advice (ESA), considering Joint Scientific Consultation (JSC), parallel EMA-JSC advice, and local ESA opportunities; (ii) end-to-end ESA support for pipeline asset
Solution: (i) Developed a decision-making tool based on uncertainty in HTA approach, risk associated with joint/parallel engagement, importance of markets, and timing requirements vs. asset approval timeline; (ii) Used the tool to assess ESA opportunity for target pipeline asset, and supported application, briefing book development, strategic review of advice, and developed recommendations
Results: (i) Playbook to facilitate ESA preparations; (ii) recommendations to refine the pipeline asset’s trial protocol
PICO simulation and evidence strategy
Client need: PICO prediction for two oncology pipeline assets, and strategic recommendations to optimize evidence generation
Solution: Assessed analogues and simulated the scoping process in line with the latest JCA guidance documents to predict likely PICOs; mapped planned evidence generation activities against PICOs to identify any gaps
Results: Asset-specific recommendations for evidence generation strategy, to optimise data package based on the anticipated PICOs
Evidence generation, JCA strategy and dossier
Client need: Development of JCA strategy, JCA dossiers and objection handler for two oncology assets, in addition to indirect treatment comparison (ITC) feasibility assessment and analyses
Solution: Define JCA strategy based on predicted PICOs, evidence package and anticipated label, and draft JCA dossier; assess ITC feasibility, define strategy, and conduct ITC analyses in line with the published JCA guidance; following JCA scope confirmation, finalise the dossiers in line with refined JCA strategy; provide post-submission support and finalise objection handler to aid local HTA communication and submissions
Results: Support currently ongoing
German 'delta' dossier and strategy
Client need: National dossier development for the client’s first two assets eligible for Joint Clinical Assessment (JCA), including strategic advice on relevant analyses for local HTA success and mitigation strategies; recommendation on best practices to incorporate local needs into regional and global JCA preparations
Solution: Planning and development of the ‘delta’ dossiers; strategic recommendations to shape new internal JCA processes to ensure local evidence requirements and dossier preparations are optimally aligned
Results: Support currently ongoing
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